"","SUBSTANCENAME","NONPROPRIETARYNAME","NDC_11","PHARM_CLASSES","PRODUCTNDC","NDCPACKAGECODE","PRODUCTID","PRODUCTTYPENAME","PROPRIETARYNAME","PROPRIETARYNAMESUFFIX","DOSAGEFORMNAME","ROUTENAME","STARTMARKETINGDATE","ENDMARKETINGDATE","MARKETINGCATEGORYNAME","APPLICATIONNUMBER","LABELERNAME","ACTIVE_NUMERATOR_STRENGTH","ACTIVE_INGRED_UNIT","DEASCHEDULE","NDC_EXCLUDE_FLAG","LISTING_RECORD_CERTIFIED_THROUGH"
"1","Clindamycin","Clindamycin","00409419701","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"2","CefePIME","CefePIME","60505068104","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"3","Azithromycin","Azithromycin","68084027801","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"4","Levofloxacin","Levofloxacin","50458016601","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"5","Levofloxacin","Levofloxacin","50458093010","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"6","Nystatin Cream","Nystatin Cream","51672126302","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"7","MetRONIDAZOLE (FLagyl)","MetRONIDAZOLE (FLagyl)","51079012620","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"8","Clindamycin","Clindamycin","00409405201","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"9","MetroNIDAZOLE","MetroNIDAZOLE","42292000120","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"10","LevoFLOXacin","LevoFLOXacin","68084048211","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"11","Azithromycin","Azithromycin","59762306003","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"12","Azithromycin","Azithromycin","54569452202","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"13","Levofloxacin","Levofloxacin","00904635361","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"14","Doxycycline Hyclate","Doxycycline Hyclate","00069095050","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"15","Amoxicillin-Clavulanic Acid","Amoxicillin-Clavulanic Acid","43598020451","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"16","Miconazole Powder 2%","Miconazole Powder 2%","00145150605","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"17","Ampicillin-Sulbactam","Ampicillin-Sulbactam","63323036920","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"18","Levofloxacin","Levofloxacin","00045152010","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"19","Levofloxacin","Levofloxacin","50458092510","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"20","Levofloxacin","Levofloxacin","50458092010","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"21","Nystatin Oral Suspension","Nystatin Oral Suspension","00472500360","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"22","Sulfameth/Trimethoprim DS","Sulfameth/Trimethoprim DS","68084023001","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"23","CefePIME","CefePIME","60505083404","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"24","Miconazole Powder 2%","Miconazole Powder 2%","00064065001","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"25","Amoxicillin","Amoxicillin","00143993801","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"26","MetRONIDAZOLE (FLagyl)","MetRONIDAZOLE (FLagyl)","68084096601","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"27","Amoxicillin","Amoxicillin","00093310793","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"28","MetroNIDAZOLE","MetroNIDAZOLE","00904145361","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"29","Nystatin Oral Suspension","Nystatin Oral Suspension","66689003750","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"30","Miconazole Powder 2%","Miconazole Powder 2%","11017025030","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"31","Piperacillin-Tazobactam","Piperacillin-Tazobactam","00206885216","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"32","MetRONIDAZOLE (FLagyl)","MetRONIDAZOLE (FLagyl)","51079021720","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"33","Linezolid","Linezolid","00009513503","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"34","Doxycycline Hyclate","Doxycycline Hyclate","63323013011","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"35","Clindamycin","Clindamycin","63739005910","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"36","Fosfomycin Tromethamine","Fosfomycin Tromethamine","00456430001","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"37","Linezolid","Linezolid","00009514001","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"38","Mupirocin Nasal Ointment 2%","Mupirocin Nasal Ointment 2%","00029152611","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"39","Mupirocin Cream 2%","Mupirocin Cream 2%","00029152725","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"40","CefazoLIN","CefazoLIN","00409080601","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"41","Levofloxacin","Levofloxacin","68084048301","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"42","Ampicillin Sodium","Ampicillin Sodium","63323039923","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"43","Minocycline","Minocycline","00591569401","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"44","Sulfameth/Trimethoprim DS","Sulfameth/Trimethoprim DS","49999064990","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"45","Doxycycline Hyclate","Doxycycline Hyclate","50268027815","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"46","Ampicillin","Ampicillin","54868311105","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"47","Piperacillin-Tazobactam","Piperacillin-Tazobactam","00206885516","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"48","Clindamycin","Clindamycin","00409405101","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"49","Nystatin Cream","Nystatin Cream","49999025130","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"50","Levofloxacin","Levofloxacin","00045006801","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"51","Clindamycin","Clindamycin","51079059820","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"52","Voriconazole","Voriconazole","51079016503","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"53","Posaconazole","Posaconazole","00085432402","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"54","Levofloxacin","Levofloxacin","25021013282","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"55","Doxycycline Hyclate","Doxycycline Hyclate","60687011821","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"56","Azithromycin","Azithromycin","25021011210","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"57","Miconazole 2% Cream","Miconazole 2% Cream","51672200102","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"58","Nystatin Ointment","Nystatin Ointment","00168000715","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"59","Levofloxacin","Levofloxacin","00045006601","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"60","Cefpodoxime Proxetil","Cefpodoxime Proxetil","63304052020","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"61","Moxifloxacin","Moxifloxacin","00085173302","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"62","Azithromycin","Azithromycin","00069306086","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"63","Terbinafine 1% Cream","Terbinafine 1% Cream","00067810012","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"64","Miconazole 2% Cream","Miconazole 2% Cream","59390006717","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"65","CefTAZidime","CefTAZidime","00781317796","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"66","Sulfameth/Trimethoprim SS","Sulfameth/Trimethoprim SS","00093008801","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"67","Nystatin Oral Suspension","Nystatin Oral Suspension","00121478505","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"68","Clindamycin","Clindamycin","00009337502","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"69","Levofloxacin","Levofloxacin","25021013283","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"70","Amoxicillin-Clavulanate Susp.","Amoxicillin-Clavulanate Susp.","00029609039","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"71","Miconazole Nitrate Vag Cream 2%","Miconazole Nitrate Vag Cream 2%","00472073041","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"72","Ampicillin-Sulbactam","Ampicillin-Sulbactam","63323036820","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"73","Isoniazid","Isoniazid","51079008320","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"74","Levofloxacin","Levofloxacin","00045152510","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"75","Nystatin Cream","Nystatin Cream","00603781878","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"76","Sulfameth/Trimethoprim Suspension","Sulfameth/Trimethoprim Suspension","00472128416","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"77","Nystatin Cream","Nystatin Cream","00168005430","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"78","MetroNIDAZOLE","MetroNIDAZOLE","00904656861","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"79","Doxycycline Hyclate","Doxycycline Hyclate","52959005500","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"80","Doxycycline Hyclate","Doxycycline Hyclate","00143314250","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"81","Amoxicillin-Clavulanic Acid","Amoxicillin-Clavulanic Acid","00029608031","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"82","Amoxicillin","Amoxicillin","55370088408","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"83","Nystatin","Nystatin","53489040001","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"84","Miconazole Nitrate (Combo Pack)","Miconazole Nitrate (Combo Pack)","00062543001","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"85","Voriconazole","Voriconazole","00049318030","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"86","Voriconazole","Voriconazole","00049317030","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"87","Caspofungin","Caspofungin","00006382310","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"88","Posaconazole Suspension","Posaconazole Suspension","00085132801","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"89","Ambisome","Ambisome","00469305130","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"90","Amoxicillin-Clavulanic Acid","Amoxicillin-Clavulanic Acid","51079026720","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"91","Mupirocin Cream 2%","Mupirocin Cream 2%","00029152722","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"92","Voriconazole","Voriconazole","59762093002","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"93","Voriconazole","Voriconazole","27241006203","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"94","Voriconazole","Voriconazole","00049319028","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"95","CefTAZidime","CefTAZidime","00173037934","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"96","CefTAZidime","CefTAZidime","24987037934","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"97","Nystatin Cream","Nystatin Cream","45802005911","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"98","moxifloxacin","moxifloxacin","00065401303","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"99","Minocycline","Minocycline","00093316501","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"100","Miconazole Powder 2%","Miconazole Powder 2%","37205065318","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"101","Linezolid","Linezolid","60505436203","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"102","Clindamycin","Clindamycin","00009338102","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"103","CefTAZidime","CefTAZidime","24987038237","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"104","Nystatin Oral Suspension","Nystatin Oral Suspension","00121481000","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"105","Amoxicillin-Clavulanate Susp.","Amoxicillin-Clavulanate Susp.","60432006500","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"106","Clindamycin","Clindamycin","47781046570","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"107","AMOXicillin Oral Susp.","AMOXicillin Oral Susp.","49999016850","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"108","Clindamycin 1% Solution","Clindamycin 1% Solution","59762372802","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"109","Nystatin Oral Suspension","Nystatin Oral Suspension","00472132002","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"110","Azithromycin","Azithromycin","00904640506","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"111","MetroNIDAZOLE","MetroNIDAZOLE","60687042401","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"112","Voriconazole","Voriconazole","00378164093","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"113","Nystatin Oral Suspension","Nystatin Oral Suspension","00121481040","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"114","Doxycycline Hyclate","Doxycycline Hyclate","00904043004","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"115","Minocycline","Minocycline","65293001410","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"116","Imipenem-Cilastatin","Imipenem-Cilastatin","00409350701","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"117","CeFAZolin","CeFAZolin","60505074905","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"118","Clindamycin","Clindamycin","00009338202","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"119","Terbinafine 1% Cream","Terbinafine 1% Cream","00067399842","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"120","Ampicillin Sodium","Ampicillin Sodium","63323038910","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"121","Levofloxacin","Levofloxacin","00045006701","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"122","Fosfomycin Tromethamine","Fosfomycin Tromethamine","00456430008","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"123","Miconazole 2% Cream","Miconazole 2% Cream","00168014231","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"124","Levofloxacin","Levofloxacin","00143972124","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"125","Azithromycin","Azithromycin","59762308001","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"126","CefazoLIN","CefazoLIN","00781933895","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"127","MetRONIDAZOLE (FLagyl)","MetRONIDAZOLE (FLagyl)","51079012220","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"128","Amoxicillin-Clavulanic Acid","Amoxicillin-Clavulanic Acid","00029607531","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"129","Levofloxacin","Levofloxacin","25021013281","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"130","Minocycline","Minocycline","00005534323","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"131","Clindamycin 1% Solution","Clindamycin 1% Solution","00472098792","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"132","Anidulafungin","Anidulafungin","00049011528","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"133","Azithromycin","Azithromycin","00781149731","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"134","nitazoxanide","nitazoxanide","67546011114","antiprotozoal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"135","paromomycin","paromomycin","57664017508","antiprotozoal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"136","Nystatin Oral Suspension","Nystatin Oral Suspension","60432053760","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"137","Terbinafine 1% Cream","Terbinafine 1% Cream","51672208001","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"138","Terconazole 0.4% Vag. Cream","Terconazole 0.4% Vag. Cream","51672130406","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"139","Piperacillin-Tazo Graded Challenge","Piperacillin-Tazo Graded Challenge","00206885416","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"140","Isoniazid","Isoniazid","51079008220","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"141","CefTAZidime","CefTAZidime","00173038237","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"142","CefazoLIN","CefazoLIN","60505076900","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"143","terbinafine","terbinafine","00078017905","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"144","Miconazole Nitrate Vag Cream 2%","Miconazole Nitrate Vag Cream 2%","51672203506","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"145","Amoxicillin-Clavulanic Acid","Amoxicillin-Clavulanic Acid","49884029812","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"146","Miconazole 2% Cream","Miconazole 2% Cream","00472073556","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"147","Nystatin Oral Suspension","Nystatin Oral Suspension","51672411704","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"148","MetroNIDAZOLE","MetroNIDAZOLE","51079021620","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"149","Amoxicillin-Clavulanate Susp.","Amoxicillin-Clavulanate Susp.","54868627100","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"150","Doxycycline Hyclate","Doxycycline Hyclate","00904042806","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"151","Piperacillin-Tazobactam","Piperacillin-Tazobactam","00206240802","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"152","Voriconazole","Voriconazole","51079016403","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"153","Miconazole Nitrate (Combo Pack)","Miconazole Nitrate (Combo Pack)","00904541501","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"154","Nystatin","Nystatin","51285053422","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"155","Isoniazid","Isoniazid","00555006602","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"156","cefUROXime axetil","cefUROXime axetil","00173038701","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"157","Terconazole 80mg Vag. Supp","Terconazole 80mg Vag. Supp","00062535101","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"158","Nystatin","Nystatin","65473070509","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"159","Gatifloxacin","Gatifloxacin","54868479700","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"160","Doxycycline Hyclate","Doxycycline Hyclate","00677059802","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"161","CefTAZidime","CefTAZidime","10019069102","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"162","CeFAZolin","CeFAZolin","70092123847","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"163","Cefuroxime Axetil","Cefuroxime Axetil","00173039442","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"164","Amphotericin B","Amphotericin B","39822105505","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"165","Levofloxacin","Levofloxacin","00904635161","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"166","Nystatin Ointment","Nystatin Ointment","45802004835","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"167","Posaconazole","Posaconazole","00085433101","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"168","CeftazIDIME","CeftazIDIME","00173041300","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"169","Mitomycin","Mitomycin","16729010811","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"170","Minocycline","Minocycline","68382031601","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"171","Nystatin Ointment","Nystatin Ointment","00713068615","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"172","Ampicillin","Ampicillin","52959013003","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"173","Ampicillin Sodium","Ampicillin Sodium","63323038810","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"174","LevoFLOXacin","LevoFLOXacin","00904635261","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"175","Ampicillin","Ampicillin","58016103201","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"176","Terconazole 80mg Vag. Supp","Terconazole 80mg Vag. Supp","45802071708","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"177","Doxycycline Hyclate","Doxycycline Hyclate","55390011010","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"178","Mitomycin","Mitomycin","55390025201","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"179","Ampicillin Sodium","Ampicillin Sodium","00015740420","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"180","Terbinafine 1% Soln","Terbinafine 1% Soln","00067400230","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"181","CefePIME","CefePIME","51479005530","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"182","CeftazIDIME","CeftazIDIME","00173041200","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"183","Amoxicillin-Clavulanate Susp.","Amoxicillin-Clavulanate Susp.","60432006575","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"184","Terconazole 0.4% Vag. Cream","Terconazole 0.4% Vag. Cream","00062535001","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"185","Nitazoxanide","Nitazoxanide","67546011132","antiprotozoal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"186","Clindamycin","Clindamycin","00009311602","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"187","Nystatin Powder","Nystatin Powder","00003059320","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"188","Miconazole 2% Cream","Miconazole 2% Cream","00536113428","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"189","CefePIME","CefePIME","51479005420","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"190","Ampicillin","Ampicillin","00904401408","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"191","metroNIDAZOLE Desensitization","metroNIDAZOLE Desensitization","36000000124","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"192","Piperacillin-Tazobactam Na","Piperacillin-Tazobactam Na","00206886201","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"193","Miconazole Powder 2%","Miconazole Powder 2%","11701003816","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"194","Ampicillin Desensitization","Ampicillin Desensitization","00015740320","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"195","amphotericin B (bulk)","amphotericin B (bulk)","38779019104","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"196","Voriconazole","Voriconazole","00904647104","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"197","CeFAZolin","CeFAZolin","00409080501","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"198","cefUROXime axetil","cefUROXime axetil","54868502200","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"199","Amphotericin B Oral Suspension","Amphotericin B Oral Suspension","00003043730","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"200","CefTAZidime","CefTAZidime","00781317895","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"201","Nystatin Oral Suspension","Nystatin Oral Suspension","00168003760","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"202","sulfamethoxazole-trimethoprim","sulfamethoxazole-trimethoprim","00703951401","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"203","CeFAZolin","CeFAZolin","71019003102","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"204","Ampicillin Sodium","Ampicillin Sodium","67457035010","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"205","Voriconazole","Voriconazole","00904659604","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"206","Voriconazole","Voriconazole","00378162693","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"207","Quinupristin/Dalfopristin","Quinupristin/Dalfopristin","00075905110","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"208","Ampicillin-Sulbactam","Ampicillin-Sulbactam","10019063002","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"209","Amoxicillin Oral Susp.","Amoxicillin Oral Susp.","54569009300","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"210","terbinafine HCl","terbinafine HCl","55289005442","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"211","Clindamycin Phosphate","Clindamycin Phosphate","47781046168","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"212","Terbinafine 1% Spray","Terbinafine 1% Spray","00067400101","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"213","Pyrid","Pyrid","00187301330","antiprotozoal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"214","Nystatin Oral Suspension","Nystatin Oral Suspension","66689000802","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"215","Nystatin","Nystatin","54868349200","antifungal",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"216","Ampicillin-Sulbactam","Ampicillin-Sulbactam","10019063101","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"217","Mitomycin","Mitomycin","00015300120","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"218","CefazoLIN","CefazoLIN","66860090203","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"219","Azithromycin","Azithromycin","00069308030","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"220","Ciprofloxacin HCl","Ciprofloxacin HCl","00172531210","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"221","Ciprofloxacin HCl","Ciprofloxacin HCl","00172531110","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"222","Ciprofloxacin","Ciprofloxacin","00703095803","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"223","Ciprofloxacin IV","Ciprofloxacin IV","00409477750","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"224","Ciprofloxacin HCl","Ciprofloxacin HCl","68084006901","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"225","Ciprofloxacin IV","Ciprofloxacin IV","00781323909","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"226","Ciprofloxacin IV","Ciprofloxacin IV","00085174102","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"227","Ciprofloxacin IV","Ciprofloxacin IV","00703095603","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"228","Ciprofloxacin IV","Ciprofloxacin IV","00085175502","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"229","Ciprofloxacin HCl","Ciprofloxacin HCl","55111029209","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"230","Ciprofloxacin IV","Ciprofloxacin IV","00409476586","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"231","Ciprofloxacin","Ciprofloxacin","00409477886","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"232","Ciprofloxacin HCl","Ciprofloxacin HCl","00085177701","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"233","Cipro","Cipro","00065853302","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"234","Ciprofloxacin HCl","Ciprofloxacin HCl","50419077701","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"235","Ciprofloxacin","Ciprofloxacin","36000001101","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"236","CefTRIAXone","CefTRIAXone","60505075304","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"237","CefTRIAXone Graded Challenge","CefTRIAXone Graded Challenge","60505075204","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"238","CeftriaXONE Desensitization","CeftriaXONE Desensitization","00004196401","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"239","CefOTAXime","CefOTAXime","64679098601","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"240","Clarithromycin","Clarithromycin","68774012060","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"241","ERYTHROMYCIN","ERYTHROMYCIN","00074630413","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"242","Erythromyc","Erythromyc","00074636902","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"243","Gentamicin Sulfate","Gentamicin Sulfate","54868410300","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"244","Gentamicin 0.1% Cream","Gentamicin 0.1% Cream","00168007115","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"245","cefOXitin","cefOXitin","60505076005","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"246","*NF* Cefoxitin Sodium","*NF* Cefoxitin Sodium","00006335645","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"247","Cephalexin","Cephalexin","00143989701","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"248","cephalexin","cephalexin","68180012401","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"249","*NF* Moxifloxacin","*NF* Moxifloxacin","00026858231","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"250","Trimethoprim","Trimethoprim","00591557101","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"251","Nitrofurantoin Monohyd (MacroBID)","Nitrofurantoin Monohyd (MacroBID)","51079034820","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"252","nitrofurantoin macrocrystal","nitrofurantoin macrocrystal","54569018100","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"253","Nitrofurantoin Macrocrystal","Nitrofurantoin Macrocrystal","00149071001","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"254","Tetracycline","Tetracycline","23155001701","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"255","Tetracycline HCl","Tetracycline HCl","00555001105","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"256","Penicillin V Potassium","Penicillin V Potassium","67253020110","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"257","Penicillamine","Penicillamine","00037440101","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"258","*NF* Cefuroxime","*NF* Cefuroxime","66860003003","antimicrobial",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA
"259","AZTREONAM","AZTREONAM","00003256016","Monobactam Antibacterial [EPC], Monobactams [CS]","0003-2560","0003-2560-16","0003-2560_48b13667-60b3-4049-b38e-0a73d5e484bf","HUMAN PRESCRIPTION DRUG","AZACTAM","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20100401","","NDA","NDA050580","E.R. Squibb & Sons, L.L.C.","1","g/1","","N","20251231"
"260","AZTREONAM","AZTREONAM","00003257016","Monobactam Antibacterial [EPC], Monobactams [CS]","0003-2570","0003-2570-16","0003-2570_48b13667-60b3-4049-b38e-0a73d5e484bf","HUMAN PRESCRIPTION DRUG","AZACTAM","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20100401","","NDA","NDA050580","E.R. Squibb & Sons, L.L.C.","2","g/1","","N","20251231"
"261","VALGANCICLOVIR HYDROCHLORIDE","valganciclovir","00004003822","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","0004-0038","0004-0038-22","0004-0038_b58c7651-0fc0-4fa3-bbd0-c7cbf9498e10","HUMAN PRESCRIPTION DRUG","Valcyte","","TABLET, FILM COATED","ORAL","20010329","20250930","NDA","NDA021304","Genentech, Inc.","450","mg/1","","N",""
"262","VALGANCICLOVIR HYDROCHLORIDE","valganciclovir hydrochloride","00004003909","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","0004-0039","0004-0039-09","0004-0039_b58c7651-0fc0-4fa3-bbd0-c7cbf9498e10","HUMAN PRESCRIPTION DRUG","Valcyte","","POWDER, FOR SOLUTION","ORAL","20090828","20250930","NDA","NDA022257","Genentech, Inc.","50","mg/mL","","N",""
"263","CILASTATIN SODIUM; IMIPENEM","imipenem and cilastatin sodium","00006351659","Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]","0006-3516","0006-3516-59","0006-3516_33d392a5-db73-4ec7-8a86-a53ac8ae1e52","HUMAN PRESCRIPTION DRUG","PRIMAXIN","IV","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","19851126","","NDA","NDA050587","Merck Sharp & Dohme LLC","500; 500","mg/100mL; mg/100mL","","N","20251231"
"264","CASPOFUNGIN ACETATE","CASPOFUNGIN ACETATE","00006382210","Echinocandin Antifungal [EPC], Lipopeptides [CS]","0006-3822","0006-3822-10","0006-3822_40a77370-57ae-4505-a061-ab919cc85006","HUMAN PRESCRIPTION DRUG","CANCIDAS","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20010126","","NDA","NDA021227","Merck Sharp & Dohme LLC","5","mg/mL","","N","20251231"
"265","ERTAPENEM SODIUM","ertapenem sodium","00006384371","Carbapenems [CS], Penem Antibacterial [EPC]","0006-3843","0006-3843-71","0006-3843_3861a2eb-29b4-4064-a7af-7a1303dd2e7b","HUMAN PRESCRIPTION DRUG","INVANZ","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20011121","","NDA","NDA021337","Merck Sharp & Dohme LLC","1","g/1","","N","20251231"
"266","CILASTATIN; IMIPENEM ANHYDROUS; RELEBACTAM ANHYDROUS","imipenem anhydrous, cilastatin, and relebactam anhydrous","00006385602","Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0006-3856","0006-3856-02","0006-3856_9cefbb0c-33f6-46e6-99eb-42b67f9f8336","HUMAN PRESCRIPTION DRUG","RECARBRIO","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20200106","","NDA","NDA212819","Merck Sharp & Dohme LLC","500; 500; 250","mg/100mL; mg/100mL; mg/100mL","","N","20251231"
"267","TIGECYCLINE","TIGECYCLINE","00008499020","Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]","0008-4990","0008-4990-20","0008-4990_403e6073-a8f7-436f-9541-f39ec0a5a73e","HUMAN PRESCRIPTION DRUG","Tygacil","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20080615","","NDA","NDA021821","Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.","50","mg/5mL","","N","20261231"
"268","TIGECYCLINE","TIGECYCLINE","00008499420","Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]","0008-4994","0008-4994-20","0008-4994_ea730223-414f-4c51-8c91-0935a56a4c01","HUMAN PRESCRIPTION DRUG","Tygacil","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20170208","","NDA","NDA021821","Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.","50","mg/5mL","","N","20261231"
"269","CLINDAMYCIN HYDROCHLORIDE","clindamycin hydrochloride","00009022502","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0009-0225","0009-0225-02","0009-0225_b3058e53-9024-486d-94c3-5f3d7a050729","HUMAN PRESCRIPTION DRUG","Cleocin Hydrochloride","","CAPSULE","ORAL","19700522","","NDA","NDA050162","Pharmacia & Upjohn Company LLC","150","mg/1","","N","20251231"
"270","CLINDAMYCIN HYDROCHLORIDE","clindamycin hydrochloride","00009033102","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0009-0331","0009-0331-02","0009-0331_b3058e53-9024-486d-94c3-5f3d7a050729","HUMAN PRESCRIPTION DRUG","Cleocin Hydrochloride","","CAPSULE","ORAL","19700522","","NDA","NDA050162","Pharmacia & Upjohn Company LLC","75","mg/1","","N","20251231"
"271","CLINDAMYCIN HYDROCHLORIDE","clindamycin hydrochloride","00009039514","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0009-0395","0009-0395-14","0009-0395_b3058e53-9024-486d-94c3-5f3d7a050729","HUMAN PRESCRIPTION DRUG","Cleocin Hydrochloride","","CAPSULE","ORAL","19700522","","NDA","NDA050162","Pharmacia & Upjohn Company LLC","300","mg/1","","N","20251231"
"272","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00009072809","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0009-0728","0009-0728-09","0009-0728_312704b3-5d6e-4bb0-8025-0707faa46a07","HUMAN PRESCRIPTION DRUG","Cleocin Phosphate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19721002","","NDA","NDA050441","Pharmacia & Upjohn Company LLC","150","mg/mL","","N","20261231"
"273","CLINDAMYCIN PALMITATE HYDROCHLORIDE","clindamycin palmitate hydrochloride","00009076004","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0009-0760","0009-0760-04","0009-0760_a8c91741-5b2f-4a9b-a8ad-b49a04b32747","HUMAN PRESCRIPTION DRUG","Cleocin Pediatric","","GRANULE, FOR SOLUTION","ORAL","19860417","","ANDA","ANDA062644","Pharmacia & Upjohn Company LLC","75","mg/5mL","","N","20251231"
"274","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00009077526","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0009-0775","0009-0775-26","0009-0775_312704b3-5d6e-4bb0-8025-0707faa46a07","HUMAN PRESCRIPTION DRUG","Cleocin Phosphate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19721002","","NDA","NDA050441","Pharmacia & Upjohn Company LLC","150","mg/mL","","N","20261231"
"275","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00009087026","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0009-0870","0009-0870-26","0009-0870_312704b3-5d6e-4bb0-8025-0707faa46a07","HUMAN PRESCRIPTION DRUG","Cleocin Phosphate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19721002","","NDA","NDA050441","Pharmacia & Upjohn Company LLC","150","mg/mL","","N","20261231"
"276","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00009090218","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0009-0902","0009-0902-18","0009-0902_312704b3-5d6e-4bb0-8025-0707faa46a07","HUMAN PRESCRIPTION DRUG","Cleocin Phosphate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19721002","","NDA","NDA050441","Pharmacia & Upjohn Company LLC","150","mg/mL","","N","20261231"
"277","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00009305102","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0009-3051","0009-3051-02","0009-3051_9c0a7367-763b-48c3-95b1-173b74c50f4b","HUMAN PRESCRIPTION DRUG","Cleocin Phosphate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20191118","","NDA","NDA050441","Pharmacia & Upjohn Company LLC","150","mg/mL","","N","20261231"
"278","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00009332901","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0009-3329","0009-3329-01","0009-3329_ace3af2a-85d9-410f-8d4e-19f190b1e2ec","HUMAN PRESCRIPTION DRUG","Cleocin T","","LOTION","TOPICAL","19890531","","NDA","NDA050600","Pharmacia & Upjohn Company LLC","10","mg/mL","","N","20251231"
"279","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00009344801","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0009-3448","0009-3448-01","0009-3448_f4a673c4-d52c-4707-ac92-59373839ca6a","HUMAN PRESCRIPTION DRUG","Cleocin","","CREAM","VAGINAL","19920811","","NDA","NDA050680","Pharmacia & Upjohn Company LLC","20","mg/g","","N","20261231"
"280","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00009407304","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0009-4073","0009-4073-04","0009-4073_9c0a7367-763b-48c3-95b1-173b74c50f4b","HUMAN PRESCRIPTION DRUG","Cleocin Phosphate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20191118","","NDA","NDA050441","Pharmacia & Upjohn Company LLC","150","mg/mL","","N","20261231"
"281","LINEZOLID","linezolid","00009499202","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","0009-4992","0009-4992-02","0009-4992_d904a25f-40b7-4ece-a4d5-625a059dd4ff","HUMAN PRESCRIPTION DRUG","Zyvox","","INJECTION, SOLUTION","INTRAVENOUS","20150706","","NDA","NDA021131","Pharmacia & Upjohn Company LLC","600","mg/300mL","","N","20251231"
"282","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00009509506","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0009-5095","0009-5095-06","0009-5095_9c0a7367-763b-48c3-95b1-173b74c50f4b","HUMAN PRESCRIPTION DRUG","Cleocin Phosphate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20191118","","NDA","NDA050441","Pharmacia & Upjohn Company LLC","150","mg/mL","","N","20261231"
"283","LINEZOLID","linezolid","00009513604","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","0009-5136","0009-5136-04","0009-5136_4f8d076c-c77e-42d9-90b3-c0db734b03ab","HUMAN PRESCRIPTION DRUG","Zyvox","","GRANULE, FOR SUSPENSION","ORAL","20000418","","NDA","NDA021132","Pharmacia & Upjohn Company LLC","100","mg/5mL","","N","20251231"
"284","LINEZOLID","linezolid","00009513601","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","0009-5136","0009-5136-01","0009-5136_4f8d076c-c77e-42d9-90b3-c0db734b03ab","HUMAN PRESCRIPTION DRUG","Zyvox","","GRANULE, FOR SUSPENSION","ORAL","20000418","","NDA","NDA021132","Pharmacia & Upjohn Company LLC","100","mg/5mL","","N","20251231"
"285","LINEZOLID","linezolid","00009513704","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","0009-5137","0009-5137-04","0009-5137_4f8d076c-c77e-42d9-90b3-c0db734b03ab","HUMAN PRESCRIPTION DRUG","Zyvox","","INJECTION, SOLUTION","INTRAVENOUS","20000418","","NDA","NDA021131","Pharmacia & Upjohn Company LLC","200","mg/100mL","","N","20251231"
"286","LINEZOLID","linezolid","00009513802","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","0009-5138","0009-5138-02","0009-5138_4f8d076c-c77e-42d9-90b3-c0db734b03ab","HUMAN PRESCRIPTION DRUG","Zyvox","","TABLET, FILM COATED","ORAL","20151012","","NDA","NDA021130","Pharmacia & Upjohn Company LLC","600","mg/1","","N","20251231"
"287","LINEZOLID","linezolid","00009513803","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","0009-5138","0009-5138-03","0009-5138_4f8d076c-c77e-42d9-90b3-c0db734b03ab","HUMAN PRESCRIPTION DRUG","Zyvox","","TABLET, FILM COATED","ORAL","20151012","","NDA","NDA021130","Pharmacia & Upjohn Company LLC","600","mg/1","","N","20251231"
"288","LINEZOLID","linezolid","00009514004","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","0009-5140","0009-5140-04","0009-5140_4f8d076c-c77e-42d9-90b3-c0db734b03ab","HUMAN PRESCRIPTION DRUG","Zyvox","","INJECTION, SOLUTION","INTRAVENOUS","20000418","","NDA","NDA021131","Pharmacia & Upjohn Company LLC","600","mg/300mL","","N","20251231"
"289","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00009766705","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0009-7667","0009-7667-05","0009-7667_d4555fb8-feec-4922-8c72-83819f2a1f6c","HUMAN PRESCRIPTION DRUG","Cleocin","","SUPPOSITORY","VAGINAL","19990813","","NDA","NDA050767","Pharmacia & Upjohn Company LLC","100","mg/1","","N","20261231"
"290","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00009766701","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0009-7667","0009-7667-01","0009-7667_d4555fb8-feec-4922-8c72-83819f2a1f6c","HUMAN PRESCRIPTION DRUG","Cleocin","","SUPPOSITORY","VAGINAL","19990813","","NDA","NDA050767","Pharmacia & Upjohn Company LLC","100","mg/1","","N","20261231"
"291","LINEZOLID","linezolid","00009780702","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","0009-7807","0009-7807-02","0009-7807_89f50eeb-b222-465c-8965-3dd22541a987","HUMAN PRESCRIPTION DRUG","Zyvox","","INJECTION, SOLUTION","INTRAVENOUS","20150218","","NDA","NDA021131","Pharmacia & Upjohn Company LLC","600","mg/300mL","","N","20251231"
"292","GATIFLOXACIN","gatifloxacin","00023361501","Quinolone Antimicrobial [EPC], Quinolones [CS]","0023-3615","0023-3615-01","0023-3615_8ecbdc67-bc68-4437-b99d-9924e25dfe67","HUMAN PRESCRIPTION DRUG","ZYMAXID","","SOLUTION/ DROPS","OPHTHALMIC","20100519","","NDA","NDA022548","Allergan, Inc.","5","mg/mL","","N","20251231"
"293","GATIFLOXACIN","gatifloxacin","00023361525","Quinolone Antimicrobial [EPC], Quinolones [CS]","0023-3615","0023-3615-25","0023-3615_8ecbdc67-bc68-4437-b99d-9924e25dfe67","HUMAN PRESCRIPTION DRUG","ZYMAXID","","SOLUTION/ DROPS","OPHTHALMIC","20100519","","NDA","NDA022548","Allergan, Inc.","5","mg/mL","","N","20251231"
"294","PRIMAQUINE PHOSPHATE","Primaquine Phosphate","00024159601","Antimalarial [EPC]","0024-1596","0024-1596-01","0024-1596_aaaae293-d16c-4f9d-ac48-ce2f0e2181a1","HUMAN PRESCRIPTION DRUG","Primaquine Phosphate","","TABLET, FILM COATED","ORAL","20110415","","NDA","NDA008316","Sanofi-Aventis U.S. LLC","15","mg/1","","N","20261231"
"295","FEXINIDAZOLE","Fexinidazole","00024451224","Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]","0024-4512","0024-4512-24","0024-4512_1b3dbe65-328a-450b-bc3d-0b46d9acd832","HUMAN PRESCRIPTION DRUG","Fexinidazole","","TABLET","ORAL","20210716","","NDA","NDA214429","Sanofi-Aventis U.S. LLC","600","mg/1","","N","20261231"
"296","FEXINIDAZOLE","Fexinidazole","00024451214","Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]","0024-4512","0024-4512-14","0024-4512_1b3dbe65-328a-450b-bc3d-0b46d9acd832","HUMAN PRESCRIPTION DRUG","Fexinidazole","","TABLET","ORAL","20210716","","NDA","NDA214429","Sanofi-Aventis U.S. LLC","600","mg/1","","N","20261231"
"297","METRONIDAZOLE","metronidazole","00025194234","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0025-1942","0025-1942-34","0025-1942_4a7c42e5-284c-4784-b1f1-427b0ea346f1","HUMAN PRESCRIPTION DRUG","Flagyl","","CAPSULE","ORAL","19950503","","NDA","NDA020334","Pfizer Laboratories Div Pfizer Inc","375","mg/1","","N","20251231"
"298","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin sodium and sulbactam sodium","00049001383","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0049-0013","0049-0013-83","0049-0013_6b0299f2-a683-4c8f-bf62-b79d5f652b41","HUMAN PRESCRIPTION DRUG","UNASYN","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19911122","","NDA","NDA050608","Roerig","1; .5","g/1; g/1","","N","20261231"
"299","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin sodium and sulbactam sodium","00049001483","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0049-0014","0049-0014-83","0049-0014_6b0299f2-a683-4c8f-bf62-b79d5f652b41","HUMAN PRESCRIPTION DRUG","UNASYN","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19911122","","NDA","NDA050608","Roerig","2; 1","g/1; g/1","","N","20261231"
"300","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin sodium and sulbactam sodium","00049002428","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0049-0024","0049-0024-28","0049-0024_f96b8c10-d100-47bd-9c4a-3bcce67b1758","HUMAN PRESCRIPTION DRUG","UNASYN","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19911122","","NDA","NDA050608","Roerig","100; 50","mg/mL; mg/mL","","N","20261231"
"301","ANIDULAFUNGIN","anidulafungin","00049011428","Echinocandin Antifungal [EPC], Lipopeptides [CS]","0049-0114","0049-0114-28","0049-0114_de80453f-0b97-4f2b-bb8e-88a19a3f44a2","HUMAN PRESCRIPTION DRUG","ERAXIS","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20060217","","NDA","NDA021632","Roerig","50","mg/15mL","","N","20251231"
"302","ANIDULAFUNGIN","anidulafungin","00049011628","Echinocandin Antifungal [EPC], Lipopeptides [CS]","0049-0116","0049-0116-28","0049-0116_de80453f-0b97-4f2b-bb8e-88a19a3f44a2","HUMAN PRESCRIPTION DRUG","ERAXIS","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20060217","","NDA","NDA021632","Roerig","100","mg/30mL","","N","20251231"
"303","PENICILLIN G POTASSIUM","penicillin G potassium","00049042010","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0049-0420","0049-0420-10","0049-0420_9bbe1112-d804-49de-bdff-245ce94872f6","HUMAN PRESCRIPTION DRUG","Pfizerpen","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAPLEURAL; INTRATHECAL; INTRAVENOUS","20100601","","ANDA","ANDA060657","Roerig","5000000","[iU]/1","","N","20251231"
"304","PENICILLIN G POTASSIUM","penicillin G potassium","00049043020","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0049-0430","0049-0430-20","0049-0430_9bbe1112-d804-49de-bdff-245ce94872f6","HUMAN PRESCRIPTION DRUG","Pfizerpen","","POWDER, FOR SOLUTION","INTRAVENOUS","20100601","","ANDA","ANDA060657","Roerig","20000000","[iU]/1","","N","20251231"
"305","PENICILLIN G POTASSIUM","penicillin G potassium","00049052083","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0049-0520","0049-0520-83","0049-0520_2941d530-6dad-4813-80ac-7af4f5bcfa9a","HUMAN PRESCRIPTION DRUG","Pfizerpen","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAPLEURAL; INTRATHECAL; INTRAVENOUS","20100601","","ANDA","ANDA060657","Roerig","5000000","[iU]/1","","N","20251231"
"306","PENICILLIN G POTASSIUM","penicillin G potassium","00049052022","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0049-0520","0049-0520-22","0049-0520_2941d530-6dad-4813-80ac-7af4f5bcfa9a","HUMAN PRESCRIPTION DRUG","Pfizerpen","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAPLEURAL; INTRATHECAL; INTRAVENOUS","20100601","","ANDA","ANDA060657","Roerig","5000000","[iU]/1","","N","20251231"
"307","PENICILLIN G POTASSIUM","penicillin G potassium","00049053028","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0049-0530","0049-0530-28","0049-0530_0fe9ce5c-e7dc-4526-ab48-6f910e721efd","HUMAN PRESCRIPTION DRUG","Pfizerpen","","POWDER, FOR SOLUTION","INTRAVENOUS","20100601","","ANDA","ANDA060657","Roerig","20000000","[iU]/1","","N","20251231"
"308","PENICILLIN G POTASSIUM","penicillin G potassium","00049053022","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0049-0530","0049-0530-22","0049-0530_0fe9ce5c-e7dc-4526-ab48-6f910e721efd","HUMAN PRESCRIPTION DRUG","Pfizerpen","","POWDER, FOR SOLUTION","INTRAVENOUS","20100601","","ANDA","ANDA060657","Roerig","20000000","[iU]/1","","N","20251231"
"309","ANIDULAFUNGIN","anidulafungin","00049224201","Echinocandin Antifungal [EPC], Lipopeptides [CS]","0049-2242","0049-2242-01","0049-2242_febc29a8-fd4f-40bc-9335-b4e2233ea606","HUMAN PRESCRIPTION DRUG","ERAXIS","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20240220","","NDA","NDA021632","Roerig","100","mg/30mL","","N","20251231"
"310","VORICONAZOLE","voriconazole","00049316044","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0049-3160","0049-3160-44","0049-3160_52ad9cbf-8084-4415-ab3c-d95dcc2105f1","HUMAN PRESCRIPTION DRUG","VFEND","","POWDER, FOR SUSPENSION","ORAL","20030328","","NDA","NDA021630","Roerig","40","mg/mL","","N","20261231"
"311","VORICONAZOLE","Voriconazole","00049319001","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0049-3190","0049-3190-01","0049-3190_090a37ad-7e2c-4a77-8afd-96e3725d8622","HUMAN PRESCRIPTION DRUG","VFEND","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20020524","","NDA","NDA021267","Roerig","10","mg/mL","","N","20261231"
"312","FLUCONAZOLE","fluconazole","00049342041","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0049-3420","0049-3420-41","0049-3420_1baa245b-42c1-448d-9091-179ddff1bff6","HUMAN PRESCRIPTION DRUG","Diflucan","","TABLET","ORAL","19900129","","NDA","NDA019949","Roerig","100","mg/1","","N","20261231"
"313","FLUCONAZOLE","fluconazole","00049342030","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0049-3420","0049-3420-30","0049-3420_1baa245b-42c1-448d-9091-179ddff1bff6","HUMAN PRESCRIPTION DRUG","Diflucan","","TABLET","ORAL","19900129","","NDA","NDA019949","Roerig","100","mg/1","","N","20261231"
"314","FLUCONAZOLE","fluconazole","00049343041","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0049-3430","0049-3430-41","0049-3430_1baa245b-42c1-448d-9091-179ddff1bff6","HUMAN PRESCRIPTION DRUG","Diflucan","","TABLET","ORAL","19900129","20250630","NDA","NDA019949","Roerig","200","mg/1","","N",""
"315","FLUCONAZOLE","fluconazole","00049345019","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0049-3450","0049-3450-19","0049-3450_1baa245b-42c1-448d-9091-179ddff1bff6","HUMAN PRESCRIPTION DRUG","Diflucan","","POWDER, FOR SUSPENSION","ORAL","19931223","","NDA","NDA020090","Roerig","1400","mg/35mL","","N","20261231"
"316","VORICONAZOLE","VORICONAZOLE","00049419001","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0049-4190","0049-4190-01","0049-4190_51667bfe-f28a-43b5-bc16-c30c4f178a39","HUMAN PRESCRIPTION DRUG","VFEND","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20121024","","NDA","NDA021267","Roerig","10","mg/mL","","N","20261231"
"317","MEFLOQUINE HYDROCHLORIDE","mefloquine hydrochloride","00054002511","Antimalarial [EPC]","0054-0025","0054-0025-11","0054-0025_e6ca0066-8671-4719-8707-90b4121cba11","HUMAN PRESCRIPTION DRUG","Mefloquine Hydrochloride","","TABLET","ORAL","20041001","","ANDA","ANDA076523","Hikma Pharmaceuticals USA Inc.","250","mg/1","","N","20251231"
"318","LINEZOLID","linezolid","00054031950","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","0054-0319","0054-0319-50","0054-0319_ea8ff456-80d5-4f40-b397-a25b31a77947","HUMAN PRESCRIPTION DRUG","Linezolid","","POWDER, FOR SUSPENSION","ORAL","20150603","","ANDA","ANDA200068","Hikma Pharmaceuticals USA Inc.","100","mg/5mL","","N","20261231"
"319","POSACONAZOLE","posaconazole","00054044949","Azole Antifungal [EPC], Azoles [CS]","0054-0449","0054-0449-49","0054-0449_de8dabbe-fb1c-4bab-b877-116a146fd75c","HUMAN PRESCRIPTION DRUG","posaconazole","","SUSPENSION","ORAL","20230329","","ANDA","ANDA208773","Hikma Pharmaceuticals USA Inc.","40","mg/mL","","N","20261231"
"320","CLOTRIMAZOLE","Clotrimazole","00054414622","Azole Antifungal [EPC], Azoles [CS]","0054-4146","0054-4146-22","0054-4146_3bba6ec1-cfdc-4758-95d1-6aa9ee7ab963","HUMAN PRESCRIPTION DRUG","Clotrimazole","","LOZENGE","ORAL; TOPICAL","20040729","","ANDA","ANDA076387","Hikma Pharmacuticals USA USA Inc.","10","mg/1","","N","20251231"
"321","CLOTRIMAZOLE","Clotrimazole","00054414623","Azole Antifungal [EPC], Azoles [CS]","0054-4146","0054-4146-23","0054-4146_3bba6ec1-cfdc-4758-95d1-6aa9ee7ab963","HUMAN PRESCRIPTION DRUG","Clotrimazole","","LOZENGE","ORAL; TOPICAL","20040729","","ANDA","ANDA076387","Hikma Pharmacuticals USA USA Inc.","10","mg/1","","N","20251231"
"322","CLOTRIMAZOLE","Clotrimazole","00054814622","Azole Antifungal [EPC], Azoles [CS]","0054-8146","0054-8146-22","0054-8146_3bba6ec1-cfdc-4758-95d1-6aa9ee7ab963","HUMAN PRESCRIPTION DRUG","Clotrimazole","","LOZENGE","ORAL; TOPICAL","20040729","20250731","ANDA","ANDA076387","Hikma Pharmacuticals USA USA Inc.","10","mg/1","","N",""
"323","TERBINAFINE HYDROCHLORIDE","TERBINAFINE HYDROCHLORIDE","00067399830","Allylamine Antifungal [EPC], Allylamine [CS]","0067-3998","0067-3998-30","0067-3998_e5b8a1ab-1fbf-4e14-8244-1695977c6c7b","HUMAN OTC DRUG","Lamisil","AT","CREAM","TOPICAL","20050810","20251130","NDA","NDA020980","Haleon US Holdings LLC","10","mg/g","","N",""
"324","RIFAMPIN","rifampin","00068059701","Rifamycin Antibacterial [EPC], Rifamycins [CS]","0068-0597","0068-0597-01","0068-0597_73a70d16-e9be-48b7-99d1-57ea074ddb9b","HUMAN PRESCRIPTION DRUG","Rifadin IV","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","19890525","20260930","NDA","NDA050627","Sanofi-Aventis U.S. LLC","600","mg/10mL","","N",""
"325","RIFAMPIN","rifampin","00068059901","Rifamycin Antibacterial [EPC], Rifamycins [CS]","0068-0599","0068-0599-01","0068-0599_f19b4575-716b-45b9-9049-c93e624cfb42","HUMAN PRESCRIPTION DRUG","Rifadin IV NOVAPLUS","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20170201","20251031","NDA","NDA050627","Sanofi-Aventis U.S. LLC","600","mg/10mL","","N",""
"326","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","00069040010","Macrolide Antimicrobial [EPC], Macrolides [CS]","0069-0400","0069-0400-10","0069-0400_87b9089f-c9cd-41c9-9358-29f6e4014af6","HUMAN PRESCRIPTION DRUG","Zithromax","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20140307","","NDA","NDA050733","Pfizer Laboratories Div Pfizer Inc","500","mg/5mL","","N","20261231"
"327","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN DIHYDRATE","00069305175","Macrolide Antimicrobial [EPC], Macrolides [CS]","0069-3051","0069-3051-75","0069-3051_d83c58ec-ab7c-4db2-91e0-c5693a178467","HUMAN PRESCRIPTION DRUG","ZITHROMAX","","POWDER, FOR SUSPENSION","ORAL","19940928","","NDA","NDA050693","Pfizer Laboratories Div Pfizer Inc","1","g/1","","N","20261231"
"328","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","00069306075","Macrolide Antimicrobial [EPC], Macrolides [CS]","0069-3060","0069-3060-75","0069-3060_cf87b503-d6d3-4a96-8b55-4422574c7fbf","HUMAN PRESCRIPTION DRUG","Zithromax","","TABLET, FILM COATED","ORAL","19960718","","NDA","NDA050711","Pfizer Laboratories Div Pfizer Inc","250","mg/1","","N","20261231"
"329","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","00069307075","Macrolide Antimicrobial [EPC], Macrolides [CS]","0069-3070","0069-3070-75","0069-3070_cf87b503-d6d3-4a96-8b55-4422574c7fbf","HUMAN PRESCRIPTION DRUG","Zithromax","","TABLET, FILM COATED","ORAL","20020524","","NDA","NDA050784","Pfizer Laboratories Div Pfizer Inc","500","mg/1","","N","20261231"
"330","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","00069307030","Macrolide Antimicrobial [EPC], Macrolides [CS]","0069-3070","0069-3070-30","0069-3070_cf87b503-d6d3-4a96-8b55-4422574c7fbf","HUMAN PRESCRIPTION DRUG","Zithromax","","TABLET, FILM COATED","ORAL","20020524","","NDA","NDA050784","Pfizer Laboratories Div Pfizer Inc","500","mg/1","","N","20261231"
"331","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","00069311019","Macrolide Antimicrobial [EPC], Macrolides [CS]","0069-3110","0069-3110-19","0069-3110_cf87b503-d6d3-4a96-8b55-4422574c7fbf","HUMAN PRESCRIPTION DRUG","Zithromax","","POWDER, FOR SUSPENSION","ORAL","19951019","","NDA","NDA050710","Pfizer Laboratories Div Pfizer Inc","100","mg/5mL","","N","20261231"
"332","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","00069312019","Macrolide Antimicrobial [EPC], Macrolides [CS]","0069-3120","0069-3120-19","0069-3120_cf87b503-d6d3-4a96-8b55-4422574c7fbf","HUMAN PRESCRIPTION DRUG","Zithromax","","POWDER, FOR SUSPENSION","ORAL","19951019","","NDA","NDA050710","Pfizer Laboratories Div Pfizer Inc","200","mg/5mL","","N","20261231"
"333","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","00069313019","Macrolide Antimicrobial [EPC], Macrolides [CS]","0069-3130","0069-3130-19","0069-3130_cf87b503-d6d3-4a96-8b55-4422574c7fbf","HUMAN PRESCRIPTION DRUG","Zithromax","","POWDER, FOR SUSPENSION","ORAL","19951019","","NDA","NDA050710","Pfizer Laboratories Div Pfizer Inc","200","mg/5mL","","N","20261231"
"334","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","00069314019","Macrolide Antimicrobial [EPC], Macrolides [CS]","0069-3140","0069-3140-19","0069-3140_cf87b503-d6d3-4a96-8b55-4422574c7fbf","HUMAN PRESCRIPTION DRUG","Zithromax","","POWDER, FOR SUSPENSION","ORAL","19951019","","NDA","NDA050710","Pfizer Laboratories Div Pfizer Inc","200","mg/5mL","","N","20261231"
"335","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","00069315083","Macrolide Antimicrobial [EPC], Macrolides [CS]","0069-3150","0069-3150-83","0069-3150_b0eb7eb4-90fe-4add-a327-e8be68165a3b","HUMAN PRESCRIPTION DRUG","Zithromax","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","19970130","","NDA","NDA050733","Pfizer Laboratories Div Pfizer Inc","500","mg/5mL","","N","20261231"
"336","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","00069406101","Macrolide Antimicrobial [EPC], Macrolides [CS]","0069-4061","0069-4061-01","0069-4061_cf87b503-d6d3-4a96-8b55-4422574c7fbf","HUMAN PRESCRIPTION DRUG","Zithromax","","TABLET, FILM COATED","ORAL","20190517","","NDA","NDA050711","Pfizer Laboratories Div Pfizer Inc","250","mg/1","","N","20261231"
"337","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","00069406189","Macrolide Antimicrobial [EPC], Macrolides [CS]","0069-4061","0069-4061-89","0069-4061_cf87b503-d6d3-4a96-8b55-4422574c7fbf","HUMAN PRESCRIPTION DRUG","Zithromax","","TABLET, FILM COATED","ORAL","20190517","","NDA","NDA050711","Pfizer Laboratories Div Pfizer Inc","250","mg/1","","N","20261231"
"338","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","00069950001","Macrolide Antimicrobial [EPC], Macrolides [CS]","0069-9500","0069-9500-01","0069-9500_20f4cb9d-a2d0-425c-858e-ba081b6cb033","HUMAN PRESCRIPTION DRUG","Zithromax","","TABLET, FILM COATED","ORAL","20200430","","UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE","","Pfizer Laboratories Div Pfizer Inc","250","mg/1","","N","20251231"
"339","AVIBACTAM; AZTREONAM","aztreonam and avibactam","00074387810","Monobactam Antibacterial [EPC], Monobactams [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0074-3878","0074-3878-10","0074-3878_2f93ac82-b7b6-4237-93b3-9a2f970d25ac","HUMAN PRESCRIPTION DRUG","EMBLAVEO","","POWDER, FOR SOLUTION","INTRAVENOUS","20250207","","NDA","NDA217906","AbbVie Inc.","42.3; 127","mg/mL; mg/mL","","N","20261231"
"340","ARTEMETHER; LUMEFANTRINE","artemether and lumefantrine","00078056845","Antimalarial [EPC], Antimalarial [EPC]","0078-0568","0078-0568-45","0078-0568_3890be50-58ca-4301-91c4-5e8ab19923ad","HUMAN PRESCRIPTION DRUG","COARTEM","","TABLET","ORAL","20090407","","NDA","NDA022268","Novartis Pharmaceuticals Corporation","20; 120","mg/1; mg/1","","N","20261231"
"341","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and dexamethasone","00078077101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0078-0771","0078-0771-01","0078-0771_06ba06c5-1c25-4f68-b1e9-cffcf0409c90","HUMAN PRESCRIPTION DRUG","MAXITROL","","OINTMENT","OPHTHALMIC","19720117","","NDA","NDA050065","Novartis Pharmaceuticals Corporation","1; 3.5; 10000","mg/g; mg/g; [USP'U]/g","","N","20251231"
"342","CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE","ciprofloxacin and dexamethasone","00078079975","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0078-0799","0078-0799-75","0078-0799_ccd4ff25-82eb-44ec-9b4b-0a9cef26cecc","HUMAN PRESCRIPTION DRUG","CIPRODEX","","SUSPENSION/ DROPS","AURICULAR (OTIC)","20030804","","NDA","NDA021537","Novartis Pharmaceuticals Corporation","3; 1","mg/mL; mg/mL","","N","20251231"
"343","TOBRAMYCIN","tobramycin","00078081301","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0078-0813","0078-0813-01","0078-0813_1e5c1a6e-f964-4c28-979c-2f0050889f16","HUMAN PRESCRIPTION DRUG","TOBREX","","OINTMENT","OPHTHALMIC","19810628","","NDA","NDA050555","Novartis Pharmaceuticals Corporation","3","mg/g","","N","20261231"
"344","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin hydrochloride","00078084101","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0078-0841","0078-0841-01","0078-0841_68f86590-69ca-495a-8edf-663ab2b3b68f","HUMAN PRESCRIPTION DRUG","CILOXAN","","OINTMENT","OPHTHALMIC","19980602","","NDA","NDA020369","Novartis Pharmaceuticals Corporation","3","mg/g","","N","20251231"
"345","CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE","ciprofloxacin hydrochloride and hydrocortisone","00078085526","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0078-0855","0078-0855-26","0078-0855_9e49e1c4-271b-4d37-a644-9065cda81ae7","HUMAN PRESCRIPTION DRUG","CIPRO","HC","SUSPENSION/ DROPS","AURICULAR (OTIC)","19990315","","NDA","NDA020805","Novartis Pharmaceuticals Corporation","2; 10","mg/mL; mg/mL","","N","20251231"
"346","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","00078087601","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","0078-0876","0078-0876-01","0078-0876_a2506d86-eb6a-4ed3-86b9-a15cec06299b","HUMAN PRESCRIPTION DRUG","TobraDex","","OINTMENT","OPHTHALMIC","19881015","","NDA","NDA050616","Novartis Pharmaceuticals Corporation","1; 3","mg/g; mg/g","","N","20261231"
"347","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","00078095325","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","0078-0953","0078-0953-25","0078-0953_3b30de62-e2a2-4609-9c58-26cb07135ffc","HUMAN PRESCRIPTION DRUG","TobraDex","","SUSPENSION/ DROPS","OPHTHALMIC","19880915","","NDA","NDA050592","Novartis Pharmaceuticals Corporation","1; 3","mg/mL; mg/mL","","N","20251231"
"348","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","00078095326","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","0078-0953","0078-0953-26","0078-0953_3b30de62-e2a2-4609-9c58-26cb07135ffc","HUMAN PRESCRIPTION DRUG","TobraDex","","SUSPENSION/ DROPS","OPHTHALMIC","19880915","","NDA","NDA050592","Novartis Pharmaceuticals Corporation","1; 3","mg/mL; mg/mL","","N","20251231"
"349","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","00078095340","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","0078-0953","0078-0953-40","0078-0953_3b30de62-e2a2-4609-9c58-26cb07135ffc","HUMAN PRESCRIPTION DRUG","TobraDex","","SUSPENSION/ DROPS","OPHTHALMIC","19880915","","NDA","NDA050592","Novartis Pharmaceuticals Corporation","1; 3","mg/mL; mg/mL","","N","20251231"
"350","POSACONAZOLE","posaconazole","00085222402","Azole Antifungal [EPC], Azoles [CS]","0085-2224","0085-2224-02","0085-2224_5234bc30-748a-4b14-89e8-8ebeafa13457","HUMAN PRESCRIPTION DRUG","NOXAFIL","","POWDER, FOR SUSPENSION","ORAL","20210608","","NDA","NDA214770","Merck Sharp & Dohme LLC","300","mg/1","","N","20251231"
"351","NYSTATIN","Nystatin","00093098301","Polyene Antifungal [EPC], Polyenes [CS]","0093-0983","0093-0983-01","0093-0983_b55205c3-f0be-44eb-a267-3af07c1639f4","HUMAN PRESCRIPTION DRUG","Nystatin","","TABLET, FILM COATED","ORAL","19900930","","ANDA","ANDA062506","Teva Pharmaceuticals USA, Inc.","500000","[USP'U]/1","","N","20251231"
"352","MUPIROCIN","Mupirocin","00093101042","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","0093-1010","0093-1010-42","0093-1010_128ce126-9b57-4b63-b82d-11c02a4a04d8","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20031107","","ANDA","ANDA065085","Teva Pharmaceuticals USA, Inc.","20","mg/g","","N","20261231"
"353","CEFACLOR","Cefaclor","00093108701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-1087","0093-1087-01","0093-1087_61ec00e0-d37d-4aa4-8f50-031ee7a37ecc","HUMAN PRESCRIPTION DRUG","Cefaclor","","TABLET, FILM COATED, EXTENDED RELEASE","ORAL","20020926","","ANDA","ANDA065058","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20251231"
"354","PENICILLIN V POTASSIUM","Penicillin V Potassium","00093117210","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-1172","0093-1172-10","0093-1172_165377dd-4272-4194-9d0b-36d213498f26","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET","ORAL","19900930","","ANDA","ANDA060711","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20251231"
"355","PENICILLIN V POTASSIUM","Penicillin V Potassium","00093117201","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-1172","0093-1172-01","0093-1172_165377dd-4272-4194-9d0b-36d213498f26","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET","ORAL","19900930","","ANDA","ANDA060711","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20251231"
"356","PENICILLIN V POTASSIUM","Penicillin V Potassium","00093117410","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-1174","0093-1174-10","0093-1174_165377dd-4272-4194-9d0b-36d213498f26","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET","ORAL","19900930","","ANDA","ANDA060711","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20251231"
"357","PENICILLIN V POTASSIUM","Penicillin V Potassium","00093117401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-1174","0093-1174-01","0093-1174_165377dd-4272-4194-9d0b-36d213498f26","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET","ORAL","19900930","","ANDA","ANDA060711","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20251231"
"358","NEOMYCIN SULFATE","Neomycin Sulfate","00093117701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0093-1177","0093-1177-01","0093-1177_18e9e5b7-e08c-445e-86bb-90bc0953eda9","HUMAN PRESCRIPTION DRUG","Neomycin Sulfate","","TABLET","ORAL","19900930","","ANDA","ANDA060304","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20251231"
"359","AZITHROMYCIN MONOHYDRATE","Azithromycin","00093202631","Macrolide Antimicrobial [EPC], Macrolides [CS]","0093-2026","0093-2026-31","0093-2026_cce27cc7-6d9a-496a-8989-41323c834241","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20101217","","ANDA","ANDA065246","Teva Pharmaceuticals USA, Inc.","200","mg/5mL","","N","20261231"
"360","AZITHROMYCIN MONOHYDRATE","Azithromycin","00093202694","Macrolide Antimicrobial [EPC], Macrolides [CS]","0093-2026","0093-2026-94","0093-2026_cce27cc7-6d9a-496a-8989-41323c834241","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20101217","","ANDA","ANDA065246","Teva Pharmaceuticals USA, Inc.","200","mg/5mL","","N","20261231"
"361","AZITHROMYCIN MONOHYDRATE","Azithromycin","00093202623","Macrolide Antimicrobial [EPC], Macrolides [CS]","0093-2026","0093-2026-23","0093-2026_cce27cc7-6d9a-496a-8989-41323c834241","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20101217","","ANDA","ANDA065246","Teva Pharmaceuticals USA, Inc.","200","mg/5mL","","N","20261231"
"362","AZITHROMYCIN MONOHYDRATE","Azithromycin","00093202723","Macrolide Antimicrobial [EPC], Macrolides [CS]","0093-2027","0093-2027-23","0093-2027_cce27cc7-6d9a-496a-8989-41323c834241","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20101228","","ANDA","ANDA065246","Teva Pharmaceuticals USA, Inc.","100","mg/5mL","","N","20261231"
"363","CEPHALEXIN","Cephalexin","00093223801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-2238","0093-2238-01","0093-2238_b9fd9556-6e88-4abc-bedf-666953d32d6e","HUMAN PRESCRIPTION DRUG","Cephalexin","","TABLET","ORAL","19900930","","ANDA","ANDA063023","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20251231"
"364","CEPHALEXIN","Cephalexin","00093224001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-2240","0093-2240-01","0093-2240_b9fd9556-6e88-4abc-bedf-666953d32d6e","HUMAN PRESCRIPTION DRUG","Cephalexin","","TABLET","ORAL","19900930","","ANDA","ANDA063024","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20251231"
"365","AMOXICILLIN","Amoxicillin","00093226301","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-2263","0093-2263-01","0093-2263_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20001121","","ANDA","ANDA065056","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20261231"
"366","AMOXICILLIN","Amoxicillin","00093226401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-2264","0093-2264-01","0093-2264_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20000926","","ANDA","ANDA065056","Teva Pharmaceuticals USA, Inc.","875","mg/1","","N","20261231"
"367","AMOXICILLIN","Amoxicillin","00093226701","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-2267","0093-2267-01","0093-2267_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","19951001","","ANDA","ANDA064013","Teva Pharmaceuticals USA, Inc.","125","mg/1","","N","20261231"
"368","AMOXICILLIN","Amoxicillin","00093226801","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-2268","0093-2268-01","0093-2268_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","19930101","","ANDA","ANDA064013","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20261231"
"369","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00093227434","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0093-2274","0093-2274-34","0093-2274_c1a60ec7-6569-4874-806c-96f984886f92","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065101","Teva Pharmaceuticals USA, Inc.","500; 125","mg/1; mg/1","","N","20261231"
"370","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00093227534","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0093-2275","0093-2275-34","0093-2275_c1a60ec7-6569-4874-806c-96f984886f92","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065096","Teva Pharmaceuticals USA, Inc.","875; 125","mg/1; mg/1","","N","20261231"
"371","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00093227773","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0093-2277","0093-2277-73","0093-2277_c1a60ec7-6569-4874-806c-96f984886f92","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20050113","","ANDA","ANDA065089","Teva Pharmaceuticals USA, Inc.","200; 28.5","mg/5mL; mg/5mL","","N","20261231"
"372","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00093227973","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0093-2279","0093-2279-73","0093-2279_c1a60ec7-6569-4874-806c-96f984886f92","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20050113","","ANDA","ANDA065089","Teva Pharmaceuticals USA, Inc.","400; 57","mg/5mL; mg/5mL","","N","20261231"
"373","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","00093240101","Antimalarial [EPC], Antirheumatic Agent [EPC]","0093-2401","0093-2401-01","0093-2401_0ed011f2-0881-4bd1-ab62-1cd84a48ed52","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20201008","","ANDA","ANDA040081","Teva Pharmaceuticals USA, Inc.","200","mg/1","","N","20251231"
"374","QUININE SULFATE","Quinine Sulfate","00093300256","Antimalarial [EPC]","0093-3002","0093-3002-56","0093-3002_5a590f9a-a5ae-4c4a-9c0f-8742e7cceca2","HUMAN PRESCRIPTION DRUG","Quinine Sulfate","","CAPSULE","ORAL","20120928","","ANDA","ANDA091661","Teva Pharmaceuticals USA, Inc.","324","mg/1","","N","20251231"
"375","AMOXICILLIN","Amoxicillin","00093310705","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-3107","0093-3107-05","0093-3107_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20261231"
"376","AMOXICILLIN","Amoxicillin","00093310701","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-3107","0093-3107-01","0093-3107_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20261231"
"377","AMOXICILLIN","Amoxicillin","00093310905","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-3109","0093-3109-05","0093-3109_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20261231"
"378","AMOXICILLIN","Amoxicillin","00093310953","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-3109","0093-3109-53","0093-3109_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20261231"
"379","AMOXICILLIN","Amoxicillin","00093310901","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-3109","0093-3109-01","0093-3109_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20261231"
"380","AMOXICILLIN","Amoxicillin","00093310906","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-3109","0093-3109-06","0093-3109_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20261231"
"381","DICLOXACILLIN SODIUM","Dicloxacillin Sodium","00093312301","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-3123","0093-3123-01","0093-3123_1976304d-7c32-40f7-9724-0d1903dad50e","HUMAN PRESCRIPTION DRUG","Dicloxacillin Sodium","","CAPSULE","ORAL","19900930","","ANDA","ANDA062286","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20251231"
"382","DICLOXACILLIN SODIUM","Dicloxacillin Sodium","00093312501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-3125","0093-3125-01","0093-3125_1976304d-7c32-40f7-9724-0d1903dad50e","HUMAN PRESCRIPTION DRUG","Dicloxacillin Sodium","","CAPSULE","ORAL","19900930","","ANDA","ANDA062286","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20251231"
"383","CEPHALEXIN","Cephalexin","00093314505","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-3145","0093-3145-05","0093-3145_c75c0bb6-fe3e-43c6-bdde-edd904731795","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20251231"
"384","CEPHALEXIN","Cephalexin","00093314501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-3145","0093-3145-01","0093-3145_c75c0bb6-fe3e-43c6-bdde-edd904731795","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20251231"
"385","CEPHALEXIN","Cephalexin","00093314701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-3147","0093-3147-01","0093-3147_c75c0bb6-fe3e-43c6-bdde-edd904731795","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20251231"
"386","CEPHALEXIN","Cephalexin","00093314705","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-3147","0093-3147-05","0093-3147_c75c0bb6-fe3e-43c6-bdde-edd904731795","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20251231"
"387","CEFDINIR","Cefdinir","00093316006","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-3160","0093-3160-06","0093-3160_588d0980-34a4-45b5-a1ca-a16ed3faa2be","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20070509","","ANDA","ANDA065368","Teva Pharmaceuticals USA, Inc.","300","mg/1","","N","20251231"
"388","CEFADROXIL","Cefadroxil","00093319653","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-3196","0093-3196-53","0093-3196_86b8951f-3699-4888-9eeb-7bbda995ec35","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070131","","ANDA","ANDA065282","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20261231"
"389","CEFADROXIL","Cefadroxil","00093319601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-3196","0093-3196-01","0093-3196_86b8951f-3699-4888-9eeb-7bbda995ec35","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070131","","ANDA","ANDA065282","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20261231"
"390","KETOCONAZOLE","Ketoconazole","00093321930","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","0093-3219","0093-3219-30","0093-3219_3027539e-261c-4ac2-a25d-c41fcce3da0f","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20190208","","ANDA","ANDA075581","Teva Pharmaceuticals USA, Inc.","20","mg/g","","N","20251231"
"391","KETOCONAZOLE","Ketoconazole","00093321992","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","0093-3219","0093-3219-92","0093-3219_3027539e-261c-4ac2-a25d-c41fcce3da0f","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20190208","","ANDA","ANDA075581","Teva Pharmaceuticals USA, Inc.","20","mg/g","","N","20251231"
"392","KETOCONAZOLE","Ketoconazole","00093321915","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","0093-3219","0093-3219-15","0093-3219_3027539e-261c-4ac2-a25d-c41fcce3da0f","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20190208","","ANDA","ANDA075581","Teva Pharmaceuticals USA, Inc.","20","mg/g","","N","20251231"
"393","TOBRAMYCIN","Tobramycin","00093375063","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0093-3750","0093-3750-63","0093-3750_907adb67-d97f-4128-8d69-ca22a5b4ccc9","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","RESPIRATORY (INHALATION)","20200915","","ANDA","ANDA210915","Teva Pharmaceuticals USA, Inc.","300","mg/4mL","","N","20261231"
"394","TOBRAMYCIN","Tobramycin","00093375028","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0093-3750","0093-3750-28","0093-3750_907adb67-d97f-4128-8d69-ca22a5b4ccc9","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","RESPIRATORY (INHALATION)","20200915","","ANDA","ANDA210915","Teva Pharmaceuticals USA, Inc.","300","mg/4mL","","N","20261231"
"395","CEFADROXIL","Cefadroxil","00093405953","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-4059","0093-4059-53","0093-4059_980978a7-5c16-4350-add2-dd7c88ecb91b","HUMAN PRESCRIPTION DRUG","Cefadroxil","","TABLET","ORAL","20070131","","ANDA","ANDA062774","Teva Pharmaceuticals USA, Inc.","1000","mg/1","","N","20261231"
"396","TOBRAMYCIN","Tobramycin","00093408563","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0093-4085","0093-4085-63","0093-4085_f42ab3e7-da6a-435e-987f-f99b1dc649f0","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","RESPIRATORY (INHALATION)","20131119","20260731","ANDA","ANDA091589","Teva Pharmaceuticals USA, Inc.","300","mg/5mL","","N",""
"397","PENICILLIN V POTASSIUM","Penicillin V Potassium","00093412573","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-4125","0093-4125-73","0093-4125_165377dd-4272-4194-9d0b-36d213498f26","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","POWDER, FOR SOLUTION","ORAL","19900930","","ANDA","ANDA060456","Teva Pharmaceuticals USA, Inc.","125","mg/5mL","","N","20251231"
"398","PENICILLIN V POTASSIUM","Penicillin V Potassium","00093412574","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-4125","0093-4125-74","0093-4125_165377dd-4272-4194-9d0b-36d213498f26","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","POWDER, FOR SOLUTION","ORAL","19900930","","ANDA","ANDA060456","Teva Pharmaceuticals USA, Inc.","125","mg/5mL","","N","20251231"
"399","PENICILLIN V POTASSIUM","Penicillin V Potassium","00093412774","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-4127","0093-4127-74","0093-4127_165377dd-4272-4194-9d0b-36d213498f26","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","POWDER, FOR SOLUTION","ORAL","19900930","","ANDA","ANDA060456","Teva Pharmaceuticals USA, Inc.","250","mg/5mL","","N","20251231"
"400","PENICILLIN V POTASSIUM","Penicillin V Potassium","00093412773","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-4127","0093-4127-73","0093-4127_165377dd-4272-4194-9d0b-36d213498f26","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","POWDER, FOR SOLUTION","ORAL","19900930","","ANDA","ANDA060456","Teva Pharmaceuticals USA, Inc.","250","mg/5mL","","N","20251231"
"401","CEFDINIR MONOHYDRATE","Cefdinir","00093413664","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-4136","0093-4136-64","0093-4136_7f269e55-b085-4315-807a-e425f0189b2c","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070508","","ANDA","ANDA065332","Teva Pharmaceuticals USA, Inc.","125","mg/5mL","","N","20251231"
"402","CEFDINIR MONOHYDRATE","Cefdinir","00093413673","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-4136","0093-4136-73","0093-4136_7f269e55-b085-4315-807a-e425f0189b2c","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070508","","ANDA","ANDA065332","Teva Pharmaceuticals USA, Inc.","125","mg/5mL","","N","20251231"
"403","CEFDINIR MONOHYDRATE","Cefdinir","00093413773","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-4137","0093-4137-73","0093-4137_7f269e55-b085-4315-807a-e425f0189b2c","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070508","","ANDA","ANDA065332","Teva Pharmaceuticals USA, Inc.","250","mg/5mL","","N","20251231"
"404","CEFDINIR MONOHYDRATE","Cefdinir","00093413764","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-4137","0093-4137-64","0093-4137_7f269e55-b085-4315-807a-e425f0189b2c","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070508","","ANDA","ANDA065332","Teva Pharmaceuticals USA, Inc.","250","mg/5mL","","N","20251231"
"405","AMOXICILLIN","Amoxicillin","00093415573","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-4155","0093-4155-73","0093-4155_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA061931","Teva Pharmaceuticals USA, Inc.","250","mg/5mL","","N","20261231"
"406","AMOXICILLIN","Amoxicillin","00093415579","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-4155","0093-4155-79","0093-4155_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA061931","Teva Pharmaceuticals USA, Inc.","250","mg/5mL","","N","20261231"
"407","AMOXICILLIN","Amoxicillin","00093415580","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-4155","0093-4155-80","0093-4155_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA061931","Teva Pharmaceuticals USA, Inc.","250","mg/5mL","","N","20261231"
"408","AMOXICILLIN","Amoxicillin","00093416076","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-4160","0093-4160-76","0093-4160_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20030402","","ANDA","ANDA065119","Teva Pharmaceuticals USA, Inc.","200","mg/5mL","","N","20261231"
"409","AMOXICILLIN","Amoxicillin","00093416078","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-4160","0093-4160-78","0093-4160_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20030402","","ANDA","ANDA065119","Teva Pharmaceuticals USA, Inc.","200","mg/5mL","","N","20261231"
"410","AMOXICILLIN","Amoxicillin","00093416073","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-4160","0093-4160-73","0093-4160_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20030402","","ANDA","ANDA065119","Teva Pharmaceuticals USA, Inc.","200","mg/5mL","","N","20261231"
"411","AMOXICILLIN","Amoxicillin","00093416173","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-4161","0093-4161-73","0093-4161_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20030226","","ANDA","ANDA065119","Teva Pharmaceuticals USA, Inc.","400","mg/5mL","","N","20261231"
"412","AMOXICILLIN","Amoxicillin","00093416176","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-4161","0093-4161-76","0093-4161_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20030226","","ANDA","ANDA065119","Teva Pharmaceuticals USA, Inc.","400","mg/5mL","","N","20261231"
"413","AMOXICILLIN","Amoxicillin","00093416178","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0093-4161","0093-4161-78","0093-4161_cbedd906-24b6-4a83-875d-3b9e81cf3e46","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20030226","","ANDA","ANDA065119","Teva Pharmaceuticals USA, Inc.","400","mg/5mL","","N","20261231"
"414","CEPHALEXIN","Cephalexin","00093417574","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-4175","0093-4175-74","0093-4175_c75c0bb6-fe3e-43c6-bdde-edd904731795","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA062703","Teva Pharmaceuticals USA, Inc.","125","mg/5mL","","N","20251231"
"415","CEPHALEXIN","Cephalexin","00093417573","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-4175","0093-4175-73","0093-4175_c75c0bb6-fe3e-43c6-bdde-edd904731795","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA062703","Teva Pharmaceuticals USA, Inc.","125","mg/5mL","","N","20251231"
"416","CEPHALEXIN","Cephalexin","00093417773","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-4177","0093-4177-73","0093-4177_c75c0bb6-fe3e-43c6-bdde-edd904731795","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA062703","Teva Pharmaceuticals USA, Inc.","250","mg/5mL","","N","20251231"
"417","CEPHALEXIN","Cephalexin","00093417774","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0093-4177","0093-4177-74","0093-4177_c75c0bb6-fe3e-43c6-bdde-edd904731795","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA062703","Teva Pharmaceuticals USA, Inc.","250","mg/5mL","","N","20251231"
"418","ERYTHROMYCIN","Erythromycin","00093557101","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","0093-5571","0093-5571-01","0093-5571_f750327c-00a6-48d0-9a87-b5b0af53a3c3","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20210504","","ANDA","ANDA214549","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20261231"
"419","ERYTHROMYCIN","Erythromycin","00093557156","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","0093-5571","0093-5571-56","0093-5571_f750327c-00a6-48d0-9a87-b5b0af53a3c3","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20210504","","ANDA","ANDA214549","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20261231"
"420","ERYTHROMYCIN","Erythromycin","00093557256","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","0093-5572","0093-5572-56","0093-5572_f750327c-00a6-48d0-9a87-b5b0af53a3c3","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20210504","","ANDA","ANDA214549","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20261231"
"421","ERYTHROMYCIN","Erythromycin","00093557201","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","0093-5572","0093-5572-01","0093-5572_f750327c-00a6-48d0-9a87-b5b0af53a3c3","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20210504","","ANDA","ANDA214549","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20261231"
"422","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00093867575","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0093-8675","0093-8675-75","0093-8675_828d1326-e294-4a09-a172-217d53d73ba1","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20040923","","ANDA","ANDA065162","Teva Pharmaceuticals USA, Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"423","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00093867578","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0093-8675","0093-8675-78","0093-8675_828d1326-e294-4a09-a172-217d53d73ba1","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20040923","","ANDA","ANDA065162","Teva Pharmaceuticals USA, Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"424","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00093867574","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0093-8675","0093-8675-74","0093-8675_828d1326-e294-4a09-a172-217d53d73ba1","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20040923","","ANDA","ANDA065162","Teva Pharmaceuticals USA, Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"425","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","00113008464","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0113-0084","0113-0084-64","0113-0084_a877132e-2b0b-4326-9601-2bb46d3d5789","HUMAN OTC DRUG","Good Sense First Aid Antibiotic","","OINTMENT","TOPICAL","20140428","","OTC MONOGRAPH DRUG","M004","L. Perrigo Company","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"426","MICONAZOLE NITRATE","Miconazole nitrate","00113021429","Azole Antifungal [EPC], Azoles [CS]","0113-0214","0113-0214-29","0113-0214_94cc97a6-7075-4e80-86de-71b32d366186","HUMAN OTC DRUG","Good Sense Miconazole 7","","CREAM","VAGINAL","19990730","","ANDA","ANDA074760","L Perrigo Company","2","g/100g","","N","20251231"
"427","TIOCONAZOLE","Tioconazole","00113042654","Azole Antifungal [EPC], Azoles [CS]","0113-0426","0113-0426-54","0113-0426_d8396310-fd7a-46be-b31c-41f0006605f2","HUMAN OTC DRUG","good sense tioconazole 1","","OINTMENT","VAGINAL","20191022","","ANDA","ANDA075915","L. Perrigo Company","6.5","g/100g","","N","20251231"
"428","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl","00113067964","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0113-0679","0113-0679-64","0113-0679_116157d3-f5e6-4b68-81b4-0c81695c4470","HUMAN OTC DRUG","Good Sense Triple Antibiotic","and Pain Relief","OINTMENT","TOPICAL","20060214","","OTC MONOGRAPH DRUG","M004","L. Perrigo Company","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"429","MICONAZOLE NITRATE","Miconazole nitrate","00113082529","Azole Antifungal [EPC], Azoles [CS]","0113-0825","0113-0825-29","0113-0825_684d5988-5cf7-45ca-9918-612c7de46fce","HUMAN OTC DRUG","good sense miconazole 7","","CREAM","VAGINAL","20000222","","ANDA","ANDA074760","L. Perrigo Company","2","g/100g","","N","20251231"
"430","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl","00113114058","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0113-1140","0113-1140-58","0113-1140_823c049f-e712-48ac-aad0-45dea248c08d","HUMAN OTC DRUG","good sense triple antibiotic","","OINTMENT","TOPICAL","20181229","","OTC MONOGRAPH DRUG","M004","L. Perrigo Company","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"431","NITROFURANTOIN","Nitrofurantoin Macrocrystals","00115164303","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","0115-1643","0115-1643-03","0115-1643_fa122415-d787-4019-85f0-3602f1892e8d","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Macrocrystals","","CAPSULE","ORAL","20070308","","ANDA","ANDA073671","Amneal Pharmaceuticals of New York LLC","50","mg/1","","N","20251231"
"432","NITROFURANTOIN","Nitrofurantoin Macrocrystals","00115164301","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","0115-1643","0115-1643-01","0115-1643_fa122415-d787-4019-85f0-3602f1892e8d","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Macrocrystals","","CAPSULE","ORAL","20070308","","ANDA","ANDA073671","Amneal Pharmaceuticals of New York LLC","50","mg/1","","N","20251231"
"433","NITROFURANTOIN","Nitrofurantoin Macrocrystals","00115164501","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","0115-1645","0115-1645-01","0115-1645_fa122415-d787-4019-85f0-3602f1892e8d","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Macrocrystals","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","Amneal Pharmaceuticals of New York LLC","100","mg/1","","N","20251231"
"434","NITROFURANTOIN","Nitrofurantoin Macrocrystals","00115164503","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","0115-1645","0115-1645-03","0115-1645_fa122415-d787-4019-85f0-3602f1892e8d","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Macrocrystals","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","Amneal Pharmaceuticals of New York LLC","100","mg/1","","N","20251231"
"435","CHLOROQUINE PHOSPHATE","CHLOROQUINE PHOSPHATE","00115701001","Antimalarial [EPC]","0115-7010","0115-7010-01","0115-7010_e1a40cca-a829-4aab-a1e3-3971db2746d9","HUMAN PRESCRIPTION DRUG","Chloroquine Phosphate","","TABLET","ORAL","20220510","","ANDA","ANDA040516","Amneal Pharmaceuticals of New York LLC","500","mg/1","","N","20251231"
"436","CHLOROQUINE PHOSPHATE","CHLOROQUINE PHOSPHATE","00115701002","Antimalarial [EPC]","0115-7010","0115-7010-02","0115-7010_e1a40cca-a829-4aab-a1e3-3971db2746d9","HUMAN PRESCRIPTION DRUG","Chloroquine Phosphate","","TABLET","ORAL","20220510","","ANDA","ANDA040516","Amneal Pharmaceuticals of New York LLC","500","mg/1","","N","20251231"
"437","CHLOROQUINE PHOSPHATE","CHLOROQUINE PHOSPHATE","00115701009","Antimalarial [EPC]","0115-7010","0115-7010-09","0115-7010_e1a40cca-a829-4aab-a1e3-3971db2746d9","HUMAN PRESCRIPTION DRUG","Chloroquine Phosphate","","TABLET","ORAL","20220510","","ANDA","ANDA040516","Amneal Pharmaceuticals of New York LLC","500","mg/1","","N","20251231"
"438","NYSTATIN","NYSTATIN","00121081016","Polyene Antifungal [EPC], Polyenes [CS]","0121-0810","0121-0810-16","0121-0810_d57cde69-0eb9-180d-e053-2995a90a33aa","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20160201","","ANDA","ANDA203621","Pharmaceutical Associates, Inc.","100000","[USP'U]/mL","","N","20251231"
"439","NYSTATIN","NYSTATIN","00121081002","Polyene Antifungal [EPC], Polyenes [CS]","0121-0810","0121-0810-02","0121-0810_d57cde69-0eb9-180d-e053-2995a90a33aa","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20160201","","ANDA","ANDA203621","Pharmaceutical Associates, Inc.","100000","[USP'U]/mL","","N","20251231"
"440","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","00121085320","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","0121-0853","0121-0853-20","0121-0853_533790e4-bcfb-447d-9665-0457f3c10c2a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20240805","","NDA","NDA018615","PAI Holdings, LLC dba PAI Pharma","200; 40","mg/5mL; mg/5mL","","N","20251231"
"441","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","00121085416","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","0121-0854","0121-0854-16","0121-0854_a13ce54e-96e8-437a-b4f7-0af852a5a10a","HUMAN PRESCRIPTION DRUG","SULFATRIM","","SUSPENSION","ORAL","19830703","","NDA","NDA018615","PAI Holdings, LLC dba PAI Pharma","200; 40","mg/5mL; mg/5mL","","N","20261231"
"442","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00121086720","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0121-0867","0121-0867-20","0121-0867_53ce51b4-57fa-4449-9481-b931926dc778","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190725","20250731","ANDA","ANDA210729","PAI Holdings, LLC dba PAI Pharma","125","mg/1","","N",""
"443","NYSTATIN","NYSTATIN","00121086802","Polyene Antifungal [EPC], Polyenes [CS]","0121-0868","0121-0868-02","0121-0868_15a142a2-4bb9-444e-8b22-73acf9f91f3b","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20200717","","ANDA","ANDA203621","PAI Holdings, LLC dba PAI Pharma","100000","[USP'U]/mL","","N","20251231"
"444","NYSTATIN","NYSTATIN","00121086816","Polyene Antifungal [EPC], Polyenes [CS]","0121-0868","0121-0868-16","0121-0868_15a142a2-4bb9-444e-8b22-73acf9f91f3b","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20200717","","ANDA","ANDA203621","PAI Holdings, LLC dba PAI Pharma","100000","[USP'U]/mL","","N","20251231"
"445","NYSTATIN","NYSTATIN","00121086800","Polyene Antifungal [EPC], Polyenes [CS]","0121-0868","0121-0868-00","0121-0868_15a142a2-4bb9-444e-8b22-73acf9f91f3b","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20200717","","ANDA","ANDA203621","PAI Holdings, LLC dba PAI Pharma","100000","[USP'U]/mL","","N","20251231"
"446","NYSTATIN","NYSTATIN","00121086850","Polyene Antifungal [EPC], Polyenes [CS]","0121-0868","0121-0868-50","0121-0868_15a142a2-4bb9-444e-8b22-73acf9f91f3b","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20200717","","ANDA","ANDA203621","PAI Holdings, LLC dba PAI Pharma","100000","[USP'U]/mL","","N","20251231"
"447","ATOVAQUONE","Atovaquone","00121095608","Antimalarial [EPC], Antiprotozoal [EPC]","0121-0956","0121-0956-08","0121-0956_3dd9fcd8-8f05-43cb-a095-756f191f703d","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20250404","","ANDA","ANDA214272","PAI Holdings, LLC dba PAI Pharma","750","mg/5mL","","N","20261231"
"448","CEFOTETAN DISODIUM","Cefotetan","00121097610","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0121-0976","0121-0976-10","0121-0976_7e29cb53-c401-49b0-9b47-209601f7ec55","HUMAN PRESCRIPTION DRUG","Cefotan","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240408","","NDA","NDA050588","PAI Holdings, LLC dba PAI Pharma","1","g/10mL","","N","20251231"
"449","CEFOTETAN DISODIUM","Cefotetan","00121097710","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0121-0977","0121-0977-10","0121-0977_7e29cb53-c401-49b0-9b47-209601f7ec55","HUMAN PRESCRIPTION DRUG","Cefotan","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240408","","NDA","NDA050588","PAI Holdings, LLC dba PAI Pharma","2","g/20mL","","N","20251231"
"450","ATOVAQUONE","Atovaquone","00121101618","Antimalarial [EPC], Antiprotozoal [EPC]","0121-1016","0121-1016-18","0121-1016_bf3b7146-b08f-4e14-836b-f385f1e53797","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20240110","","ANDA","ANDA214272","PAI Holdings, LLC","750","mg/5mL","","N","20251231"
"451","ATOVAQUONE","Atovaquone","00121101642","Antimalarial [EPC], Antiprotozoal [EPC]","0121-1016","0121-1016-42","0121-1016_bf3b7146-b08f-4e14-836b-f385f1e53797","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20240110","","ANDA","ANDA214272","PAI Holdings, LLC","750","mg/5mL","","N","20251231"
"452","NYSTATIN","NYSTATIN","00121104516","Polyene Antifungal [EPC], Polyenes [CS]","0121-1045","0121-1045-16","0121-1045_4901e044-ed1c-4f55-add3-c33e1399f91a","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20240621","","ANDA","ANDA203621","PAI Holdings, LLC dba PAI Pharma","100000","[USP'U]/mL","","N","20251231"
"453","ATOVAQUONE","Atovaquone","00121179620","Antimalarial [EPC], Antiprotozoal [EPC]","0121-1796","0121-1796-20","0121-1796_0a0c94aa-fc6f-4966-8b21-51f7acdc1e4b","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20181011","","ANDA","ANDA210692","PAI Holdings, LLC dba PAI Pharma","1500","mg/10mL","","N","20261231"
"454","NITROFURANTOIN","Nitrofurantoin Oral Suspension","00121199695","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","0121-1996","0121-1996-95","0121-1996_8aa7b4ad-452d-45e7-9d8f-a18e5bcda347","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Oral Suspension","","SUSPENSION","ORAL","20240610","","ANDA","ANDA201355","PAI Holdings, LLC dba PAI Pharma","25","mg/5mL","","N","20251231"
"455","NYSTATIN","NYSTATIN","00121481050","Polyene Antifungal [EPC], Polyenes [CS]","0121-4810","0121-4810-50","0121-4810_d57cde69-0eb9-180d-e053-2995a90a33aa","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20160201","","ANDA","ANDA203621","Pharmaceutical Associates, Inc.","100000","[USP'U]/mL","","N","20251231"
"456","GENTAMICIN SULFATE","Gentamicin","00143912825","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0143-9128","0143-9128-25","0143-9128_9908273d-c700-4036-82fe-312f25a8aacd","HUMAN PRESCRIPTION DRUG","Gentamicin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220215","","ANDA","ANDA062251","Hikma Pharmaceuticals USA Inc.","40","mg/mL","","N","20251231"
"457","GENTAMICIN SULFATE","Gentamicin","00143912910","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0143-9129","0143-9129-10","0143-9129_9908273d-c700-4036-82fe-312f25a8aacd","HUMAN PRESCRIPTION DRUG","Gentamicin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220215","","ANDA","ANDA062251","Hikma Pharmaceuticals USA Inc.","40","mg/mL","","N","20251231"
"458","CEFAZOLIN SODIUM","Cefazolin","00143913925","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9139","0143-9139-25","0143-9139_e32063de-96fe-4fb4-9176-5a9d6dc4a722","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20230301","","NDA","NDA216109","Hikma Pharmaceuticals USA Inc.","2","g/1","","N","20261231"
"459","CEFAZOLIN SODIUM","Cefazolin","00143914025","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9140","0143-9140-25","0143-9140_e32063de-96fe-4fb4-9176-5a9d6dc4a722","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20230301","","NDA","NDA216109","Hikma Pharmaceuticals USA Inc.","3","g/1","","N","20261231"
"460","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","00143915210","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0143-9152","0143-9152-10","0143-9152_5c3580ce-c509-4ab6-9238-85503c609119","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230717","","ANDA","ANDA217489","Hikma Pharmaceuticals USA Inc.","1.25","g/1","","N","20261231"
"461","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","00143915310","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0143-9153","0143-9153-10","0143-9153_5c3580ce-c509-4ab6-9238-85503c609119","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230717","","ANDA","ANDA217489","Hikma Pharmaceuticals USA Inc.","1.5","g/1","","N","20261231"
"462","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","00143916125","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0143-9161","0143-9161-25","0143-9161_6a8f1747-4c6e-4686-9484-fbd003cd3af9","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS; ORAL","20230202","","NDA","NDA210274","HIKMA PHARMACEUTICALS USA INC.","513","mg/mg","","N","20251231"
"463","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","00143916110","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0143-9161","0143-9161-10","0143-9161_6a8f1747-4c6e-4686-9484-fbd003cd3af9","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS; ORAL","20230202","","NDA","NDA210274","HIKMA PHARMACEUTICALS USA INC.","513","mg/mg","","N","20251231"
"464","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","00143916210","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0143-9162","0143-9162-10","0143-9162_6a8f1747-4c6e-4686-9484-fbd003cd3af9","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS; ORAL","20230202","","NDA","NDA210274","HIKMA PHARMACEUTICALS USA INC.","1025","mg/mg","","N","20251231"
"465","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","00143916301","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0143-9163","0143-9163-01","0143-9163_0e6d2908-b33a-4f3e-a283-e8e1a2d38e5f","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS; ORAL","20230203","","NDA","NDA210274","HIKMA PHARMACEUTICALS USA INC.","5.13","g/g","","N","20251231"
"466","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","00143916401","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0143-9164","0143-9164-01","0143-9164_0e6d2908-b33a-4f3e-a283-e8e1a2d38e5f","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS; ORAL","20230202","","NDA","NDA210274","HIKMA PHARMACEUTICALS USA INC.","10.25","g/g","","N","20251231"
"467","RIFAMPIN","Rifampin","00143923001","Rifamycin Antibacterial [EPC], Rifamycins [CS]","0143-9230","0143-9230-01","0143-9230_1a816eb9-6de4-4751-831b-d183254f36af","HUMAN PRESCRIPTION DRUG","Rifampin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20160303","","ANDA","ANDA205039","Hikma Pharmaceuticals USA Inc.","600","mg/1","","N","20251231"
"468","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00143924920","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0143-9249","0143-9249-20","0143-9249_d41b7ed4-156c-4053-909f-3a7de73d691e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","Hikma Pharmaceuticals USA Inc.","875; 125","mg/1; mg/1","","N","20261231"
"469","CEFAZOLIN SODIUM","Cefazolin","00143926110","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9261","0143-9261-10","0143-9261_644b4431-ccac-49d7-b378-5f39b2c7f767","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20041018","","ANDA","ANDA065143","Hikma Pharmaceuticals USA Inc.","10","g/1","","N","20251231"
"470","CEFAZOLIN SODIUM","Cefazolin","00143926225","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9262","0143-9262-25","0143-9262_c87f21f8-8e28-4a36-afdb-8af226a54339","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20010918","","ANDA","ANDA065047","Hikma Pharmaceuticals USA Inc.","330","mg/mL","","N","20251231"
"471","CLINDAMYCIN","Clindamycin in percent Dextrose","00143926701","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0143-9267","0143-9267-01","0143-9267_0dbb7c39-4e79-4a6a-9f25-d4920b2e6562","HUMAN PRESCRIPTION DRUG","Clindamycin in 5 percent Dextrose","","INJECTION, SOLUTION","INTRAVENOUS","20240612","","ANDA","ANDA214401","Hikma Pharmaceuticals USA Inc.","6","mg/mL","","N","20251231"
"472","CLINDAMYCIN","Clindamycin in 5 percent Dextrose","00143926801","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0143-9268","0143-9268-01","0143-9268_0dbb7c39-4e79-4a6a-9f25-d4920b2e6562","HUMAN PRESCRIPTION DRUG","Clindamycin in 5 percent Dextrose","","INJECTION, SOLUTION","INTRAVENOUS","20240612","","ANDA","ANDA214401","Hikma Pharmaceuticals USA Inc.","12","mg/mL","","N","20251231"
"473","CLINDAMYCIN","Clindamycin in 5 percent Dextrose","00143926901","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0143-9269","0143-9269-01","0143-9269_0dbb7c39-4e79-4a6a-9f25-d4920b2e6562","HUMAN PRESCRIPTION DRUG","Clindamycin in 5 percent Dextrose","","INJECTION, SOLUTION","INTRAVENOUS","20240612","","ANDA","ANDA214401","Hikma Pharmaceuticals USA Inc.","18","mg/mL","","N","20251231"
"474","AMOXICILLIN","Amoxicillin","00143928501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9285","0143-9285-01","0143-9285_a4cd19b3-f938-4afe-9409-3bdea10deb63","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, COATED","ORAL","20060329","","ANDA","ANDA065255","Hikma Pharmaceuticals USA Inc.","875","mg/1","","N","20251231"
"475","AMOXICILLIN","Amoxicillin","00143928520","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9285","0143-9285-20","0143-9285_a4cd19b3-f938-4afe-9409-3bdea10deb63","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, COATED","ORAL","20060329","","ANDA","ANDA065255","Hikma Pharmaceuticals USA Inc.","875","mg/1","","N","20251231"
"476","GANCICLOVIR SODIUM","Ganciclovir sodium","00143929910","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","0143-9299","0143-9299-10","0143-9299_192fd7cc-3a38-4afe-82f3-a4d89238b1ad","HUMAN PRESCRIPTION DRUG","Ganciclovir","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210617","","ANDA","ANDA076222","Hikma Pharmaceuticals USA Inc.","50","mg/mL","","N","20261231"
"477","VANCOMYCIN","Vancomycin Hydrochloride","00143935510","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0143-9355","0143-9355-10","0143-9355_e298d434-6e7e-4a46-9744-a098386a89d6","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20181003","","ANDA","ANDA206616","Hikma Pharmaceuticals USA Inc.","750","mg/1","","N","20251231"
"478","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","00143935625","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0143-9356","0143-9356-25","0143-9356_431d7445-e798-40a7-a8aa-6a8b1ac5813f","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200811","","ANDA","ANDA203300","Hikma Pharmaceuticals USA Inc.","500","mg/1","","N","20251231"
"479","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","00143935710","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0143-9357","0143-9357-10","0143-9357_431d7445-e798-40a7-a8aa-6a8b1ac5813f","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200811","","ANDA","ANDA203300","Hikma Pharmaceuticals USA Inc.","1","g/1","","N","20251231"
"480","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","00143935801","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0143-9358","0143-9358-01","0143-9358_fcd91c44-1388-4e34-8078-678c1a640c9c","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20181015","","ANDA","ANDA204360","Hikma Pharmaceuticals USA Inc.","5","g/1","","N","20251231"
"481","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","00143935901","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0143-9359","0143-9359-01","0143-9359_fcd91c44-1388-4e34-8078-678c1a640c9c","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20181015","","ANDA","ANDA204360","Hikma Pharmaceuticals USA Inc.","10","g/1","","N","20251231"
"482","MICAFUNGIN","Micafungin sodium","00143936101","Echinocandin Antifungal [EPC], Lipopeptides [CS]","0143-9361","0143-9361-01","0143-9361_0e475355-4342-49bb-be84-da2178a1130f","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210709","","ANDA","ANDA213261","Hikma Pharmaceuticals USA Inc.","50","mg/1","","N","20251231"
"483","MICAFUNGIN","Micafungin sodium","00143936201","Echinocandin Antifungal [EPC], Lipopeptides [CS]","0143-9362","0143-9362-01","0143-9362_0e475355-4342-49bb-be84-da2178a1130f","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210709","","ANDA","ANDA213261","Hikma Pharmaceuticals USA Inc.","100","mg/1","","N","20251231"
"484","DAPTOMYCIN","Daptomycin","00143937801","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","0143-9378","0143-9378-01","0143-9378_806f1a3f-9c54-4a7d-9749-9e7348b5409b","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200101","","ANDA","ANDA212022","Hikma Pharmaceuticals USA Inc.","500","mg/10mL","","N","20251231"
"485","ERTAPENEM SODIUM","ertapenem sodium","00143939810","Carbapenems [CS], Penem Antibacterial [EPC]","0143-9398","0143-9398-10","0143-9398_0563c487-5b62-46fe-a7e3-8ade454f1f4f","HUMAN PRESCRIPTION DRUG","ertapenem sodium","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20210802","","ANDA","ANDA208790","Hikma Pharmaceuticals USA, Inc.","1","g/1","","N","20251231"
"486","ERTAPENEM SODIUM","ertapenem sodium","00143942910","Carbapenems [CS], Penem Antibacterial [EPC]","0143-9429","0143-9429-10","0143-9429_e50b4c3f-e5c3-45c2-b3a6-d0e87d996109","HUMAN PRESCRIPTION DRUG","Ertapenem","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20250228","","ANDA","ANDA218067","Hikma Pharmaceuticals USA Inc.","1","g/1","","N","20251231"
"487","MEROPENEM","Meropenem","00143943010","Carbapenems [CS], Penem Antibacterial [EPC]","0143-9430","0143-9430-10","0143-9430_9f2a2947-434c-4f43-aef4-b914cd862815","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20240901","","ANDA","ANDA216424","Hikma Pharmaceuticals USA Inc.","500","mg/20mL","","N","20261231"
"488","MEROPENEM","Meropenem","00143943110","Carbapenems [CS], Penem Antibacterial [EPC]","0143-9431","0143-9431-10","0143-9431_9f2a2947-434c-4f43-aef4-b914cd862815","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20240901","","ANDA","ANDA216424","Hikma Pharmaceuticals USA Inc.","1","g/30mL","","N","20261231"
"489","LINEZOLID","Linezolid","00143953410","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","0143-9534","0143-9534-10","0143-9534_0bd016ef-acc0-41fd-8c2a-e14c94cb3f01","HUMAN PRESCRIPTION DRUG","Linezolid","","INJECTION, SOLUTION","INTRAVENOUS","20221227","","ANDA","ANDA206454","Hikma Pharmaceuticals USA Inc.","600","mg/300mL","","N","20251231"
"490","CEFUROXIME SODIUM","Cefuroxime","00143956725","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9567","0143-9567-25","0143-9567_e43d5edd-fd78-43d3-b8d2-4b22b7541042","HUMAN PRESCRIPTION DRUG","Cefuroxime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20040109","","ANDA","ANDA065048","Hikma Pharmaceuticals USA Inc.","1.5","g/1","","N","20251231"
"491","CEFUROXIME SODIUM","Cefuroxime","00143956825","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9568","0143-9568-25","0143-9568_e43d5edd-fd78-43d3-b8d2-4b22b7541042","HUMAN PRESCRIPTION DRUG","Cefuroxime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20040109","","ANDA","ANDA065048","Hikma Pharmaceuticals USA Inc.","750","mg/1","","N","20251231"
"492","CEFUROXIME SODIUM","Cefuroxime","00143956910","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9569","0143-9569-10","0143-9569_a44c47cd-1104-4275-b859-d7ed2af78b8e","HUMAN PRESCRIPTION DRUG","Cefuroxime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20040109","","ANDA","ANDA065046","Hikma Pharmaceuticals USA Inc.","7.5","g/1","","N","20251231"
"493","CEFAZOLIN SODIUM","Cefazolin","00143966510","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9665","0143-9665-10","0143-9665_a1fc6bdd-6f1b-402f-9e84-b6e5ed5febb4","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20041018","","ANDA","ANDA065143","Hikma Pharmaceuticals USA Inc.","20","g/1","","N","20251231"
"494","FLUCONAZOLE","Fluconazole","00143966606","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0143-9666","0143-9666-06","0143-9666_a90257a3-d842-4990-81a5-614293e23119","HUMAN PRESCRIPTION DRUG","Fluconazole","","INJECTION","INTRAVENOUS","20120130","","ANDA","ANDA078764","Hikma Pharmaceuticals USA Inc.","2","mg/mL","","N","20251231"
"495","FLUCONAZOLE","Fluconazole","00143966706","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0143-9667","0143-9667-06","0143-9667_a90257a3-d842-4990-81a5-614293e23119","HUMAN PRESCRIPTION DRUG","Fluconazole","","INJECTION","INTRAVENOUS","20120130","","ANDA","ANDA078764","Hikma Pharmaceuticals USA Inc.","2","mg/mL","","N","20251231"
"496","FLUCONAZOLE","Fluconazole","00143966810","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0143-9668","0143-9668-10","0143-9668_a90257a3-d842-4990-81a5-614293e23119","HUMAN PRESCRIPTION DRUG","Fluconazole","","INJECTION","INTRAVENOUS","20120130","","ANDA","ANDA078698","Hikma Pharmaceuticals USA Inc.","2","mg/mL","","N","20251231"
"497","FLUCONAZOLE","Fluconazole","00143966910","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0143-9669","0143-9669-10","0143-9669_a90257a3-d842-4990-81a5-614293e23119","HUMAN PRESCRIPTION DRUG","Fluconazole","","INJECTION","INTRAVENOUS","20120130","","ANDA","ANDA078698","Hikma Pharmaceuticals USA Inc.","2","mg/mL","","N","20251231"
"498","CEFOTETAN","Cefotetan","00143967010","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9670","0143-9670-10","0143-9670_239c7e32-be35-41ea-b466-2e15d3339398","HUMAN PRESCRIPTION DRUG","Cefotetan","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20111026","","ANDA","ANDA091031","Hikma Pharmaceuticals USA Inc.","1","g/1","","N","20251231"
"499","CEFOTETAN","Cefotetan","00143967110","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9671","0143-9671-10","0143-9671_239c7e32-be35-41ea-b466-2e15d3339398","HUMAN PRESCRIPTION DRUG","Cefotetan","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20111026","","ANDA","ANDA091031","Hikma Pharmaceuticals USA Inc.","2","g/1","","N","20251231"
"500","CEFTRIAXONE SODIUM","Ceftriaxone","00143967801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9678","0143-9678-01","0143-9678_e9f12b84-2885-442d-b53c-0fd5a9946d38","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20171004","","ANDA","ANDA090701","Hikma Pharmaceuticals USA Inc.","10","g/1","","N","20251231"
"501","PENICILLIN V POTASSIUM","Penicillin V Potassium","00143983610","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9836","0143-9836-10","0143-9836_dd8905b6-bf91-4624-bad7-ad27b01f8113","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","Hikma Pharmaceuticals USA Inc.","500","mg/1","","N","20251231"
"502","PENICILLIN V POTASSIUM","Penicillin V Potassium","00143983601","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9836","0143-9836-01","0143-9836_dd8905b6-bf91-4624-bad7-ad27b01f8113","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","Hikma Pharmaceuticals USA Inc.","500","mg/1","","N","20251231"
"503","PENICILLIN V POTASSIUM","Penicillin V Potassium","00143983701","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9837","0143-9837-01","0143-9837_dd8905b6-bf91-4624-bad7-ad27b01f8113","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","Hikma Pharmaceuticals USA Inc.","250","mg/1","","N","20251231"
"504","PENICILLIN V POTASSIUM","Penicillin V Potassium","00143983710","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9837","0143-9837-10","0143-9837_dd8905b6-bf91-4624-bad7-ad27b01f8113","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","Hikma Pharmaceuticals USA Inc.","250","mg/1","","N","20251231"
"505","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00143985316","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0143-9853","0143-9853-16","0143-9853_45f95702-3be8-47a5-8de8-3b17457aa04a","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","SUSPENSION","ORAL","20090803","","ANDA","ANDA065373","Hikma Pharmaceuticals USA Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"506","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00143985375","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0143-9853","0143-9853-75","0143-9853_45f95702-3be8-47a5-8de8-3b17457aa04a","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","SUSPENSION","ORAL","20090803","","ANDA","ANDA065373","Hikma Pharmaceuticals USA Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"507","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00143985324","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0143-9853","0143-9853-24","0143-9853_45f95702-3be8-47a5-8de8-3b17457aa04a","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","SUSPENSION","ORAL","20090803","","ANDA","ANDA065373","Hikma Pharmaceuticals USA Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"508","CEFTRIAXONE SODIUM","Ceftriaxone","00143985625","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9856","0143-9856-25","0143-9856_ff2e929e-05bc-4771-9af4-53b52acfd5bc","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20080110","","ANDA","ANDA065342","Hikma Pharmaceuticals USA Inc.","2","g/1","","N","20251231"
"509","CEFTRIAXONE SODIUM","Ceftriaxone","00143985725","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9857","0143-9857-25","0143-9857_ff2e929e-05bc-4771-9af4-53b52acfd5bc","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20080110","","ANDA","ANDA065342","Hikma Pharmaceuticals USA Inc.","1","g/1","","N","20251231"
"510","CEFTRIAXONE SODIUM","Ceftriaxone","00143985825","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9858","0143-9858-25","0143-9858_ff2e929e-05bc-4771-9af4-53b52acfd5bc","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20080110","","ANDA","ANDA065342","Hikma Pharmaceuticals USA Inc.","500","mg/1","","N","20251231"
"511","CEFTRIAXONE SODIUM","ceftriaxone","00143985925","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9859","0143-9859-25","0143-9859_ff2e929e-05bc-4771-9af4-53b52acfd5bc","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20080110","","ANDA","ANDA065342","Hikma Pharmaceuticals USA Inc.","250","mg/1","","N","20251231"
"512","CEFOXITIN SODIUM","Cefoxitin","00143987610","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9876","0143-9876-10","0143-9876_3de36693-e566-4f2a-b9fe-8b777b275fa4","HUMAN PRESCRIPTION DRUG","Cefoxitin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20100226","","ANDA","ANDA065239","Hikma Pharmaceuticals USA Inc.","10","g/1","","N","20261231"
"513","CEFOXITIN SODIUM","Cefoxitin","00143987725","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9877","0143-9877-25","0143-9877_4638263b-1c03-4a32-ba82-70270cf42490","HUMAN PRESCRIPTION DRUG","Cefoxitin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20100312","","ANDA","ANDA065238","Hikma Pharmaceuticals USA Inc.","2","g/1","","N","20251231"
"514","CEFOXITIN SODIUM","Cefoxitin","00143987825","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9878","0143-9878-25","0143-9878_4638263b-1c03-4a32-ba82-70270cf42490","HUMAN PRESCRIPTION DRUG","Cefoxitin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20100312","","ANDA","ANDA065238","Hikma Pharmaceuticals USA Inc.","1","g/1","","N","20251231"
"515","AMOXICILLIN","Amoxicillin","00143988601","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9886","0143-9886-01","0143-9886_606474e1-adba-4ffa-83d5-6565fc12c892","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065325","Hikma Pharmaceuticals USA Inc.","200","mg/5mL","","N","20251231"
"516","AMOXICILLIN","Amoxicillin","00143988675","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9886","0143-9886-75","0143-9886_606474e1-adba-4ffa-83d5-6565fc12c892","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065325","Hikma Pharmaceuticals USA Inc.","200","mg/5mL","","N","20251231"
"517","AMOXICILLIN","Amoxicillin","00143988650","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9886","0143-9886-50","0143-9886_606474e1-adba-4ffa-83d5-6565fc12c892","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065325","Hikma Pharmaceuticals USA Inc.","200","mg/5mL","","N","20251231"
"518","AMOXICILLIN","Amoxicillin","00143988701","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9887","0143-9887-01","0143-9887_606474e1-adba-4ffa-83d5-6565fc12c892","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065325","Hikma Pharmaceuticals USA Inc.","400","mg/5mL","","N","20251231"
"519","AMOXICILLIN","Amoxicillin","00143988750","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9887","0143-9887-50","0143-9887_606474e1-adba-4ffa-83d5-6565fc12c892","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065325","Hikma Pharmaceuticals USA Inc.","400","mg/5mL","","N","20251231"
"520","AMOXICILLIN","Amoxicillin","00143988775","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9887","0143-9887-75","0143-9887_606474e1-adba-4ffa-83d5-6565fc12c892","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065325","Hikma Pharmaceuticals USA Inc.","400","mg/5mL","","N","20251231"
"521","AMOXICILLIN","Amoxicillin","00143988815","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9888","0143-9888-15","0143-9888_c2fa2c99-c735-4834-a8a5-04a30da8a002","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","Hikma Pharmaceuticals USA Inc.","125","mg/5mL","","N","20251231"
"522","AMOXICILLIN","Amoxicillin","00143988880","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9888","0143-9888-80","0143-9888_c2fa2c99-c735-4834-a8a5-04a30da8a002","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","Hikma Pharmaceuticals USA Inc.","125","mg/5mL","","N","20251231"
"523","AMOXICILLIN","Amoxicillin","00143988801","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9888","0143-9888-01","0143-9888_c2fa2c99-c735-4834-a8a5-04a30da8a002","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","Hikma Pharmaceuticals USA Inc.","125","mg/5mL","","N","20251231"
"524","AMOXICILLIN","Amoxicillin","00143988980","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9889","0143-9889-80","0143-9889_c2fa2c99-c735-4834-a8a5-04a30da8a002","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","Hikma Pharmaceuticals USA Inc.","250","mg/5mL","","N","20251231"
"525","AMOXICILLIN","Amoxicillin","00143988901","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9889","0143-9889-01","0143-9889_c2fa2c99-c735-4834-a8a5-04a30da8a002","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","Hikma Pharmaceuticals USA Inc.","250","mg/5mL","","N","20251231"
"526","AMOXICILLIN","Amoxicillin","00143988915","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9889","0143-9889-15","0143-9889_c2fa2c99-c735-4834-a8a5-04a30da8a002","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","Hikma Pharmaceuticals USA Inc.","250","mg/5mL","","N","20251231"
"527","FLUCONAZOLE","Fluconazole","00143989991","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0143-9899","0143-9899-91","0143-9899_a90257a3-d842-4990-81a5-614293e23119","HUMAN PRESCRIPTION DRUG","Fluconazole","","INJECTION","INTRAVENOUS","20050823","","ANDA","ANDA076736","Hikma Pharmaceuticals USA Inc.","2","mg/mL","","N","20251231"
"528","CEFAZOLIN SODIUM","Cefazolin","00143992390","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9923","0143-9923-90","0143-9923_a4e97132-f711-404f-93b8-8ee5e4254c96","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20010918","","ANDA","ANDA065047","Hikma Pharmaceuticals USA Inc.","225","mg/mL","","N","20251231"
"529","CEFAZOLIN SODIUM","Cefazolin","00143992490","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9924","0143-9924-90","0143-9924_a4e97132-f711-404f-93b8-8ee5e4254c96","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20010918","","ANDA","ANDA065047","Hikma Pharmaceuticals USA Inc.","330","mg/mL","","N","20251231"
"530","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","00143992705","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0143-9927","0143-9927-05","0143-9927_570d11c9-d12f-47fd-be83-37fa26d1262f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Hikma Pharmaceuticals USA Inc.","250","mg/1","","N","20251231"
"531","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","00143992730","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0143-9927","0143-9927-30","0143-9927_570d11c9-d12f-47fd-be83-37fa26d1262f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Hikma Pharmaceuticals USA Inc.","250","mg/1","","N","20251231"
"532","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","00143992701","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0143-9927","0143-9927-01","0143-9927_570d11c9-d12f-47fd-be83-37fa26d1262f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Hikma Pharmaceuticals USA Inc.","250","mg/1","","N","20251231"
"533","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","00143992830","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0143-9928","0143-9928-30","0143-9928_570d11c9-d12f-47fd-be83-37fa26d1262f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Hikma Pharmaceuticals USA Inc.","500","mg/1","","N","20251231"
"534","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","00143992801","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0143-9928","0143-9928-01","0143-9928_570d11c9-d12f-47fd-be83-37fa26d1262f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Hikma Pharmaceuticals USA Inc.","500","mg/1","","N","20251231"
"535","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","00143992805","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0143-9928","0143-9928-05","0143-9928_570d11c9-d12f-47fd-be83-37fa26d1262f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Hikma Pharmaceuticals USA Inc.","500","mg/1","","N","20251231"
"536","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","00143992901","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0143-9929","0143-9929-01","0143-9929_570d11c9-d12f-47fd-be83-37fa26d1262f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Hikma Pharmaceuticals USA Inc.","750","mg/1","","N","20251231"
"537","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","00143992950","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0143-9929","0143-9929-50","0143-9929_570d11c9-d12f-47fd-be83-37fa26d1262f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Hikma Pharmaceuticals USA Inc.","750","mg/1","","N","20251231"
"538","CEFOTAXIME SODIUM","Cefotaxime","00143993010","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9930","0143-9930-10","0143-9930_7e0897ec-2275-4438-9cc5-4c951e52ad97","HUMAN PRESCRIPTION DRUG","Cefotaxime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20021120","","ANDA","ANDA065072","Hikma Pharmaceuticals USA Inc.","500","mg/1","","N","20251231"
"539","CEFOTAXIME SODIUM","Cefotaxime","00143993125","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9931","0143-9931-25","0143-9931_7e0897ec-2275-4438-9cc5-4c951e52ad97","HUMAN PRESCRIPTION DRUG","Cefotaxime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20021120","","ANDA","ANDA065072","Hikma Pharmaceuticals USA Inc.","1","g/1","","N","20251231"
"540","CEFOTAXIME SODIUM","Cefotaxime","00143993325","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9933","0143-9933-25","0143-9933_7e0897ec-2275-4438-9cc5-4c951e52ad97","HUMAN PRESCRIPTION DRUG","Cefotaxime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20021120","","ANDA","ANDA065072","Hikma Pharmaceuticals USA Inc.","2","g/1","","N","20251231"
"541","CEFOTAXIME SODIUM","Cefotaxime","00143993501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9935","0143-9935-01","0143-9935_e25af43f-54cb-4526-a8a5-6bef0a7939c7","HUMAN PRESCRIPTION DRUG","Cefotaxime","","INJECTION","INTRAVENOUS","20021120","","ANDA","ANDA065071","Hikma Pharmaceuticals USA Inc.","10","g/1","","N","20251231"
"542","AMOXICILLIN","Amoxicillin","00143993905","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0143-9939","0143-9939-05","0143-9939_55c7e3ab-5fc7-4d3a-b6ae-f04e33ff11f1","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20070301","","ANDA","ANDA065291","Hikma Pharmaceuticals USA Inc.","500","mg/1","","N","20251231"
"543","POLYMYXIN B SULFATE","Polymyxin B sulfate","00143994110","Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0143-9941","0143-9941-10","0143-9941_dc529b6b-bbf4-44da-a829-f506c41d47f6","HUMAN PRESCRIPTION DRUG","Polymyxin B","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC","19980601","","ANDA","ANDA060716","Hikma Pharmaceuticals USA Inc.","500000","[iU]/1","","N","20251231"
"544","CEFUROXIME SODIUM","Cefuroxime","00143997603","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9976","0143-9976-03","0143-9976_5621cde0-74c5-45b2-8f76-329eb22b4a0a","HUMAN PRESCRIPTION DRUG","Cefuroxime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20040109","","ANDA","ANDA065046","Hikma Pharmaceuticals USA Inc.","750","mg/8mL","","N","20251231"
"545","CEFUROXIME SODIUM","Cefuroxime","00143997722","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9977","0143-9977-22","0143-9977_6341f645-bd5f-4d4f-a532-2c0740ab95f5","HUMAN PRESCRIPTION DRUG","Cefuroxime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20040109","","ANDA","ANDA065048","Hikma Pharmaceuticals USA Inc.","1.5","g/1","","N","20251231"
"546","CEFUROXIME SODIUM","Cefuroxime","00143997922","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9979","0143-9979-22","0143-9979_6341f645-bd5f-4d4f-a532-2c0740ab95f5","HUMAN PRESCRIPTION DRUG","Cefuroxime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20040109","","ANDA","ANDA065048","Hikma Pharmaceuticals USA Inc.","750","mg/1","","N","20251231"
"547","AMOXICILLIN; CLAVULANIC ACID","Amoxicillin and Clavulanate Potassium","00143998150","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0143-9981","0143-9981-50","0143-9981_d26c7880-d893-458e-8cc9-327a8ad2d7df","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20071201","","ANDA","ANDA065191","Hikma Pharmaceuticals USA Inc.","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"548","AMOXICILLIN; CLAVULANIC ACID","Amoxicillin and Clavulanate Potassium","00143998175","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0143-9981","0143-9981-75","0143-9981_d26c7880-d893-458e-8cc9-327a8ad2d7df","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20071201","","ANDA","ANDA065191","Hikma Pharmaceuticals USA Inc.","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"549","AMOXICILLIN; CLAVULANIC ACID","Amoxicillin and Clavulanate Potassium","00143998101","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0143-9981","0143-9981-01","0143-9981_d26c7880-d893-458e-8cc9-327a8ad2d7df","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20071201","","ANDA","ANDA065191","Hikma Pharmaceuticals USA Inc.","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"550","AMOXICILLIN; CLAVULANIC ACID","Amoxicillin and Clavulanate Potassium","00143998275","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0143-9982","0143-9982-75","0143-9982_d26c7880-d893-458e-8cc9-327a8ad2d7df","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20071201","","ANDA","ANDA065191","Hikma Pharmaceuticals USA Inc.","400; 57","mg/5mL; mg/5mL","","N","20251231"
"551","AMOXICILLIN; CLAVULANIC ACID","Amoxicillin and Clavulanate Potassium","00143998201","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0143-9982","0143-9982-01","0143-9982_d26c7880-d893-458e-8cc9-327a8ad2d7df","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20071201","","ANDA","ANDA065191","Hikma Pharmaceuticals USA Inc.","400; 57","mg/5mL; mg/5mL","","N","20251231"
"552","AMOXICILLIN; CLAVULANIC ACID","Amoxicillin and Clavulanate Potassium","00143998250","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0143-9982","0143-9982-50","0143-9982_d26c7880-d893-458e-8cc9-327a8ad2d7df","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20071201","","ANDA","ANDA065191","Hikma Pharmaceuticals USA Inc.","400; 57","mg/5mL; mg/5mL","","N","20251231"
"553","CEFAZOLIN SODIUM","Cefazolin","00143998303","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0143-9983","0143-9983-03","0143-9983_a1fc6bdd-6f1b-402f-9e84-b6e5ed5febb4","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20041018","","ANDA","ANDA065143","Hikma Pharmaceuticals USA Inc.","10","g/1","","N","20251231"
"554","MICONAZOLE NITRATE","Selan Antifungal","00159250004","Azole Antifungal [EPC], Azoles [CS]","0159-2500","0159-2500-04","0159-2500_29691410-8fa4-ba33-e063-6394a90aeda7","HUMAN OTC DRUG","Selan Antifungal","","CREAM","TOPICAL","20031105","","OTC MONOGRAPH DRUG","M005","Trividia Manufacturing Solutions, Inc","2","g/100g","","N","20251231"
"555","KETOCONAZOLE","ketoconazole","00168009930","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","0168-0099","0168-0099-30","0168-0099_b4ef7400-7e35-47f2-bd1c-3c5e15cc90ee","HUMAN PRESCRIPTION DRUG","ketoconazole","","CREAM","TOPICAL","20040428","","ANDA","ANDA076294","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","20","mg/g","","N","20251231"
"556","KETOCONAZOLE","ketoconazole","00168009960","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","0168-0099","0168-0099-60","0168-0099_b4ef7400-7e35-47f2-bd1c-3c5e15cc90ee","HUMAN PRESCRIPTION DRUG","ketoconazole","","CREAM","TOPICAL","20040428","","ANDA","ANDA076294","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","20","mg/g","","N","20251231"
"557","KETOCONAZOLE","ketoconazole","00168009915","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","0168-0099","0168-0099-15","0168-0099_b4ef7400-7e35-47f2-bd1c-3c5e15cc90ee","HUMAN PRESCRIPTION DRUG","ketoconazole","","CREAM","TOPICAL","20040428","","ANDA","ANDA076294","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","20","mg/g","","N","20251231"
"558","CLOTRIMAZOLE","clotrimazole","00168013330","Azole Antifungal [EPC], Azoles [CS]","0168-0133","0168-0133-30","0168-0133_41af1c38-dbb2-46ac-94da-64e4639825c8","HUMAN PRESCRIPTION DRUG","Clotrimazole","","CREAM","TOPICAL","20080902","","ANDA","ANDA078338","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","10","mg/g","","N","20251231"
"559","CLOTRIMAZOLE","clotrimazole","00168013346","Azole Antifungal [EPC], Azoles [CS]","0168-0133","0168-0133-46","0168-0133_41af1c38-dbb2-46ac-94da-64e4639825c8","HUMAN PRESCRIPTION DRUG","Clotrimazole","","CREAM","TOPICAL","20080902","","ANDA","ANDA078338","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","10","mg/g","","N","20251231"
"560","CLOTRIMAZOLE","clotrimazole","00168013315","Azole Antifungal [EPC], Azoles [CS]","0168-0133","0168-0133-15","0168-0133_41af1c38-dbb2-46ac-94da-64e4639825c8","HUMAN PRESCRIPTION DRUG","Clotrimazole","","CREAM","TOPICAL","20080902","","ANDA","ANDA078338","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","10","mg/g","","N","20251231"
"561","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00168020160","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0168-0201","0168-0201-60","0168-0201_30743ed0-409c-4fec-bdd5-d113ef8ec838","HUMAN PRESCRIPTION DRUG","clindamycin phosphate","","SOLUTION","TOPICAL","19970605","","ANDA","ANDA064159","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","10","mg/mL","","N","20251231"
"562","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00168020130","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0168-0201","0168-0201-30","0168-0201_30743ed0-409c-4fec-bdd5-d113ef8ec838","HUMAN PRESCRIPTION DRUG","clindamycin phosphate","","SOLUTION","TOPICAL","19970605","","ANDA","ANDA064159","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","10","mg/mL","","N","20251231"
"563","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00168020260","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0168-0202","0168-0202-60","0168-0202_30743ed0-409c-4fec-bdd5-d113ef8ec838","HUMAN PRESCRIPTION DRUG","clindamycin phosphate","","GEL","TOPICAL","20000128","","ANDA","ANDA064160","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","10","mg/g","","N","20251231"
"564","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00168020230","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0168-0202","0168-0202-30","0168-0202_30743ed0-409c-4fec-bdd5-d113ef8ec838","HUMAN PRESCRIPTION DRUG","clindamycin phosphate","","GEL","TOPICAL","20000128","","ANDA","ANDA064160","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","10","mg/g","","N","20251231"
"565","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00168020360","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0168-0203","0168-0203-60","0168-0203_30743ed0-409c-4fec-bdd5-d113ef8ec838","HUMAN PRESCRIPTION DRUG","clindamycin phosphate","","LOTION","TOPICAL","20020131","","ANDA","ANDA065067","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","10","mg/mL","","N","20251231"
"566","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","00168025846","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","0168-0258","0168-0258-46","0168-0258_49ee0b08-4d97-44e3-b506-48d9049c0526","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20010605","","ANDA","ANDA075502","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",".5; 10","mg/g; mg/g","","N","20251231"
"567","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","00168025815","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","0168-0258","0168-0258-15","0168-0258_49ee0b08-4d97-44e3-b506-48d9049c0526","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20010605","","ANDA","ANDA075502","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",".5; 10","mg/g; mg/g","","N","20251231"
"568","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00168027740","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0168-0277","0168-0277-40","0168-0277_fff399c8-a606-4ccf-9800-0bb3ccf6a71b","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","CREAM","VAGINAL","20041227","","ANDA","ANDA065139","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","20","mg/g","","N","20251231"
"569","METRONIDAZOLE","Metronidazole","00168032346","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0168-0323","0168-0323-46","0168-0323_bfe32c3b-9d0e-4438-8417-3f948262b37d","HUMAN PRESCRIPTION DRUG","Metronidazole","","CREAM","TOPICAL","20040528","","ANDA","ANDA076408","Fougera Pharmaceuticals Inc.","7.5","mg/g","","N","20251231"
"570","TERCONAZOLE","terconazole","00168034646","Azole Antifungal [EPC], Azoles [CS]","0168-0346","0168-0346-46","0168-0346_5107e247-7c98-46a7-94d7-4fbf4e1114cb","HUMAN PRESCRIPTION DRUG","Terconazole","","CREAM","VAGINAL","20050218","","ANDA","ANDA076712","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","4","mg/g","","N","20251231"
"571","TERCONAZOLE","terconazole","00168034720","Azole Antifungal [EPC], Azoles [CS]","0168-0347","0168-0347-20","0168-0347_b0d40d8f-d90e-4aea-9485-5f021f34df69","HUMAN PRESCRIPTION DRUG","Terconazole","Vaginal Cream 0.8%","CREAM","VAGINAL","20050201","","NDA","NDA021735","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","8","mg/g","","N","20261231"
"572","OXICONAZOLE NITRATE","Oxiconazole Nitrate","00168035860","Azole Antifungal [EPC], Azoles [CS]","0168-0358","0168-0358-60","0168-0358_ced09ac9-d81c-4812-905e-80abec8141da","HUMAN PRESCRIPTION DRUG","Oxiconazole Nitrate","","CREAM","TOPICAL","20160309","","NDA AUTHORIZED GENERIC","NDA019828","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","10","mg/g","","N","20251231"
"573","OXICONAZOLE NITRATE","Oxiconazole Nitrate","00168035890","Azole Antifungal [EPC], Azoles [CS]","0168-0358","0168-0358-90","0168-0358_ced09ac9-d81c-4812-905e-80abec8141da","HUMAN PRESCRIPTION DRUG","Oxiconazole Nitrate","","CREAM","TOPICAL","20160309","","NDA AUTHORIZED GENERIC","NDA019828","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","10","mg/g","","N","20251231"
"574","OXICONAZOLE NITRATE","Oxiconazole Nitrate","00168035830","Azole Antifungal [EPC], Azoles [CS]","0168-0358","0168-0358-30","0168-0358_ced09ac9-d81c-4812-905e-80abec8141da","HUMAN PRESCRIPTION DRUG","Oxiconazole Nitrate","","CREAM","TOPICAL","20160309","","NDA AUTHORIZED GENERIC","NDA019828","E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.","10","mg/g","","N","20251231"
"575","METRONIDAZOLE","Metronidazole","00168038360","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0168-0383","0168-0383-60","0168-0383_820d66fb-a1d0-4f01-b108-de3162c8a88e","HUMAN PRESCRIPTION DRUG","Metronidazole","","LOTION","TOPICAL","20060524","","ANDA","ANDA077197","Fougera Pharmaceuticals Inc.","7.5","mg/mL","","N","20251231"
"576","ATOVAQUONE","atovaquone","00173054700","Antimalarial [EPC], Antiprotozoal [EPC]","0173-0547","0173-0547-00","0173-0547_69339d6a-db12-445a-aa8c-3fc0aa11136b","HUMAN PRESCRIPTION DRUG","MEPRON","","SUSPENSION","ORAL","19980918","","NDA","NDA020500","GlaxoSmithKline LLC","750","mg/5mL","","N","20251231"
"577","ATOVAQUONE","atovaquone","00173066518","Antimalarial [EPC], Antiprotozoal [EPC]","0173-0665","0173-0665-18","0173-0665_69339d6a-db12-445a-aa8c-3fc0aa11136b","HUMAN PRESCRIPTION DRUG","MEPRON","","SUSPENSION","ORAL","19950228","","NDA","NDA020500","GlaxoSmithKline LLC","750","mg/5mL","","N","20251231"
"578","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","00173067501","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","0173-0675","0173-0675-01","0173-0675_f9507726-ee19-41c7-8456-c6e2e94eb344","HUMAN PRESCRIPTION DRUG","MALARONE","","TABLET, FILM COATED","ORAL","20000726","","NDA","NDA021078","GlaxoSmithKline LLC","250; 100","mg/1; mg/1","","N","20251231"
"579","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","00173067502","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","0173-0675","0173-0675-02","0173-0675_f9507726-ee19-41c7-8456-c6e2e94eb344","HUMAN PRESCRIPTION DRUG","MALARONE","","TABLET, FILM COATED","ORAL","20000726","","NDA","NDA021078","GlaxoSmithKline LLC","250; 100","mg/1; mg/1","","N","20251231"
"580","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","00173067601","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","0173-0676","0173-0676-01","0173-0676_f9507726-ee19-41c7-8456-c6e2e94eb344","HUMAN PRESCRIPTION DRUG","MALARONE","","TABLET, FILM COATED","ORAL","20000726","","NDA","NDA021078","GlaxoSmithKline LLC","62.5; 25","mg/1; mg/1","","N","20251231"
"581","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","00178046002","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0460","0178-0460-02","0178-0460_099223af-a429-c370-e063-6394a90aa17f","HUMAN PRESCRIPTION DRUG","Avar-e Green","","CREAM","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","100; 50","mg/g; mg/g","","N","20251231"
"582","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","00178046004","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0460","0178-0460-04","0178-0460_099223af-a429-c370-e063-6394a90aa17f","HUMAN PRESCRIPTION DRUG","Avar-e Green","","CREAM","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","100; 50","mg/g; mg/g","","N","20251231"
"583","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","00178046502","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0465","0178-0465-02","0178-0465_f7843c0f-b7f8-0b30-e053-6294a90aeb6e","HUMAN PRESCRIPTION DRUG","Avar-e LS","","CREAM","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","100; 20","mg/g; mg/g","","N","20251231"
"584","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","00178046504","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0465","0178-0465-04","0178-0465_f7843c0f-b7f8-0b30-e053-6294a90aeb6e","HUMAN PRESCRIPTION DRUG","Avar-e LS","","CREAM","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","100; 20","mg/g; mg/g","","N","20251231"
"585","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","00178047002","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0470","0178-0470-02","0178-0470_f7844b5e-dd65-9baa-e053-6394a90a96e6","HUMAN PRESCRIPTION DRUG","Avar-e","","CREAM","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","100; 50","mg/g; mg/g","","N","20251231"
"586","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","00178047508","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0475","0178-0475-08","0178-0475_f7845bcc-5b38-4e2c-e053-6294a90a51b1","HUMAN PRESCRIPTION DRUG","AVAR LS","","EMULSION","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","100; 20","mg/g; mg/g","","N","20251231"
"587","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","00178047504","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0475","0178-0475-04","0178-0475_f7845bcc-5b38-4e2c-e053-6294a90a51b1","HUMAN PRESCRIPTION DRUG","AVAR LS","","EMULSION","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","100; 20","mg/g; mg/g","","N","20251231"
"588","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","00178048008","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0480","0178-0480-08","0178-0480_f7846b0e-0157-76f7-e053-6294a90af394","HUMAN PRESCRIPTION DRUG","AVAR","","EMULSION","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","100; 50","mg/g; mg/g","","N","20251231"
"589","SULFACETAMIDE SODIUM","SULFACETAMIDE SODIUM","00178048508","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0485","0178-0485-08","0178-0485_f797ecc8-1b4d-d9be-e053-6294a90a7af5","HUMAN PRESCRIPTION DRUG","OVACE Plus","","SHAMPOO","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","100","mg/mL","","N","20251231"
"590","SULFACETAMIDE SODIUM","SULFACETAMIDE SODIUM","00178048504","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0485","0178-0485-04","0178-0485_f797ecc8-1b4d-d9be-e053-6294a90a7af5","HUMAN PRESCRIPTION DRUG","OVACE Plus","","SHAMPOO","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","100","mg/mL","","N","20251231"
"591","SULFACETAMIDE SODIUM","SULFACETAMIDE SODIUM","00178049004","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0490","0178-0490-04","0178-0490_f79394ee-e1ad-a404-e053-6394a90a9910","HUMAN PRESCRIPTION DRUG","OVACE Plus","","LIQUID","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","100","mg/mL","","N","20251231"
"592","SULFACETAMIDE SODIUM","SULFACETAMIDE SODIUM","00178049012","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0490","0178-0490-12","0178-0490_f79394ee-e1ad-a404-e053-6394a90a9910","HUMAN PRESCRIPTION DRUG","OVACE Plus","","LIQUID","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","100","mg/mL","","N","20251231"
"593","SULFACETAMIDE SODIUM","SULFACETAMIDE SODIUM","00178049504","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0495","0178-0495-04","0178-0495_f78467ae-c40f-cbde-e053-6394a90acad2","HUMAN PRESCRIPTION DRUG","OvacePlus","Plus","CREAM","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","100","mg/g","","N","20251231"
"594","SULFACETAMIDE SODIUM","SULFACETAMIDE SODIUM","00178049502","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0495","0178-0495-02","0178-0495_f78467ae-c40f-cbde-e053-6394a90acad2","HUMAN PRESCRIPTION DRUG","OvacePlus","Plus","CREAM","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","100","mg/g","","N","20251231"
"595","SULFACETAMIDE SODIUM","SULFACETAMIDE SODIUM","00178049906","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0499","0178-0499-06","0178-0499_f797f681-1106-2396-e053-6394a90ab801","HUMAN PRESCRIPTION DRUG","OVACE","","LIQUID","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","100","mg/mL","","N","20251231"
"596","SULFACETAMIDE SODIUM","SULFACETAMIDE SODIUM","00178062004","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0620","0178-0620-04","0178-0620_032507e2-c9f8-f285-e063-6394a90a0fbf","HUMAN PRESCRIPTION DRUG","Ovace","Plus","LOTION","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","98","mg/g","","N","20251231"
"597","SULFACETAMIDE SODIUM","SULFACETAMIDE SODIUM","00178062002","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0620","0178-0620-02","0178-0620_032507e2-c9f8-f285-e063-6394a90a0fbf","HUMAN PRESCRIPTION DRUG","Ovace","Plus","LOTION","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","98","mg/g","","N","20251231"
"598","SULFACETAMIDE SODIUM","SODIUM SULFACETAMIDE","00178063016","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0178-0630","0178-0630-16","0178-0630_f7938654-e4f4-fb07-e053-6394a90a588a","HUMAN PRESCRIPTION DRUG","OVACE","PLUS","LIQUID","TOPICAL","20110907","","UNAPPROVED DRUG OTHER","","Mission Pharmacal Company","100","mg/mL","","N","20251231"
"599","TINIDAZOLE","tinidazole","00178825040","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0178-8250","0178-8250-40","0178-8250_d423971d-34c8-c7d2-e053-2a95a90abe74","HUMAN PRESCRIPTION DRUG","Tindamax","","TABLET, FILM COATED","ORAL","20040517","","NDA","NDA021618","Mission Pharmacal Company","250","mg/1","","N","20251231"
"600","TINIDAZOLE","tinidazole","00178850060","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0178-8500","0178-8500-60","0178-8500_d423971d-34c8-c7d2-e053-2a95a90abe74","HUMAN PRESCRIPTION DRUG","Tindamax","","TABLET, FILM COATED","ORAL","20040517","","NDA","NDA021618","Mission Pharmacal Company","500","mg/1","","N","20251231"
"601","TINIDAZOLE","tinidazole","00178850020","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0178-8500","0178-8500-20","0178-8500_d423971d-34c8-c7d2-e053-2a95a90abe74","HUMAN PRESCRIPTION DRUG","Tindamax","","TABLET, FILM COATED","ORAL","20040517","","NDA","NDA021618","Mission Pharmacal Company","500","mg/1","","N","20251231"
"602","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","00185012201","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","0185-0122","0185-0122-01","0185-0122_dbade175-4f7c-476a-8ecf-5b2b7b99c616","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Sandoz Inc","25; 75","mg/1; mg/1","","N","20251231"
"603","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","00185012210","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","0185-0122","0185-0122-10","0185-0122_dbade175-4f7c-476a-8ecf-5b2b7b99c616","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Sandoz Inc","25; 75","mg/1; mg/1","","N","20251231"
"604","RIFAMPIN","Rifampin","00185080130","Rifamycin Antibacterial [EPC], Rifamycins [CS]","0185-0801","0185-0801-30","0185-0801_b57ddd24-b8a3-4b5e-950b-4c5f772b91b1","HUMAN PRESCRIPTION DRUG","Rifampin","","CAPSULE","ORAL","19980102","20250630","ANDA","ANDA064150","Eon Labs, Inc.","150","mg/1","","N",""
"605","ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","clindamycin phosphate/benzoyl peroxide/adapalene","00187000625","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]","0187-0006","0187-0006-25","0187-0006_338bc721-434d-cbc2-e063-6394a90abc47","HUMAN PRESCRIPTION DRUG","Cabtreo","","GEL","TOPICAL","20231020","","NDA","NDA216632","Bausch Health US LLC","1.5; 31; 12","mg/g; mg/g; mg/g","","N","20261231"
"606","ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","clindamycin phosphate/benzoyl peroxide/adapalene","00187000635","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]","0187-0006","0187-0006-35","0187-0006_338bc721-434d-cbc2-e063-6394a90abc47","HUMAN PRESCRIPTION DRUG","Cabtreo","","GEL","TOPICAL","20231020","","NDA","NDA216632","Bausch Health US LLC","1.5; 31; 12","mg/g; mg/g; mg/g","","N","20261231"
"607","ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","clindamycin phosphate/benzoyl peroxide/adapalene","00187000610","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]","0187-0006","0187-0006-10","0187-0006_338bc721-434d-cbc2-e063-6394a90abc47","HUMAN PRESCRIPTION DRUG","Cabtreo","","GEL","TOPICAL","20231020","","NDA","NDA216632","Bausch Health US LLC","1.5; 31; 12","mg/g; mg/g; mg/g","","N","20261231"
"608","RIBAVIRIN","Ribavirin","00187000701","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","0187-0007","0187-0007-01","0187-0007_164da93c-e915-4164-b3d1-61b4075a01bd","HUMAN PRESCRIPTION DRUG","Virazole","","POWDER, FOR SOLUTION","RESPIRATORY (INHALATION)","19860101","","NDA","NDA018859","Bausch Health US, LLC","6","g/1","","N","20251231"
"609","RIBAVIRIN","Ribavirin","00187000714","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","0187-0007","0187-0007-14","0187-0007_164da93c-e915-4164-b3d1-61b4075a01bd","HUMAN PRESCRIPTION DRUG","Virazole","","POWDER, FOR SOLUTION","RESPIRATORY (INHALATION)","19860101","","NDA","NDA018859","Bausch Health US, LLC","6","g/1","","N","20251231"
"610","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate and Benzoyl Peroxide","00187305035","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS]","0187-3050","0187-3050-35","0187-3050_c1de59e9-2d05-42bf-9ed7-d744854db763","HUMAN PRESCRIPTION DRUG","ONEXTON","","GEL","TOPICAL","20141124","","NDA","NDA050819","Bausch Health US, LLC","37.5; 10","mg/g; mg/g","","N","20251231"
"611","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate and Benzoyl Peroxide","00187305050","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS]","0187-3050","0187-3050-50","0187-3050_c1de59e9-2d05-42bf-9ed7-d744854db763","HUMAN PRESCRIPTION DRUG","ONEXTON","","GEL","TOPICAL","20141124","","NDA","NDA050819","Bausch Health US, LLC","37.5; 10","mg/g; mg/g","","N","20251231"
"612","FLUCYTOSINE","Flucytosine","00187355410","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","0187-3554","0187-3554-10","0187-3554_2611b6d9-1f11-4c1d-a2b6-ae818d39d299","HUMAN PRESCRIPTION DRUG","ANCOBON","","CAPSULE","ORAL","19711126","","NDA","NDA017001","Bausch Health US LLC","250","mg/1","","N","20251231"
"613","FLUCYTOSINE","Flucytosine","00187355510","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","0187-3555","0187-3555-10","0187-3555_2611b6d9-1f11-4c1d-a2b6-ae818d39d299","HUMAN PRESCRIPTION DRUG","ANCOBON","","CAPSULE","ORAL","19711126","","NDA","NDA017001","Bausch Health US LLC","500","mg/1","","N","20251231"
"614","SERTACONAZOLE NITRATE","Sertaconazole Nitrate","00187511560","Azole Antifungal [EPC], Azoles [CS]","0187-5115","0187-5115-60","0187-5115_c5d11596-8c13-483a-93f9-f7016fb8c663","HUMAN PRESCRIPTION DRUG","Ertaczo","","CREAM","TOPICAL","20031210","","NDA","NDA021385","Bausch Health US, LLC","20","mg/g","","N","20251231"
"615","SULFACETAMIDE SODIUM","sulfacetamide sodium","00187519804","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0187-5198","0187-5198-04","0187-5198_4dd0038b-2f5d-436c-8a6d-6db44760c37a","HUMAN PRESCRIPTION DRUG","Klaron","","LOTION","TOPICAL","19961223","","NDA","NDA019931","Bausch Health US, LLC","100","mg/mL","","N","20251231"
"616","METRONIDAZOLE","metronidazole","00187520260","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0187-5202","0187-5202-60","0187-5202_453f532e-bb72-4ea7-b9e5-b9ac903ffafe","HUMAN PRESCRIPTION DRUG","Noritate","","CREAM","TOPICAL","20130809","","NDA","NDA020743","Bausch Health US, LLC","10","mg/60g","","N","20251231"
"617","EFINACONAZOLE","efinaconazole","00187540002","Azole Antifungal [EPC], Azoles [CS]","0187-5400","0187-5400-02","0187-5400_f3c0bfe9-3cdf-41df-8e6e-77901a8c8f3e","HUMAN PRESCRIPTION DRUG","JUBLIA","","SOLUTION","TOPICAL","20140606","","NDA","NDA203567","Bausch Health US LLC","100","mg/mL","","N","20251231"
"618","EFINACONAZOLE","efinaconazole","00187540004","Azole Antifungal [EPC], Azoles [CS]","0187-5400","0187-5400-04","0187-5400_f3c0bfe9-3cdf-41df-8e6e-77901a8c8f3e","HUMAN PRESCRIPTION DRUG","JUBLIA","","SOLUTION","TOPICAL","20140606","","NDA","NDA203567","Bausch Health US LLC","100","mg/mL","","N","20251231"
"619","EFINACONAZOLE","efinaconazole","00187540008","Azole Antifungal [EPC], Azoles [CS]","0187-5400","0187-5400-08","0187-5400_f3c0bfe9-3cdf-41df-8e6e-77901a8c8f3e","HUMAN PRESCRIPTION DRUG","JUBLIA","","SOLUTION","TOPICAL","20140606","","NDA","NDA203567","Bausch Health US LLC","100","mg/mL","","N","20251231"
"620","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","TAZOBACTAM SODIUM and PIPERACILLIN SODIUM","00206886002","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0206-8860","0206-8860-02","0206-8860_30496b61-307a-43af-8369-971593382a70","HUMAN PRESCRIPTION DRUG","Zosyn","in Galaxy Containers","INJECTION, SOLUTION","INTRAVENOUS","19980301","","NDA","NDA050750","Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.","2; 250","g/50mL; mg/50mL","","N","20251231"
"621","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","TAZOBACTAM SODIUM and PIPERACILLIN SODIUM","00206886102","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0206-8861","0206-8861-02","0206-8861_30496b61-307a-43af-8369-971593382a70","HUMAN PRESCRIPTION DRUG","Zosyn","in Galaxy Containers","INJECTION, SOLUTION","INTRAVENOUS","19980301","","NDA","NDA050750","Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.","3; 375","g/50mL; mg/50mL","","N","20251231"
"622","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","TAZOBACTAM SODIUM and PIPERACILLIN SODIUM","00206886202","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0206-8862","0206-8862-02","0206-8862_30496b61-307a-43af-8369-971593382a70","HUMAN PRESCRIPTION DRUG","Zosyn","in Galaxy Containers","INJECTION, SOLUTION","INTRAVENOUS","19980301","","NDA","NDA050750","Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.","4; 500","g/100mL; mg/100mL","","N","20251231"
"623","QUININE SULFATE","QUININE SULFATE","00220130641","Antimalarial [EPC]","0220-1306","0220-1306-41","0220-1306_09bf1e5f-9600-9b3b-e063-6294a90a3d92","HUMAN OTC DRUG","Chininum sulphuricum","","PELLET","ORAL","19830303","","UNAPPROVED HOMEOPATHIC","","Boiron","9","[hp_C]/9[hp_C]","","N","20251231"
"624","QUININE SULFATE","QUININE SULFATE","00220130741","Antimalarial [EPC]","0220-1307","0220-1307-41","0220-1307_09bf2b7b-4a92-66b6-e063-6394a90a847f","HUMAN OTC DRUG","Chininum sulphuricum","","PELLET","ORAL","19830303","","UNAPPROVED HOMEOPATHIC","","Boiron","12","[hp_C]/12[hp_C]","","N","20251231"
"625","QUININE ARSENITE","QUININE ARSENITE","00220130941","Antimalarial [EPC]","0220-1309","0220-1309-41","0220-1309_09bf1e5f-9601-9b3b-e063-6294a90a3d92","HUMAN OTC DRUG","Chininum arsenicosum","","PELLET","ORAL","19830303","","UNAPPROVED HOMEOPATHIC","","Boiron","30","[hp_C]/30[hp_C]","","N","20251231"
"626","QUININE SULFATE","QUININE SULFATE","00220131041","Antimalarial [EPC]","0220-1310","0220-1310-41","0220-1310_09bf1e5f-9602-9b3b-e063-6294a90a3d92","HUMAN OTC DRUG","Chininum sulphuricum","","PELLET","ORAL","19830303","","UNAPPROVED HOMEOPATHIC","","Boiron","15","[hp_C]/15[hp_C]","","N","20251231"
"627","QUININE SULFATE","QUININE SULFATE","00220131141","Antimalarial [EPC]","0220-1311","0220-1311-41","0220-1311_fd64badf-0788-7fb1-e053-6294a90a3ab4","HUMAN OTC DRUG","Chininum sulphuricum","","PELLET","ORAL","19830303","","UNAPPROVED HOMEOPATHIC","","Boiron","30","[hp_C]/30[hp_C]","","N","20251231"
"628","QUININE SULFATE","QUININE SULFATE","00220131441","Antimalarial [EPC]","0220-1314","0220-1314-41","0220-1314_09bf01a1-7a37-609d-e063-6394a90a6408","HUMAN OTC DRUG","Chininum sulphuricum","","PELLET","ORAL","19830303","","UNAPPROVED HOMEOPATHIC","","Boiron","200","[kp_C]/200[kp_C]","","N","20251231"
"629","QUININE SALICYLATE","QUININE SALICYLATE","00220132141","Antimalarial [EPC]","0220-1321","0220-1321-41","0220-1321_1e68810b-fd42-a904-e063-6394a90a3741","HUMAN OTC DRUG","Chininum salicylicum","","PELLET","ORAL","19830303","","UNAPPROVED HOMEOPATHIC","","Boiron","30","[hp_C]/30[hp_C]","","N","20251231"
"630","QUININE SALICYLATE","QUININE SALICYLATE","00220132241","Antimalarial [EPC]","0220-1322","0220-1322-41","0220-1322_1e686478-1e59-36cf-e063-6294a90a929a","HUMAN OTC DRUG","Chininum salicylicum","","PELLET","ORAL","20240101","","UNAPPROVED HOMEOPATHIC","","Boiron","200","[kp_C]/200[kp_C]","","N","20251231"
"631","QUININE SULFATE","QUININE SULFATE","00220132541","Antimalarial [EPC]","0220-1325","0220-1325-41","0220-1325_09bf2450-da9d-ab38-e063-6294a90ab744","HUMAN OTC DRUG","Chininum sulphuricum","","PELLET","ORAL","19830303","","UNAPPROVED HOMEOPATHIC","","Boiron","6","[hp_C]/1","","N","20251231"
"632","METRONIDAZOLE","Metronidazole","00245086070","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0245-0860","0245-0860-70","0245-0860_56d2d3bc-b54a-47d3-be98-732831279775","HUMAN PRESCRIPTION DRUG","Vandazole","","GEL","VAGINAL","20051004","","NDA","NDA021806","Upsher-Smith Laboratories, LLC","7.5","mg/g","","N","20251231"
"633","POSACONAZOLE","posaconazole","00254101636","Azole Antifungal [EPC], Azoles [CS]","0254-1016","0254-1016-36","0254-1016_13a71d11-5aa1-4d57-97a6-8a972103dbca","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","SUSPENSION","ORAL","20230329","","NDA AUTHORIZED GENERIC","NDA022003","ENDO USA, Inc.","40","mg/mL","","N","20251231"
"634","POSACONAZOLE","posaconazole","00254204502","Azole Antifungal [EPC], Azoles [CS]","0254-2045","0254-2045-02","0254-2045_13a71d11-5aa1-4d57-97a6-8a972103dbca","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","TABLET, COATED","ORAL","20190830","","NDA AUTHORIZED GENERIC","NDA205053","ENDO USA, Inc.","100","mg/1","","N","20251231"
"635","CEFAZOLIN SODIUM","Cefazolin Sodium","00264310311","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0264-3103","0264-3103-11","0264-3103_fb2f076a-22b3-46e0-86c8-7678e89c9edf","HUMAN PRESCRIPTION DRUG","Cefazolin Sodium","","SOLUTION","INTRAVENOUS","20000727","","NDA","NDA050779","B. Braun Medical Inc.","1","g/50mL","","N","20261231"
"636","CEFAZOLIN SODIUM","Cefazolin Sodium","00264310511","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0264-3105","0264-3105-11","0264-3105_fb2f076a-22b3-46e0-86c8-7678e89c9edf","HUMAN PRESCRIPTION DRUG","Cefazolin Sodium","","SOLUTION","INTRAVENOUS","20120113","","NDA","NDA050779","B. Braun Medical Inc.","2","g/50mL","","N","20261231"
"637","CEFAZOLIN SODIUM","Cefazolin Sodium","00264310711","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0264-3107","0264-3107-11","0264-3107_fb2f076a-22b3-46e0-86c8-7678e89c9edf","HUMAN PRESCRIPTION DRUG","Cefazolin Sodium","","SOLUTION","INTRAVENOUS","20250310","","NDA","NDA050779","B. Braun Medical Inc.","3","g/50mL","","N","20261231"
"638","CEFUROXIME SODIUM","CEFUROXIME AND DEXTROSE","00264311211","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0264-3112","0264-3112-11","0264-3112_6874a295-7ec7-4822-9d04-4dd9932b4546","HUMAN PRESCRIPTION DRUG","Cefuroxime and Dextrose","","INJECTION, SOLUTION","INTRAVENOUS","20010221","","NDA","NDA050780","B. Braun Medical Inc.","750","mg/50mL","","N","20251231"
"639","CEFUROXIME SODIUM","CEFUROXIME AND DEXTROSE","00264311411","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0264-3114","0264-3114-11","0264-3114_6874a295-7ec7-4822-9d04-4dd9932b4546","HUMAN PRESCRIPTION DRUG","Cefuroxime and Dextrose","","INJECTION, SOLUTION","INTRAVENOUS","20010221","","NDA","NDA050780","B. Braun Medical Inc.","1.5","g/50mL","","N","20251231"
"640","CEFOXITIN SODIUM","CEFOXITIN SODIUM","00264312311","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0264-3123","0264-3123-11","0264-3123_0cca0e6a-3047-4142-af33-d9b98efe85b1","HUMAN PRESCRIPTION DRUG","Cefoxitin and Dextrose","","INJECTION, SOLUTION","INTRAVENOUS","20060310","","NDA","NDA065214","B. Braun Medical Inc.","1","g/50mL","","N","20251231"
"641","CEFOXITIN SODIUM","CEFOXITIN SODIUM","00264312511","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0264-3125","0264-3125-11","0264-3125_0cca0e6a-3047-4142-af33-d9b98efe85b1","HUMAN PRESCRIPTION DRUG","Cefoxitin and Dextrose","","INJECTION, SOLUTION","INTRAVENOUS","20060310","","NDA","NDA065214","B. Braun Medical Inc.","2","g/50mL","","N","20251231"
"642","CEFTRIAXONE SODIUM","CEFTRIAXONE","00264315311","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0264-3153","0264-3153-11","0264-3153_05bf8d04-202d-472f-94b5-4f5d9020f0c7","HUMAN PRESCRIPTION DRUG","CEFTRIAXONE AND DEXTROSE","","INJECTION, SOLUTION","INTRAVENOUS","20050420","","NDA","NDA050796","B. Braun Medical Inc.","1","g/50mL","","N","20251231"
"643","CEFTRIAXONE SODIUM","CEFTRIAXONE","00264315511","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0264-3155","0264-3155-11","0264-3155_05bf8d04-202d-472f-94b5-4f5d9020f0c7","HUMAN PRESCRIPTION DRUG","CEFTRIAXONE AND DEXTROSE","","INJECTION, SOLUTION","INTRAVENOUS","20050420","","NDA","NDA050796","B. Braun Medical Inc.","2","g/50mL","","N","20251231"
"644","MEROPENEM","Meropenem and Sodium Chloride","00264318311","Carbapenems [CS], Penem Antibacterial [EPC]","0264-3183","0264-3183-11","0264-3183_434f50bc-bc03-4001-9b23-cecb3d49a188","HUMAN PRESCRIPTION DRUG","Meropenem and Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","20150430","","NDA","NDA202106","B. Braun Medical Inc.","500","mg/50mL","","N","20261231"
"645","MEROPENEM","Meropenem and Sodium Chloride","00264318511","Carbapenems [CS], Penem Antibacterial [EPC]","0264-3185","0264-3185-11","0264-3185_434f50bc-bc03-4001-9b23-cecb3d49a188","HUMAN PRESCRIPTION DRUG","Meropenem and Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","20150430","","NDA","NDA202106","B. Braun Medical Inc.","1","g/50mL","","N","20261231"
"646","CEFEPIME HYDROCHLORIDE","CEFEPIME HYDROCHLORIDE","00264319311","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0264-3193","0264-3193-11","0264-3193_afe666d5-84ec-45a7-ae00-c643b4eaeb35","HUMAN PRESCRIPTION DRUG","CEFEPIME HYDROCHLORIDE AND DEXTROSE","","INJECTION, SOLUTION","INTRAVENOUS","20100506","","NDA","NDA050821","B. Braun Medical Inc.","1","g/50mL","","N","20251231"
"647","CEFEPIME HYDROCHLORIDE","CEFEPIME HYDROCHLORIDE","00264319511","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0264-3195","0264-3195-11","0264-3195_afe666d5-84ec-45a7-ae00-c643b4eaeb35","HUMAN PRESCRIPTION DRUG","CEFEPIME HYDROCHLORIDE AND DEXTROSE","","INJECTION, SOLUTION","INTRAVENOUS","20100506","","NDA","NDA050821","B. Braun Medical Inc.","2","g/50mL","","N","20251231"
"648","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam and Sodium Chloride","00264344611","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0264-3446","0264-3446-11","0264-3446_665bf3ee-17b1-49dc-acfa-ed7fc2d82c8e","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam and Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","20250620","","NDA","NDA206056","B. Braun Medical Inc.","2; 250","g/50mL; mg/50mL","","N","20261231"
"649","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam and Sodium Chloride","00264344811","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0264-3448","0264-3448-11","0264-3448_665bf3ee-17b1-49dc-acfa-ed7fc2d82c8e","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam and Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","20250620","","NDA","NDA206056","B. Braun Medical Inc.","3; 375","g/50mL; mg/50mL","","N","20261231"
"650","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam and Sodium Chloride","00264345022","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0264-3450","0264-3450-22","0264-3450_665bf3ee-17b1-49dc-acfa-ed7fc2d82c8e","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam and Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","20250620","","NDA","NDA206056","B. Braun Medical Inc.","4; 500","g/100mL; mg/100mL","","N","20261231"
"651","METRONIDAZOLE","METRONIDAZOLE","00264553532","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0264-5535","0264-5535-32","0264-5535_ff10d27d-6a3a-45db-ae74-72ba2f442dd6","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","SOLUTION","INTRAVENOUS","19830929","","NDA","NDA018900","B. Braun Medical Inc.","500","mg/100mL","","N","20261231"
"652","METRONIDAZOLE","metronidazole","00299382060","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0299-3820","0299-3820-60","0299-3820_c61f8bdc-60b9-4292-a9de-d418c31e9ad7","HUMAN PRESCRIPTION DRUG","METROGEL","","GEL","TOPICAL","20050630","20260531","NDA","NDA021789","Galderma Laboratories, L.P.","10","mg/g","","N",""
"653","METRONIDAZOLE","metronidazole","00299383645","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0299-3836","0299-3836-45","0299-3836_02c98a23-7923-4f37-b2e5-627e688f3e09","HUMAN PRESCRIPTION DRUG","MetroCream","","CREAM","TOPICAL","19950920","","NDA","NDA020531","Galderma Laboratories, L.P.","7.5","mg/g","","N","20251231"
"654","METRONIDAZOLE","metronidazole","00299383802","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0299-3838","0299-3838-02","0299-3838_986498be-52fe-47ba-a639-5267a03e98bf","HUMAN PRESCRIPTION DRUG","MetroLotion","","LOTION","TOPICAL","19981124","","NDA","NDA020901","Galderma Laboratories, L.P.","7.5","mg/mL","","N","20251231"
"655","NYSTATIN","Nystatin Cream","00316022115","Polyene Antifungal [EPC], Polyenes [CS]","0316-0221","0316-0221-15","0316-0221_087c02ff-9dd7-4053-e063-6394a90a4937","HUMAN PRESCRIPTION DRUG","Nystatin Cream","","CREAM","TOPICAL","20171010","","ANDA","ANDA207733","Crown Laboratories","100000","[USP'U]/g","","N","20251231"
"656","NYSTATIN","Nystatin Cream","00316022130","Polyene Antifungal [EPC], Polyenes [CS]","0316-0221","0316-0221-30","0316-0221_087c02ff-9dd7-4053-e063-6394a90a4937","HUMAN PRESCRIPTION DRUG","Nystatin Cream","","CREAM","TOPICAL","20171010","","ANDA","ANDA207733","Crown Laboratories","100000","[USP'U]/g","","N","20251231"
"657","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","00316022330","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","0316-0223","0316-0223-30","0316-0223_087be530-68c1-bfaa-e063-6294a90ae1d3","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20180102","","ANDA","ANDA207730","Crown Laboratories","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"658","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","00316022360","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","0316-0223","0316-0223-60","0316-0223_087be530-68c1-bfaa-e063-6294a90ae1d3","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20180102","","ANDA","ANDA207730","Crown Laboratories","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"659","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","00316022315","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","0316-0223","0316-0223-15","0316-0223_087be530-68c1-bfaa-e063-6294a90ae1d3","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20180102","","ANDA","ANDA207730","Crown Laboratories","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"660","MICONAZOLE NITRATE","MICONAZOLE NITRATE","00316022501","Azole Antifungal [EPC], Azoles [CS]","0316-0225","0316-0225-01","0316-0225_0c935646-fc62-0630-e063-6394a90acc57","HUMAN OTC DRUG","Desenex","","POWDER","TOPICAL","20090803","20250724","OTC MONOGRAPH DRUG","M005","Crown Laboratories","20","mg/g","","N",""
"661","MICONAZOLE NITRATE","MICONAZOLE NITRATE","00316022530","Azole Antifungal [EPC], Azoles [CS]","0316-0225","0316-0225-30","0316-0225_0c935646-fc62-0630-e063-6394a90acc57","HUMAN OTC DRUG","Desenex","","POWDER","TOPICAL","20090803","20250724","OTC MONOGRAPH DRUG","M005","Crown Laboratories","20","mg/g","","N",""
"662","MICONAZOLE NITRATE","MICONAZOLE NITRATE","00316022502","Azole Antifungal [EPC], Azoles [CS]","0316-0225","0316-0225-02","0316-0225_0c935646-fc62-0630-e063-6394a90acc57","HUMAN OTC DRUG","Desenex","","POWDER","TOPICAL","20090803","20250724","OTC MONOGRAPH DRUG","M005","Crown Laboratories","20","mg/g","","N",""
"663","MICONAZOLE NITRATE","Miconazole Nitrate","00316025501","Azole Antifungal [EPC], Azoles [CS]","0316-0255","0316-0255-01","0316-0255_3119e4da-1f2a-1404-e063-6294a90a7093","HUMAN OTC DRUG","Desenex Antifungal Foot Cream","","CREAM","TOPICAL","20250301","","OTC MONOGRAPH DRUG","M005","Crown Laboratories, Inc.","20","mg/g","","N","20261231"
"664","MICONAZOLE NITRATE","MICONAZOLE NITRATE","00316800001","Azole Antifungal [EPC], Azoles [CS]","0316-8000","0316-8000-01","0316-8000_09bb313e-90cb-5629-e063-6294a90ac268","HUMAN OTC DRUG","Zeasorb Athletes Foot","","POWDER","TOPICAL","20231019","","OTC MONOGRAPH DRUG","M005","Crown Laboratories","20","mg/g","","N","20251231"
"665","MICONAZOLE NITRATE","MICONAZOLE NITRATE","00316800102","Azole Antifungal [EPC], Azoles [CS]","0316-8001","0316-8001-02","0316-8001_09d088ef-aab3-5565-e063-6394a90af263","HUMAN OTC DRUG","Zeasorb Jock Itch","","POWDER","TOPICAL","20231019","","OTC MONOGRAPH DRUG","M005","Crown Laboratories","20","mg/g","","N","20251231"
"666","CEFAZOLIN SODIUM","Cefazolin Sodium","00338009606","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0338-0096","0338-0096-06","0338-0096_91298b84-e636-4b4d-8848-593964f9c8d5","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, SOLUTION","INTRAVENOUS","20240531","","NDA","NDA207131","Baxter Healthcare Corporation","3","g/150mL","","N","20261231"
"667","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00338012204","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0338-0122","0338-0122-04","0338-0122_db8b59dd-edfd-4c37-b875-7e73f1f0bf35","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, SOLUTION","INTRAVITREAL","19581114","","NDA","NDA050671","Baxter Healthcare Corporation","1.25","g/250mL","","N","20261231"
"668","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00338012404","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0338-0124","0338-0124-04","0338-0124_db8b59dd-edfd-4c37-b875-7e73f1f0bf35","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, SOLUTION","INTRAVITREAL","19581114","","NDA","NDA050671","Baxter Healthcare Corporation","1.5","g/300mL","","N","20261231"
"669","GENTAMICIN SULFATE","Gentamicin Sulfate","00338050348","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0338-0503","0338-0503-48","0338-0503_1853c7b2-32b0-487c-9d3c-7e884858ac7b","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate in Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","19820907","","ANDA","ANDA062373","Baxter Healthcare Corporation","80","mg/100mL","","N","20261231"
"670","GENTAMICIN SULFATE","Gentamicin Sulfate","00338050548","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0338-0505","0338-0505-48","0338-0505_1853c7b2-32b0-487c-9d3c-7e884858ac7b","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate in Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","19820907","","ANDA","ANDA062373","Baxter Healthcare Corporation","100","mg/100mL","","N","20261231"
"671","GENTAMICIN SULFATE","Gentamicin Sulfate","00338050741","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0338-0507","0338-0507-41","0338-0507_1853c7b2-32b0-487c-9d3c-7e884858ac7b","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate in Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","19820907","","ANDA","ANDA062373","Baxter Healthcare Corporation","60","mg/50mL","","N","20261231"
"672","GENTAMICIN SULFATE","Gentamicin Sulfate","00338050748","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0338-0507","0338-0507-48","0338-0507_1853c7b2-32b0-487c-9d3c-7e884858ac7b","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate in Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","19820907","","ANDA","ANDA062373","Baxter Healthcare Corporation","60","mg/50mL","","N","20261231"
"673","GENTAMICIN SULFATE","Gentamicin Sulfate","00338050941","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0338-0509","0338-0509-41","0338-0509_1853c7b2-32b0-487c-9d3c-7e884858ac7b","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate in Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","19820907","","ANDA","ANDA062373","Baxter Healthcare Corporation","80","mg/50mL","","N","20261231"
"674","GENTAMICIN SULFATE","Gentamicin Sulfate","00338051141","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0338-0511","0338-0511-41","0338-0511_1853c7b2-32b0-487c-9d3c-7e884858ac7b","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate in Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","19820907","","ANDA","ANDA062373","Baxter Healthcare Corporation","100","mg/50mL","","N","20261231"
"675","DAPTOMYCIN","Daptomycin in Sodium Chloride","00338071224","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","0338-0712","0338-0712-24","0338-0712_04d836cf-0428-4990-9c09-762c56b08942","HUMAN PRESCRIPTION DRUG","Daptomycin in Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","20220125","","NDA","NDA213645","Baxter Healthcare Corporation","350","mg/50mL","","N","20261231"
"676","DAPTOMYCIN","Daptomycin in Sodium Chloride","00338071424","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","0338-0714","0338-0714-24","0338-0714_04d836cf-0428-4990-9c09-762c56b08942","HUMAN PRESCRIPTION DRUG","Daptomycin in Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","20220125","","NDA","NDA213645","Baxter Healthcare Corporation","500","mg/50mL","","N","20261231"
"677","DAPTOMYCIN","Daptomycin in Sodium Chloride","00338071612","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","0338-0716","0338-0716-12","0338-0716_04d836cf-0428-4990-9c09-762c56b08942","HUMAN PRESCRIPTION DRUG","Daptomycin in Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","20220125","","NDA","NDA213645","Baxter Healthcare Corporation","700","mg/100mL","","N","20261231"
"678","DAPTOMYCIN","Daptomycin in Sodium Chloride","00338071812","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","0338-0718","0338-0718-12","0338-0718_04d836cf-0428-4990-9c09-762c56b08942","HUMAN PRESCRIPTION DRUG","Daptomycin in Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","20220125","","NDA","NDA213645","Baxter Healthcare Corporation","1000","mg/100mL","","N","20261231"
"679","OXACILLIN SODIUM","OXACILLIN","00338101541","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0338-1015","0338-1015-41","0338-1015_dc761dcc-7333-4b1c-90be-e9ec96e7b2aa","HUMAN PRESCRIPTION DRUG","OXACILLIN","","INJECTION, SOLUTION","INTRAVENOUS","19891026","","NDA","NDA050640","Baxter Healthcare Corporation","2","g/50mL","","N","20261231"
"680","NAFCILLIN SODIUM","NAFCILLIN","00338101948","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0338-1019","0338-1019-48","0338-1019_ad3cc424-4e9f-49e8-b72b-6969ae6b16b8","HUMAN PRESCRIPTION DRUG","NAFCILLIN","","INJECTION, SOLUTION","INTRAVENOUS","19891031","","NDA","NDA050655","Baxter Healthcare Corporation","2","g/100mL","","N","20261231"
"681","PENICILLIN G POTASSIUM","PENICILLIN G","00338102141","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0338-1021","0338-1021-41","0338-1021_b7e68f35-c49a-4137-841d-902b1b2b400a","HUMAN PRESCRIPTION DRUG","PENICILLIN G POTASSIUM","","INJECTION, SOLUTION","INTRAVENOUS","19900625","","NDA","NDA050638","Baxter Healthcare Corporation","1000000","[iU]/50mL","","N","20261231"
"682","PENICILLIN G POTASSIUM","PENICILLIN G","00338102341","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0338-1023","0338-1023-41","0338-1023_b7e68f35-c49a-4137-841d-902b1b2b400a","HUMAN PRESCRIPTION DRUG","PENICILLIN G POTASSIUM","","INJECTION, SOLUTION","INTRAVENOUS","19900625","","NDA","NDA050638","Baxter Healthcare Corporation","2000000","[iU]/50mL","","N","20261231"
"683","PENICILLIN G POTASSIUM","PENICILLIN G","00338102541","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0338-1025","0338-1025-41","0338-1025_b7e68f35-c49a-4137-841d-902b1b2b400a","HUMAN PRESCRIPTION DRUG","PENICILLIN G POTASSIUM","","INJECTION, SOLUTION","INTRAVENOUS","19900625","","NDA","NDA050638","Baxter Healthcare Corporation","3000000","[iU]/50mL","","N","20261231"
"684","METRONIDAZOLE","Metronidazole","00338105548","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0338-1055","0338-1055-48","0338-1055_3e7d4d73-778e-4e49-bd5b-2c70c5c92488","HUMAN PRESCRIPTION DRUG","Metronidazole","","INJECTION, SOLUTION","INTRAVENOUS","19811224","","NDA","NDA018657","Baxter Healthcare Corporation","500","mg/100mL","","N","20261231"
"685","CEFEPIME HYDROCHLORIDE","cefepime","00338130148","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0338-1301","0338-1301-48","0338-1301_c5dbd51b-47b1-4a3b-9a8a-f73a91471bd7","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, SOLUTION","INTRAVENOUS","20080805","","NDA","NDA050817","Baxter Healthcare Company","1","g/50mL","","N","20261231"
"686","CEFEPIME HYDROCHLORIDE","cefepime","00338130141","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0338-1301","0338-1301-41","0338-1301_c5dbd51b-47b1-4a3b-9a8a-f73a91471bd7","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, SOLUTION","INTRAVENOUS","20080805","","NDA","NDA050817","Baxter Healthcare Company","1","g/50mL","","N","20261231"
"687","CLINDAMYCIN PHOSPHATE","Clindamycin phosphate","00338341024","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0338-3410","0338-3410-24","0338-3410_9373fc85-1d70-4907-842a-ae9e2a3958b3","HUMAN PRESCRIPTION DRUG","Clindamycin phosphate","","INJECTION, SOLUTION","INTRAVENOUS","20170628","","ANDA","ANDA208084","Baxter Healthcare Company","300","mg/50mL","","N","20261231"
"688","CEFAZOLIN SODIUM","Cefazolin Sodium","00338350341","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0338-3503","0338-3503-41","0338-3503_91298b84-e636-4b4d-8848-593964f9c8d5","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, SOLUTION","INTRAVENOUS","20150807","","NDA","NDA207131","Baxter Healthcare Corporation","1","g/50mL","","N","20261231"
"689","CEFAZOLIN SODIUM","Cefazolin Sodium","00338350841","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0338-3508","0338-3508-41","0338-3508_91298b84-e636-4b4d-8848-593964f9c8d5","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, SOLUTION","INTRAVENOUS","20150807","","NDA","NDA207131","Baxter Healthcare Corporation","2","g/100mL","","N","20261231"
"690","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00338355148","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0338-3551","0338-3551-48","0338-3551_db8b59dd-edfd-4c37-b875-7e73f1f0bf35","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, SOLUTION","INTRAVENOUS","19581114","","NDA","NDA050671","Baxter Healthcare Corporation","500","mg/100mL","","N","20261231"
"691","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00338355248","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0338-3552","0338-3552-48","0338-3552_db8b59dd-edfd-4c37-b875-7e73f1f0bf35","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, SOLUTION","INTRAVENOUS","19581114","","NDA","NDA050671","Baxter Healthcare Corporation","1","g/200mL","","N","20261231"
"692","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00338358048","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0338-3580","0338-3580-48","0338-3580_db8b59dd-edfd-4c37-b875-7e73f1f0bf35","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, SOLUTION","INTRAVENOUS","19581114","","NDA","NDA050671","Baxter Healthcare Corporation","750","mg/150mL","","N","20261231"
"693","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00338358101","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0338-3581","0338-3581-01","0338-3581_db8b59dd-edfd-4c37-b875-7e73f1f0bf35","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, SOLUTION","INTRAVENOUS","19581114","","NDA","NDA050671","Baxter Healthcare Corporation","500","mg/100mL","","N","20261231"
"694","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00338358201","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0338-3582","0338-3582-01","0338-3582_db8b59dd-edfd-4c37-b875-7e73f1f0bf35","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, SOLUTION","INTRAVENOUS","19581114","","NDA","NDA050671","Baxter Healthcare Corporation","750","mg/150mL","","N","20261231"
"695","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00338358301","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0338-3583","0338-3583-01","0338-3583_db8b59dd-edfd-4c37-b875-7e73f1f0bf35","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, SOLUTION","INTRAVENOUS","19581114","","NDA","NDA050671","Baxter Healthcare Corporation","1","g/200mL","","N","20261231"
"696","CLINDAMYCIN PHOSPHATE","Clindamycin phosphate","00338361224","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0338-3612","0338-3612-24","0338-3612_9373fc85-1d70-4907-842a-ae9e2a3958b3","HUMAN PRESCRIPTION DRUG","Clindamycin phosphate","","INJECTION, SOLUTION","INTRAVENOUS","20170628","","ANDA","ANDA208084","Baxter Healthcare Company","600","mg/50mL","","N","20261231"
"697","CLINDAMYCIN PHOSPHATE","Clindamycin phosphate","00338361624","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0338-3616","0338-3616-24","0338-3616_151b9dab-e2c2-4af6-9a4a-981e3ae81f1e","HUMAN PRESCRIPTION DRUG","Clindamycin phosphate","","INJECTION, SOLUTION","INTRAVENOUS","20170628","","ANDA","ANDA208084","Baxter Healthcare Company","600","mg/50mL","","N","20261231"
"698","CLINDAMYCIN PHOSPHATE","Clindamycin phosphate","00338381424","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0338-3814","0338-3814-24","0338-3814_9373fc85-1d70-4907-842a-ae9e2a3958b3","HUMAN PRESCRIPTION DRUG","Clindamycin phosphate","","INJECTION, SOLUTION","INTRAVENOUS","20170628","","ANDA","ANDA208084","Baxter Healthcare Company","900","mg/50mL","","N","20261231"
"699","CLINDAMYCIN PHOSPHATE","Clindamycin phosphate","00338411424","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0338-4114","0338-4114-24","0338-4114_151b9dab-e2c2-4af6-9a4a-981e3ae81f1e","HUMAN PRESCRIPTION DRUG","Clindamycin phosphate","","INJECTION, SOLUTION","INTRAVENOUS","20170628","","ANDA","ANDA208084","Baxter Healthcare Company","900","mg/50mL","","N","20261231"
"700","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00338500241","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0338-5002","0338-5002-41","0338-5002_c995bfa9-ea1d-4612-9a58-976c505f8281","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, SOLUTION","INTRAVENOUS","20050823","","ANDA","ANDA065224","Baxter Healthcare Company","1","g/50mL","","N","20261231"
"701","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00338500341","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0338-5003","0338-5003-41","0338-5003_c995bfa9-ea1d-4612-9a58-976c505f8281","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, SOLUTION","INTRAVENOUS","20050823","","ANDA","ANDA065224","Baxter Healthcare Company","2","g/50mL","","N","20261231"
"702","FLUCONAZOLE","Fluconazole","00338604537","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0338-6045","0338-6045-37","0338-6045_cd799cf9-3fc9-431e-a1a3-e5fc7fe57544","HUMAN PRESCRIPTION DRUG","Fluconazole","","INJECTION, SOLUTION","INTRAVENOUS","20040729","","ANDA","ANDA076766","Baxter Healthcare Company","400","mg/200mL","","N","20261231"
"703","FLUCONAZOLE","Fluconazole","00338604648","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0338-6046","0338-6046-48","0338-6046_cd799cf9-3fc9-431e-a1a3-e5fc7fe57544","HUMAN PRESCRIPTION DRUG","Fluconazole","","INJECTION, SOLUTION","INTRAVENOUS","20040729","","ANDA","ANDA076766","Baxter Healthcare Company","200","mg/100mL","","N","20261231"
"704","MICAFUNGIN SODIUM","Micafungin in Sodium Chloride","00338905112","Echinocandin Antifungal [EPC], Lipopeptides [CS]","0338-9051","0338-9051-12","0338-9051_c4a06712-4236-4c33-b5ae-77db633e8303","HUMAN PRESCRIPTION DRUG","Micafungin in Sodium Chloride","","INJECTION","INTRAVENOUS","20230929","","NDA","NDA216142","Baxter Healthcare Corporation","50","mg/50mL","","N","20261231"
"705","MICAFUNGIN SODIUM","Micafungin in Sodium Chloride","00338905312","Echinocandin Antifungal [EPC], Lipopeptides [CS]","0338-9053","0338-9053-12","0338-9053_c4a06712-4236-4c33-b5ae-77db633e8303","HUMAN PRESCRIPTION DRUG","Micafungin in Sodium Chloride","","INJECTION","INTRAVENOUS","20230929","","NDA","NDA216142","Baxter Healthcare Corporation","100","mg/100mL","","N","20261231"
"706","MICAFUNGIN SODIUM","Micafungin in Sodium Chloride","00338905510","Echinocandin Antifungal [EPC], Lipopeptides [CS]","0338-9055","0338-9055-10","0338-9055_c4a06712-4236-4c33-b5ae-77db633e8303","HUMAN PRESCRIPTION DRUG","Micafungin in Sodium Chloride","","INJECTION","INTRAVENOUS","20230929","","NDA","NDA216142","Baxter Healthcare Corporation","150","mg/150mL","","N","20261231"
"707","METRONIDAZOLE","Metronidazole","00338954124","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0338-9541","0338-9541-24","0338-9541_c71643a8-e010-407a-bbcb-c60677227ed0","HUMAN PRESCRIPTION DRUG","Metronidazole","","INJECTION, SOLUTION","INTRAVENOUS","19811224","","NDA","NDA018657","Baxter Healthcare Corporation","500","mg/100mL","","N","20261231"
"708","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00338954524","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0338-9545","0338-9545-24","0338-9545_12bdbbc9-fbb0-4a0a-9147-37df8ac5dc5e","HUMAN PRESCRIPTION DRUG","clindamycin phosphate","","INJECTION, SOLUTION","INTRAVENOUS","20170420","","NDA","NDA208083","Baxter Healthcare Company","300","mg/50mL","","N","20261231"
"709","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00338954924","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0338-9549","0338-9549-24","0338-9549_12bdbbc9-fbb0-4a0a-9147-37df8ac5dc5e","HUMAN PRESCRIPTION DRUG","clindamycin phosphate","","INJECTION, SOLUTION","INTRAVENOUS","20170420","","NDA","NDA208083","Baxter Healthcare Company","600","mg/50mL","","N","20261231"
"710","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00338955324","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0338-9553","0338-9553-24","0338-9553_12bdbbc9-fbb0-4a0a-9147-37df8ac5dc5e","HUMAN PRESCRIPTION DRUG","clindamycin phosphate","","INJECTION, SOLUTION","INTRAVENOUS","20170420","","NDA","NDA208083","Baxter Healthcare Company","900","mg/50mL","","N","20261231"
"711","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin sodium and tazobactam sodium","00338963224","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0338-9632","0338-9632-24","0338-9632_d1d6e9c8-a033-4e26-a687-e6325808fa0a","HUMAN PRESCRIPTION DRUG","Zosyn","","INJECTION, SOLUTION","INTRAVENOUS","20230401","","NDA","NDA050750","Baxter Healthcare Corporation","2; .25","g/50mL; g/50mL","","N","20261231"
"712","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin sodium and tazobactam sodium","00338963624","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0338-9636","0338-9636-24","0338-9636_d1d6e9c8-a033-4e26-a687-e6325808fa0a","HUMAN PRESCRIPTION DRUG","Zosyn","","INJECTION, SOLUTION","INTRAVENOUS","20230401","","NDA","NDA050750","Baxter Healthcare Corporation","3; .375","g/50mL; g/50mL","","N","20261231"
"713","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin sodium and tazobactam sodium","00338963812","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0338-9638","0338-9638-12","0338-9638_d1d6e9c8-a033-4e26-a687-e6325808fa0a","HUMAN PRESCRIPTION DRUG","Zosyn","","INJECTION, SOLUTION","INTRAVENOUS","20230401","","NDA","NDA050750","Baxter Healthcare Corporation","4; .5","g/100mL; g/100mL","","N","20261231"
"714","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate","00363001856","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0363-0018","0363-0018-56","0363-0018_cd61611a-d7bc-4466-b439-080ff720c878","HUMAN OTC DRUG","Antibiotic","Maximum Strength","OINTMENT","TOPICAL","19980616","","OTC MONOGRAPH DRUG","M004","Walgreens","500; 3.5; 10000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"715","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate","00363017934","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0363-0179","0363-0179-34","0363-0179_a85125fe-e9c9-4bd8-adb7-b292e39fe484","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20050119","20260119","OTC MONOGRAPH DRUG","M004","Walgreens","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N",""
"716","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate","00363017956","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0363-0179","0363-0179-56","0363-0179_a85125fe-e9c9-4bd8-adb7-b292e39fe484","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20050119","20260119","OTC MONOGRAPH DRUG","M004","Walgreens","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N",""
"717","CLOTRIMAZOLE","Clotrimazole","00363022063","Azole Antifungal [EPC], Azoles [CS]","0363-0220","0363-0220-63","0363-0220_e7fded81-1545-4c35-a24d-82dbbb31ca24","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","19980901","","ANDA","ANDA074165","Walgreens","10","mg/g","","N","20251231"
"718","TIOCONAZOLE","Tioconazole","00363042654","Azole Antifungal [EPC], Azoles [CS]","0363-0426","0363-0426-54","0363-0426_b3a3bba8-ee12-4e9d-a39a-7e88e3e96e35","HUMAN OTC DRUG","Tioconazole 1","","OINTMENT","VAGINAL","20071219","","ANDA","ANDA075915","Walgreen Company","6.5","g/100g","","N","20251231"
"719","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","00363053926","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0363-0539","0363-0539-26","0363-0539_801aadf0-611d-4ea9-8015-3542dc981d5b","HUMAN OTC DRUG","triple antibiotic","","OINTMENT","TOPICAL","20150507","","OTC MONOGRAPH DRUG","M004","Walgreen Company","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"720","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","00363053916","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0363-0539","0363-0539-16","0363-0539_801aadf0-611d-4ea9-8015-3542dc981d5b","HUMAN OTC DRUG","triple antibiotic","","OINTMENT","TOPICAL","20150507","","OTC MONOGRAPH DRUG","M004","Walgreen Company","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"721","MICONAZOLE NITRATE","Miconazole Nitrate","00363073041","Azole Antifungal [EPC], Azoles [CS]","0363-0730","0363-0730-41","0363-0730_3ee5a5de-3747-48fe-b1ab-acc28d787e0a","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20001201","","ANDA","ANDA074164","Walgreens","20","mg/g","","N","20251231"
"722","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl","00363084158","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0363-0841","0363-0841-58","0363-0841_f072c90e-0654-4837-b936-c4bebb5f23f8","HUMAN OTC DRUG","First Aid Antibiotic","","OINTMENT","TOPICAL","20170216","","OTC MONOGRAPH DRUG","M004","Walgreen Company","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"723","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate","00363133101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0363-1331","0363-1331-01","0363-1331_653c88bf-5b7d-45be-a131-d59990573e9c","HUMAN OTC DRUG","ANTIBIOTIC","Maximum Strength","OINTMENT","TOPICAL","20250129","","OTC MONOGRAPH DRUG","M004","Walgreens Co.","500; 3.5; 10000","[iU]/g; mg/g; [iU]/g","","N","20261231"
"724","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","00363133201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0363-1332","0363-1332-01","0363-1332_32df5cca-77bc-45d2-b1f6-2cfdfc371ea9","HUMAN OTC DRUG","triple antibiotic","","OINTMENT","TOPICAL","20250129","","OTC MONOGRAPH DRUG","M004","Walgreens Co.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"725","CLOTRIMAZOLE","Clotrimazole","00363206201","Azole Antifungal [EPC], Azoles [CS]","0363-2062","0363-2062-01","0363-2062_284ed948-4d7b-7f4f-e063-6394a90af9a9","HUMAN OTC DRUG","Walgreens","Clotrimazole 3","CREAM","VAGINAL","20000412","","NDA","NDA021143","Walgreen Company","2","g/100g","","N","20251231"
"726","MICONAZOLE NITRATE","miconazole nitrate","00363207014","Azole Antifungal [EPC], Azoles [CS]","0363-2070","0363-2070-14","0363-2070_083e194f-b107-45e6-b95d-25ae191cccb6","HUMAN OTC DRUG","miconazole 3","","CREAM","VAGINAL","20180615","","ANDA","ANDA091366","Walgreen Company","40","mg/g","","N","20261231"
"727","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","00363208001","Allylamine Antifungal [EPC], Allylamine [CS]","0363-2080","0363-2080-01","0363-2080_155ef807-1c73-765d-e063-6294a90ae8a0","HUMAN OTC DRUG","Walgreens","Athletes Foot","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Walgreen Company","1","g/100g","","N","20251231"
"728","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","00363208002","Allylamine Antifungal [EPC], Allylamine [CS]","0363-2080","0363-2080-02","0363-2080_155ef807-1c73-765d-e063-6294a90ae8a0","HUMAN OTC DRUG","Walgreens","Athletes Foot","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Walgreen Company","1","g/100g","","N","20251231"
"729","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","00363208301","Allylamine Antifungal [EPC], Allylamine [CS]","0363-2083","0363-2083-01","0363-2083_aab4fe7d-4fa1-4751-b681-3d041dc116ce","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Walgreen Company","1","g/100g","","N","20251231"
"730","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","00363210002","Benzylamine Antifungal [EPC], Benzylamines [CS]","0363-2100","0363-2100-02","0363-2100_10ca0433-7157-3635-e063-6294a90ab906","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","Walgreen Company","10","mg/g","","N","20251231"
"731","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","00363210108","Benzylamine Antifungal [EPC], Benzylamines [CS]","0363-2101","0363-2101-08","0363-2101_4c018fd2-bfdc-4f58-b62a-d4c39ce5d6fa","HUMAN OTC DRUG","Jock Itch","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","Walgreen Company","10","mg/g","","N","20251231"
"732","CLOTRIMAZOLE","Clotrimazole","00363210501","Azole Antifungal [EPC], Azoles [CS]","0363-2105","0363-2105-01","0363-2105_12a1e4d8-d0ee-4626-e063-6394a90ade3f","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Walgreen Company","10","mg/g","","N","20251231"
"733","CLOTRIMAZOLE","Clotrimazole","00363210502","Azole Antifungal [EPC], Azoles [CS]","0363-2105","0363-2105-02","0363-2105_12a1e4d8-d0ee-4626-e063-6394a90ade3f","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Walgreen Company","10","mg/g","","N","20251231"
"734","CLOTRIMAZOLE","Clotrimazole","00363210701","Azole Antifungal [EPC], Azoles [CS]","0363-2107","0363-2107-01","0363-2107_308f7d5f-db2c-2edb-e063-6394a90a2d56","HUMAN OTC DRUG","Ringworm","","CREAM","TOPICAL","20210402","","OTC MONOGRAPH DRUG","M005","Walgreen Company","10","mg/g","","N","20261231"
"735","CLOTRIMAZOLE","Clotrimazole","00363210901","Azole Antifungal [EPC], Azoles [CS]","0363-2109","0363-2109-01","0363-2109_e1a6fc36-5eb9-407b-a815-f703d51c1bd5","HUMAN OTC DRUG","Walgreens","Jock Itch","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Walgreen Company","10","mg/g","","N","20251231"
"736","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Polymyxin B Sulfate, Neomycin Sulfate, Pramoxine Hydrochloride","00363212214","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0363-2122","0363-2122-14","0363-2122_e2259c15-7a2e-4cae-bca8-791d41b35f12","HUMAN OTC DRUG","Walgreens Kids Multi-Antibiotic with Pain Relief Cream","","CREAM","TOPICAL","20221201","","OTC MONOGRAPH DRUG","M004","Walgreens Company","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"737","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Polymyxin B Sulfate, Neomycin Sulfate, Pramoxine Hydrochloride","00363212328","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0363-2123","0363-2123-28","0363-2123_cc7521e6-18ba-45d1-8dba-1151da0162e7","HUMAN OTC DRUG","Walgreens Multi-Antibiotic with Pain Relief Cream","","CREAM","TOPICAL","20150715","","OTC MONOGRAPH DRUG","M004","Walgreens Company","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"738","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Polymyxin B Sulfate, Neomycin Sulfate, Pramoxine Hydrochloride","00363212314","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0363-2123","0363-2123-14","0363-2123_cc7521e6-18ba-45d1-8dba-1151da0162e7","HUMAN OTC DRUG","Walgreens Multi-Antibiotic with Pain Relief Cream","","CREAM","TOPICAL","20150715","","OTC MONOGRAPH DRUG","M004","Walgreens Company","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"739","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate, Pramoxine hydrochloride","00363290005","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0363-2900","0363-2900-05","0363-2900_1c5c07a4-41a6-44b4-a4f5-59203bf3607b","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20201127","20260127","OTC MONOGRAPH DRUG","M004","Walgreens","500; 3.5; 10000; 10","[iU]/g; mg/g; [USP'U]/g; mg/g","","N",""
"740","MICONAZOLE NITRATE","Anti-fungal Powder Miconazole Nitrate Talc Free","00363311525","Azole Antifungal [EPC], Azoles [CS]","0363-3115","0363-3115-25","0363-3115_2916aace-d977-f0cf-e063-6294a90a7492","HUMAN OTC DRUG","Miconazole Nitrate","","POWDER","TOPICAL","20180601","20260531","OTC MONOGRAPH DRUG","M005","Walgreens Company","1.42","g/71g","","N",""
"741","MICONAZOLE NITRATE","Athletes Foot Liquid","00363420853","Azole Antifungal [EPC], Azoles [CS]","0363-4208","0363-4208-53","0363-4208_2916e6c3-dfda-2066-e063-6394a90a7a46","HUMAN OTC DRUG","Miconazole Nitrate","","SPRAY","TOPICAL","20100518","","OTC MONOGRAPH DRUG","M005","Walgreens Company","3","g/150g","","N","20251231"
"742","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","00363450202","Allylamine Antifungal [EPC], Allylamine [CS]","0363-4502","0363-4502-02","0363-4502_17f56c6c-8e8b-b4fc-e063-6294a90a7160","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20231025","","ANDA","ANDA077511","WALGREEN COMPANY","1","g/100g","","N","20251231"
"743","MICONAZOLE NITRATE","Jock Itch Spray","00363535300","Azole Antifungal [EPC], Azoles [CS]","0363-5353","0363-5353-00","0363-5353_28dc1e34-7027-9c8c-e063-6394a90acc3c","HUMAN OTC DRUG","Miconazole Nitrate 2%","","AEROSOL, SPRAY","TOPICAL","20211028","","OTC MONOGRAPH DRUG","M005","Walgreens Company","1.3","g/131g","","N","20251231"
"744","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl","00363679058","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0363-6790","0363-6790-58","0363-6790_6d975a99-4c09-412b-a9ae-59962e3d4d94","HUMAN OTC DRUG","triple antibiotic pain relief","","OINTMENT","TOPICAL","20240307","","OTC MONOGRAPH DRUG","M004","Walgreen Company","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"745","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl","00363679064","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0363-6790","0363-6790-64","0363-6790_6d975a99-4c09-412b-a9ae-59962e3d4d94","HUMAN OTC DRUG","triple antibiotic pain relief","","OINTMENT","TOPICAL","20240307","","OTC MONOGRAPH DRUG","M004","Walgreen Company","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"746","MICONAZOLE NITRATE","Antifungal Miconazole Powder Spray","00363741800","Azole Antifungal [EPC], Azoles [CS]","0363-7418","0363-7418-00","0363-7418_2759f3eb-b0d5-8b63-e063-6394a90a6ccd","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, SPRAY","TOPICAL","20211014","","OTC MONOGRAPH DRUG","M005","Walgreens Company","2.6","g/130g","","N","20251231"
"747","MICONAZOLE NITRATE","Miconazole Nitrate","00363799901","Azole Antifungal [EPC], Azoles [CS]","0363-7999","0363-7999-01","0363-7999_292c89a3-c9b9-946e-e063-6294a90ae45f","HUMAN OTC DRUG","Foot Powder","","POWDER","TOPICAL","20240312","","OTC MONOGRAPH DRUG","M005","Walgreens Company","20","mg/g","","N","20251231"
"748","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and pramoxine hydrochloride","00363888815","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0363-8888","0363-8888-15","0363-8888_2630bfec-db6b-290a-e063-6394a90a82c7","HUMAN OTC DRUG","Triple Antibiotic","Plus Pain Relief","OINTMENT","TOPICAL","20120331","","OTC MONOGRAPH DRUG","M004","Walgreen Company","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"749","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and pramoxine hydrochloride","00363888830","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0363-8888","0363-8888-30","0363-8888_2630bfec-db6b-290a-e063-6394a90a82c7","HUMAN OTC DRUG","Triple Antibiotic","Plus Pain Relief","OINTMENT","TOPICAL","20120331","","OTC MONOGRAPH DRUG","M004","Walgreen Company","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"750","MICONAZOLE NITRATE","Miconazole Nitrate","00363922301","Azole Antifungal [EPC], Azoles [CS]","0363-9223","0363-9223-01","0363-9223_28d955ae-eec5-64fc-e063-6294a90a154d","HUMAN OTC DRUG","Jock Itch Powder","","POWDER","TOPICAL","20240509","","OTC MONOGRAPH DRUG","M005","Walgreens Company","20","mg/g","","N","20251231"
"751","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","00378416001","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","0378-4160","0378-4160-01","0378-4160_bcbdccd4-74df-4499-9d98-2e95c958c7f6","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil Hydrochloride","","TABLET, FILM COATED","ORAL","20140528","","ANDA","ANDA202362","Mylan Pharmaceuticals Inc.","62.5; 25","mg/1; mg/1","","N","20251231"
"752","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","00378416201","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","0378-4162","0378-4162-01","0378-4162_bcbdccd4-74df-4499-9d98-2e95c958c7f6","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil Hydrochloride","","TABLET, FILM COATED","ORAL","20140528","","ANDA","ANDA202362","Mylan Pharmaceuticals Inc.","250; 100","mg/1; mg/1","","N","20251231"
"753","ERYTHROMYCIN","erythromycin","00378807593","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","0378-8075","0378-8075-93","0378-8075_774c4992-ab95-47ec-aef9-e2c767a4b81f","HUMAN PRESCRIPTION DRUG","ERYGEL","","GEL","TOPICAL","20190307","20250930","NDA","NDA050617","Mylan Pharmaceuticals Inc.","20","mg/g","","N",""
"754","ERYTHROMYCIN","erythromycin","00378807560","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","0378-8075","0378-8075-60","0378-8075_774c4992-ab95-47ec-aef9-e2c767a4b81f","HUMAN PRESCRIPTION DRUG","ERYGEL","","GEL","TOPICAL","20190307","20250930","NDA","NDA050617","Mylan Pharmaceuticals Inc.","20","mg/g","","N",""
"755","ERYTHROMYCIN","erythromycin","00378821260","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","0378-8212","0378-8212-60","0378-8212_11eb1f78-044c-4110-8f9b-a6b733972876","HUMAN PRESCRIPTION DRUG","Erythromycin","","GEL","TOPICAL","20181019","20250930","NDA AUTHORIZED GENERIC","NDA050617","Mylan Pharmaceuticals Inc.","20","mg/g","","N",""
"756","ERYTHROMYCIN","erythromycin","00378821293","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","0378-8212","0378-8212-93","0378-8212_11eb1f78-044c-4110-8f9b-a6b733972876","HUMAN PRESCRIPTION DRUG","Erythromycin","","GEL","TOPICAL","20181019","20250930","NDA AUTHORIZED GENERIC","NDA050617","Mylan Pharmaceuticals Inc.","20","mg/g","","N",""
"757","MICONAZOLE NITRATE; PETROLATUM; ZINC OXIDE","miconazole nitrate, zinc oxide, white petrolatum","00378822250","Azole Antifungal [EPC], Azoles [CS]","0378-8222","0378-8222-50","0378-8222_1b5de1cf-d19f-424b-86c0-e2ebcb0b3cf0","HUMAN PRESCRIPTION DRUG","VUSION","","OINTMENT","TOPICAL","20181106","20261231","NDA AUTHORIZED GENERIC","NDA021026","Mylan Pharmaceuticals Inc.","2.5; 813.5; 150","mg/g; mg/g; mg/g","","N",""
"758","MICONAZOLE NITRATE; PETROLATUM; ZINC OXIDE","miconazole nitrate, zinc oxide, white petrolatum","00378973050","Azole Antifungal [EPC], Azoles [CS]","0378-9730","0378-9730-50","0378-9730_ef8a249b-a7e8-441f-be59-e8fd2d168627","HUMAN PRESCRIPTION DRUG","VUSION","","OINTMENT","TOPICAL","20200206","","NDA","NDA021026","Mylan Pharmaceuticals Inc.","2.5; 813.5; 150","mg/g; mg/g; mg/g","","N","20251231"
"759","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","00404016750","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0404-0167","0404-0167-50","0404-0167_27e95eeb-e5b0-ca71-e063-6394a90a675d","HUMAN OTC DRUG","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","","OINTMENT","TOPICAL","20221103","","OTC MONOGRAPH DRUG","M004","Henry Schein","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"760","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate","00404017150","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0404-0171","0404-0171-50","0404-0171_27e95e9b-1558-f121-e063-6394a90ad739","HUMAN OTC DRUG","Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate","","OINTMENT","TOPICAL","20221104","","OTC MONOGRAPH DRUG","M004","Henry Schein","400; 5; 50000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"761","AMPICILLIN SODIUM","ampicillin sodium","00404980399","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0404-9803","0404-9803-99","0404-9803_bf1b28f8-31cd-4e2d-9aa4-621ffca2bb3a","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240826","","ANDA","ANDA062719","Henry Schein, Inc.","1","g/1","","N","20251231"
"762","AMPICILLIN SODIUM","AMPICILLIN SODIUM","00404981699","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0404-9816","0404-9816-99","0404-9816_bd962345-a6a6-4357-829a-97945b31311f","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220108","20260430","ANDA","ANDA065499","Henry Schein, Inc.","1","g/1","","N",""
"763","AMPICILLIN SODIUM","AMPICILLIN SODIUM","00404981899","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0404-9818","0404-9818-99","0404-9818_8cc56899-c997-4004-9eea-e46b4fdc661d","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20220117","","ANDA","ANDA065499","Henry Schein, Inc.","2","g/1","","N","20251231"
"764","CEFAZOLIN SODIUM","cefazolin","00404983399","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0404-9833","0404-9833-99","0404-9833_b4269c9b-dd69-4b0e-bfb5-54055a48fc30","HUMAN PRESCRIPTION DRUG","CEFAZOLIN","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220109","","ANDA","ANDA203661","Henry Schein, Inc.","1","g/1","","N","20251231"
"765","CEFAZOLIN SODIUM","cefazolin","00404983499","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0404-9834","0404-9834-99","0404-9834_7368abed-2684-45e4-89f9-3b4a363280ef","HUMAN PRESCRIPTION DRUG","CEFAZOLIN","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220109","","ANDA","ANDA065047","Henry Schein, Inc.","330","mg/mL","","N","20251231"
"766","CEFAZOLIN SODIUM","cefazolin","00404983599","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0404-9835","0404-9835-99","0404-9835_704b9e57-d3f7-43d4-9202-8025398f6538","HUMAN PRESCRIPTION DRUG","CEFAZOLIN","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220109","","ANDA","ANDA065047","Henry Schein Inc.","225","mg/mL","","N","20251231"
"767","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","00404983702","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0404-9837","0404-9837-02","0404-9837_9d617c75-9ae0-45e0-b938-78e27d2bab87","HUMAN PRESCRIPTION DRUG","CLEOCIN PHOSPHATE","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220109","","NDA","NDA050441","Henry Schein, Inc.","150","mg/mL","","N","20261231"
"768","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","00404983806","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0404-9838","0404-9838-06","0404-9838_263be3fc-7e28-4454-a69e-e869e1d3616b","HUMAN PRESCRIPTION DRUG","Clindamycin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220109","","ANDA","ANDA090108","Henry Schein, Inc.","150","mg/mL","","N","20261231"
"769","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","00404983802","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0404-9838","0404-9838-02","0404-9838_263be3fc-7e28-4454-a69e-e869e1d3616b","HUMAN PRESCRIPTION DRUG","Clindamycin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220109","","ANDA","ANDA090108","Henry Schein, Inc.","150","mg/mL","","N","20261231"
"770","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","00404983804","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0404-9838","0404-9838-04","0404-9838_263be3fc-7e28-4454-a69e-e869e1d3616b","HUMAN PRESCRIPTION DRUG","Clindamycin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220109","","ANDA","ANDA090108","Henry Schein, Inc.","150","mg/mL","","N","20261231"
"771","GENTAMICIN SULFATE","Gentamicin Sulfate","00404986502","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0404-9865","0404-9865-02","0404-9865_592ecf05-8def-418b-9624-942a355afbad","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220110","","ANDA","ANDA062420","Henry Schein, Inc.","40","mg/mL","","N","20251231"
"772","GENTAMICIN SULFATE","Gentamicin Sulfate","00404986620","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0404-9866","0404-9866-20","0404-9866_bfeb4cd4-f094-4a2a-9d6d-8cead9083dd1","HUMAN PRESCRIPTION DRUG","Gentamicin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220110","","ANDA","ANDA062366","Henry Schein, Inc","40","mg/mL","","N","20251231"
"773","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","00404996599","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0404-9965","0404-9965-99","0404-9965_1958a430-4417-4550-925c-2e115cff843f","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220111","","ANDA","ANDA062911","Henry Schein, Inc.","500","mg/1","","N","20251231"
"774","METRONIDAZOLE","metronidazole","00404999100","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0404-9991","0404-9991-00","0404-9991_78d81dbb-655c-4828-a281-bd63f83f9cee","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","INJECTION, SOLUTION","INTRAVENOUS","20230224","","ANDA","ANDA206191","Henry Schein, Inc.","500","mg/100mL","","N","20251231"
"775","POSACONAZOLE","posaconazole","00406771160","Azole Antifungal [EPC], Azoles [CS]","0406-7711","0406-7711-60","0406-7711_b1a030e6-0310-4cce-b900-886aa3daca88","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","TABLET, DELAYED RELEASE","ORAL","20220510","","ANDA","ANDA212226","SpecGx LLC","100","mg/1","","N","20261231"
"776","DAPTOMYCIN","DAPTOMYCIN","00409012001","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","0409-0120","0409-0120-01","0409-0120_82b124e9-01d4-4e8c-b9cc-0dec0dc282a5","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210802","","NDA","NDA210282","Hospira, Inc.","350","mg/7mL","","N","20261231"
"777","DAPTOMYCIN","DAPTOMYCIN","00409012201","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","0409-0122","0409-0122-01","0409-0122_82b124e9-01d4-4e8c-b9cc-0dec0dc282a5","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210802","","NDA","NDA210282","Hospira, Inc.","500","mg/10mL","","N","20261231"
"778","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN","00409014411","Macrolide Antimicrobial [EPC], Macrolides [CS]","0409-0144","0409-0144-11","0409-0144_0daee3b8-efec-4ff2-aedf-87035563373f","HUMAN PRESCRIPTION DRUG","Azithromycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20090626","","ANDA","ANDA065500","Hospira, Inc.","500","mg/1","","N","20261231"
"779","METRONIDAZOLE","Metronidazole","00409015224","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0409-0152","0409-0152-24","0409-0152_016415af-48d9-4058-a80e-f5dd1704e6fc","HUMAN PRESCRIPTION DRUG","Metronidazole","","INJECTION, SOLUTION","INTRAVENOUS","20211213","","ANDA","ANDA206191","Hospira, Inc.","5","mg/mL","","N","20251231"
"780","MEROPENEM","Meropenem","00409022210","Carbapenems [CS], Penem Antibacterial [EPC]","0409-0222","0409-0222-10","0409-0222_2ad24c61-4908-4053-997a-9d0a9e6810dc","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20221206","","ANDA","ANDA091404","Hospira, Inc.","500","mg/10mL","","N","20251231"
"781","AZTREONAM","Aztreonam","00409082901","Monobactam Antibacterial [EPC], Monobactams [CS]","0409-0829","0409-0829-01","0409-0829_8664bd65-dcd7-420f-a8e3-01eaf3e02b36","HUMAN PRESCRIPTION DRUG","Aztreonam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220124","","ANDA","ANDA206517","Hospira, Inc.","1","g/1","","N","20251231"
"782","AZTREONAM","Aztreonam","00409083001","Monobactam Antibacterial [EPC], Monobactams [CS]","0409-0830","0409-0830-01","0409-0830_8664bd65-dcd7-420f-a8e3-01eaf3e02b36","HUMAN PRESCRIPTION DRUG","Aztreonam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220124","","ANDA","ANDA206517","Hospira, Inc.","2","g/1","","N","20251231"
"783","GENTAMICIN SULFATE","GENTAMICIN SULFATE","00409120703","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0409-1207","0409-1207-03","0409-1207_90119984-4be7-494f-9ba0-61ec49c15143","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050829","","ANDA","ANDA062420","Hospira, Inc.","40","mg/mL","","N","20251231"
"784","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00409131901","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0409-1319","0409-1319-01","0409-1319_39396834-5ba8-43a0-8ba2-719755e332b9","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20211102","","ANDA","ANDA063076","Hospira, Inc.","500","mg/5mL","","N","20261231"
"785","MEROPENEM","Meropenem","00409139051","Carbapenems [CS], Penem Antibacterial [EPC]","0409-1390","0409-1390-51","0409-1390_6bd78500-6717-4df3-86d4-23cba124547e","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20191009","","ANDA","ANDA091404","Hospira, Inc.","500","mg/10mL","","N","20251231"
"786","MEROPENEM","Meropenem","00409139122","Carbapenems [CS], Penem Antibacterial [EPC]","0409-1391","0409-1391-22","0409-1391_6bd78500-6717-4df3-86d4-23cba124547e","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20191009","","ANDA","ANDA091404","Hospira, Inc.","1","g/20mL","","N","20251231"
"787","CIPROFLOXACIN","ciprofloxacin","00409230024","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0409-2300","0409-2300-24","0409-2300_6f4bacb9-10fd-4e44-9037-dae6c583f708","HUMAN PRESCRIPTION DRUG","Ciprofloxacin in Dextrose","","INJECTION, SOLUTION","INTRAVENOUS","20230630","","ANDA","ANDA078252","Hospira, Inc.","200","mg/100mL","","N","20251231"
"788","CEFAZOLIN SODIUM","Cefazolin","00409258501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-2585","0409-2585-01","0409-2585_24419190-91d0-4ec9-9ee6-478b5775af1d","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20070509","","ANDA","ANDA065345","Hospira, Inc","1","g/1","","N","20251231"
"789","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin sodium and Sulbactam sodium","00409268901","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0409-2689","0409-2689-01","0409-2689_a7becee9-0e7e-4732-9cae-bc7369a5d91b","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20060725","","ANDA","ANDA065310","Hospira, Inc","1; .5","g/1; g/1","","N","20251231"
"790","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin sodium and Sulbactam sodium","00409298703","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0409-2987","0409-2987-03","0409-2987_a7becee9-0e7e-4732-9cae-bc7369a5d91b","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20060725","","ANDA","ANDA065310","Hospira, Inc","2; 1","g/1; g/1","","N","20251231"
"791","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","00409299914","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0409-2999","0409-2999-14","0409-2999_af500e36-42ae-496e-8e2c-caa5802ede7c","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS; PARENTERAL","20161214","","ANDA","ANDA203557","Hospira, Inc","12; 1.5","g/60mL; g/60mL","","N","20261231"
"792","CIPROFLOXACIN","ciprofloxacin","00409330024","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0409-3300","0409-3300-24","0409-3300_6f4bacb9-10fd-4e44-9037-dae6c583f708","HUMAN PRESCRIPTION DRUG","Ciprofloxacin in Dextrose","","INJECTION, SOLUTION","INTRAVENOUS","20221201","","ANDA","ANDA078252","Hospira, Inc.","400","mg/200mL","","N","20251231"
"793","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","00409338310","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0409-3383","0409-3383-10","0409-3383_84342016-d586-4c53-bd31-6ae431d24fdd","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS; PARENTERAL","20101021","","ANDA","ANDA065362","Hospira, Inc","2; .25","g/10mL; g/10mL","","N","20261231"
"794","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","00409338515","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0409-3385","0409-3385-15","0409-3385_84342016-d586-4c53-bd31-6ae431d24fdd","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS; PARENTERAL","20101021","","ANDA","ANDA065362","Hospira, Inc","3; .375","g/15mL; g/15mL","","N","20261231"
"795","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","00409339010","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0409-3390","0409-3390-10","0409-3390_84342016-d586-4c53-bd31-6ae431d24fdd","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS; PARENTERAL","20101021","","ANDA","ANDA065362","Hospira, Inc","4; .5","g/20mL; g/20mL","","N","20261231"
"796","MEROPENEM","Meropenem","00409341210","Carbapenems [CS], Penem Antibacterial [EPC]","0409-3412","0409-3412-10","0409-3412_2ad24c61-4908-4053-997a-9d0a9e6810dc","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20221206","","ANDA","ANDA091404","Hospira, Inc.","1","g/20mL","","N","20251231"
"797","FLUCONAZOLE","Fluconazole","00409343524","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0409-3435","0409-3435-24","0409-3435_f49a2c6f-6b6f-43a4-8faf-d21b97ccbbf5","HUMAN PRESCRIPTION DRUG","Fluconazole","","INJECTION, SOLUTION","INTRAVENOUS","20250106","","ANDA","ANDA079104","Hospira, Inc","200","mg/100mL","","N","20251231"
"798","ERTAPENEM SODIUM","Ertapenem","00409351022","Carbapenems [CS], Penem Antibacterial [EPC]","0409-3510","0409-3510-22","0409-3510_7dea65ba-ff7e-445b-972e-c972c3140d91","HUMAN PRESCRIPTION DRUG","Ertapenem","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20201019","","ANDA","ANDA208790","Hospira, Inc.","1","g/1","","N","20251231"
"799","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00409351501","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0409-3515","0409-3515-01","0409-3515_6b13ef5a-c456-4bcf-a9ec-ddc91bbd809a","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210528","","ANDA","ANDA062912","Hospira, Inc.","1.5","g/1","","N","20261231"
"800","TOBRAMYCIN SULFATE","TOBRAMYCIN","00409357801","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0409-3578","0409-3578-01","0409-3578_74f907dc-5692-48e6-b734-64aa63e89c7f","HUMAN PRESCRIPTION DRUG","TOBRAMYCIN","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050505","","ANDA","ANDA063111","Hospira, Inc.","40","mg/mL","","N","20251231"
"801","FLUCONAZOLE","Fluconazole","00409432124","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0409-4321","0409-4321-24","0409-4321_f49a2c6f-6b6f-43a4-8faf-d21b97ccbbf5","HUMAN PRESCRIPTION DRUG","Fluconazole","","INJECTION, SOLUTION","INTRAVENOUS","20250106","","ANDA","ANDA079104","Hospira, Inc","400","mg/200mL","","N","20251231"
"802","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00409433201","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0409-4332","0409-4332-01","0409-4332_6b13ef5a-c456-4bcf-a9ec-ddc91bbd809a","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20050430","","ANDA","ANDA062911","Hospira, Inc.","500","mg/1","","N","20261231"
"803","FLUCONAZOLE","Fluconazole in Sodium Chloride","00409468818","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0409-4688","0409-4688-18","0409-4688_5f7a9015-3040-4591-8ae9-cc7281c31517","HUMAN PRESCRIPTION DRUG","Fluconazole in Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","20060417","","ANDA","ANDA076303","Hospira, Inc.","2","mg/mL","","N","20251231"
"804","FLUCONAZOLE","Fluconazole in Sodium Chloride","00409468812","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0409-4688","0409-4688-12","0409-4688_5f7a9015-3040-4591-8ae9-cc7281c31517","HUMAN PRESCRIPTION DRUG","Fluconazole in Sodium Chloride","","INJECTION, SOLUTION","INTRAVENOUS","20060417","","ANDA","ANDA076303","Hospira, Inc.","2","mg/mL","","N","20251231"
"805","LINEZOLID","LINEZOLID","00409488301","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","0409-4883","0409-4883-01","0409-4883_2b490a64-b68f-43a8-b1d9-4cdbedce2f20","HUMAN PRESCRIPTION DRUG","Linezolid","","INJECTION, SOLUTION","INTRAVENOUS","20150618","","NDA","NDA206473","Hospira, Inc.","2","mg/mL","","N","20261231"
"806","LINEZOLID","LINEZOLID","00409488310","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","0409-4883","0409-4883-10","0409-4883_2b490a64-b68f-43a8-b1d9-4cdbedce2f20","HUMAN PRESCRIPTION DRUG","Linezolid","","INJECTION, SOLUTION","INTRAVENOUS","20150618","","NDA","NDA206473","Hospira, Inc.","2","mg/mL","","N","20261231"
"807","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00409501701","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0409-5017","0409-5017-01","0409-5017_818f60e1-7062-4ed0-9839-7cab15866330","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20211102","","ANDA","ANDA063076","Hospira, Inc.","500","mg/5mL","","N","20261231"
"808","CEFTAZIDIME","CEFTAZIDIME","00409508216","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-5082","0409-5082-16","0409-5082_a0763a23-5d1e-4fc3-9e3c-1a426fff42b0","HUMAN PRESCRIPTION DRUG","TAZICEF","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20051102","","ANDA","ANDA062662","Hospira, Inc.","1","g/1","","N","20251231"
"809","CEFTAZIDIME","CEFTAZIDIME","00409508411","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-5084","0409-5084-11","0409-5084_a0763a23-5d1e-4fc3-9e3c-1a426fff42b0","HUMAN PRESCRIPTION DRUG","TAZICEF","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20051216","","ANDA","ANDA062662","Hospira, Inc.","2","g/1","","N","20251231"
"810","CEFTAZIDIME","CEFTAZIDIME","00409508611","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-5086","0409-5086-11","0409-5086_b4cff5d5-d1ec-4959-b062-e754517aab2d","HUMAN PRESCRIPTION DRUG","TAZICEF","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20060420","","ANDA","ANDA062662","Hospira, Inc.","6","g/1","","N","20251231"
"811","CEFTAZIDIME","CEFTAZIDIME","00409509216","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-5092","0409-5092-16","0409-5092_3f749ee0-db14-4ed0-9056-d545a38bbe3b","HUMAN PRESCRIPTION DRUG","TAZICEF","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20060508","","ANDA","ANDA064032","Hospira, Inc.","1","g/1","","N","20251231"
"812","CEFTAZIDIME","CEFTAZIDIME","00409509311","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-5093","0409-5093-11","0409-5093_3f749ee0-db14-4ed0-9056-d545a38bbe3b","HUMAN PRESCRIPTION DRUG","TAZICEF","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20060405","","ANDA","ANDA064032","Hospira, Inc.","2","g/1","","N","20251231"
"813","ERYTHROMYCIN LACTOBIONATE","ERYTHROMYCIN LACTOBIONATE","00409647644","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","0409-6476","0409-6476-44","0409-6476_6742de9a-f274-4d4e-85c4-afdad85ddb00","HUMAN PRESCRIPTION DRUG","Erythrocin Lactobionate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20060316","","ANDA","ANDA062638","Hospira, Inc.","500","mg/100mL","","N","20251231"
"814","ERYTHROMYCIN LACTOBIONATE","ERYTHROMYCIN LACTOBIONATE","00409648201","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","0409-6482","0409-6482-01","0409-6482_94c8bf36-909a-49ad-8b24-53101c3c41c0","HUMAN PRESCRIPTION DRUG","Erythrocin Lactobionate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20050525","","NDA","NDA050609","Hospira, Inc.","500","mg/10mL","","N","20251231"
"815","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00409650901","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0409-6509","0409-6509-01","0409-6509_39396834-5ba8-43a0-8ba2-719755e332b9","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20050606","","ANDA","ANDA063076","Hospira, Inc.","500","mg/10mL","","N","20261231"
"816","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00409650949","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0409-6509","0409-6509-49","0409-6509_39396834-5ba8-43a0-8ba2-719755e332b9","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20050606","","ANDA","ANDA063076","Hospira, Inc.","500","mg/10mL","","N","20261231"
"817","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00409653101","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0409-6531","0409-6531-01","0409-6531_771a44e0-5858-449c-be36-438a9ff52e67","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20120323","","ANDA","ANDA062933","Hospira, Inc.","750","mg/1","","N","20261231"
"818","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00409653102","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0409-6531","0409-6531-02","0409-6531_771a44e0-5858-449c-be36-438a9ff52e67","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20120323","","ANDA","ANDA062933","Hospira, Inc.","750","mg/1","","N","20261231"
"819","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00409653321","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0409-6533","0409-6533-21","0409-6533_f8d4245d-aed5-4fdf-8532-1acd94cc4228","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200218","","ANDA","ANDA062912","Hospira, Inc.","1","g/1","","N","20261231"
"820","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00409653331","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0409-6533","0409-6533-31","0409-6533_f8d4245d-aed5-4fdf-8532-1acd94cc4228","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200218","","ANDA","ANDA062912","Hospira, Inc.","1","g/1","","N","20261231"
"821","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00409653401","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0409-6534","0409-6534-01","0409-6534_771a44e0-5858-449c-be36-438a9ff52e67","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20050616","","ANDA","ANDA062931","Hospira, Inc.","500","mg/1","","N","20261231"
"822","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","00409653501","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","0409-6535","0409-6535-01","0409-6535_771a44e0-5858-449c-be36-438a9ff52e67","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20050430","","ANDA","ANDA062933","Hospira, Inc.","1","g/1","","N","20261231"
"823","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00409733201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-7332","0409-7332-01","0409-7332_c89e0cee-3419-4c53-bce1-796a1f911117","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","Hospira, Inc","1","g/1","","N","20251231"
"824","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00409733220","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-7332","0409-7332-20","0409-7332_c89e0cee-3419-4c53-bce1-796a1f911117","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","Hospira, Inc","1","g/1","","N","20251231"
"825","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00409733304","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-7333","0409-7333-04","0409-7333_adaa85f2-ecb4-404a-aa60-8a594fb26fed","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20050720","","ANDA","ANDA065204","Hospira, Inc","1","g/1","","N","20251231"
"826","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00409733349","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-7333","0409-7333-49","0409-7333_adaa85f2-ecb4-404a-aa60-8a594fb26fed","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20050720","","ANDA","ANDA065204","Hospira, Inc","1","g/1","","N","20251231"
"827","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00409733420","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-7334","0409-7334-20","0409-7334_8e4e37f3-759b-407b-b5d7-1dfbff1c2e88","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20050517","","ANDA","ANDA065168","Hospira, Inc","10","g/100mL","","N","20251231"
"828","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00409733410","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-7334","0409-7334-10","0409-7334_8e4e37f3-759b-407b-b5d7-1dfbff1c2e88","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20050517","","ANDA","ANDA065168","Hospira, Inc","10","g/100mL","","N","20251231"
"829","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00409733520","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-7335","0409-7335-20","0409-7335_38ef79d7-afdd-4d32-b27b-974b7aa265e8","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","Hospira, Inc","2","g/1","","N","20251231"
"830","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00409733503","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-7335","0409-7335-03","0409-7335_38ef79d7-afdd-4d32-b27b-974b7aa265e8","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","Hospira, Inc","2","g/1","","N","20251231"
"831","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00409733604","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-7336","0409-7336-04","0409-7336_adaa85f2-ecb4-404a-aa60-8a594fb26fed","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20050720","","ANDA","ANDA065204","Hospira, Inc","2","g/1","","N","20251231"
"832","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00409733720","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-7337","0409-7337-20","0409-7337_c89e0cee-3419-4c53-bce1-796a1f911117","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","Hospira, Inc","250","mg/1","","N","20251231"
"833","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00409733701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-7337","0409-7337-01","0409-7337_c89e0cee-3419-4c53-bce1-796a1f911117","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","Hospira, Inc","250","mg/1","","N","20251231"
"834","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00409733820","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-7338","0409-7338-20","0409-7338_38ef79d7-afdd-4d32-b27b-974b7aa265e8","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","Hospira, Inc","500","mg/1","","N","20251231"
"835","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00409733801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-7338","0409-7338-01","0409-7338_38ef79d7-afdd-4d32-b27b-974b7aa265e8","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","Hospira, Inc","500","mg/1","","N","20251231"
"836","CEFEPIME HYDROCHLORIDE","Cefepime","00409956610","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-9566","0409-9566-10","0409-9566_ab7654ec-e6eb-499c-9aab-63d9b76394a9","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20200824","","ANDA","ANDA065441","Hospira, Inc.","1","g/1","","N","20251231"
"837","CEFEPIME HYDROCHLORIDE","Cefepime","00409973510","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0409-9735","0409-9735-10","0409-9735_ab7654ec-e6eb-499c-9aab-63d9b76394a9","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20200824","","ANDA","ANDA065441","Hospira, Inc.","2","g/1","","N","20251231"
"838","CEFTAROLINE FOSAMIL","ceftaroline fosamil","00456040010","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0456-0400","0456-0400-10","0456-0400_0804a64c-0359-4cc1-9e02-23d7efb7afbf","HUMAN PRESCRIPTION DRUG","Teflaro","","POWDER, FOR SOLUTION","INTRAVENOUS","20101029","","NDA","NDA200327","Allergan, Inc.","400","mg/20mL","","N","20251231"
"839","CEFTAROLINE FOSAMIL","ceftaroline fosamil","00456060010","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0456-0600","0456-0600-10","0456-0600_0804a64c-0359-4cc1-9e02-23d7efb7afbf","HUMAN PRESCRIPTION DRUG","Teflaro","","POWDER, FOR SOLUTION","INTRAVENOUS","20101029","","NDA","NDA200327","Allergan, Inc.","600","mg/20mL","","N","20251231"
"840","AVIBACTAM SODIUM; CEFTAZIDIME","ceftazidime, avibactam","00456270010","Cephalosporin Antibacterial [EPC], Cephalosporins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0456-2700","0456-2700-10","0456-2700_5da940bc-28c3-4e0c-ac51-912f8cc1beb1","HUMAN PRESCRIPTION DRUG","AVYCAZ","","POWDER, FOR SOLUTION","INTRAVENOUS","20141226","","NDA","NDA206494","Allergan, Inc.",".5; 2","g/1; g/1","","N","20261231"
"841","ISAVUCONAZONIUM SULFATE","isavuconazonium sulfate","00469042001","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","0469-0420","0469-0420-01","0469-0420_7e6e45d4-9266-4451-b6b6-0d054bbcab63","HUMAN PRESCRIPTION DRUG","CRESEMBA","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20150306","","NDA","NDA207501","Astellas Pharma US, Inc.","40","mg/mL","","N","20261231"
"842","ISAVUCONAZONIUM SULFATE","isavuconazonium sulfate","00469052002","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","0469-0520","0469-0520-02","0469-0520_7e6e45d4-9266-4451-b6b6-0d054bbcab63","HUMAN PRESCRIPTION DRUG","CRESEMBA","","CAPSULE","ORAL","20151104","","NDA","NDA207500","Astellas Pharma US, Inc.","100","mg/1","","N","20261231"
"843","ISAVUCONAZONIUM SULFATE","isavuconazonium sulfate","00469286035","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","0469-2860","0469-2860-35","0469-2860_7e6e45d4-9266-4451-b6b6-0d054bbcab63","HUMAN PRESCRIPTION DRUG","CRESEMBA","","CAPSULE","ORAL","20221122","","NDA","NDA207500","Astellas Pharma US, Inc.","40","mg/1","","N","20261231"
"844","MICAFUNGIN SODIUM","Micafungin sodium","00469321110","Echinocandin Antifungal [EPC], Lipopeptides [CS]","0469-3211","0469-3211-10","0469-3211_cf33a1ae-ae66-4e64-8a9b-42b81188b179","HUMAN PRESCRIPTION DRUG","Mycamine","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20060627","","NDA","NDA021506","Astellas Pharma US, Inc.","20","mg/mL","","N","20251231"
"845","MICAFUNGIN SODIUM","Micafungin sodium","00469325010","Echinocandin Antifungal [EPC], Lipopeptides [CS]","0469-3250","0469-3250-10","0469-3250_cf33a1ae-ae66-4e64-8a9b-42b81188b179","HUMAN PRESCRIPTION DRUG","Mycamine","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20050316","","NDA","NDA021506","Astellas Pharma US, Inc.","10","mg/mL","","N","20251231"
"846","NYSTATIN","Nystatin","00472016615","Polyene Antifungal [EPC], Polyenes [CS]","0472-0166","0472-0166-15","0472-0166_de020480-1249-4b03-b7fd-f7d4071292a4","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20020903","","ANDA","ANDA062840","Actavis Pharma, Inc.","100000","[USP'U]/g","","N","20251231"
"847","NYSTATIN","Nystatin","00472016630","Polyene Antifungal [EPC], Polyenes [CS]","0472-0166","0472-0166-30","0472-0166_de020480-1249-4b03-b7fd-f7d4071292a4","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20020903","","ANDA","ANDA062840","Actavis Pharma, Inc.","100000","[USP'U]/g","","N","20251231"
"848","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","00472037945","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","0472-0379","0472-0379-45","0472-0379_427c69dd-569c-4f71-8971-36de1258409e","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20031216","","ANDA","ANDA076002","Actavis Pharma, Inc.",".5; 10","mg/g; mg/g","","N","20251231"
"849","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","00472037915","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","0472-0379","0472-0379-15","0472-0379_427c69dd-569c-4f71-8971-36de1258409e","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20031216","","ANDA","ANDA076002","Actavis Pharma, Inc.",".5; 10","mg/g; mg/g","","N","20251231"
"850","MICONAZOLE NITRATE","Miconazole Nitrate","00472173803","Azole Antifungal [EPC], Azoles [CS]","0472-1738","0472-1738-03","0472-1738_bb1aad58-4ca7-4be9-8649-0f29e22b81f5","HUMAN PRESCRIPTION DRUG","Miconazole Nitrate","","SUPPOSITORY","VAGINAL","19950118","","ANDA","ANDA073508","Actavis Pharma, Inc.","200","mg/1","","N","20251231"
"851","CLINDAMYCIN PHOSPHATE; TRETINOIN","Clindamycin Phosphate and Tretinoin","00472179060","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]","0472-1790","0472-1790-60","0472-1790_8d92b9da-5fea-4457-a757-a589d443fd7a","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Tretinoin","","GEL","TOPICAL","20160705","","ANDA","ANDA202564","Actavis Pharma, Inc.","12; .25","mg/g; mg/g","","N","20251231"
"852","CLINDAMYCIN PHOSPHATE; TRETINOIN","Clindamycin Phosphate and Tretinoin","00472179030","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]","0472-1790","0472-1790-30","0472-1790_8d92b9da-5fea-4457-a757-a589d443fd7a","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Tretinoin","","GEL","TOPICAL","20160705","","ANDA","ANDA202564","Actavis Pharma, Inc.","12; .25","mg/g; mg/g","","N","20251231"
"853","PYRIMETHAMINE","Pyrimethamine","00480372001","Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]","0480-3720","0480-3720-01","0480-3720_90ea4054-7c0a-4971-be57-d72e482491b8","HUMAN PRESCRIPTION DRUG","Pyrimethamine","","TABLET","ORAL","20211215","","ANDA","ANDA215506","Teva Pharmaceuticals, Inc.","25","mg/1","","N","20251231"
"854","PYRIMETHAMINE","Pyrimethamine","00480372056","Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]","0480-3720","0480-3720-56","0480-3720_90ea4054-7c0a-4971-be57-d72e482491b8","HUMAN PRESCRIPTION DRUG","Pyrimethamine","","TABLET","ORAL","20211215","","ANDA","ANDA215506","Teva Pharmaceuticals, Inc.","25","mg/1","","N","20251231"
"855","CLARITHROMYCIN","Clarithromycin","00527193006","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","0527-1930","0527-1930-06","0527-1930_05ef280b-60a9-77ec-e063-6394a90a7821","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED, EXTENDED RELEASE","ORAL","20190910","","ANDA","ANDA208987","Lannett Company, Inc.","500","mg/1","","N","20251231"
"856","CLARITHROMYCIN","Clarithromycin","00527193106","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","0527-1931","0527-1931-06","0527-1931_0a136962-d1f1-f728-e063-6394a90a01b0","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20191123","","ANDA","ANDA203584","Lannett Company, Inc.","250","mg/1","","N","20251231"
"857","CLARITHROMYCIN","Clarithromycin","00527193206","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","0527-1932","0527-1932-06","0527-1932_0a136962-d1f1-f728-e063-6394a90a01b0","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20191123","","ANDA","ANDA203584","Lannett Company, Inc.","500","mg/1","","N","20251231"
"858","POSACONAZOLE","Posaconazole","00527213335","Azole Antifungal [EPC], Azoles [CS]","0527-2133","0527-2133-35","0527-2133_291b0655-036f-4073-a475-c33a411db178","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","TABLET, DELAYED RELEASE","ORAL","20190828","","ANDA","ANDA212411","Lannett Company Inc.","100","mg/1","","N","20261231"
"859","POSACONAZOLE","Posaconazole","00527213343","Azole Antifungal [EPC], Azoles [CS]","0527-2133","0527-2133-43","0527-2133_291b0655-036f-4073-a475-c33a411db178","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","TABLET, DELAYED RELEASE","ORAL","20190828","","ANDA","ANDA212411","Lannett Company Inc.","100","mg/1","","N","20261231"
"860","POSACONAZOLE","Posaconazole","00527213330","Azole Antifungal [EPC], Azoles [CS]","0527-2133","0527-2133-30","0527-2133_291b0655-036f-4073-a475-c33a411db178","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","TABLET, DELAYED RELEASE","ORAL","20190828","","ANDA","ANDA212411","Lannett Company Inc.","100","mg/1","","N","20261231"
"861","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN MONOHYDRATE","00527237020","Macrolide Antimicrobial [EPC], Macrolides [CS]","0527-2370","0527-2370-20","0527-2370_13817549-094c-9653-e063-6394a90a3b89","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20190704","","ANDA","ANDA209045","Lannett Company, Inc.","250","mg/1","","N","20251231"
"862","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN MONOHYDRATE","00527237032","Macrolide Antimicrobial [EPC], Macrolides [CS]","0527-2370","0527-2370-32","0527-2370_13817549-094c-9653-e063-6394a90a3b89","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20190704","","ANDA","ANDA209045","Lannett Company, Inc.","250","mg/1","","N","20251231"
"863","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN MONOHYDRATE","00527239532","Macrolide Antimicrobial [EPC], Macrolides [CS]","0527-2395","0527-2395-32","0527-2395_13817549-094c-9653-e063-6394a90a3b89","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20190704","","ANDA","ANDA209044","Lannett Company, Inc.","500","mg/1","","N","20251231"
"864","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN MONOHYDRATE","00527239519","Macrolide Antimicrobial [EPC], Macrolides [CS]","0527-2395","0527-2395-19","0527-2395_13817549-094c-9653-e063-6394a90a3b89","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20190704","","ANDA","ANDA209044","Lannett Company, Inc.","500","mg/1","","N","20251231"
"865","CLOTRIMAZOLE","Clotrimazole","00536118170","Azole Antifungal [EPC], Azoles [CS]","0536-1181","0536-1181-70","0536-1181_2733c72f-762a-c588-e063-6294a90a97c8","HUMAN OTC DRUG","Clotrimazole","","SOLUTION","TOPICAL","20180820","","OTC MONOGRAPH DRUG","M005","RUGBY LABORATORIES","1","g/mL","","N","20251231"
"866","CLOTRIMAZOLE","Clotrimazole","00536126526","Azole Antifungal [EPC], Azoles [CS]","0536-1265","0536-1265-26","0536-1265_29b43e9e-352d-2018-e063-6394a90a27f7","HUMAN OTC DRUG","Rugby Clotrimazole Antifungal Cream","","CREAM","TOPICAL","20200319","","OTC MONOGRAPH DRUG","M005","Rugby Laboratories","1","g/100g","","N","20251231"
"867","CLOTRIMAZOLE","Clotrimazole","00536126595","Azole Antifungal [EPC], Azoles [CS]","0536-1265","0536-1265-95","0536-1265_29b43e9e-352d-2018-e063-6394a90a27f7","HUMAN OTC DRUG","Rugby Clotrimazole Antifungal Cream","","CREAM","TOPICAL","20200319","","OTC MONOGRAPH DRUG","M005","Rugby Laboratories","1","g/100g","","N","20251231"
"868","CLOTRIMAZOLE","Clotrimazole","00536126511","Azole Antifungal [EPC], Azoles [CS]","0536-1265","0536-1265-11","0536-1265_29b43e9e-352d-2018-e063-6394a90a27f7","HUMAN OTC DRUG","Rugby Clotrimazole Antifungal Cream","","CREAM","TOPICAL","20200319","","OTC MONOGRAPH DRUG","M005","Rugby Laboratories","1","g/100g","","N","20251231"
"869","CLOTRIMAZOLE","CLOTRIMAZOLE","00536127222","Azole Antifungal [EPC], Azoles [CS]","0536-1272","0536-1272-22","0536-1272_763fe5b9-b41d-4b2e-9a64-a2d141221fa2","HUMAN OTC DRUG","RUGBY ANTIFUNGAL CLOTRIMAZOLE","","CREAM","TOPICAL","20200114","","OTC MONOGRAPH DRUG","M005","RUGBY",".01","g/g","","N","20261231"
"870","CLOTRIMAZOLE","CLOTRIMAZOLE","00536127211","Azole Antifungal [EPC], Azoles [CS]","0536-1272","0536-1272-11","0536-1272_763fe5b9-b41d-4b2e-9a64-a2d141221fa2","HUMAN OTC DRUG","RUGBY ANTIFUNGAL CLOTRIMAZOLE","","CREAM","TOPICAL","20200114","","OTC MONOGRAPH DRUG","M005","RUGBY",".01","g/g","","N","20261231"
"871","MICONAZOLE NITRATE","MICONAZOLE NITRATE","00536137575","Azole Antifungal [EPC], Azoles [CS]","0536-1375","0536-1375-75","0536-1375_297d80f9-921c-0850-e063-6294a90a721a","HUMAN OTC DRUG","MICONAZOLE Nitrate 2% Cream ANTIFUNGAL","","CREAM","TOPICAL","20230207","","OTC MONOGRAPH DRUG","M005","Rugby","2","g/100g","","N","20251231"
"872","CLOTRIMAZOLE","CLOTRIMAZOLE","00536144370","Azole Antifungal [EPC], Azoles [CS]","0536-1443","0536-1443-70","0536-1443_27e8759f-1100-0aa9-e063-6394a90a851f","HUMAN OTC DRUG","CLOTRIMAZOLE","","SOLUTION","TOPICAL","20241121","","OTC MONOGRAPH DRUG","M005","Rugby Laboratories, Inc.","1","g/100mL","","N","20251231"
"873","MEFLOQUINE HYDROCHLORIDE","Mefloquine Hydrochloride","00555017178","Antimalarial [EPC]","0555-0171","0555-0171-78","0555-0171_33a105c5-0e51-4759-857b-6ca8dfae1d13","HUMAN PRESCRIPTION DRUG","Mefloquine Hydrochloride","","TABLET","ORAL","20040106","","ANDA","ANDA076392","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20251231"
"874","CLOTRIMAZOLE","clotrimazole","00574010770","Azole Antifungal [EPC], Azoles [CS]","0574-0107","0574-0107-70","0574-0107_c3d8e3ce-0429-4979-a91d-58dd19bbe996","HUMAN PRESCRIPTION DRUG","Clotrimazole","","LOZENGE","ORAL","20051201","","ANDA","ANDA076763","Padagis US LLC","10","mg/1","","N","20251231"
"875","CLOTRIMAZOLE","clotrimazole","00574010777","Azole Antifungal [EPC], Azoles [CS]","0574-0107","0574-0107-77","0574-0107_c3d8e3ce-0429-4979-a91d-58dd19bbe996","HUMAN PRESCRIPTION DRUG","Clotrimazole","","LOZENGE","ORAL","20051201","","ANDA","ANDA076763","Padagis US LLC","10","mg/1","","N","20251231"
"876","CLOTRIMAZOLE","clotrimazole","00574010714","Azole Antifungal [EPC], Azoles [CS]","0574-0107","0574-0107-14","0574-0107_c3d8e3ce-0429-4979-a91d-58dd19bbe996","HUMAN PRESCRIPTION DRUG","Clotrimazole","","LOZENGE","ORAL","20051201","","ANDA","ANDA076763","Padagis US LLC","10","mg/1","","N","20251231"
"877","CLINDAMYCIN PALMITATE HYDROCHLORIDE","Clindamycin Palmitate Hydrochloride","00574012901","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0574-0129","0574-0129-01","0574-0129_2361ba91-a492-498a-aeff-ddfac2a534cd","HUMAN PRESCRIPTION DRUG","Clindamycin Palmitate Hydrochloride","","GRANULE, FOR SOLUTION","ORAL","20100121","20250630","ANDA","ANDA090902","Padagis US LLC","75","mg/5mL","","N",""
"878","NYSTATIN","Nystatin","00574200815","Polyene Antifungal [EPC], Polyenes [CS]","0574-2008","0574-2008-15","0574-2008_b164d1c9-e720-49f6-8bd3-fa767fb2179e","HUMAN PRESCRIPTION DRUG","Nystop","","POWDER","TOPICAL","19960816","","ANDA","ANDA064118","Padagis US LLC","100000","[USP'U]/g","","N","20251231"
"879","NYSTATIN","Nystatin","00574200830","Polyene Antifungal [EPC], Polyenes [CS]","0574-2008","0574-2008-30","0574-2008_b164d1c9-e720-49f6-8bd3-fa767fb2179e","HUMAN PRESCRIPTION DRUG","Nystop","","POWDER","TOPICAL","19960816","","ANDA","ANDA064118","Padagis US LLC","100000","[USP'U]/g","","N","20251231"
"880","NYSTATIN","Nystatin","00574200802","Polyene Antifungal [EPC], Polyenes [CS]","0574-2008","0574-2008-02","0574-2008_b164d1c9-e720-49f6-8bd3-fa767fb2179e","HUMAN PRESCRIPTION DRUG","Nystop","","POWDER","TOPICAL","19960816","","ANDA","ANDA064118","Padagis US LLC","100000","[USP'U]/g","","N","20251231"
"881","BACITRACIN ZINC; POLYMYXIN B SULFATE","bacitracin zinc and polymyxin b sulfates","00574402135","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0574-4021","0574-4021-35","0574-4021_64c51556-c8f4-4f2e-987c-13825419f833","HUMAN PRESCRIPTION DRUG","polycin","","OINTMENT","OPHTHALMIC","20141112","","ANDA","ANDA065022","Padagis US LLC","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"882","ERYTHROMYCIN","erythromycin","00574402439","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","0574-4024","0574-4024-39","0574-4024_f4848350-bc5c-4ab4-b3ad-21df57427cc6","HUMAN PRESCRIPTION DRUG","erythromycin","","OINTMENT","OPHTHALMIC","20140508","","ANDA","ANDA062447","Padagis US LLC","5","mg/g","","N","20251231"
"883","ERYTHROMYCIN","erythromycin","00574402450","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","0574-4024","0574-4024-50","0574-4024_f4848350-bc5c-4ab4-b3ad-21df57427cc6","HUMAN PRESCRIPTION DRUG","erythromycin","","OINTMENT","OPHTHALMIC","20140508","","ANDA","ANDA062447","Padagis US LLC","5","mg/g","","N","20251231"
"884","ERYTHROMYCIN","erythromycin","00574402435","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","0574-4024","0574-4024-35","0574-4024_f4848350-bc5c-4ab4-b3ad-21df57427cc6","HUMAN PRESCRIPTION DRUG","erythromycin","","OINTMENT","OPHTHALMIC","20140508","","ANDA","ANDA062447","Padagis US LLC","5","mg/g","","N","20251231"
"885","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","00574403125","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","0574-4031","0574-4031-25","0574-4031_7c012e78-01c6-4b9a-a971-62a64fe6885a","HUMAN PRESCRIPTION DRUG","TOBRAMYCIN AND DEXAMETHASONE","","SUSPENSION/ DROPS","OPHTHALMIC","20220317","","ANDA","ANDA212715","Padagis US LLC","1; 3","mg/mL; mg/mL","","N","20251231"
"886","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","00574403110","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","0574-4031","0574-4031-10","0574-4031_7c012e78-01c6-4b9a-a971-62a64fe6885a","HUMAN PRESCRIPTION DRUG","TOBRAMYCIN AND DEXAMETHASONE","","SUSPENSION/ DROPS","OPHTHALMIC","20220317","","ANDA","ANDA212715","Padagis US LLC","1; 3","mg/mL; mg/mL","","N","20251231"
"887","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","00574403105","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","0574-4031","0574-4031-05","0574-4031_7c012e78-01c6-4b9a-a971-62a64fe6885a","HUMAN PRESCRIPTION DRUG","TOBRAMYCIN AND DEXAMETHASONE","","SUSPENSION/ DROPS","OPHTHALMIC","20220317","","ANDA","ANDA212715","Padagis US LLC","1; 3","mg/mL; mg/mL","","N","20251231"
"888","BACITRACIN ZINC; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin and polymyxin b sulfates, bacitracin zinc and hydrocortisone acetate","00574414435","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0574-4144","0574-4144-35","0574-4144_46eb5efc-032c-4544-a495-fa2348ab86e5","HUMAN PRESCRIPTION DRUG","Neo Polycin HC","","OINTMENT","OPHTHALMIC","20150107","","ANDA","ANDA062166","Padagis US LLC","400; 10; 3.5; 10000","[USP'U]/g; mg/g; mg/g; [USP'U]/g","","N","20251231"
"889","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin, Polymyxin B Sulfates, Dexamethasone","00574416035","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0574-4160","0574-4160-35","0574-4160_0fc834e5-7804-4209-b59b-e2dd7dd45323","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Dexamethasone","","OINTMENT","OPHTHALMIC","20140703","","ANDA","ANDA062938","Padagis US LLC","1; 3.5; 10000","mg/g; mg/g; [USP'U]/g","","N","20251231"
"890","SULFACETAMIDE SODIUM","Sulfacetamide Sodium","00574419035","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","0574-4190","0574-4190-35","0574-4190_221e33ad-c66d-4755-a40f-6f1eac3bbe9c","HUMAN PRESCRIPTION DRUG","Sulfacetamide Sodium","","OINTMENT","OPHTHALMIC","20140813","","ANDA","ANDA080029","Padagis US LLC","100","mg/g","","N","20251231"
"891","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin and polymyxin B sulfates and bacitracin zinc","00574425035","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0574-4250","0574-4250-35","0574-4250_8482ca1e-d647-4e53-9326-218a0cd5bb18","HUMAN PRESCRIPTION DRUG","Neo Polycin","","OINTMENT","OPHTHALMIC","20150105","","ANDA","ANDA060764","Padagis US LLC","400; 3.5; 10000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"892","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","00591247401","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","0591-2474","0591-2474-01","0591-2474_62a25e1c-9d76-480f-b87b-0b3b7370005b","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20110815","","ANDA","ANDA061837","Actavis Pharma, Inc.","250","mg/1","","N","20261231"
"893","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","00591247501","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","0591-2475","0591-2475-01","0591-2475_62a25e1c-9d76-480f-b87b-0b3b7370005b","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20110815","","ANDA","ANDA061837","Actavis Pharma, Inc.","500","mg/1","","N","20261231"
"894","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir hydrochloride","00591257920","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","0591-2579","0591-2579-20","0591-2579_9f669f81-9b46-440d-bb4f-0696098da2cc","HUMAN PRESCRIPTION DRUG","Valganciclovir hydrochloride for Oral","","POWDER, FOR SOLUTION","ORAL","20160826","","ANDA","ANDA205220","Actavis Pharma, Inc.","50","mg/mL","","N","20251231"
"895","CLARITHROMYCIN","clarithromycin","00591280560","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","0591-2805","0591-2805-60","0591-2805_d97b84fc-7e0b-4f73-804d-522c2448b058","HUMAN PRESCRIPTION DRUG","clarithromycin","","TABLET, FILM COATED, EXTENDED RELEASE","ORAL","20140227","","ANDA","ANDA065145","Actavis Pharma, Inc.","500","mg/1","","N","20261231"
"896","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin phosphate and benzoyl peroxide","00591391668","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0591-3916","0591-3916-68","0591-3916_b299e473-19df-4bf8-969b-13eec45b5003","HUMAN PRESCRIPTION DRUG","Clindamycin phosphate and benzoyl peroxide","","GEL","TOPICAL","20190219","","ANDA","ANDA205128","Actavis Pharma, Inc.","25; 10","mg/g; mg/g","","N","20251231"
"897","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","00615812114","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","0615-8121","0615-8121-14","0615-8121_18da7fe1-4328-4868-9e5f-65e7d3dde75d","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NCS HealthCare of KY, LLC dba Vangard Labs","800; 160","mg/1; mg/1","","N","20251231"
"898","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","00615812139","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","0615-8121","0615-8121-39","0615-8121_18da7fe1-4328-4868-9e5f-65e7d3dde75d","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NCS HealthCare of KY, LLC dba Vangard Labs","800; 160","mg/1; mg/1","","N","20251231"
"899","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","00615812110","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","0615-8121","0615-8121-10","0615-8121_18da7fe1-4328-4868-9e5f-65e7d3dde75d","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NCS HealthCare of KY, LLC dba Vangard Labs","800; 160","mg/1; mg/1","","N","20251231"
"900","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","00615812120","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","0615-8121","0615-8121-20","0615-8121_18da7fe1-4328-4868-9e5f-65e7d3dde75d","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NCS HealthCare of KY, LLC dba Vangard Labs","800; 160","mg/1; mg/1","","N","20251231"
"901","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","00615845939","Antimalarial [EPC], Antirheumatic Agent [EPC]","0615-8459","0615-8459-39","0615-8459_da9a93a0-69ed-4967-b7c5-94d742615fae","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","NCS HealthCare of KY, LLC dba Vangard Labs","200","mg/1","","N","20251231"
"902","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","00615853114","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","0615-8531","0615-8531-14","0615-8531_b8cd8a42-7614-4082-885c-ef2baf8ff2a5","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","NCS HealthCare of KY, LLC dba Vangard Labs","25; 75","mg/1; mg/1","","N","20261231"
"903","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","00615853110","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","0615-8531","0615-8531-10","0615-8531_b8cd8a42-7614-4082-885c-ef2baf8ff2a5","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","NCS HealthCare of KY, LLC dba Vangard Labs","25; 75","mg/1; mg/1","","N","20261231"
"904","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","00615854610","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0615-8546","0615-8546-10","0615-8546_e9e10ef0-050b-4030-bc6f-0c23413f9517","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","NCS HealthCare of KY, LLC dba Vangard Labs","500","mg/1","","N","20251231"
"905","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","00615854620","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0615-8546","0615-8546-20","0615-8546_e9e10ef0-050b-4030-bc6f-0c23413f9517","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","NCS HealthCare of KY, LLC dba Vangard Labs","500","mg/1","","N","20251231"
"906","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","00615854614","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0615-8546","0615-8546-14","0615-8546_e9e10ef0-050b-4030-bc6f-0c23413f9517","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","NCS HealthCare of KY, LLC dba Vangard Labs","500","mg/1","","N","20251231"
"907","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin and Sulbactam","00641611610","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0641-6116","0641-6116-10","0641-6116_c0a3fa06-81d0-410a-8f9b-2be2b03fdc3b","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20091222","","ANDA","ANDA065406","Hikma Pharmaceuticals USA Inc.","1; .5","g/1.5g; g/1.5g","","N","20251231"
"908","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin and Sulbactam","00641611710","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0641-6117","0641-6117-10","0641-6117_c0a3fa06-81d0-410a-8f9b-2be2b03fdc3b","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20091222","","ANDA","ANDA065406","Hikma Pharmaceuticals USA Inc.","2; 1","g/3g; g/3g","","N","20251231"
"909","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin and Sulbactam","00641611801","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0641-6118","0641-6118-01","0641-6118_43dd9102-1a8e-47c9-a65c-fc50ab4bbf5a","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20091203","","ANDA","ANDA065403","Hikma Pharmaceuticals USA Inc.","100; 50","mg/mL; mg/mL","","N","20251231"
"910","AMIKACIN SULFATE","Amikacin Sulfate","00641616610","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0641-6166","0641-6166-10","0641-6166_36fb925f-8beb-4691-9136-500772c736fa","HUMAN PRESCRIPTION DRUG","Amikacin Sulfate","","INJECTION","INTRAMUSCULAR; INTRAVENOUS","20150801","","ANDA","ANDA063315","Hikma Pharmaceuticals USA Inc.","250","mg/mL","","N","20251231"
"911","AMIKACIN SULFATE","Amikacin Sulfate","00641616710","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0641-6167","0641-6167-10","0641-6167_36fb925f-8beb-4691-9136-500772c736fa","HUMAN PRESCRIPTION DRUG","Amikacin Sulfate","","INJECTION","INTRAMUSCULAR; INTRAVENOUS","20150801","","ANDA","ANDA063315","Hikma Pharmaceuticals USA Inc.","250","mg/mL","","N","20251231"
"912","METRONIDAZOLE","metronidazole","00642746605","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0642-7466","0642-7466-05","0642-7466_09d13114-f228-f0bc-e063-6394a90a84f5","HUMAN PRESCRIPTION DRUG","Nuvessa","","GEL","TOPICAL","20180310","","NDA","NDA205223","Exeltis USA, Inc.","65","mg/5g","","N","20251231"
"913","METRONIDAZOLE","metronidazole","00642746606","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0642-7466","0642-7466-06","0642-7466_09d13114-f228-f0bc-e063-6394a90a84f5","HUMAN PRESCRIPTION DRUG","Nuvessa","","GEL","TOPICAL","20180310","","NDA","NDA205223","Exeltis USA, Inc.","65","mg/5g","","N","20251231"
"914","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","00703950303","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","0703-9503","0703-9503-03","0703-9503_75bddfb3-c199-47a4-b54a-a74cef7dec9a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","INJECTION, SOLUTION, CONCENTRATE","INTRAVENOUS","19911101","","ANDA","ANDA073303","Teva Parenteral Medicines, Inc.","80; 16","mg/mL; mg/mL","","N","20261231"
"915","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","00703951493","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","0703-9514","0703-9514-93","0703-9514_75bddfb3-c199-47a4-b54a-a74cef7dec9a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","INJECTION, SOLUTION, CONCENTRATE","INTRAVENOUS","19911101","","ANDA","ANDA073303","Teva Parenteral Medicines, Inc.","80; 16","mg/mL; mg/mL","","N","20261231"
"916","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","00703951403","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","0703-9514","0703-9514-03","0703-9514_75bddfb3-c199-47a4-b54a-a74cef7dec9a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","INJECTION, SOLUTION, CONCENTRATE","INTRAVENOUS","19911101","","ANDA","ANDA073303","Teva Parenteral Medicines, Inc.","80; 16","mg/mL; mg/mL","","N","20261231"
"917","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","00703951483","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","0703-9514","0703-9514-83","0703-9514_75bddfb3-c199-47a4-b54a-a74cef7dec9a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","INJECTION, SOLUTION, CONCENTRATE","INTRAVENOUS","19911101","","ANDA","ANDA073303","Teva Parenteral Medicines, Inc.","80; 16","mg/mL; mg/mL","","N","20261231"
"918","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","00703952681","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","0703-9526","0703-9526-81","0703-9526_03a1a8ab-99e0-4f3a-bcd8-79a902eaf27e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","INJECTION, SOLUTION, CONCENTRATE","INTRAVENOUS","20240815","","ANDA","ANDA073303","Teva Parenteral Medicines, Inc.","80; 16","mg/mL; mg/mL","","N","20261231"
"919","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","00703952601","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","0703-9526","0703-9526-01","0703-9526_03a1a8ab-99e0-4f3a-bcd8-79a902eaf27e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","INJECTION, SOLUTION, CONCENTRATE","INTRAVENOUS","20240815","","ANDA","ANDA073303","Teva Parenteral Medicines, Inc.","80; 16","mg/mL; mg/mL","","N","20261231"
"920","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Polymyxin B Sulfate, Bacitracin Zinc and Neomycin Sulfate","00713026831","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0713-0268","0713-0268-31","0713-0268_0cf1cf3a-c318-a32a-e063-6394a90a884d","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","19950111","","OTC MONOGRAPH DRUG","M004","Cosette Pharmaceuticals, Inc.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"921","TERCONAZOLE","Terconazole","00713055273","Azole Antifungal [EPC], Azoles [CS]","0713-0552","0713-0552-73","0713-0552_ee20ae91-d9b6-6f7f-e053-2a95a90a3171","HUMAN PRESCRIPTION DRUG","Terconazole","","SUPPOSITORY","VAGINAL","20150925","","ANDA","ANDA077553","Cosette Pharmaceuticals, Inc.","80","mg/1","","N","20251231"
"922","METRONIDAZOLE","metronidazole","00713057460","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0713-0574","0713-0574-60","0713-0574_f38e0e45-e6e7-84f3-e053-2995a90a197c","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20230201","","ANDA","ANDA216692","Cosette Pharmaceuticals, Inc.","10","mg/g","","N","20251231"
"923","METRONIDAZOLE","metronidazole","00713057571","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0713-0575","0713-0575-71","0713-0575_00beeda9-9cf9-730b-e063-6294a90a8ad0","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","VAGINAL","20230712","","ANDA","ANDA216323","Cosette Pharmaceuticals, Inc.","7.5","mg/g","","N","20251231"
"924","KETOCONAZOLE","Ketoconazole","00713059204","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","0713-0592","0713-0592-04","0713-0592_2d7c8c0c-b20f-b41a-e063-6294a90af27c","HUMAN PRESCRIPTION DRUG","Ketoconazole","","SHAMPOO, SUSPENSION","TOPICAL","20250207","","ANDA","ANDA076942","Cosette Pharmaceuticals, Inc.","20","mg/mL","","N","20261231"
"925","BACITRACIN ZINC; NEOMYCIN; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Polymyxin B Sulfate, Bacitracin Zinc, Neomycin Sulfate, Pramoxine HCl","00713062231","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0713-0622","0713-0622-31","0713-0622_bbe9b82b-867d-4f19-8948-bcc36695092c","HUMAN OTC DRUG","Triple Antibiotic Plus","","OINTMENT","TOPICAL","19980228","","OTC MONOGRAPH DRUG","M004","Cosette Pharmaceuticals, Inc.","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"926","METRONIDAZOLE","Metronidazole","00713063337","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0713-0633","0713-0633-37","0713-0633_0b47088a-fa40-b41e-e063-6394a90acfb1","HUMAN PRESCRIPTION DRUG","Metronidazole","","CREAM","TOPICAL","20080313","","ANDA","ANDA077549","Cosette Pharmaceuticals, Inc.","7.5","mg/g","","N","20251231"
"927","METRONIDAZOLE","Metronidazole","00713063737","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0713-0637","0713-0637-37","0713-0637_edf61c59-f083-6b15-e053-2995a90a675b","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20110401","","ANDA","ANDA078178","Cosette Pharmaceuticals, Inc.","7.5","mg/g","","N","20251231"
"928","NYSTATIN","Nystatin Cream","00713067815","Polyene Antifungal [EPC], Polyenes [CS]","0713-0678","0713-0678-15","0713-0678_ee0cb97f-1642-0dc0-e053-2995a90a8db3","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20150401","","ANDA","ANDA061966","Cosette Pharmaceuticals, Inc.","100000","[USP'U]/g","","N","20251231"
"929","NYSTATIN","Nystatin Cream","00713067831","Polyene Antifungal [EPC], Polyenes [CS]","0713-0678","0713-0678-31","0713-0678_ee0cb97f-1642-0dc0-e053-2995a90a8db3","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20150401","","ANDA","ANDA061966","Cosette Pharmaceuticals, Inc.","100000","[USP'U]/g","","N","20251231"
"930","GENTAMICIN SULFATE","Gentamicin Sulfate","00713068215","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0713-0682","0713-0682-15","0713-0682_0acd2432-98da-018e-e063-6294a90ad373","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","OINTMENT","TOPICAL","20141128","","ANDA","ANDA064054","Cosette Pharmaceuticals, Inc.","1","mg/g","","N","20251231"
"931","GENTAMICIN SULFATE","Gentamicin Sulfate","00713068231","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0713-0682","0713-0682-31","0713-0682_0acd2432-98da-018e-e063-6294a90ad373","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","OINTMENT","TOPICAL","20141128","","ANDA","ANDA064054","Cosette Pharmaceuticals, Inc.","1","mg/g","","N","20251231"
"932","GENTAMICIN SULFATE","Gentamicin Sulfate","00713068315","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0713-0683","0713-0683-15","0713-0683_0abc5db4-9344-8946-e063-6394a90abf1c","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","CREAM","TOPICAL","20161111","","ANDA","ANDA064056","Cosette Pharmaceuticals, Inc.","1","mg/g","","N","20251231"
"933","GENTAMICIN SULFATE","Gentamicin Sulfate","00713068331","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0713-0683","0713-0683-31","0713-0683_0abc5db4-9344-8946-e063-6394a90abf1c","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","CREAM","TOPICAL","20161111","","ANDA","ANDA064056","Cosette Pharmaceuticals, Inc.","1","mg/g","","N","20251231"
"934","NYSTATIN","Nystatin Ointment","00713068631","Polyene Antifungal [EPC], Polyenes [CS]","0713-0686","0713-0686-31","0713-0686_0b479d47-d58c-1457-e063-6394a90a1256","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20171006","","ANDA","ANDA209114","Cosette Pharmaceuticals, Inc.","100000","[USP'U]/g","","N","20251231"
"935","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781183101","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-1831","0781-1831-01","0781-1831_bd3c4acc-09ff-49ef-af5a-7087d2ada599","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20020315","","ANDA","ANDA065064","Sandoz Inc","500; 125","mg/1; mg/1","","N","20251231"
"936","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781183113","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-1831","0781-1831-13","0781-1831_bd3c4acc-09ff-49ef-af5a-7087d2ada599","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20020315","","ANDA","ANDA065064","Sandoz Inc","500; 125","mg/1; mg/1","","N","20251231"
"937","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781183120","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-1831","0781-1831-20","0781-1831_bd3c4acc-09ff-49ef-af5a-7087d2ada599","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20020315","","ANDA","ANDA065064","Sandoz Inc","500; 125","mg/1; mg/1","","N","20251231"
"938","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781185213","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-1852","0781-1852-13","0781-1852_bd3c4acc-09ff-49ef-af5a-7087d2ada599","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20020314","","ANDA","ANDA065063","Sandoz Inc","875; 125","mg/1; mg/1","","N","20251231"
"939","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781185220","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-1852","0781-1852-20","0781-1852_bd3c4acc-09ff-49ef-af5a-7087d2ada599","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20020314","","ANDA","ANDA065063","Sandoz Inc","875; 125","mg/1; mg/1","","N","20251231"
"940","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781185201","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-1852","0781-1852-01","0781-1852_bd3c4acc-09ff-49ef-af5a-7087d2ada599","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20020314","","ANDA","ANDA065063","Sandoz Inc","875; 125","mg/1; mg/1","","N","20251231"
"941","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781187431","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-1874","0781-1874-31","0781-1874_bd3c4acc-09ff-49ef-af5a-7087d2ada599","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20050823","","ANDA","ANDA065189","Sandoz Inc","250; 125","mg/1; mg/1","","N","20251231"
"942","AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781194382","Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-1943","0781-1943-82","0781-1943_cc33a5f2-0cdc-44d0-a139-eddc08532c1f","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, MULTILAYER, EXTENDED RELEASE","ORAL","20100421","","ANDA","ANDA090227","Sandoz Inc","562.5; 437.5; 62.5","mg/1; mg/1; mg/1","","N","20261231"
"943","AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781194339","Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-1943","0781-1943-39","0781-1943_cc33a5f2-0cdc-44d0-a139-eddc08532c1f","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, MULTILAYER, EXTENDED RELEASE","ORAL","20100421","","ANDA","ANDA090227","Sandoz Inc","562.5; 437.5; 62.5","mg/1; mg/1; mg/1","","N","20261231"
"944","CLARITHROMYCIN","Clarithromycin","00781196160","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","0781-1961","0781-1961-60","0781-1961_a18fa357-b294-48b9-aabe-dad7d6259ba3","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20051018","","ANDA","ANDA065144","Sandoz Inc","250","mg/1","","N","20251231"
"945","CLARITHROMYCIN","Clarithromycin","00781196260","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","0781-1962","0781-1962-60","0781-1962_a18fa357-b294-48b9-aabe-dad7d6259ba3","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","Sandoz Inc","500","mg/1","","N","20251231"
"946","AMOXICILLIN","Amoxicillin","00781202076","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-2020","0781-2020-76","0781-2020_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Sandoz Inc","250","mg/1","","N","20261231"
"947","AMOXICILLIN","Amoxicillin","00781202005","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-2020","0781-2020-05","0781-2020_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Sandoz Inc","250","mg/1","","N","20261231"
"948","AMOXICILLIN","Amoxicillin","00781202001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-2020","0781-2020-01","0781-2020_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Sandoz Inc","250","mg/1","","N","20261231"
"949","AMPICILLIN TRIHYDRATE","Ampicillin","00781214405","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-2144","0781-2144-05","0781-2144_69724e61-a4f4-4497-b8f1-b77fb40a2200","HUMAN PRESCRIPTION DRUG","Ampicillin","","CAPSULE","ORAL","19950829","","ANDA","ANDA064082","Sandoz Inc","250","mg/1","","N","20251231"
"950","AMPICILLIN TRIHYDRATE","Ampicillin","00781214401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-2144","0781-2144-01","0781-2144_69724e61-a4f4-4497-b8f1-b77fb40a2200","HUMAN PRESCRIPTION DRUG","Ampicillin","","CAPSULE","ORAL","19950829","","ANDA","ANDA064082","Sandoz Inc","250","mg/1","","N","20251231"
"951","AMPICILLIN TRIHYDRATE","Ampicillin","00781214501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-2145","0781-2145-01","0781-2145_69724e61-a4f4-4497-b8f1-b77fb40a2200","HUMAN PRESCRIPTION DRUG","Ampicillin","","CAPSULE","ORAL","19950829","","ANDA","ANDA064082","Sandoz Inc","500","mg/1","","N","20251231"
"952","AMPICILLIN TRIHYDRATE","Ampicillin","00781214505","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-2145","0781-2145-05","0781-2145_69724e61-a4f4-4497-b8f1-b77fb40a2200","HUMAN PRESCRIPTION DRUG","Ampicillin","","CAPSULE","ORAL","19950829","","ANDA","ANDA064082","Sandoz Inc","500","mg/1","","N","20251231"
"953","CEFDINIR","Cefdinir","00781217660","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-2176","0781-2176-60","0781-2176_977d4566-20b3-4909-ad00-6cbea017798d","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20070406","","ANDA","ANDA065330","Sandoz Inc","300","mg/1","","N","20251231"
"954","CEFDINIR","Cefdinir","00781217664","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-2176","0781-2176-64","0781-2176_977d4566-20b3-4909-ad00-6cbea017798d","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20070406","","ANDA","ANDA065330","Sandoz Inc","300","mg/1","","N","20251231"
"955","CEFDINIR","Cefdinir","00781217601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-2176","0781-2176-01","0781-2176_977d4566-20b3-4909-ad00-6cbea017798d","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20070406","","ANDA","ANDA065330","Sandoz Inc","300","mg/1","","N","20251231"
"956","CEFDINIR","Cefdinir","00781217669","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-2176","0781-2176-69","0781-2176_977d4566-20b3-4909-ad00-6cbea017798d","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20070406","","ANDA","ANDA065330","Sandoz Inc","300","mg/1","","N","20251231"
"957","AMOXICILLIN","Amoxicillin","00781261305","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-2613","0781-2613-05","0781-2613_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Sandoz Inc","500","mg/1","","N","20261231"
"958","AMOXICILLIN","Amoxicillin","00781261376","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-2613","0781-2613-76","0781-2613_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Sandoz Inc","500","mg/1","","N","20261231"
"959","AMOXICILLIN","Amoxicillin","00781261301","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-2613","0781-2613-01","0781-2613_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Sandoz Inc","500","mg/1","","N","20261231"
"960","MEROPENEM","MEROPENEM","00781300096","Carbapenems [CS], Penem Antibacterial [EPC]","0781-3000","0781-3000-96","0781-3000_34745c71-cfe8-172a-e063-6394a90adc67","HUMAN PRESCRIPTION DRUG","MEROPENEM","","INJECTION","INTRAVENOUS","20160829","","ANDA","ANDA206086","Sandoz Inc","500","mg/20mL","","N","20261231"
"961","MEROPENEM","MEROPENEM","00781300095","Carbapenems [CS], Penem Antibacterial [EPC]","0781-3000","0781-3000-95","0781-3000_34745c71-cfe8-172a-e063-6394a90adc67","HUMAN PRESCRIPTION DRUG","MEROPENEM","","INJECTION","INTRAVENOUS","20160829","","ANDA","ANDA206086","Sandoz Inc","500","mg/20mL","","N","20261231"
"962","MEROPENEM","MEROPENEM","00781309895","Carbapenems [CS], Penem Antibacterial [EPC]","0781-3098","0781-3098-95","0781-3098_34745c71-cfe8-172a-e063-6394a90adc67","HUMAN PRESCRIPTION DRUG","MEROPENEM","","INJECTION","INTRAVENOUS","20160829","","ANDA","ANDA206086","Sandoz Inc","1","g/30mL","","N","20261231"
"963","MEROPENEM","MEROPENEM","00781309896","Carbapenems [CS], Penem Antibacterial [EPC]","0781-3098","0781-3098-96","0781-3098_34745c71-cfe8-172a-e063-6394a90adc67","HUMAN PRESCRIPTION DRUG","MEROPENEM","","INJECTION","INTRAVENOUS","20160829","","ANDA","ANDA206086","Sandoz Inc","1","g/30mL","","N","20261231"
"964","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","00781311095","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-3110","0781-3110-95","0781-3110_d96e8f0c-7f0d-4d27-8836-91935dc2981f","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS; PARENTERAL","20101021","","ANDA","ANDA065362","Sandoz Inc","2; .25","g/10mL; g/10mL","","N","20261231"
"965","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","00781311395","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-3113","0781-3113-95","0781-3113_d96e8f0c-7f0d-4d27-8836-91935dc2981f","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS; PARENTERAL","20101021","","ANDA","ANDA065362","Sandoz Inc","3; .375","g/15mL; g/15mL","","N","20261231"
"966","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","00781311495","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-3114","0781-3114-95","0781-3114_d96e8f0c-7f0d-4d27-8836-91935dc2981f","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS; PARENTERAL","20101021","","ANDA","ANDA065362","Sandoz Inc","4; .5","g/20mL; g/20mL","","N","20261231"
"967","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","00781318094","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-3180","0781-3180-94","0781-3180_c1b1e978-4826-4926-b022-1d5889c7a14a","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS; PARENTERAL","20211025","","ANDA","ANDA203557","Sandoz Inc","36; 4.5","g/250mL; g/250mL","","N","20251231"
"968","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00781320685","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-3206","0781-3206-85","0781-3206_371d8db2-5d67-4339-92b7-aee2a52b2293","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","Sandoz Inc","250","mg/1","","N","20261231"
"969","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00781320695","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-3206","0781-3206-95","0781-3206_371d8db2-5d67-4339-92b7-aee2a52b2293","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","Sandoz Inc","250","mg/1","","N","20261231"
"970","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00781320785","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-3207","0781-3207-85","0781-3207_371d8db2-5d67-4339-92b7-aee2a52b2293","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","Sandoz Inc","500","mg/1","","N","20261231"
"971","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00781320795","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-3207","0781-3207-95","0781-3207_371d8db2-5d67-4339-92b7-aee2a52b2293","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","Sandoz Inc","500","mg/1","","N","20261231"
"972","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00781320895","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-3208","0781-3208-95","0781-3208_371d8db2-5d67-4339-92b7-aee2a52b2293","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","Sandoz Inc","1","g/1","","N","20261231"
"973","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00781320885","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-3208","0781-3208-85","0781-3208_371d8db2-5d67-4339-92b7-aee2a52b2293","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","Sandoz Inc","1","g/1","","N","20261231"
"974","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00781320995","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-3209","0781-3209-95","0781-3209_371d8db2-5d67-4339-92b7-aee2a52b2293","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","Sandoz Inc","2","g/1","","N","20261231"
"975","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","00781321046","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-3210","0781-3210-46","0781-3210_fae8140e-99cc-45f1-84d7-676288a2f327","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20050517","","ANDA","ANDA065168","Sandoz Inc","10","g/100mL","","N","20261231"
"976","CLINDAMYCIN","Clindamycin in 5 Percent Dextrose","00781328809","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0781-3288","0781-3288-09","0781-3288_e9ea55df-4c10-43a8-97f1-02e6fce12f2b","HUMAN PRESCRIPTION DRUG","Clindamycin in 5 Percent Dextrose","","INJECTION, SOLUTION","INTRAVENOUS","20130207","","ANDA","ANDA201692","Sandoz Inc","6","mg/mL","","N","20251231"
"977","CLINDAMYCIN","Clindamycin in 5 Percent Dextrose","00781328909","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0781-3289","0781-3289-09","0781-3289_e9ea55df-4c10-43a8-97f1-02e6fce12f2b","HUMAN PRESCRIPTION DRUG","Clindamycin in 5 Percent Dextrose","","INJECTION, SOLUTION","INTRAVENOUS","20130207","","ANDA","ANDA201692","Sandoz Inc","12","mg/mL","","N","20251231"
"978","CLINDAMYCIN","Clindamycin in 5 Percent Dextrose","00781329009","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0781-3290","0781-3290-09","0781-3290_e9ea55df-4c10-43a8-97f1-02e6fce12f2b","HUMAN PRESCRIPTION DRUG","Clindamycin in 5 Percent Dextrose","","INJECTION, SOLUTION","INTRAVENOUS","20130207","","ANDA","ANDA201692","Sandoz Inc","18","mg/mL","","N","20251231"
"979","AMPICILLIN SODIUM","Ampicillin sodium","00781340295","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-3402","0781-3402-95","0781-3402_1b9cb7bc-7588-4c66-b2d9-927e5e850683","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19710303","","ANDA","ANDA061395","Sandoz Inc","250","mg/1","","N","20261231"
"980","AMPICILLIN SODIUM","Ampicillin sodium","00781340495","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-3404","0781-3404-95","0781-3404_1b9cb7bc-7588-4c66-b2d9-927e5e850683","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19710303","","ANDA","ANDA061395","Sandoz Inc","1","g/1","","N","20261231"
"981","AMPICILLIN SODIUM","Ampicillin sodium","00781340795","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-3407","0781-3407-95","0781-3407_1b9cb7bc-7588-4c66-b2d9-927e5e850683","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19710303","","ANDA","ANDA061395","Sandoz Inc","500","mg/1","","N","20261231"
"982","AMPICILLIN SODIUM","Ampicillin sodium","00781340895","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-3408","0781-3408-95","0781-3408_1b9cb7bc-7588-4c66-b2d9-927e5e850683","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19710303","","ANDA","ANDA061395","Sandoz Inc","2","g/1","","N","20261231"
"983","AMPICILLIN SODIUM","Ampicillin Sodium","00781340995","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-3409","0781-3409-95","0781-3409_ca309c9e-8236-47fb-a0dd-2c2231b98650","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","19710303","","ANDA","ANDA061395","Sandoz Inc","10","g/1","","N","20261231"
"984","AMPICILLIN SODIUM","Ampicillin Sodium","00781341292","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-3412","0781-3412-92","0781-3412_a4c2a8ec-b73a-43e3-ac67-4c6f0d0bef37","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","19870219","","ANDA","ANDA062738","Sandoz Inc","1","g/1","","N","20261231"
"985","AMPICILLIN SODIUM","Ampicillin Sodium","00781341392","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-3413","0781-3413-92","0781-3413_a4c2a8ec-b73a-43e3-ac67-4c6f0d0bef37","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","19870219","","ANDA","ANDA062738","Sandoz Inc","2","g/1","","N","20261231"
"986","VORICONAZOLE","Voriconazole","00781341694","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0781-3416","0781-3416-94","0781-3416_c0e24b42-8021-4101-a68d-1735fbf6c6cb","HUMAN PRESCRIPTION DRUG","Voriconazole","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20120530","","ANDA","ANDA090862","Sandoz Inc","10","mg/mL","","N","20261231"
"987","CASPOFUNGIN ACETATE","CASPOFUNGIN ACETATE","00781342194","Echinocandin Antifungal [EPC], Lipopeptides [CS]","0781-3421","0781-3421-94","0781-3421_d70d52c0-6601-f632-e053-2995a90a9291","HUMAN PRESCRIPTION DRUG","CASPOFUNGIN ACETATE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180904","","ANDA","ANDA200833","Sandoz Inc","5","mg/mL","","N","20251231"
"988","CASPOFUNGIN ACETATE","CASPOFUNGIN ACETATE","00781342394","Echinocandin Antifungal [EPC], Lipopeptides [CS]","0781-3423","0781-3423-94","0781-3423_d70d52c0-6601-f632-e053-2995a90a9291","HUMAN PRESCRIPTION DRUG","CASPOFUNGIN ACETATE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180904","","ANDA","ANDA200833","Sandoz Inc","7","mg/mL","","N","20251231"
"989","LINEZOLID","Linezolid","00781343395","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","0781-3433","0781-3433-95","0781-3433_731258b6-fb75-4612-b7e6-cfec8f312aaf","HUMAN PRESCRIPTION DRUG","Linezolid","","INJECTION, SOLUTION","INTRAVENOUS","20160615","","ANDA","ANDA200904","Sandoz Inc","600","mg/300mL","","N","20251231"
"990","CEFAZOLIN SODIUM","Cefazolin","00781345095","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-3450","0781-3450-95","0781-3450_5fa78ed4-14be-485c-9e36-fd46a19d18fb","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS; PARENTERAL","19881209","","ANDA","ANDA062831","Sandoz Inc","500","mg/1","","N","20251231"
"991","CEFAZOLIN SODIUM","Cefazolin","00781345196","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-3451","0781-3451-96","0781-3451_5fa78ed4-14be-485c-9e36-fd46a19d18fb","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS; PARENTERAL","19881209","","ANDA","ANDA062831","Sandoz Inc","1","g/1","","N","20251231"
"992","CEFAZOLIN SODIUM","Cefazolin","00781345295","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-3452","0781-3452-95","0781-3452_c888c95b-df82-4261-854e-f74f9b2179e1","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS; PARENTERAL","19881209","","ANDA","ANDA062831","Sandoz Inc","10","g/1","","N","20251231"
"993","TIGECYCLINE","Tigecycline","00781348192","Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]","0781-3481","0781-3481-92","0781-3481_7eeef6bf-1bb2-42d7-9ee2-1a3865b9b11c","HUMAN PRESCRIPTION DRUG","Tigecycline","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS; PARENTERAL","20171130","","ANDA","ANDA091620","Sandoz Inc","50","mg/10mL","","N","20261231"
"994","AMOXICILLIN","Amoxicillin","00781506101","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-5061","0781-5061-01","0781-5061_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20050713","","ANDA","ANDA065228","Sandoz Inc","875","mg/1","","N","20261231"
"995","AMOXICILLIN","Amoxicillin","00781506120","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-5061","0781-5061-20","0781-5061_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20050713","","ANDA","ANDA065228","Sandoz Inc","875","mg/1","","N","20261231"
"996","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","00781543801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-5438","0781-5438-01","0781-5438_6878b572-5711-43a8-9972-1410927f1f14","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20080528","","ANDA","ANDA065462","Sandoz Inc","100","mg/1","","N","20251231"
"997","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","00781543820","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-5438","0781-5438-20","0781-5438_6878b572-5711-43a8-9972-1410927f1f14","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20080528","","ANDA","ANDA065462","Sandoz Inc","100","mg/1","","N","20251231"
"998","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","00781543901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-5439","0781-5439-01","0781-5439_6878b572-5711-43a8-9972-1410927f1f14","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20080528","","ANDA","ANDA065462","Sandoz Inc","200","mg/1","","N","20251231"
"999","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","00781543920","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0781-5439","0781-5439-20","0781-5439_6878b572-5711-43a8-9972-1410927f1f14","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20080528","","ANDA","ANDA065462","Sandoz Inc","200","mg/1","","N","20251231"
"1000","VORICONAZOLE","voriconazole","00781566705","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0781-5667","0781-5667-05","0781-5667_d76dcbf4-6839-4396-9eb5-b0e6edadbed9","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20111212","","ANDA","ANDA200265","Sandoz Inc","50","mg/1","","N","20261231"
"1001","VORICONAZOLE","voriconazole","00781566710","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0781-5667","0781-5667-10","0781-5667_d76dcbf4-6839-4396-9eb5-b0e6edadbed9","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20111212","","ANDA","ANDA200265","Sandoz Inc","50","mg/1","","N","20261231"
"1002","VORICONAZOLE","voriconazole","00781566731","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0781-5667","0781-5667-31","0781-5667_d76dcbf4-6839-4396-9eb5-b0e6edadbed9","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20111212","","ANDA","ANDA200265","Sandoz Inc","50","mg/1","","N","20261231"
"1003","VORICONAZOLE","voriconazole","00781566713","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0781-5667","0781-5667-13","0781-5667_d76dcbf4-6839-4396-9eb5-b0e6edadbed9","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20111212","","ANDA","ANDA200265","Sandoz Inc","50","mg/1","","N","20261231"
"1004","VORICONAZOLE","voriconazole","00781566805","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0781-5668","0781-5668-05","0781-5668_d76dcbf4-6839-4396-9eb5-b0e6edadbed9","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20111212","","ANDA","ANDA200265","Sandoz Inc","200","mg/1","","N","20261231"
"1005","VORICONAZOLE","voriconazole","00781566810","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0781-5668","0781-5668-10","0781-5668_d76dcbf4-6839-4396-9eb5-b0e6edadbed9","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20111212","","ANDA","ANDA200265","Sandoz Inc","200","mg/1","","N","20261231"
"1006","VORICONAZOLE","voriconazole","00781566831","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0781-5668","0781-5668-31","0781-5668_d76dcbf4-6839-4396-9eb5-b0e6edadbed9","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20111212","","ANDA","ANDA200265","Sandoz Inc","200","mg/1","","N","20261231"
"1007","VORICONAZOLE","voriconazole","00781566813","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0781-5668","0781-5668-13","0781-5668_d76dcbf4-6839-4396-9eb5-b0e6edadbed9","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20111212","","ANDA","ANDA200265","Sandoz Inc","200","mg/1","","N","20261231"
"1008","CLARITHROMYCIN","Clarithromycin","00781602252","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","0781-6022","0781-6022-52","0781-6022_fcbab0c3-9fdb-40aa-9a17-e53f88a19bbc","HUMAN PRESCRIPTION DRUG","Clarithromycin","","FOR SUSPENSION","ORAL","20070904","","ANDA","ANDA065283","Sandoz Inc","125","mg/5mL","","N","20251231"
"1009","CLARITHROMYCIN","Clarithromycin","00781602246","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","0781-6022","0781-6022-46","0781-6022_fcbab0c3-9fdb-40aa-9a17-e53f88a19bbc","HUMAN PRESCRIPTION DRUG","Clarithromycin","","FOR SUSPENSION","ORAL","20070904","","ANDA","ANDA065283","Sandoz Inc","125","mg/5mL","","N","20251231"
"1010","CLARITHROMYCIN","Clarithromycin","00781602346","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","0781-6023","0781-6023-46","0781-6023_fcbab0c3-9fdb-40aa-9a17-e53f88a19bbc","HUMAN PRESCRIPTION DRUG","Clarithromycin","","FOR SUSPENSION","ORAL","20070904","","ANDA","ANDA065283","Sandoz Inc","250","mg/5mL","","N","20251231"
"1011","CLARITHROMYCIN","Clarithromycin","00781602352","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","0781-6023","0781-6023-52","0781-6023_fcbab0c3-9fdb-40aa-9a17-e53f88a19bbc","HUMAN PRESCRIPTION DRUG","Clarithromycin","","FOR SUSPENSION","ORAL","20070904","","ANDA","ANDA065283","Sandoz Inc","250","mg/5mL","","N","20251231"
"1012","AMOXICILLIN","Amoxicillin","00781603958","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-6039","0781-6039-58","0781-6039_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065387","Sandoz Inc","125","mg/5mL","","N","20261231"
"1013","AMOXICILLIN","Amoxicillin","00781603946","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-6039","0781-6039-46","0781-6039_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065387","Sandoz Inc","125","mg/5mL","","N","20261231"
"1014","AMOXICILLIN","Amoxicillin","00781603955","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-6039","0781-6039-55","0781-6039_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065387","Sandoz Inc","125","mg/5mL","","N","20261231"
"1015","AMOXICILLIN","Amoxicillin","00781604146","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-6041","0781-6041-46","0781-6041_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065387","Sandoz Inc","250","mg/5mL","","N","20261231"
"1016","AMOXICILLIN","Amoxicillin","00781604155","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-6041","0781-6041-55","0781-6041_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065387","Sandoz Inc","250","mg/5mL","","N","20261231"
"1017","AMOXICILLIN","Amoxicillin","00781604158","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-6041","0781-6041-58","0781-6041_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065387","Sandoz Inc","250","mg/5mL","","N","20261231"
"1018","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781610252","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-6102","0781-6102-52","0781-6102_bd3c4acc-09ff-49ef-af5a-7087d2ada599","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20020605","","ANDA","ANDA065066","Sandoz Inc","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"1019","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781610257","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-6102","0781-6102-57","0781-6102_bd3c4acc-09ff-49ef-af5a-7087d2ada599","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20020605","","ANDA","ANDA065066","Sandoz Inc","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"1020","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781610246","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-6102","0781-6102-46","0781-6102_bd3c4acc-09ff-49ef-af5a-7087d2ada599","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20020605","","ANDA","ANDA065066","Sandoz Inc","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"1021","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781610457","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-6104","0781-6104-57","0781-6104_bd3c4acc-09ff-49ef-af5a-7087d2ada599","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20020605","","ANDA","ANDA065066","Sandoz Inc","400; 57","mg/5mL; mg/5mL","","N","20251231"
"1022","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781610452","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-6104","0781-6104-52","0781-6104_bd3c4acc-09ff-49ef-af5a-7087d2ada599","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20020605","","ANDA","ANDA065066","Sandoz Inc","400; 57","mg/5mL; mg/5mL","","N","20251231"
"1023","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781610446","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-6104","0781-6104-46","0781-6104_bd3c4acc-09ff-49ef-af5a-7087d2ada599","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20020605","","ANDA","ANDA065066","Sandoz Inc","400; 57","mg/5mL; mg/5mL","","N","20251231"
"1024","PENICILLIN G POTASSIUM","Penicillin G Potassium","00781613595","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-6135","0781-6135-95","0781-6135_e76e56d8-13b5-4520-8aa3-9202ceef1a03","HUMAN PRESCRIPTION DRUG","Penicillin G Potassium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20010830","","ANDA","ANDA065079","Sandoz Inc","5000000","[iU]/1","","N","20251231"
"1025","PENICILLIN G POTASSIUM","Penicillin G Potassium","00781613694","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-6136","0781-6136-94","0781-6136_e76e56d8-13b5-4520-8aa3-9202ceef1a03","HUMAN PRESCRIPTION DRUG","Penicillin G Potassium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20010830","","ANDA","ANDA065079","Sandoz Inc","20000000","[iU]/1","","N","20251231"
"1026","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781613954","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-6139","0781-6139-54","0781-6139_a64b73f7-9181-47db-9150-8ca6d2fbd189","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","SUSPENSION","ORAL","20070813","","ANDA","ANDA065358","Sandoz Inc","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"1027","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781613957","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-6139","0781-6139-57","0781-6139_a64b73f7-9181-47db-9150-8ca6d2fbd189","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","SUSPENSION","ORAL","20070813","","ANDA","ANDA065358","Sandoz Inc","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"1028","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","00781613948","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-6139","0781-6139-48","0781-6139_a64b73f7-9181-47db-9150-8ca6d2fbd189","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","SUSPENSION","ORAL","20070813","","ANDA","ANDA065358","Sandoz Inc","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"1029","PENICILLIN G SODIUM","Penicillin G Sodium","00781615395","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-6153","0781-6153-95","0781-6153_0e84343e-8796-4c54-8dcc-8448a231fcfa","HUMAN PRESCRIPTION DRUG","Penicillin G Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20010226","","ANDA","ANDA065068","Sandoz Inc","5000000","[USP'U]/1","","N","20251231"
"1030","AMOXICILLIN","Amoxicillin","00781615652","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-6156","0781-6156-52","0781-6156_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065378","Sandoz Inc","200","mg/5mL","","N","20261231"
"1031","AMOXICILLIN","Amoxicillin","00781615657","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-6156","0781-6156-57","0781-6156_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065378","Sandoz Inc","200","mg/5mL","","N","20261231"
"1032","AMOXICILLIN","Amoxicillin","00781615646","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-6156","0781-6156-46","0781-6156_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065378","Sandoz Inc","200","mg/5mL","","N","20261231"
"1033","AMOXICILLIN","Amoxicillin","00781615746","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-6157","0781-6157-46","0781-6157_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065378","Sandoz Inc","400","mg/5mL","","N","20261231"
"1034","AMOXICILLIN","Amoxicillin","00781615757","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-6157","0781-6157-57","0781-6157_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065378","Sandoz Inc","400","mg/5mL","","N","20261231"
"1035","AMOXICILLIN","Amoxicillin","00781615752","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-6157","0781-6157-52","0781-6157_e527fe15-73c1-4924-8874-41e3e2ea2776","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065378","Sandoz Inc","400","mg/5mL","","N","20261231"
"1036","CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE","ciprofloxacin and dexamethasone","00781618667","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0781-6186","0781-6186-67","0781-6186_39a8b845-aa32-4c9d-bef8-18cea1ef7bc9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin and Dexamethasone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","20200810","","NDA AUTHORIZED GENERIC","NDA021537","Sandoz Inc","3; 1","mg/mL; mg/mL","","N","20261231"
"1037","MOXIFLOXACIN HYDROCHLORIDE","moxifloxacin hydrochloride","00781713593","Quinolone Antimicrobial [EPC], Quinolones [CS]","0781-7135","0781-7135-93","0781-7135_fe09f635-c4f0-4698-8468-d226257b6d58","HUMAN PRESCRIPTION DRUG","Moxifloxacin Ophthalmic Solution","","SOLUTION/ DROPS","OPHTHALMIC","20030507","","NDA AUTHORIZED GENERIC","NDA021598","Sandoz Inc","5","mg/mL","","N","20251231"
"1038","AZITHROMYCIN DIHYDRATE","Azithromycin","00781808931","Macrolide Antimicrobial [EPC], Macrolides [CS]","0781-8089","0781-8089-31","0781-8089_a43a036c-9af9-4429-b0c0-731001003fea","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20051114","","ANDA","ANDA065211","Sandoz Inc","250","mg/1","","N","20251231"
"1039","AZITHROMYCIN DIHYDRATE","Azithromycin","00781808969","Macrolide Antimicrobial [EPC], Macrolides [CS]","0781-8089","0781-8089-69","0781-8089_a43a036c-9af9-4429-b0c0-731001003fea","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20051114","","ANDA","ANDA065211","Sandoz Inc","250","mg/1","","N","20251231"
"1040","AZITHROMYCIN DIHYDRATE","Azithromycin","00781808926","Macrolide Antimicrobial [EPC], Macrolides [CS]","0781-8089","0781-8089-26","0781-8089_a43a036c-9af9-4429-b0c0-731001003fea","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20051114","","ANDA","ANDA065211","Sandoz Inc","250","mg/1","","N","20251231"
"1041","AZITHROMYCIN DIHYDRATE","Azithromycin","00781809003","Macrolide Antimicrobial [EPC], Macrolides [CS]","0781-8090","0781-8090-03","0781-8090_a43a036c-9af9-4429-b0c0-731001003fea","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20051114","","ANDA","ANDA065212","Sandoz Inc","500","mg/1","","N","20251231"
"1042","AZITHROMYCIN DIHYDRATE","Azithromycin","00781809031","Macrolide Antimicrobial [EPC], Macrolides [CS]","0781-8090","0781-8090-31","0781-8090_a43a036c-9af9-4429-b0c0-731001003fea","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20051114","","ANDA","ANDA065212","Sandoz Inc","500","mg/1","","N","20251231"
"1043","AZITHROMYCIN DIHYDRATE","Azithromycin","00781809131","Macrolide Antimicrobial [EPC], Macrolides [CS]","0781-8091","0781-8091-31","0781-8091_5cec3961-a2a4-4f61-a73e-1656021b4195","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20051114","","ANDA","ANDA065209","Sandoz Inc","600","mg/1","","N","20251231"
"1044","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","00781921095","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-9210","0781-9210-95","0781-9210_f9958d78-af7a-4804-9755-a004fed5c432","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS; PARENTERAL","20101021","","ANDA","ANDA065362","Sandoz Inc","2; .25","g/10mL; g/10mL","","N","20261231"
"1045","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","00781921395","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-9213","0781-9213-95","0781-9213_f9958d78-af7a-4804-9755-a004fed5c432","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS; PARENTERAL","20101021","","ANDA","ANDA065362","Sandoz Inc","3; .375","g/15mL; g/15mL","","N","20261231"
"1046","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","00781921495","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","0781-9214","0781-9214-95","0781-9214_f9958d78-af7a-4804-9755-a004fed5c432","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS; PARENTERAL","20101021","","ANDA","ANDA065362","Sandoz Inc","4; .5","g/20mL; g/20mL","","N","20261231"
"1047","AMPICILLIN SODIUM","Ampicillin sodium","00781924295","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-9242","0781-9242-95","0781-9242_2f01d12b-49f3-4310-915d-47710645c96b","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19710303","","ANDA","ANDA061395","Sandoz Inc","250","mg/1","","N","20261231"
"1048","AMPICILLIN SODIUM","Ampicillin sodium","00781926195","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-9261","0781-9261-95","0781-9261_2f01d12b-49f3-4310-915d-47710645c96b","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19710303","","ANDA","ANDA061395","Sandoz Inc","1","g/1","","N","20261231"
"1049","AMPICILLIN SODIUM","Ampicillin sodium","00781927395","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-9273","0781-9273-95","0781-9273_2f01d12b-49f3-4310-915d-47710645c96b","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19710303","","ANDA","ANDA061395","Sandoz Inc","2","g/1","","N","20261231"
"1050","AMPICILLIN SODIUM","Ampicillin sodium","00781940295","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-9402","0781-9402-95","0781-9402_a3ddae6c-ac4c-425f-82b0-eb388d92bc0e","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19710303","","ANDA","ANDA061395","Sandoz Inc","250","mg/1","","N","20261231"
"1051","AMPICILLIN SODIUM","Ampicillin sodium","00781940495","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-9404","0781-9404-95","0781-9404_a3ddae6c-ac4c-425f-82b0-eb388d92bc0e","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19710303","","ANDA","ANDA061395","Sandoz Inc","1","g/1","","N","20261231"
"1052","AMPICILLIN SODIUM","Ampicillin sodium","00781940795","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-9407","0781-9407-95","0781-9407_a3ddae6c-ac4c-425f-82b0-eb388d92bc0e","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19710303","","ANDA","ANDA061395","Sandoz Inc","500","mg/1","","N","20261231"
"1053","AMPICILLIN SODIUM","Ampicillin sodium","00781940895","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-9408","0781-9408-95","0781-9408_a3ddae6c-ac4c-425f-82b0-eb388d92bc0e","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19710303","","ANDA","ANDA061395","Sandoz Inc","2","g/1","","N","20261231"
"1054","AMPICILLIN SODIUM","Ampicillin Sodium","00781940995","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-9409","0781-9409-95","0781-9409_86e9a3cc-bc65-4d4f-916d-98c916588730","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","19710303","","ANDA","ANDA061395","Sandoz Inc","10","g/1","","N","20251231"
"1055","AMPICILLIN SODIUM","Ampicillin Sodium","00781941292","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-9412","0781-9412-92","0781-9412_f1afd007-8e8c-40e2-b353-8def35a0ce8b","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","19870219","","ANDA","ANDA062738","Sandoz Inc","1","g/1","","N","20251231"
"1056","AMPICILLIN SODIUM","Ampicillin Sodium","00781941392","Penicillin-class Antibacterial [EPC], Penicillins [CS]","0781-9413","0781-9413-92","0781-9413_f1afd007-8e8c-40e2-b353-8def35a0ce8b","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","19870219","","ANDA","ANDA062738","Sandoz Inc","2","g/1","","N","20251231"
"1057","NYSTATIN","Nystatin","00832046530","Polyene Antifungal [EPC], Polyenes [CS]","0832-0465","0832-0465-30","0832-0465_1b2e0f61-8590-77db-e063-6294a90a72c9","HUMAN PRESCRIPTION DRUG","Nyamyc","","POWDER","TOPICAL","20050503","","ANDA","ANDA065183","Upsher-Smith Laboratories, LLC","100000","[USP'U]/g","","N","20251231"
"1058","NYSTATIN","Nystatin","00832046560","Polyene Antifungal [EPC], Polyenes [CS]","0832-0465","0832-0465-60","0832-0465_1b2e0f61-8590-77db-e063-6294a90a72c9","HUMAN PRESCRIPTION DRUG","Nyamyc","","POWDER","TOPICAL","20050503","","ANDA","ANDA065183","Upsher-Smith Laboratories, LLC","100000","[USP'U]/g","","N","20251231"
"1059","NYSTATIN","Nystatin","00832046515","Polyene Antifungal [EPC], Polyenes [CS]","0832-0465","0832-0465-15","0832-0465_1b2e0f61-8590-77db-e063-6294a90a72c9","HUMAN PRESCRIPTION DRUG","Nyamyc","","POWDER","TOPICAL","20050503","","ANDA","ANDA065183","Upsher-Smith Laboratories, LLC","100000","[USP'U]/g","","N","20251231"
"1060","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin Hydrochloride","00832141003","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0832-1410","0832-1410-03","0832-1410_b740604e-1d7a-4382-90ca-26b0186f7a93","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride","","SOLUTION","OPHTHALMIC","20210210","","ANDA","ANDA212616","Upsher-Smith Laboratories, LLC","5","mg/mL","","N","20251231"
"1061","MICONAZOLE NITRATE","miconazole nitrate","00884029301","Azole Antifungal [EPC], Azoles [CS]","0884-0293","0884-0293-01","0884-0293_24ae5b13-853c-1311-e063-6394a90aa6ac","HUMAN OTC DRUG","fungoid tincture","","TINCTURE","TOPICAL","20120411","","OTC MONOGRAPH DRUG","M014","Pedinol Pharmacal, Inc.","20","mg/mL","","N","20251231"
"1062","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate","00904073431","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0904-0734","0904-0734-31","0904-0734_793b7c82-b488-4f94-89c5-eaa3f3984567","HUMAN OTC DRUG","TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20110601","","OTC MONOGRAPH DRUG","M004","Major Pharmaceuticals","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20261231"
"1063","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","00904272561","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","0904-2725","0904-2725-61","0904-2725_32e35ba8-8acb-4af1-a3e0-89a09027d5ce","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Major Pharmaceuticals","800; 160","mg/1; mg/1","","N","20261231"
"1064","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","00904595961","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0904-5959","0904-5959-61","0904-5959_5855ec79-6100-43ba-8675-8a1784fcc317","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20090410","","ANDA","ANDA065061","Major Pharmaceuticals","150","mg/1","","N","20261231"
"1065","FLUCONAZOLE","Fluconazole","00904650006","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0904-6500","0904-6500-06","0904-6500_a734a240-4f7d-447f-8eb0-19c16465c57a","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20150625","","ANDA","ANDA076658","Major Pharmaceuticals","100","mg/1","","N","20261231"
"1066","FLUCONAZOLE","Fluconazole","00904650061","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0904-6500","0904-6500-61","0904-6500_a734a240-4f7d-447f-8eb0-19c16465c57a","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20150625","","ANDA","ANDA076658","Major Pharmaceuticals","100","mg/1","","N","20261231"
"1067","FLUCONAZOLE","Fluconazole","00904650161","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0904-6501","0904-6501-61","0904-6501_a734a240-4f7d-447f-8eb0-19c16465c57a","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20150625","","ANDA","ANDA076658","Major Pharmaceuticals","200","mg/1","","N","20261231"
"1068","FLUCONAZOLE","Fluconazole","00904650106","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0904-6501","0904-6501-06","0904-6501_a734a240-4f7d-447f-8eb0-19c16465c57a","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20150625","","ANDA","ANDA076658","Major Pharmaceuticals","200","mg/1","","N","20261231"
"1069","LINEZOLID","Linezolid","00904655304","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","0904-6553","0904-6553-04","0904-6553_8f9c2435-37ea-42ad-ad5c-efd312223bb0","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151221","","ANDA","ANDA205517","Major Pharmaceuticals","600","mg/1","","N","20251231"
"1070","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate","00904668067","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0904-6680","0904-6680-67","0904-6680_ee56d579-77a1-4b39-b320-413565166905","HUMAN OTC DRUG","Major Triple Antibiotic","","OINTMENT","TOPICAL","20181004","","OTC MONOGRAPH DRUG","M004","Major Pharmaceuticals","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1071","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir","00904679610","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","0904-6796","0904-6796-10","0904-6796_cab8eef9-3094-4824-a5a6-3e11cd06853c","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET, FILM COATED","ORAL","20160318","","ANDA","ANDA205166","Major Pharmaceuticals","450","mg/1","","N","20261231"
"1072","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir","00904679604","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","0904-6796","0904-6796-04","0904-6796_cab8eef9-3094-4824-a5a6-3e11cd06853c","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET, FILM COATED","ORAL","20160318","","ANDA","ANDA205166","Major Pharmaceuticals","450","mg/1","","N","20261231"
"1073","FLUCYTOSINE","Flucytosine","00904683407","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","0904-6834","0904-6834-07","0904-6834_dd4985ce-742f-4633-9fe1-642f0350250d","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170707","","ANDA","ANDA204652","Major Pharmaceuticals","250","mg/1","","N","20261231"
"1074","FLUCYTOSINE","Flucytosine","00904683507","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","0904-6835","0904-6835-07","0904-6835_dd4985ce-742f-4633-9fe1-642f0350250d","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170707","","ANDA","ANDA204652","Major Pharmaceuticals","500","mg/1","","N","20261231"
"1075","CLARITHROMYCIN","Clarithromycin","00904687204","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","0904-6872","0904-6872-04","0904-6872_7e27e3f6-e160-49d7-9f34-9c7e2cfa299b","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Major Pharmaceuticals","500","mg/1","","N","20261231"
"1076","VORICONAZOLE","Voriconazole","00904702404","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","0904-7024","0904-7024-04","0904-7024_cd69a6b1-257c-446f-90b7-9a799598d3bd","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET","ORAL","20160531","","ANDA","ANDA206181","Major Pharmaceuticals","200","mg/1","","N","20261231"
"1077","NITROFURANTOIN","nitrofurantoin macrocrystals","00904702661","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","0904-7026","0904-7026-61","0904-7026_66463c95-18d9-46e0-9905-b8b5af8cd122","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Major Pharmaceuticals","50","mg/1","","N","20261231"
"1078","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","00904704661","Antimalarial [EPC], Antirheumatic Agent [EPC]","0904-7046","0904-7046-61","0904-7046_1dd7e137-890e-4a50-b8b9-5cb27ba50fed","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20180501","","ANDA","ANDA210441","Major Pharmaceuticals","200","mg/1","","N","20261231"
"1079","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","00904704606","Antimalarial [EPC], Antirheumatic Agent [EPC]","0904-7046","0904-7046-06","0904-7046_1dd7e137-890e-4a50-b8b9-5cb27ba50fed","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20180501","","ANDA","ANDA210441","Major Pharmaceuticals","200","mg/1","","N","20261231"
"1080","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","00904708361","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0904-7083","0904-7083-61","0904-7083_a68e1cb3-9231-4245-8a60-7ceb92aca249","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","20251130","ANDA","ANDA076558","Major Pharmaceuticals","500","mg/1","","N",""
"1081","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","00904708395","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0904-7083","0904-7083-95","0904-7083_a68e1cb3-9231-4245-8a60-7ceb92aca249","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","20251130","ANDA","ANDA076558","Major Pharmaceuticals","500","mg/1","","N",""
"1082","METRONIDAZOLE","METRONIDAZOLE","00904712661","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0904-7126","0904-7126-61","0904-7126_e34d3c1f-2689-469b-b82c-7f8360327553","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20171129","","ANDA","ANDA205245","Major Pharmaceuticals","500","mg/1","","N","20261231"
"1083","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystalline","00904713761","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","0904-7137","0904-7137-61","0904-7137_ce968c06-099e-4ea0-b0c2-1fa0321aa147","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/ Macrocrystalline","","CAPSULE","ORAL","20110525","","NDA","NDA020064","Major Pharmaceuticals","25; 75","mg/1; mg/1","","N","20251231"
"1084","POSACONAZOLE","POSACONAZOLE","00904714910","Azole Antifungal [EPC], Azoles [CS]","0904-7149","0904-7149-10","0904-7149_7823bcaf-46d8-4a8b-86ae-271fc60df433","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","TABLET, DELAYED RELEASE","ORAL","20210203","","ANDA","ANDA213454","Major Pharmaceuticals","100","mg/1","","N","20261231"
"1085","POSACONAZOLE","POSACONAZOLE","00904714904","Azole Antifungal [EPC], Azoles [CS]","0904-7149","0904-7149-04","0904-7149_7823bcaf-46d8-4a8b-86ae-271fc60df433","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","TABLET, DELAYED RELEASE","ORAL","20210203","","ANDA","ANDA213454","Major Pharmaceuticals","100","mg/1","","N","20261231"
"1086","METRONIDAZOLE","METRONIDAZOLE","00904715661","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","0904-7156","0904-7156-61","0904-7156_e34d3c1f-2689-469b-b82c-7f8360327553","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20171129","","ANDA","ANDA205245","Major Pharmaceuticals","250","mg/1","","N","20261231"
"1087","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","00904719461","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","0904-7194","0904-7194-61","0904-7194_3d17632f-136b-4ad5-b440-5e7f9989a51f","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Major Pharmaceuticals","300","mg/1","","N","20261231"
"1088","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","00904724361","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0904-7243","0904-7243-61","0904-7243_a68b6643-7c15-403a-abf1-35c84b52acc8","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20220823","","ANDA","ANDA076639","Major Pharmaceuticals","500","mg/1","","N","20261231"
"1089","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","00904724395","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0904-7243","0904-7243-95","0904-7243_a68b6643-7c15-403a-abf1-35c84b52acc8","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20220823","","ANDA","ANDA076639","Major Pharmaceuticals","500","mg/1","","N","20261231"
"1090","NYSTATIN","NYSTATIN","00904727670","Polyene Antifungal [EPC], Polyenes [CS]","0904-7276","0904-7276-70","0904-7276_f54a4504-5ad6-418d-a883-a282583073fe","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20200717","","ANDA","ANDA203621","Major Pharmaceuticals","100000","[USP'U]/mL","","N","20261231"
"1091","NYSTATIN","NYSTATIN","00904727692","Polyene Antifungal [EPC], Polyenes [CS]","0904-7276","0904-7276-92","0904-7276_f54a4504-5ad6-418d-a883-a282583073fe","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20200717","","ANDA","ANDA203621","Major Pharmaceuticals","100000","[USP'U]/mL","","N","20261231"
"1092","MUPIROCIN","Mupirocin","00904728469","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","0904-7284","0904-7284-69","0904-7284_2a94aff5-90c1-a99b-e063-6394a90a1efc","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20230327","","ANDA","ANDA065170","MAJOR PHARMACEUTICALS","20","mg/g","","N","20251231"
"1093","RIFAMPIN","rifampin","00904731561","Rifamycin Antibacterial [EPC], Rifamycins [CS]","0904-7315","0904-7315-61","0904-7315_3f3534c1-95e4-4bdd-b044-9026e4addf0c","HUMAN PRESCRIPTION DRUG","rifampin","","CAPSULE","ORAL","20250225","","ANDA","ANDA090034","Major Pharmaceuticals","300","mg/1","","N","20261231"
"1094","CEPHALEXIN","Cephalexin","00904733661","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0904-7336","0904-7336-61","0904-7336_1c1fbad7-bef4-42a0-a8c9-b35168f5d533","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20231106","","ANDA","ANDA090836","Major Pharmaceuticals","250","mg/1","","N","20251231"
"1095","CEPHALEXIN","Cephalexin","00904733761","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0904-7337","0904-7337-61","0904-7337_1c1fbad7-bef4-42a0-a8c9-b35168f5d533","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20231106","","ANDA","ANDA090836","Major Pharmaceuticals","500","mg/1","","N","20251231"
"1096","CEPHALEXIN","Cephalexin","00904733706","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","0904-7337","0904-7337-06","0904-7337_1c1fbad7-bef4-42a0-a8c9-b35168f5d533","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20231106","","ANDA","ANDA090836","Major Pharmaceuticals","500","mg/1","","N","20251231"
"1097","AZITHROMYCIN DIHYDRATE","azithromycin","00904735006","Macrolide Antimicrobial [EPC], Macrolides [CS]","0904-7350","0904-7350-06","0904-7350_62443ae3-6500-41b3-977b-582838a2ccd5","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20230501","","ANDA","ANDA065398","Major Pharmaceuticals","250","mg/1","","N","20261231"
"1098","AZITHROMYCIN DIHYDRATE","azithromycin","00904735061","Macrolide Antimicrobial [EPC], Macrolides [CS]","0904-7350","0904-7350-61","0904-7350_62443ae3-6500-41b3-977b-582838a2ccd5","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20230501","","ANDA","ANDA065398","Major Pharmaceuticals","250","mg/1","","N","20261231"
"1099","AZITHROMYCIN DIHYDRATE","azithromycin","00904735104","Macrolide Antimicrobial [EPC], Macrolides [CS]","0904-7351","0904-7351-04","0904-7351_62443ae3-6500-41b3-977b-582838a2ccd5","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20230501","","ANDA","ANDA065399","Major Pharmaceuticals","500","mg/1","","N","20261231"
"1100","MOXIFLOXACIN HYDROCHLORIDE","moxifloxacin hydrochloride","00904740704","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0904-7407","0904-7407-04","0904-7407_0f1fb8ea-b56f-4307-82cb-9ba6008d9ecb","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN HYDROCHLORIDE","","TABLET, FILM COATED","ORAL","20240308","","ANDA","ANDA202632","Major Pharmaceuticals","400","mg/1","","N","20261231"
"1101","MOXIFLOXACIN HYDROCHLORIDE","moxifloxacin hydrochloride","00904740706","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","0904-7407","0904-7407-06","0904-7407_0f1fb8ea-b56f-4307-82cb-9ba6008d9ecb","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN HYDROCHLORIDE","","TABLET, FILM COATED","ORAL","20240308","","ANDA","ANDA202632","Major Pharmaceuticals","400","mg/1","","N","20261231"
"1102","VALGANCICLOVIR HYDROCHLORIDE","valganciclovir hydrochloride","00904741904","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","0904-7419","0904-7419-04","0904-7419_f656a741-7f9c-4173-8893-c259b0d96f5b","HUMAN PRESCRIPTION DRUG","valganciclovir hydrochloride","","FOR SOLUTION","ORAL","20220217","","ANDA","ANDA210169","MAJOR PHARMACEUTICALS","50","mg/mL","","N","20251231"
"1103","OFLOXACIN","ofloxacin","00904743405","Quinolone Antimicrobial [EPC], Quinolones [CS]","0904-7434","0904-7434-05","0904-7434_53a8315c-ae56-4ea0-bdab-ac0d8590d628","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20241111","","ANDA","ANDA215886","Major Pharmaceuticals","3","mg/mL","","N","20251231"
"1104","OFLOXACIN","ofloxacin","00904743410","Quinolone Antimicrobial [EPC], Quinolones [CS]","0904-7434","0904-7434-10","0904-7434_53a8315c-ae56-4ea0-bdab-ac0d8590d628","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20241111","","ANDA","ANDA215886","Major Pharmaceuticals","3","mg/mL","","N","20251231"
"1105","ATOVAQUONE","Atovaquone Oral Suspension","00904745941","Antimalarial [EPC], Antiprotozoal [EPC]","0904-7459","0904-7459-41","0904-7459_5290c16f-78cd-4502-8242-e3b3b631e539","HUMAN PRESCRIPTION DRUG","ATOVAQUONE","","SUSPENSION","ORAL","20240708","","ANDA","ANDA214272","Major Pharmaceuticals","750","mg/5mL","","N","20251231"
"1106","ATOVAQUONE","Atovaquone Oral Suspension","00904745925","Antimalarial [EPC], Antiprotozoal [EPC]","0904-7459","0904-7459-25","0904-7459_5290c16f-78cd-4502-8242-e3b3b631e539","HUMAN PRESCRIPTION DRUG","ATOVAQUONE","","SUSPENSION","ORAL","20240708","","ANDA","ANDA214272","Major Pharmaceuticals","750","mg/5mL","","N","20251231"
"1107","ATOVAQUONE","Atovaquone Oral Suspension","00904745953","Antimalarial [EPC], Antiprotozoal [EPC]","0904-7459","0904-7459-53","0904-7459_5290c16f-78cd-4502-8242-e3b3b631e539","HUMAN PRESCRIPTION DRUG","ATOVAQUONE","","SUSPENSION","ORAL","20240708","","ANDA","ANDA214272","Major Pharmaceuticals","750","mg/5mL","","N","20251231"
"1108","MICONAZOLE NITRATE","Miconazole Nitrate","00904773445","Azole Antifungal [EPC], Azoles [CS]","0904-7734","0904-7734-45","0904-7734_3fe3ac94-a530-48d1-a5b4-fa0d607f6deb","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20090421","","ANDA","ANDA074164","Major Pharmaceuticals","20","mg/g","","N","20251231"
"1109","CLOTRIMAZOLE","CLOTRIMAZOLE","00904782231","Azole Antifungal [EPC], Azoles [CS]","0904-7822","0904-7822-31","0904-7822_2fb5429d-ba9d-48fc-bb79-9ed7333bc0a9","HUMAN OTC DRUG","Major Clotrimazole","","CREAM","TOPICAL","20041004","","OTC MONOGRAPH DRUG","M005","Major Pharmaceuticals","10","mg/g","","N","20251231"
"1110","CLOTRIMAZOLE","CLOTRIMAZOLE","00904782236","Azole Antifungal [EPC], Azoles [CS]","0904-7822","0904-7822-36","0904-7822_2fb5429d-ba9d-48fc-bb79-9ed7333bc0a9","HUMAN OTC DRUG","Major Clotrimazole","","CREAM","TOPICAL","20041004","","OTC MONOGRAPH DRUG","M005","Major Pharmaceuticals","10","mg/g","","N","20251231"
"1111","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin, Polymyxin B Sulfat","00904880531","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0904-8805","0904-8805-31","0904-8805_21dbd44e-7fb5-874e-e063-6394a90a4e8b","HUMAN OTC DRUG","Major Triple Antibiotic","","OINTMENT","TOPICAL","20200420","","OTC MONOGRAPH DRUG","M004","Major Pharmaceuticals","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1112","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin, Polymyxin B Sulfat","00904880567","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0904-8805","0904-8805-67","0904-8805_21dbd44e-7fb5-874e-e063-6394a90a4e8b","HUMAN OTC DRUG","Major Triple Antibiotic","","OINTMENT","TOPICAL","20200420","","OTC MONOGRAPH DRUG","M004","Major Pharmaceuticals","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1113","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","00924560401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0924-5604","0924-5604-01","0924-5604_27495546-006d-ad90-e063-6394a90a71ce","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20230424","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1114","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","00924560402","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0924-5604","0924-5604-02","0924-5604_27495546-006d-ad90-e063-6394a90a71ce","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20230424","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1115","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","00924560403","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0924-5604","0924-5604-03","0924-5604_27495546-006d-ad90-e063-6394a90a71ce","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20230424","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1116","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","00924560405","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0924-5604","0924-5604-05","0924-5604_27495546-006d-ad90-e063-6394a90a71ce","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20230424","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1117","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","00924560406","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0924-5604","0924-5604-06","0924-5604_27495546-006d-ad90-e063-6394a90a71ce","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20230424","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1118","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","00924560404","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0924-5604","0924-5604-04","0924-5604_27495546-006d-ad90-e063-6394a90a71ce","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20230424","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1119","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","00924560400","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0924-5604","0924-5604-00","0924-5604_27495546-006d-ad90-e063-6394a90a71ce","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20230424","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1120","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","00924561000","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0924-5610","0924-5610-00","0924-5610_27497a82-401e-7cb5-e063-6394a90a87c1","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20220804","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1121","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","00924561002","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0924-5610","0924-5610-02","0924-5610_27497a82-401e-7cb5-e063-6394a90a87c1","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20220804","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1122","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","00924561001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0924-5610","0924-5610-01","0924-5610_27497a82-401e-7cb5-e063-6394a90a87c1","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20220804","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1123","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","00924561802","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0924-5618","0924-5618-02","0924-5618_2749912f-9bf8-7cf9-e063-6394a90a5a94","HUMAN OTC DRUG","First Aid Only Triple Antibiotic","","OINTMENT","TOPICAL","20230224","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","400; 5; 5000","U/g; mg/g; U/g","","N","20251231"
"1124","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","00924561803","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0924-5618","0924-5618-03","0924-5618_2749912f-9bf8-7cf9-e063-6394a90a5a94","HUMAN OTC DRUG","First Aid Only Triple Antibiotic","","OINTMENT","TOPICAL","20230224","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","400; 5; 5000","U/g; mg/g; U/g","","N","20251231"
"1125","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","00924561804","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0924-5618","0924-5618-04","0924-5618_2749912f-9bf8-7cf9-e063-6394a90a5a94","HUMAN OTC DRUG","First Aid Only Triple Antibiotic","","OINTMENT","TOPICAL","20230224","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","400; 5; 5000","U/g; mg/g; U/g","","N","20251231"
"1126","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","00924561800","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","0924-5618","0924-5618-00","0924-5618_2749912f-9bf8-7cf9-e063-6394a90a5a94","HUMAN OTC DRUG","First Aid Only Triple Antibiotic","","OINTMENT","TOPICAL","20230224","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","400; 5; 5000","U/g; mg/g; U/g","","N","20251231"
"1127","NEOMYCIN SULFATE","neomycin sulfate","00924562001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0924-5620","0924-5620-01","0924-5620_274a854a-cbfe-ffa1-e063-6294a90a1ea2","HUMAN OTC DRUG","First Aid Only Neomycin Antibiotic","","OINTMENT","TOPICAL","20210716","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","3.5","mg/g","","N","20251231"
"1128","NEOMYCIN SULFATE","neomycin sulfate","00924562002","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0924-5620","0924-5620-02","0924-5620_274a854a-cbfe-ffa1-e063-6294a90a1ea2","HUMAN OTC DRUG","First Aid Only Neomycin Antibiotic","","OINTMENT","TOPICAL","20210716","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","3.5","mg/g","","N","20251231"
"1129","NEOMYCIN SULFATE","neomycin sulfate","00924562000","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","0924-5620","0924-5620-00","0924-5620_274a854a-cbfe-ffa1-e063-6294a90a1ea2","HUMAN OTC DRUG","First Aid Only Neomycin Antibiotic","","OINTMENT","TOPICAL","20210716","","OTC MONOGRAPH DRUG","M004","Acme United Corporation","3.5","mg/g","","N","20251231"
"1130","TOBRAMYCIN","tobramycin","10122082004","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","10122-820","10122-820-04","10122-820_32442297-00c4-4800-b7c4-1e2e290f3162","HUMAN PRESCRIPTION DRUG","BETHKIS","","SOLUTION","RESPIRATORY (INHALATION)","20130415","","NDA","NDA201820","Chiesi USA, Inc.","300","mg/4mL","","N","20251231"
"1131","TOBRAMYCIN","tobramycin","10122082028","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","10122-820","10122-820-28","10122-820_32442297-00c4-4800-b7c4-1e2e290f3162","HUMAN PRESCRIPTION DRUG","BETHKIS","","SOLUTION","RESPIRATORY (INHALATION)","20130415","","NDA","NDA201820","Chiesi USA, Inc.","300","mg/4mL","","N","20251231"
"1132","TOBRAMYCIN","tobramycin","10122082056","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","10122-820","10122-820-56","10122-820_32442297-00c4-4800-b7c4-1e2e290f3162","HUMAN PRESCRIPTION DRUG","BETHKIS","","SOLUTION","RESPIRATORY (INHALATION)","20130415","","NDA","NDA201820","Chiesi USA, Inc.","300","mg/4mL","","N","20251231"
"1133","CLOTRIMAZOLE","Clotrimazole","10135067181","Azole Antifungal [EPC], Azoles [CS]","10135-671","10135-671-81","10135-671_1d884f40-477b-1488-e063-6394a90aa394","HUMAN OTC DRUG","Clotrimazole","","SOLUTION","TOPICAL","20181201","","OTC MONOGRAPH DRUG","M005","Marlex Pharmaceuticals Inc","1","g/mL","","N","20251231"
"1134","CLOTRIMAZOLE","Clotrimazole","10135067191","Azole Antifungal [EPC], Azoles [CS]","10135-671","10135-671-91","10135-671_1d884f40-477b-1488-e063-6394a90aa394","HUMAN OTC DRUG","Clotrimazole","","SOLUTION","TOPICAL","20181201","","OTC MONOGRAPH DRUG","M005","Marlex Pharmaceuticals Inc","1","g/mL","","N","20251231"
"1135","MICONAZOLE NITRATE","Miconazole Nitrate Antifungal Powder","10135072085","Azole Antifungal [EPC], Azoles [CS]","10135-720","10135-720-85","10135-720_247215c4-d7b7-479e-e063-6394a90a2f7a","HUMAN OTC DRUG","Miconazole Nitrate Antifungal Powder","","POWDER","TOPICAL","20220501","","OTC MONOGRAPH DRUG","M005","Marlex Pharmaceuticals, Inc.","2","g/100g","","N","20251231"
"1136","ITRACONAZOLE","ITRACONAZOLE","10147170003","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","10147-1700","10147-1700-3","10147-1700_2cca3625-96e8-34cf-e063-6294a90ac975","HUMAN PRESCRIPTION DRUG","itraconazole","","CAPSULE","ORAL","20050201","","NDA","NDA020083","Patriot Pharmaceuticals","100","mg/1","","N","20261231"
"1137","ATOVAQUONE","Atovaquone","10702022321","Antimalarial [EPC], Antiprotozoal [EPC]","10702-223","10702-223-21","10702-223_116f0b5b-cbad-8216-e063-6294a90a9a13","HUMAN PRESCRIPTION DRUG","Atovaquone Oral Suspension","","SUSPENSION","ORAL","20190329","","ANDA","ANDA210510","KVK-Tech, Inc.","750","mg/5mL","","N","20251231"
"1138","TIOCONAZOLE","Tioconazole","11509042601","Azole Antifungal [EPC], Azoles [CS]","11509-0426","11509-0426-1","11509-0426_8c436269-2f52-4ddf-b3be-cec3069a8865","HUMAN OTC DRUG","VAGISTAT","","OINTMENT","VAGINAL","20200729","","ANDA","ANDA075915","Combe Incorporated","6.5","g/100g","","N","20251231"
"1139","MICONAZOLE NITRATE","Miconazole nitrate","11509082501","Azole Antifungal [EPC], Azoles [CS]","11509-0825","11509-0825-1","11509-0825_42a55863-e89f-4ec0-97a0-2d7b1e2b6b36","HUMAN OTC DRUG","vagisil brand vagistat","","CREAM","VAGINAL","20201008","","ANDA","ANDA074760","Combe Incorporated","2","g/100g","","N","20261231"
"1140","BUTENAFINE HYDROCHLORIDE","Butenafine hydrochloride","11523008201","Benzylamine Antifungal [EPC], Benzylamines [CS]","11523-0082","11523-0082-1","11523-0082_289db392-b570-1729-e063-6294a90ab4b1","HUMAN OTC DRUG","Lotrimin Ultra","","CREAM","TOPICAL","20211220","","NDA","NDA021307","Bayer Healthcare LLC.","1","g/100g","","N","20251231"
"1141","MICONAZOLE NITRATE","Miconazole nitrate","11523013301","Azole Antifungal [EPC], Azoles [CS]","11523-0133","11523-0133-1","11523-0133_0c53cf0f-767f-a422-e063-6394a90ab764","HUMAN OTC DRUG","Lotrimin","AF Jock Itch","AEROSOL, POWDER","TOPICAL","20231129","","OTC MONOGRAPH DRUG","M005","Bayer Healthcare LLC.","20","mg/g","","N","20251231"
"1142","MICONAZOLE NITRATE","Miconazole nitrate","11523013401","Azole Antifungal [EPC], Azoles [CS]","11523-0134","11523-0134-1","11523-0134_163996c6-af55-21ac-e063-6394a90ac05c","HUMAN OTC DRUG","Lotrimin AF","","AEROSOL, POWDER","TOPICAL","20240226","","OTC MONOGRAPH DRUG","M005","Bayer Healthcare LLC.","20","mg/g","","N","20251231"
"1143","MICONAZOLE NITRATE","Miconazole nitrate","11523013501","Azole Antifungal [EPC], Azoles [CS]","11523-0135","11523-0135-1","11523-0135_0bee54eb-df30-15fe-e063-6294a90a2fd2","HUMAN OTC DRUG","Lotrimin","AF Deodorant","AEROSOL, POWDER","TOPICAL","20231129","","OTC MONOGRAPH DRUG","M005","Bayer HealthCare LLC.","20","mg/g","","N","20251231"
"1144","MICONAZOLE NITRATE","Miconazole nitrate","11523015001","Azole Antifungal [EPC], Azoles [CS]","11523-0150","11523-0150-1","11523-0150_1300d84f-d800-ec57-e063-6294a90ae0de","HUMAN OTC DRUG","Lotrimin","AF Jock Itch","POWDER","TOPICAL","20231106","","OTC MONOGRAPH DRUG","M005","Bayer HealthCare LLC.","20","mg/g","","N","20251231"
"1145","BUTENAFINE HYDROCHLORIDE","Butenafine hydrochloride","11523015802","Benzylamine Antifungal [EPC], Benzylamines [CS]","11523-0158","11523-0158-2","11523-0158_1c4562a1-1423-c0e6-e063-6294a90ad643","HUMAN OTC DRUG","Lotrimin Ultra","Ringworm","CREAM","TOPICAL","20240102","","NDA","NDA021307","Bayer Healthcare LLC.","1","g/100g","","N","20251231"
"1146","MICONAZOLE NITRATE","Miconazole nitrate","11523054402","Azole Antifungal [EPC], Azoles [CS]","11523-0544","11523-0544-2","11523-0544_289dd4d1-bed5-42a7-e063-6394a90ace68","HUMAN OTC DRUG","Lotrimin","Antifungal","AEROSOL, POWDER","TOPICAL","19930901","","OTC MONOGRAPH DRUG","M005","Bayer Healthcare LLC.","20","mg/g","","N","20251231"
"1147","MICONAZOLE NITRATE","Miconazole nitrate","11523091901","Azole Antifungal [EPC], Azoles [CS]","11523-0919","11523-0919-1","11523-0919_289ddd77-a221-307b-e063-6394a90ad6a7","HUMAN OTC DRUG","Lotrimin","Antifungal","POWDER","TOPICAL","19930901","","OTC MONOGRAPH DRUG","M005","Bayer HealthCare LLC.","20","mg/g","","N","20251231"
"1148","CLOTRIMAZOLE","Clotrimazole","11523096301","Azole Antifungal [EPC], Azoles [CS]","11523-0963","11523-0963-1","11523-0963_289de908-7be1-ace6-e063-6294a90a2080","HUMAN OTC DRUG","Lotrimin","","CREAM","TOPICAL","20020201","","OTC MONOGRAPH DRUG","M005","Bayer HealthCare LLC","10","mg/g","","N","20251231"
"1149","CLOTRIMAZOLE","Clotrimazole","11523096302","Azole Antifungal [EPC], Azoles [CS]","11523-0963","11523-0963-2","11523-0963_289de908-7be1-ace6-e063-6294a90a2080","HUMAN OTC DRUG","Lotrimin","","CREAM","TOPICAL","20020201","","OTC MONOGRAPH DRUG","M005","Bayer HealthCare LLC","10","mg/g","","N","20251231"
"1150","CLOTRIMAZOLE","Clotrimazole","11523096307","Azole Antifungal [EPC], Azoles [CS]","11523-0963","11523-0963-7","11523-0963_289de908-7be1-ace6-e063-6294a90a2080","HUMAN OTC DRUG","Lotrimin","","CREAM","TOPICAL","20020201","","OTC MONOGRAPH DRUG","M005","Bayer HealthCare LLC","10","mg/g","","N","20251231"
"1151","CLOTRIMAZOLE","Clotrimazole","11523096305","Azole Antifungal [EPC], Azoles [CS]","11523-0963","11523-0963-5","11523-0963_289de908-7be1-ace6-e063-6294a90a2080","HUMAN OTC DRUG","Lotrimin","","CREAM","TOPICAL","20020201","","OTC MONOGRAPH DRUG","M005","Bayer HealthCare LLC","10","mg/g","","N","20251231"
"1152","CLOTRIMAZOLE","Clotrimazole","11523112501","Azole Antifungal [EPC], Azoles [CS]","11523-1125","11523-1125-1","11523-1125_289dffb5-f19d-311c-e063-6394a90a5a7c","HUMAN OTC DRUG","Lotrimin","Antifungal","CREAM","TOPICAL","20020201","","OTC MONOGRAPH DRUG","M005","Bayer HealthCare LLC.","10","mg/g","","N","20251231"
"1153","MICONAZOLE NITRATE","Miconazole nitrate","11523127202","Azole Antifungal [EPC], Azoles [CS]","11523-1272","11523-1272-2","11523-1272_289de908-7be4-ace6-e063-6294a90a2080","HUMAN OTC DRUG","Lotrimin","Antifungal","AEROSOL, POWDER","TOPICAL","19930901","","OTC MONOGRAPH DRUG","M005","Bayer HealthCare LLC.","20","mg/g","","N","20251231"
"1154","MICONAZOLE NITRATE","Miconazole nitrate","11523414002","Azole Antifungal [EPC], Azoles [CS]","11523-4140","11523-4140-2","11523-4140_289f35a4-2020-cced-e063-6394a90a408d","HUMAN OTC DRUG","Lotrimin","Antifungal","AEROSOL, POWDER","TOPICAL","19930901","","OTC MONOGRAPH DRUG","M005","Bayer Healthcare LLC.","20","mg/g","","N","20251231"
"1155","MICONAZOLE NITRATE","Miconazole nitrate","11523432701","Azole Antifungal [EPC], Azoles [CS]","11523-4327","11523-4327-1","11523-4327_289f2ae0-fccd-df93-e063-6394a90a270f","HUMAN OTC DRUG","Lotrimin AF","Antifungal","SPRAY","TOPICAL","19930901","","OTC MONOGRAPH DRUG","M005","Bayer Healthcare LLC.","20","mg/g","","N","20251231"
"1156","BUTENAFINE HYDROCHLORIDE","Butenafine hydrochloride","11523433801","Benzylamine Antifungal [EPC], Benzylamines [CS]","11523-4338","11523-4338-1","11523-4338_289f52f4-77b0-0985-e063-6394a90a4add","HUMAN OTC DRUG","Lotrimin Ultra","Athletes Foot","CREAM","TOPICAL","20020222","","NDA","NDA021307","Bayer Healthcare LLC.","1","g/100g","","N","20251231"
"1157","BUTENAFINE HYDROCHLORIDE","Butenafine hydrochloride","11523433804","Benzylamine Antifungal [EPC], Benzylamines [CS]","11523-4338","11523-4338-4","11523-4338_289f52f4-77b0-0985-e063-6394a90a4add","HUMAN OTC DRUG","Lotrimin Ultra","Athletes Foot","CREAM","TOPICAL","20020222","","NDA","NDA021307","Bayer Healthcare LLC.","1","g/100g","","N","20251231"
"1158","BUTENAFINE HYDROCHLORIDE","Butenafine hydrochloride","11523433802","Benzylamine Antifungal [EPC], Benzylamines [CS]","11523-4338","11523-4338-2","11523-4338_289f52f4-77b0-0985-e063-6394a90a4add","HUMAN OTC DRUG","Lotrimin Ultra","Athletes Foot","CREAM","TOPICAL","20020222","","NDA","NDA021307","Bayer Healthcare LLC.","1","g/100g","","N","20251231"
"1159","BUTENAFINE HYDROCHLORIDE","Butenafine hydrochloride","11523433901","Benzylamine Antifungal [EPC], Benzylamines [CS]","11523-4339","11523-4339-1","11523-4339_289f2ae0-fcce-df93-e063-6394a90a270f","HUMAN OTC DRUG","Lotrimin Ultra","Jock Itch","CREAM","TOPICAL","20020222","","NDA","NDA021307","Bayer Healthcare LLC.","1","g/100g","","N","20251231"
"1160","BUTENAFINE HYDROCHLORIDE","Butenafine hydrochloride","11523433902","Benzylamine Antifungal [EPC], Benzylamines [CS]","11523-4339","11523-4339-2","11523-4339_289f2ae0-fcce-df93-e063-6394a90a270f","HUMAN OTC DRUG","Lotrimin Ultra","Jock Itch","CREAM","TOPICAL","20020222","","NDA","NDA021307","Bayer Healthcare LLC.","1","g/100g","","N","20251231"
"1161","BUTENAFINE HYDROCHLORIDE","Butenafine hydrochloride","11523433903","Benzylamine Antifungal [EPC], Benzylamines [CS]","11523-4339","11523-4339-3","11523-4339_289f2ae0-fcce-df93-e063-6394a90a270f","HUMAN OTC DRUG","Lotrimin Ultra","Jock Itch","CREAM","TOPICAL","20020222","","NDA","NDA021307","Bayer Healthcare LLC.","1","g/100g","","N","20251231"
"1162","CLOTRIMAZOLE","Clotrimazole","11523654901","Azole Antifungal [EPC], Azoles [CS]","11523-6549","11523-6549-1","11523-6549_289f5b6e-a1c1-5b7a-e063-6294a90a60bb","HUMAN OTC DRUG","Lotrimin","","CREAM","TOPICAL","20090102","","OTC MONOGRAPH DRUG","M005","Bayer HealthCare LLC.","10","mg/g","","N","20251231"
"1163","CLOTRIMAZOLE","CLOTRIMAZOLE","11527007151","Azole Antifungal [EPC], Azoles [CS]","11527-071","11527-071-51","11527-071_609949ed-f872-440f-b3f3-2147acc856bc","HUMAN OTC DRUG","Dr Sheffield Athletes Foot","","CREAM","TOPICAL","20041004","","OTC MONOGRAPH DRUG","M005","Sheffield Pharmaceuticals LLC","10","mg/g","","N","20261231"
"1164","CLOTRIMAZOLE","CLOTRIMAZOLE","11527007140","Azole Antifungal [EPC], Azoles [CS]","11527-071","11527-071-40","11527-071_609949ed-f872-440f-b3f3-2147acc856bc","HUMAN OTC DRUG","Dr Sheffield Athletes Foot","","CREAM","TOPICAL","20041004","","OTC MONOGRAPH DRUG","M005","Sheffield Pharmaceuticals LLC","10","mg/g","","N","20261231"
"1165","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate, Pramoxine Hydrochloride","11527016155","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11527-161","11527-161-55","11527-161_d91f9d30-8d50-4e41-8ba5-38989db9180b","HUMAN OTC DRUG","Sheffield Triple Antibiotic Plus Pain Relief","","OINTMENT","TOPICAL","20110123","","OTC MONOGRAPH DRUG","M004","Sheffield Pharmaceuticals LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1166","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate","11527016247","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11527-162","11527-162-47","11527-162_e78cd65b-8aeb-4fc5-8551-2deceb5d01e2","HUMAN OTC DRUG","Sheffield Triple Antibiotic","","OINTMENT","TOPICAL","20110123","","OTC MONOGRAPH DRUG","M004","Sheffield Pharmaceuticals LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"1167","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate","11527016251","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11527-162","11527-162-51","11527-162_e78cd65b-8aeb-4fc5-8551-2deceb5d01e2","HUMAN OTC DRUG","Sheffield Triple Antibiotic","","OINTMENT","TOPICAL","20110123","","OTC MONOGRAPH DRUG","M004","Sheffield Pharmaceuticals LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"1168","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate","11527016255","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11527-162","11527-162-55","11527-162_e78cd65b-8aeb-4fc5-8551-2deceb5d01e2","HUMAN OTC DRUG","Sheffield Triple Antibiotic","","OINTMENT","TOPICAL","20110123","","OTC MONOGRAPH DRUG","M004","Sheffield Pharmaceuticals LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"1169","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","11673001602","Benzylamine Antifungal [EPC], Benzylamines [CS]","11673-016","11673-016-02","11673-016_18adad72-9633-f83a-e063-6394a90ad5a2","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","Target Corporation","10","mg/g","","N","20251231"
"1170","MICONAZOLE NITRATE","Miconazole Nitrate","11673004906","Azole Antifungal [EPC], Azoles [CS]","11673-049","11673-049-06","11673-049_362a4665-34b2-f3d3-e063-6294a90a091a","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","19970113","","ANDA","ANDA074444","TARGET Corporation","20","mg/g","","N","20261231"
"1171","CLOTRIMAZOLE","Clotrimazole","11673006215","Azole Antifungal [EPC], Azoles [CS]","11673-062","11673-062-15","11673-062_26e33c46-db03-0c7f-e063-6394a90a9872","HUMAN OTC DRUG","Jock Itch","","CREAM","TOPICAL","20190427","","OTC MONOGRAPH DRUG","M005","TARGET Corporation","10","mg/g","","N","20251231"
"1172","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","11673008002","Allylamine Antifungal [EPC], Allylamine [CS]","11673-080","11673-080-02","11673-080_170962fb-fc96-a281-e063-6394a90aebf9","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Target Corporation","1","g/100g","","N","20251231"
"1173","MICONAZOLE NITRATE","Miconazole Nitrate","11673039106","Azole Antifungal [EPC], Azoles [CS]","11673-391","11673-391-06","11673-391_ad19abde-5cba-4cf6-8e37-d6a9ae3a84ff","HUMAN OTC DRUG","Miconazole 3","","CREAM","VAGINAL","20050302","","ANDA","ANDA076773","TARGET Corporation","40","mg/g","","N","20251231"
"1174","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride","11673039301","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11673-393","11673-393-01","11673-393_25dd8ba4-6978-3305-e063-6294a90a05a3","HUMAN OTC DRUG","Antibiotic Plus Pain Relief","","CREAM","TOPICAL","20201016","","OTC MONOGRAPH DRUG","M017","TARGET Corporation","3.5; 10000; 10","mg/g; [iU]/g; mg/g","","N","20251231"
"1175","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","11673040516","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11673-405","11673-405-16","11673-405_b16ae893-fa5c-4bfb-90ed-82bea687e164","HUMAN OTC DRUG","up and up antibiotic","","OINTMENT","TOPICAL","20140608","20250630","OTC MONOGRAPH DRUG","M004","Target Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N",""
"1176","TIOCONAZOLE","Tioconazole","11673042654","Azole Antifungal [EPC], Azoles [CS]","11673-426","11673-426-54","11673-426_b1e87969-fddb-45a6-9056-fe784a9c1c51","HUMAN OTC DRUG","Up and up tioconazole 1","","OINTMENT","VAGINAL","20090708","","ANDA","ANDA075915","Target Corporation","6.5","g/100g","","N","20251231"
"1177","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","11673043601","Benzylamine Antifungal [EPC], Benzylamines [CS]","11673-436","11673-436-01","11673-436_258eac65-69f0-404f-e063-6394a90a19ef","HUMAN OTC DRUG","Jock Itch Cream","","CREAM","TOPICAL","20241115","","ANDA","ANDA205181","TARGET CORPORATION","10","mg/g","","N","20251231"
"1178","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Triple Antibiotic","11673074628","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11673-746","11673-746-28","11673-746_f358223c-786b-4113-9a59-f5b9dbb9b37d","HUMAN OTC DRUG","Triple Antibiotic and Pain Relief","","OINTMENT","TOPICAL","20240131","","OTC MONOGRAPH DRUG","M004","Target Corporation","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1179","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride","11673077014","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11673-770","11673-770-14","11673-770_198a8cc8-c708-42c9-b533-0b688475411e","HUMAN OTC DRUG","Antibiotic and Pain Relief","","CREAM","TOPICAL","20240131","","OTC MONOGRAPH DRUG","M004","Target Corporation","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"1180","MICONAZOLE NITRATE","Miconazole nitrate","11673082529","Azole Antifungal [EPC], Azoles [CS]","11673-825","11673-825-29","11673-825_1a673c72-8de9-4061-9644-fdf46046699c","HUMAN OTC DRUG","up and up miconazole 7","","CREAM","VAGINAL","20090826","","ANDA","ANDA074760","Target Corporation","2","g/100g","","N","20251231"
"1181","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment","11673087514","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11673-875","11673-875-14","11673-875_6a455804-7017-401c-8d6a-730d7db76ddc","HUMAN OTC DRUG","Multi-Action Antibiotic and Pain Relief","","OINTMENT","TOPICAL","20240131","","OTC MONOGRAPH DRUG","M004","Target Corporation","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1182","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, and polymyxin b sulfate","11673089256","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11673-892","11673-892-56","11673-892_383955f7-4534-4f5a-ae1e-f889e95737ac","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20240131","","OTC MONOGRAPH DRUG","M004","Target Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1183","CLOTRIMAZOLE","Clotrimazole 1%","11673089314","Azole Antifungal [EPC], Azoles [CS]","11673-893","11673-893-14","11673-893_2d8ce5a3-5900-4e41-8075-ce87a2e350a9","HUMAN OTC DRUG","Target Jock Itch","","CREAM","TOPICAL","20240131","","OTC MONOGRAPH DRUG","M005","Target Corporation","10","mg/g","","N","20251231"
"1184","CLOTRIMAZOLE","Clotrimazole","11673091012","Azole Antifungal [EPC], Azoles [CS]","11673-910","11673-910-12","11673-910_26be8c5b-235d-3f10-e063-6394a90aeb49","HUMAN OTC DRUG","UpandUp","Clotrimazole","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Target Corporation","10","mg/g","","N","20251231"
"1185","CLOTRIMAZOLE","Clotrimazole","11673091016","Azole Antifungal [EPC], Azoles [CS]","11673-910","11673-910-16","11673-910_26be8c5b-235d-3f10-e063-6394a90aeb49","HUMAN OTC DRUG","UpandUp","Clotrimazole","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Target Corporation","10","mg/g","","N","20251231"
"1186","CLOTRIMAZOLE","Clotrimazole","11673091002","Azole Antifungal [EPC], Azoles [CS]","11673-910","11673-910-02","11673-910_26be8c5b-235d-3f10-e063-6394a90aeb49","HUMAN OTC DRUG","UpandUp","Clotrimazole","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Target Corporation","10","mg/g","","N","20251231"
"1187","MICONAZOLE NITRATE","Miconazole nitrate","11701004514","Azole Antifungal [EPC], Azoles [CS]","11701-045","11701-045-14","11701-045_ebeb2407-0b01-4111-856e-9a68f756edea","HUMAN OTC DRUG","Baza Antifungal","","CREAM","TOPICAL","20090615","","OTC MONOGRAPH DRUG","M005","Coloplast Manufacturing US, LLC","20","mg/g","","N","20251231"
"1188","MICONAZOLE NITRATE","Miconazole nitrate","11701004522","Azole Antifungal [EPC], Azoles [CS]","11701-045","11701-045-22","11701-045_ebeb2407-0b01-4111-856e-9a68f756edea","HUMAN OTC DRUG","Baza Antifungal","","CREAM","TOPICAL","20090615","","OTC MONOGRAPH DRUG","M005","Coloplast Manufacturing US, LLC","20","mg/g","","N","20251231"
"1189","MICONAZOLE NITRATE","Miconazole nitrate","11701004523","Azole Antifungal [EPC], Azoles [CS]","11701-045","11701-045-23","11701-045_ebeb2407-0b01-4111-856e-9a68f756edea","HUMAN OTC DRUG","Baza Antifungal","","CREAM","TOPICAL","20090615","","OTC MONOGRAPH DRUG","M005","Coloplast Manufacturing US, LLC","20","mg/g","","N","20251231"
"1190","MICONAZOLE NITRATE","Miconazole Nitrate","11701006722","Azole Antifungal [EPC], Azoles [CS]","11701-067","11701-067-22","11701-067_c71c629a-b18b-4711-bee6-742cb205febc","HUMAN OTC DRUG","Critic Aid Clear AF","","OINTMENT","TOPICAL","20090615","","OTC MONOGRAPH DRUG","M005","Coloplast Manufacturing US, LLC","20","mg/g","","N","20251231"
"1191","MICONAZOLE NITRATE","Miconazole Nitrate","11701006723","Azole Antifungal [EPC], Azoles [CS]","11701-067","11701-067-23","11701-067_c71c629a-b18b-4711-bee6-742cb205febc","HUMAN OTC DRUG","Critic Aid Clear AF","","OINTMENT","TOPICAL","20090615","","OTC MONOGRAPH DRUG","M005","Coloplast Manufacturing US, LLC","20","mg/g","","N","20251231"
"1192","MICONAZOLE NITRATE","Miconazole Nitrate","11701006714","Azole Antifungal [EPC], Azoles [CS]","11701-067","11701-067-14","11701-067_c71c629a-b18b-4711-bee6-742cb205febc","HUMAN OTC DRUG","Critic Aid Clear AF","","OINTMENT","TOPICAL","20090615","","OTC MONOGRAPH DRUG","M005","Coloplast Manufacturing US, LLC","20","mg/g","","N","20251231"
"1193","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","11822008002","Allylamine Antifungal [EPC], Allylamine [CS]","11822-0080","11822-0080-2","11822-0080_1738d740-3d1b-d509-e063-6394a90a6530","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Rite Aid Corporation","1","g/100g","","N","20251231"
"1194","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","11822008001","Allylamine Antifungal [EPC], Allylamine [CS]","11822-0080","11822-0080-1","11822-0080_1738d740-3d1b-d509-e063-6394a90a6530","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Rite Aid Corporation","1","g/100g","","N","20251231"
"1195","BACITRACIN ZINC; POLYMYXIN B SULFATE","Double Antibiotic","11822009305","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11822-0093","11822-0093-5","11822-0093_0b83d4b0-5a29-4b1a-b7ec-07d86ead45d9","HUMAN OTC DRUG","RITE AID Double Antibiotic","","OINTMENT","TOPICAL","20221001","","OTC MONOGRAPH DRUG","M004","RITE AID","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"1196","MICONAZOLE NITRATE","Athletes Foot Powder Spray Talc Free","11822013504","Azole Antifungal [EPC], Azoles [CS]","11822-0135","11822-0135-4","11822-0135_38104051-8ddc-ce54-e063-6394a90a025b","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, POWDER","TOPICAL","20171222","20261231","OTC MONOGRAPH DRUG","M005","Rite Aid Corporation","2.6","g/130g","","N",""
"1197","CLOTRIMAZOLE","Clotrimazole","11822022006","Azole Antifungal [EPC], Azoles [CS]","11822-0220","11822-0220-6","11822-0220_5e655973-6409-451d-bb0a-09e74929262e","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","19961122","","ANDA","ANDA074165","Rite Aid Corporation","10","mg/g","","N","20251231"
"1198","CLOTRIMAZOLE","Clotrimazole","11822035003","Azole Antifungal [EPC], Azoles [CS]","11822-0350","11822-0350-3","11822-0350_2c182a3b-a5d4-472d-a17b-45351bbb7cf6","HUMAN OTC DRUG","Foot Care Clotrimazole","","CREAM","TOPICAL","20250306","","OTC MONOGRAPH DRUG","M005","Rite Aid Corporation","10","mg/g","","N","20261231"
"1199","CLOTRIMAZOLE","Clotrimazole","11822035103","Azole Antifungal [EPC], Azoles [CS]","11822-0351","11822-0351-3","11822-0351_4cd8a94b-9161-41b3-a477-d4d6b27c9cb6","HUMAN OTC DRUG","Antifungal","","CREAM","TOPICAL","20110415","","OTC MONOGRAPH DRUG","M005","Rite Aid Corporation","10","mg/g","","N","20251231"
"1200","TIOCONAZOLE","Tioconazole","11822042601","Azole Antifungal [EPC], Azoles [CS]","11822-0426","11822-0426-1","11822-0426_26259cf6-79c4-479b-ac98-d0ac2a6a5722","HUMAN OTC DRUG","tioconazole 1","1 dose treatment","OINTMENT","VAGINAL","20071213","","ANDA","ANDA075915","Rite Aid Corporation","6.5","g/100g","","N","20251231"
"1201","MICONAZOLE NITRATE","Miconazole Nitrate","11822073001","Azole Antifungal [EPC], Azoles [CS]","11822-0730","11822-0730-1","11822-0730_8085cfa7-0a1f-4ee5-8d0a-c80fff182861","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20010301","","ANDA","ANDA074164","Rite Aid Corporation","20","mg/g","","N","20251231"
"1202","CLOTRIMAZOLE","Clotrimazole","11822111001","Azole Antifungal [EPC], Azoles [CS]","11822-1110","11822-1110-1","11822-1110_1288bd74-fe38-2dd2-e063-6394a90ae7c2","HUMAN OTC DRUG","Rite Aid","antifungal ringworm","CREAM","TOPICAL","19950601","","OTC MONOGRAPH DRUG","M005","Rite Aid Corporation","1","g/100g","","N","20251231"
"1203","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","11822210002","Benzylamine Antifungal [EPC], Benzylamines [CS]","11822-2100","11822-2100-2","11822-2100_1c5cf3ec-29be-c22b-e063-6394a90adf95","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","Rite Aid Corporation","10","mg/g","","N","20251231"
"1204","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","11822210008","Benzylamine Antifungal [EPC], Benzylamines [CS]","11822-2100","11822-2100-8","11822-2100_1c5cf3ec-29be-c22b-e063-6394a90adf95","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","Rite Aid Corporation","10","mg/g","","N","20251231"
"1205","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Antibiotic With Pain Relief","11822216301","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11822-2163","11822-2163-1","11822-2163_c7d0efb5-b977-4fbf-b439-853669867963","HUMAN OTC DRUG","Rite Aid Pharmacy Antibiotic With Pain Relief","","CREAM","TOPICAL","20221001","","OTC MONOGRAPH DRUG","M004","RITE AID","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"1206","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate, Pramoxine hydrochloride","11822270002","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11822-2700","11822-2700-2","11822-2700_a1699998-b615-4abd-b502-bae942385233","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20220225","","OTC MONOGRAPH DRUG","M004","Rite Aid Corporation","500; 3.5; 10000; 10","[iU]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1207","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate, Pramoxine hydrochloride","11822270005","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11822-2700","11822-2700-5","11822-2700_a1699998-b615-4abd-b502-bae942385233","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20220225","","OTC MONOGRAPH DRUG","M004","Rite Aid Corporation","500; 3.5; 10000; 10","[iU]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1208","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate, Pramoxine hydrochloride","11822270001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11822-2700","11822-2700-1","11822-2700_a1699998-b615-4abd-b502-bae942385233","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20220225","","OTC MONOGRAPH DRUG","M004","Rite Aid Corporation","500; 3.5; 10000; 10","[iU]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1209","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate","11822290005","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11822-2900","11822-2900-5","11822-2900_3141c302-f96e-4345-a80c-bb4281c912c2","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20220225","","OTC MONOGRAPH DRUG","M004","Rite Aid Corporation","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1210","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate","11822290001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11822-2900","11822-2900-1","11822-2900_3141c302-f96e-4345-a80c-bb4281c912c2","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20220225","","OTC MONOGRAPH DRUG","M004","Rite Aid Corporation","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1211","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate","11822290002","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","11822-2900","11822-2900-2","11822-2900_3141c302-f96e-4345-a80c-bb4281c912c2","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20220225","","OTC MONOGRAPH DRUG","M004","Rite Aid Corporation","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1212","CLOTRIMAZOLE","Clotrimazole","11822307802","Azole Antifungal [EPC], Azoles [CS]","11822-3078","11822-3078-2","11822-3078_a48f1b2b-e130-45ed-89d0-f8481da02451","HUMAN OTC DRUG","Antifungal","","CREAM","TOPICAL","20210226","20260226","OTC MONOGRAPH DRUG","M005","Rite Aid Corporation","10","mg/g","","N",""
"1213","CLOTRIMAZOLE","Clotrimazole","11822342301","Azole Antifungal [EPC], Azoles [CS]","11822-3423","11822-3423-1","11822-3423_261d4386-6ee4-131f-e063-6394a90ad80d","HUMAN OTC DRUG","Clotrimazole","Jock Itch","CREAM","TOPICAL","20230130","","OTC MONOGRAPH DRUG","M005","Rite Aid Corporation","10","mg/g","","N","20251231"
"1214","OFLOXACIN","ofloxacin","11980077905","Quinolone Antimicrobial [EPC], Quinolones [CS]","11980-779","11980-779-05","11980-779_4ba88457-b1b2-4bbc-b086-a2bab56752a0","HUMAN PRESCRIPTION DRUG","OCUFLOX","","SOLUTION/ DROPS","OPHTHALMIC","19930801","","NDA","NDA019921","Allergan, Inc.","3","mg/mL","","N","20261231"
"1215","MICONAZOLE NITRATE","Miconazole Nitrate","12258024101","Azole Antifungal [EPC], Azoles [CS]","12258-241","12258-241-01","12258-241_2bea5414-c7be-d010-e063-6294a90aa138","HUMAN OTC DRUG","Green Tetterine","","OINTMENT","TOPICAL","19940731","","OTC MONOGRAPH DRUG","M005","S.S.S. Company","2","g/100g","","N","20261231"
"1216","MICONAZOLE NITRATE","Miconazole Nitrate","12258024201","Azole Antifungal [EPC], Azoles [CS]","12258-242","12258-242-01","12258-242_2bea7909-bad1-64ec-e063-6294a90a91a4","HUMAN OTC DRUG","White Tetterine","","OINTMENT","TOPICAL","19950228","","OTC MONOGRAPH DRUG","M005","S.S.S. Company","2","g/100g","","N","20261231"
"1217","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate and Benzoyl Peroxide","13548013250","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS]","13548-132","13548-132-50","13548-132_110dde63-b7d7-49af-aa96-9daefccb84ff","HUMAN PRESCRIPTION DRUG","Acanya","","GEL","TOPICAL","20100726","","NDA","NDA050819","Bausch Health US, LLC","25; 10","mg/g; mg/g","","N","20251231"
"1218","ITRACONAZOLE","Itraconazole","13668046305","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","13668-463","13668-463-05","13668-463_190020d3-1073-4c51-a948-ed1e371b72ea","HUMAN PRESCRIPTION DRUG","Itraconazole","","CAPSULE","ORAL","20180824","","ANDA","ANDA209460","Torrent Pharmaceuticals Limited","100","mg/1","","N","20261231"
"1219","ITRACONAZOLE","Itraconazole","13668046330","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","13668-463","13668-463-30","13668-463_190020d3-1073-4c51-a948-ed1e371b72ea","HUMAN PRESCRIPTION DRUG","Itraconazole","","CAPSULE","ORAL","20180824","","ANDA","ANDA209460","Torrent Pharmaceuticals Limited","100","mg/1","","N","20261231"
"1220","ITRACONAZOLE","Itraconazole","13668046390","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","13668-463","13668-463-90","13668-463_190020d3-1073-4c51-a948-ed1e371b72ea","HUMAN PRESCRIPTION DRUG","Itraconazole","","CAPSULE","ORAL","20180824","","ANDA","ANDA209460","Torrent Pharmaceuticals Limited","100","mg/1","","N","20261231"
"1221","ITRACONAZOLE","Itraconazole","13668046337","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","13668-463","13668-463-37","13668-463_190020d3-1073-4c51-a948-ed1e371b72ea","HUMAN PRESCRIPTION DRUG","Itraconazole","","CAPSULE","ORAL","20180824","","ANDA","ANDA209460","Torrent Pharmaceuticals Limited","100","mg/1","","N","20261231"
"1222","NYSTATIN","Nystatin","13668053401","Polyene Antifungal [EPC], Polyenes [CS]","13668-534","13668-534-01","13668-534_82487bf8-8bff-4d9b-8ab8-652f22004e75","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20190129","","ANDA","ANDA211838","Torrent Pharmaceuticals Limited","100000","U/g","","N","20251231"
"1223","NYSTATIN","Nystatin","13668053402","Polyene Antifungal [EPC], Polyenes [CS]","13668-534","13668-534-02","13668-534_82487bf8-8bff-4d9b-8ab8-652f22004e75","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20190129","","ANDA","ANDA211838","Torrent Pharmaceuticals Limited","100000","U/g","","N","20251231"
"1224","ERYTHROMYCIN","ERYTHROMYCIN","13668058601","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","13668-586","13668-586-01","13668-586_8c400049-2b9b-476d-a993-06aa5d3beba9","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, DELAYED RELEASE","ORAL","20210726","","ANDA","ANDA211975","Torrent Pharmaceuticals Limited","250","mg/1","","N","20251231"
"1225","ERYTHROMYCIN","ERYTHROMYCIN","13668058605","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","13668-586","13668-586-05","13668-586_8c400049-2b9b-476d-a993-06aa5d3beba9","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, DELAYED RELEASE","ORAL","20210726","","ANDA","ANDA211975","Torrent Pharmaceuticals Limited","250","mg/1","","N","20251231"
"1226","ERYTHROMYCIN","ERYTHROMYCIN","13668058630","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","13668-586","13668-586-30","13668-586_8c400049-2b9b-476d-a993-06aa5d3beba9","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, DELAYED RELEASE","ORAL","20210726","","ANDA","ANDA211975","Torrent Pharmaceuticals Limited","250","mg/1","","N","20251231"
"1227","ERYTHROMYCIN","ERYTHROMYCIN","13668058705","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","13668-587","13668-587-05","13668-587_8c400049-2b9b-476d-a993-06aa5d3beba9","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, DELAYED RELEASE","ORAL","20241021","","ANDA","ANDA211975","Torrent Pharmaceuticals Limited","333","mg/1","","N","20251231"
"1228","ERYTHROMYCIN","ERYTHROMYCIN","13668058730","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","13668-587","13668-587-30","13668-587_8c400049-2b9b-476d-a993-06aa5d3beba9","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, DELAYED RELEASE","ORAL","20241021","","ANDA","ANDA211975","Torrent Pharmaceuticals Limited","333","mg/1","","N","20251231"
"1229","ERYTHROMYCIN","ERYTHROMYCIN","13668058701","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","13668-587","13668-587-01","13668-587_8c400049-2b9b-476d-a993-06aa5d3beba9","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, DELAYED RELEASE","ORAL","20241021","","ANDA","ANDA211975","Torrent Pharmaceuticals Limited","333","mg/1","","N","20251231"
"1230","ERYTHROMYCIN","ERYTHROMYCIN","13668058805","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","13668-588","13668-588-05","13668-588_8c400049-2b9b-476d-a993-06aa5d3beba9","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, DELAYED RELEASE","ORAL","20210726","","ANDA","ANDA211975","Torrent Pharmaceuticals Limited","500","mg/1","","N","20251231"
"1231","ERYTHROMYCIN","ERYTHROMYCIN","13668058801","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","13668-588","13668-588-01","13668-588_8c400049-2b9b-476d-a993-06aa5d3beba9","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, DELAYED RELEASE","ORAL","20210726","","ANDA","ANDA211975","Torrent Pharmaceuticals Limited","500","mg/1","","N","20251231"
"1232","ERYTHROMYCIN","ERYTHROMYCIN","13668058830","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","13668-588","13668-588-30","13668-588_8c400049-2b9b-476d-a993-06aa5d3beba9","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, DELAYED RELEASE","ORAL","20210726","","ANDA","ANDA211975","Torrent Pharmaceuticals Limited","500","mg/1","","N","20251231"
"1233","NYSTATIN","Nystatin","13668059501","Polyene Antifungal [EPC], Polyenes [CS]","13668-595","13668-595-01","13668-595_8af0f2a4-5575-4bfc-b567-5933fdb81c60","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20190724","","ANDA","ANDA212557","Torrent Pharmaceuticals Limited","100000","U/g","","N","20261231"
"1234","NYSTATIN","Nystatin","13668059502","Polyene Antifungal [EPC], Polyenes [CS]","13668-595","13668-595-02","13668-595_8af0f2a4-5575-4bfc-b567-5933fdb81c60","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20190724","","ANDA","ANDA212557","Torrent Pharmaceuticals Limited","100000","U/g","","N","20261231"
"1235","ERYTHROMYCIN","Erythromycin","13668060601","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","13668-606","13668-606-01","13668-606_296e3113-acfe-464a-b423-150f0112965f","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, COATED","ORAL","20200706","","ANDA","ANDA212015","Torrent Pharmaceuticals Limited","250","mg/1","","N","20251231"
"1236","ERYTHROMYCIN","Erythromycin","13668060605","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","13668-606","13668-606-05","13668-606_296e3113-acfe-464a-b423-150f0112965f","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, COATED","ORAL","20200706","","ANDA","ANDA212015","Torrent Pharmaceuticals Limited","250","mg/1","","N","20251231"
"1237","ERYTHROMYCIN","Erythromycin","13668060630","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","13668-606","13668-606-30","13668-606_296e3113-acfe-464a-b423-150f0112965f","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, COATED","ORAL","20200706","","ANDA","ANDA212015","Torrent Pharmaceuticals Limited","250","mg/1","","N","20251231"
"1238","ERYTHROMYCIN","Erythromycin","13668060701","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","13668-607","13668-607-01","13668-607_296e3113-acfe-464a-b423-150f0112965f","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, COATED","ORAL","20200706","","ANDA","ANDA212015","Torrent Pharmaceuticals Limited","500","mg/1","","N","20251231"
"1239","ERYTHROMYCIN","Erythromycin","13668060705","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","13668-607","13668-607-05","13668-607_296e3113-acfe-464a-b423-150f0112965f","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, COATED","ORAL","20200706","","ANDA","ANDA212015","Torrent Pharmaceuticals Limited","500","mg/1","","N","20251231"
"1240","ERYTHROMYCIN","Erythromycin","13668060730","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","13668-607","13668-607-30","13668-607_296e3113-acfe-464a-b423-150f0112965f","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, COATED","ORAL","20200706","","ANDA","ANDA212015","Torrent Pharmaceuticals Limited","500","mg/1","","N","20251231"
"1241","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","13668061002","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","13668-610","13668-610-02","13668-610_bc17b856-f6f4-4f64-831c-1819811c0ecb","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20200714","","ANDA","ANDA213142","Torrent Pharmaceuticals Limited","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"1242","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","13668061005","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","13668-610","13668-610-05","13668-610_bc17b856-f6f4-4f64-831c-1819811c0ecb","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20200714","","ANDA","ANDA213142","Torrent Pharmaceuticals Limited","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"1243","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","13668061001","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","13668-610","13668-610-01","13668-610_bc17b856-f6f4-4f64-831c-1819811c0ecb","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20200714","","ANDA","ANDA213142","Torrent Pharmaceuticals Limited","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"1244","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","13811071910","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","13811-719","13811-719-10","13811-719_fb696b06-d8b4-81df-e053-6394a90af1e3","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Trigen Laboratories, LLC","25; 75","mg/1; mg/1","","N","20251231"
"1245","PENTAMIDINE ISETHIONATE","Pentamidine Isethionate","13925051510","Antiprotozoal [EPC]","13925-515","13925-515-10","13925-515_c83ced5f-9bf2-4367-9146-5b17d0b83371","HUMAN PRESCRIPTION DRUG","Pentamidine Isethionate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20180401","","ANDA","ANDA206666","Seton Pharmaceuticals","300","mg/300mg","","N","20261231"
"1246","PENTAMIDINE ISETHIONATE","Pentamidine Isethionate","13925052201","Antiprotozoal [EPC]","13925-522","13925-522-01","13925-522_d00d85f7-4ea4-4da2-8c13-7ecc598893e6","HUMAN PRESCRIPTION DRUG","Pentamidine Isethionate","","INHALANT","RESPIRATORY (INHALATION)","20191014","","ANDA","ANDA206667","Seton Pharmaceuticals","300","mg/300mg","","N","20261231"
"1247","DAPTOMYCIN","daptomycin","14335012001","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","14335-120","14335-120-01","14335-120_0a1a4553-120c-b67d-e063-6294a90a0572","HUMAN PRESCRIPTION DRUG","daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION","INTRAVENOUS","20231114","","ANDA","ANDA215890","Hainan Poly Pharm., Co., Ltd.","500","mg/20mL","","N","20251231"
"1248","ERYTHROMYCIN LACTOBIONATE","Erythromycin Lactobionate","14789011605","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","14789-116","14789-116-05","14789-116_248996fd-c1f3-5b11-e063-6394a90ad2e3","HUMAN PRESCRIPTION DRUG","Erythromycin Lactobionate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210801","","ANDA","ANDA215290","Nexus Pharmaceuticals LLC","500","mg/10mL","","N","20251231"
"1249","METRONIDAZOLE","Metronidazole","15955038805","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","15955-388","15955-388-05","15955-388_4bc960cb-872d-43da-81eb-0dbb058cfaad","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20190626","","ANDA","ANDA208681","Alembic Labs LLC","250","mg/1","","N","20251231"
"1250","METRONIDAZOLE","Metronidazole","15955038801","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","15955-388","15955-388-01","15955-388_4bc960cb-872d-43da-81eb-0dbb058cfaad","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20190626","","ANDA","ANDA208681","Alembic Labs LLC","250","mg/1","","N","20251231"
"1251","METRONIDAZOLE","Metronidazole","15955038901","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","15955-389","15955-389-01","15955-389_4bc960cb-872d-43da-81eb-0dbb058cfaad","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20190626","","ANDA","ANDA208681","Alembic Labs LLC","500","mg/1","","N","20251231"
"1252","METRONIDAZOLE","Metronidazole","15955038905","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","15955-389","15955-389-05","15955-389_4bc960cb-872d-43da-81eb-0dbb058cfaad","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20190626","","ANDA","ANDA208681","Alembic Labs LLC","500","mg/1","","N","20251231"
"1253","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","16252051401","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","16252-514","16252-514-01","16252-514_102b18ad-5814-4bda-9b89-2991af2480e1","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20061101","20260331","ANDA","ANDA076794","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N",""
"1254","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","16252051501","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","16252-515","16252-515-01","16252-515_102b18ad-5814-4bda-9b89-2991af2480e1","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20061101","20270831","ANDA","ANDA076794","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N",""
"1255","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","16252051605","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","16252-516","16252-516-05","16252-516_102b18ad-5814-4bda-9b89-2991af2480e1","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20061101","20260331","ANDA","ANDA076794","Teva Pharmaceuticals USA, Inc.","750","mg/1","","N",""
"1256","SULFACETAMIDE SODIUM","Sodium Sulfacetamide","16477041012","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","16477-410","16477-410-12","16477-410_33de40bd-2015-90b6-e063-6294a90a2617","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide","","LIQUID","TOPICAL","20210317","","UNAPPROVED DRUG OTHER","","Laser Pharmaceuticals, LLC","100","mg/mL","","N","20261231"
"1257","SULFACETAMIDE SODIUM","Sodium Sulfacetamide","16477041006","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","16477-410","16477-410-06","16477-410_33de40bd-2015-90b6-e063-6294a90a2617","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide","","LIQUID","TOPICAL","20210317","","UNAPPROVED DRUG OTHER","","Laser Pharmaceuticals, LLC","100","mg/mL","","N","20261231"
"1258","SULFACETAMIDE SODIUM","Sodium Sulfacetamide","16477041108","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","16477-411","16477-411-08","16477-411_173ba5f9-d9a3-04ca-e063-6294a90a40cb","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide","","SHAMPOO","TOPICAL","20230913","","UNAPPROVED DRUG OTHER","","Laser Pharmaceuticals, LLC","100","mg/mL","","N","20251231"
"1259","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","16571011201","Antimalarial [EPC], Antirheumatic Agent [EPC]","16571-112","16571-112-01","16571-112_40679f36-52b2-4c4f-9a83-cc0c136077ef","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20230529","","ANDA","ANDA210959","Rising Pharma Holdings, Inc.","200","mg/1","","N","20251231"
"1260","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","16571011210","Antimalarial [EPC], Antirheumatic Agent [EPC]","16571-112","16571-112-10","16571-112_40679f36-52b2-4c4f-9a83-cc0c136077ef","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20230529","","ANDA","ANDA210959","Rising Pharma Holdings, Inc.","200","mg/1","","N","20251231"
"1261","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","16571011206","Antimalarial [EPC], Antirheumatic Agent [EPC]","16571-112","16571-112-06","16571-112_40679f36-52b2-4c4f-9a83-cc0c136077ef","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20230529","","ANDA","ANDA210959","Rising Pharma Holdings, Inc.","200","mg/1","","N","20251231"
"1262","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","16571011250","Antimalarial [EPC], Antirheumatic Agent [EPC]","16571-112","16571-112-50","16571-112_40679f36-52b2-4c4f-9a83-cc0c136077ef","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20230529","","ANDA","ANDA210959","Rising Pharma Holdings, Inc.","200","mg/1","","N","20251231"
"1263","ITRACONAZOLE","Itraconazole","16571024503","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","16571-245","16571-245-03","16571-245_c7336946-9638-4837-9046-1aef77694672","HUMAN PRESCRIPTION DRUG","Itraconazole","","CAPSULE","ORAL","20250203","","ANDA","ANDA205724","Rising Pharma Holdings, Inc.","100","mg/1","","N","20261231"
"1264","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","16571041110","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","16571-411","16571-411-10","16571-411_0e0ae327-f90c-4f06-a71a-87891385c733","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Rising Pharma Holdings, Inc.","250","mg/1","","N","20261231"
"1265","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","16571041250","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","16571-412","16571-412-50","16571-412_0e0ae327-f90c-4f06-a71a-87891385c733","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Rising Pharma Holdings, Inc.","500","mg/1","","N","20261231"
"1266","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","16571041210","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","16571-412","16571-412-10","16571-412_0e0ae327-f90c-4f06-a71a-87891385c733","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Rising Pharma Holdings, Inc.","500","mg/1","","N","20261231"
"1267","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","16571041305","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","16571-413","16571-413-05","16571-413_0e0ae327-f90c-4f06-a71a-87891385c733","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Rising Pharma Holdings, Inc.","750","mg/1","","N","20261231"
"1268","METRONIDAZOLE","Metronidazole","16571066450","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","16571-664","16571-664-50","16571-664_241c7c4c-5fd9-4c0e-b7b7-4094f77e9721","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Rising Pharma Holdings, Inc.","500","mg/1","","N","20251231"
"1269","METRONIDAZOLE","Metronidazole","16571066401","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","16571-664","16571-664-01","16571-664_241c7c4c-5fd9-4c0e-b7b7-4094f77e9721","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Rising Pharma Holdings, Inc.","500","mg/1","","N","20251231"
"1270","METRONIDAZOLE","Metronidazole","16571066501","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","16571-665","16571-665-01","16571-665_241c7c4c-5fd9-4c0e-b7b7-4094f77e9721","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Rising Pharma Holdings, Inc.","250","mg/1","","N","20251231"
"1271","METRONIDAZOLE","Metronidazole","16571066550","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","16571-665","16571-665-50","16571-665_241c7c4c-5fd9-4c0e-b7b7-4094f77e9721","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Rising Pharma Holdings, Inc.","250","mg/1","","N","20251231"
"1272","CLOTRIMAZOLE","CLOTRIMAZOLE","16571068607","Azole Antifungal [EPC], Azoles [CS]","16571-686","16571-686-07","16571-686_de2c09da-6280-4873-859a-80e779643612","HUMAN PRESCRIPTION DRUG","CLOTRIMAZOLE","","LOZENGE","ORAL","20240501","","ANDA","ANDA215641","Rising Pharma Holdings, Inc.","10","mg/1","","N","20261231"
"1273","CLOTRIMAZOLE","CLOTRIMAZOLE","16571068614","Azole Antifungal [EPC], Azoles [CS]","16571-686","16571-686-14","16571-686_de2c09da-6280-4873-859a-80e779643612","HUMAN PRESCRIPTION DRUG","CLOTRIMAZOLE","","LOZENGE","ORAL","20240501","","ANDA","ANDA215641","Rising Pharma Holdings, Inc.","10","mg/1","","N","20261231"
"1274","MAFENIDE ACETATE","mafenide acetate","16571072312","Methylated Sulfonamide Antibacterial [EPC], Methylated Sulfonamides [EXT]","16571-723","16571-723-12","16571-723_58d3a059-d175-4740-bf57-f156588c99b5","HUMAN PRESCRIPTION DRUG","SULFAMYLON","","CREAM","TOPICAL","20200518","","NDA","NDA016763","Rising Pharma Holdings, Inc.","85","mg/g","","N","20251231"
"1275","MAFENIDE ACETATE","mafenide acetate","16571072348","Methylated Sulfonamide Antibacterial [EPC], Methylated Sulfonamides [EXT]","16571-723","16571-723-48","16571-723_58d3a059-d175-4740-bf57-f156588c99b5","HUMAN PRESCRIPTION DRUG","SULFAMYLON","","CREAM","TOPICAL","20200518","","NDA","NDA016763","Rising Pharma Holdings, Inc.","85","mg/g","","N","20251231"
"1276","MAFENIDE ACETATE","mafenide acetate","16571072360","Methylated Sulfonamide Antibacterial [EPC], Methylated Sulfonamides [EXT]","16571-723","16571-723-60","16571-723_58d3a059-d175-4740-bf57-f156588c99b5","HUMAN PRESCRIPTION DRUG","SULFAMYLON","","CREAM","TOPICAL","20200518","","NDA","NDA016763","Rising Pharma Holdings, Inc.","85","mg/g","","N","20251231"
"1277","NITROFURANTOIN","Nitrofurantoin","16571074024","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","16571-740","16571-740-24","16571-740_1118d2c8-278d-4e83-94a5-3435e8fdc72f","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","SUSPENSION","ORAL","20201223","","NDA AUTHORIZED GENERIC","NDA009175","Rising Pharma Holdings, Inc.","25","mg/5mL","","N","20251231"
"1278","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin and Polymyxin B Sulfates and Bacitracin Zinc","16571075453","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","16571-754","16571-754-53","16571-754_48173c90-79ed-459d-b259-947bc7952c13","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Bacitracin Zinc","","OINTMENT","OPHTHALMIC","20170407","","NDA AUTHORIZED GENERIC","NDA050417","Rising Pharma Holdings, Inc.","400; 3.5; 10000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1279","NITROFURANTOIN","Nitrofurantoin","16571088806","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","16571-888","16571-888-06","16571-888_1118d2c8-278d-4e83-94a5-3435e8fdc72f","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","SUSPENSION","ORAL","20240201","","NDA AUTHORIZED GENERIC","NDA009175","Rising Pharma Holdings, Inc.","50","mg/5mL","","N","20251231"
"1280","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714001401","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-014","16714-014-01","16714-014_b27651c4-7ff8-4137-ade1-d445311fa77e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","Northstar RxLLC","875; 125","mg/1; mg/1","","N","20251231"
"1281","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714001402","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-014","16714-014-02","16714-014_b27651c4-7ff8-4137-ade1-d445311fa77e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","Northstar RxLLC","875; 125","mg/1; mg/1","","N","20251231"
"1282","MUPIROCIN CALCIUM","mupirocin calcium","16714005502","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","16714-055","16714-055-02","16714-055_d67221d7-7844-4a8a-8c32-8856d49b572a","HUMAN PRESCRIPTION DRUG","Mupirocin","","CREAM","TOPICAL","20201125","","ANDA","ANDA207116","NORTHSTAR RX LLC","20","mg/g","","N","20251231"
"1283","MUPIROCIN CALCIUM","mupirocin calcium","16714005501","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","16714-055","16714-055-01","16714-055_d67221d7-7844-4a8a-8c32-8856d49b572a","HUMAN PRESCRIPTION DRUG","Mupirocin","","CREAM","TOPICAL","20201125","","ANDA","ANDA207116","NORTHSTAR RX LLC","20","mg/g","","N","20251231"
"1284","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","16714011001","Antimalarial [EPC], Antirheumatic Agent [EPC]","16714-110","16714-110-01","16714-110_09ec5070-4e0b-4cf5-b3f1-67c0152b84a5","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20191001","","ANDA","ANDA040657","Northstar Rx LLC.","200","mg/1","","N","20251231"
"1285","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","16714011002","Antimalarial [EPC], Antirheumatic Agent [EPC]","16714-110","16714-110-02","16714-110_09ec5070-4e0b-4cf5-b3f1-67c0152b84a5","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20191001","","ANDA","ANDA040657","Northstar Rx LLC.","200","mg/1","","N","20251231"
"1286","TOBRAMYCIN","Tobramycin Inhalation Solution","16714011903","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","16714-119","16714-119-03","16714-119_0d13da03-959b-b10f-07b3-577690fec0db","HUMAN PRESCRIPTION DRUG","Tobramycin Inhalation Solution","","INHALANT","RESPIRATORY (INHALATION)","20200521","","ANDA","ANDA207080","NorthStar RxLLC","300","mg/5mL","","N","20251231"
"1287","POSACONAZOLE","Posaconazole","16714015601","Azole Antifungal [EPC], Azoles [CS]","16714-156","16714-156-01","16714-156_7861b625-4070-40c4-bcf2-c52516957653","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","TABLET, DELAYED RELEASE","ORAL","20210518","20250630","ANDA","ANDA212411","NorthStar RxLLC","100","mg/1","","N",""
"1288","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","16714016102","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","16714-161","16714-161-02","16714-161_00b72cb7-8c7b-49f5-a735-405718e0f451","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20210310","","ANDA","ANDA214251","NORTHSTAR RX LLC","10","mg/g","","N","20251231"
"1289","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","16714016101","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","16714-161","16714-161-01","16714-161_00b72cb7-8c7b-49f5-a735-405718e0f451","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20210310","","ANDA","ANDA214251","NORTHSTAR RX LLC","10","mg/g","","N","20251231"
"1290","MICAFUNGIN SODIUM","Micafungin","16714016410","Echinocandin Antifungal [EPC], Lipopeptides [CS]","16714-164","16714-164-10","16714-164_b96dcf3b-1308-4a44-9dcd-3dc35f9f5bf0","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20221101","","ANDA","ANDA215241","Northstar Rx LLC.","10","mg/mL","","N","20251231"
"1291","VORICONAZOLE","Voriconazole","16714019801","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","16714-198","16714-198-01","16714-198_45de5a3f-4e1f-4870-b4aa-3057e4e2ba7f","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, FILM COATED","ORAL","20160122","20270430","ANDA","ANDA206837","NorthStar Rx LLC","50","mg/1","","N",""
"1292","VORICONAZOLE","Voriconazole","16714019901","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","16714-199","16714-199-01","16714-199_45de5a3f-4e1f-4870-b4aa-3057e4e2ba7f","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, FILM COATED","ORAL","20160122","20270430","ANDA","ANDA206837","NorthStar Rx LLC","200","mg/1","","N",""
"1293","PENICILLIN V POTASSIUM","Penicillin V Potassium","16714023402","Penicillin-class Antibacterial [EPC], Penicillins [CS]","16714-234","16714-234-02","16714-234_20659e2d-f79a-447a-87d9-0baeee7567fc","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NorthStar Rx LLC","250","mg/1","","N","20251231"
"1294","PENICILLIN V POTASSIUM","Penicillin V Potassium","16714023401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","16714-234","16714-234-01","16714-234_20659e2d-f79a-447a-87d9-0baeee7567fc","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NorthStar Rx LLC","250","mg/1","","N","20251231"
"1295","PENICILLIN V POTASSIUM","Penicillin V Potassium","16714023502","Penicillin-class Antibacterial [EPC], Penicillins [CS]","16714-235","16714-235-02","16714-235_20659e2d-f79a-447a-87d9-0baeee7567fc","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NorthStar Rx LLC","500","mg/1","","N","20251231"
"1296","PENICILLIN V POTASSIUM","Penicillin V Potassium","16714023501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","16714-235","16714-235-01","16714-235_20659e2d-f79a-447a-87d9-0baeee7567fc","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NorthStar Rx LLC","500","mg/1","","N","20251231"
"1297","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","16714024601","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","16714-246","16714-246-01","16714-246_e794576c-46e9-481b-8c68-5a6be27acd64","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","LOTION","TOPICAL","20210628","","ANDA","ANDA214526","NORTHSTAR RX LLC","10","ug/mL","","N","20251231"
"1298","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","16714024710","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","16714-247","16714-247-10","16714-247_a42cb3cc-973a-46b7-8f67-35d2fe21a251","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20160331","","ANDA","ANDA205780","NorthStar Rx LLC","500","mg/10mL","","N","20251231"
"1299","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714029202","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-292","16714-292-02","16714-292_581a5622-f3ca-4a4f-9241-9810694c791a","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","NorthStar Rx LLC","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"1300","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714029203","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-292","16714-292-03","16714-292_581a5622-f3ca-4a4f-9241-9810694c791a","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","NorthStar Rx LLC","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"1301","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714029201","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-292","16714-292-01","16714-292_581a5622-f3ca-4a4f-9241-9810694c791a","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","NorthStar Rx LLC","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"1302","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714029303","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-293","16714-293-03","16714-293_581a5622-f3ca-4a4f-9241-9810694c791a","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","NorthStar Rx LLC","400; 57","mg/5mL; mg/5mL","","N","20251231"
"1303","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714029302","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-293","16714-293-02","16714-293_581a5622-f3ca-4a4f-9241-9810694c791a","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","NorthStar Rx LLC","400; 57","mg/5mL; mg/5mL","","N","20251231"
"1304","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714029301","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-293","16714-293-01","16714-293_581a5622-f3ca-4a4f-9241-9810694c791a","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","NorthStar Rx LLC","400; 57","mg/5mL; mg/5mL","","N","20251231"
"1305","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714029401","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-294","16714-294-01","16714-294_04e2b9cd-a5cb-4762-86f9-1afbd53b4bc6","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201091","NorthStar Rx LLC","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"1306","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714029402","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-294","16714-294-02","16714-294_04e2b9cd-a5cb-4762-86f9-1afbd53b4bc6","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201091","NorthStar Rx LLC","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"1307","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714029403","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-294","16714-294-03","16714-294_04e2b9cd-a5cb-4762-86f9-1afbd53b4bc6","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201091","NorthStar Rx LLC","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"1308","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714029501","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-295","16714-295-01","16714-295_09599f95-761a-4206-bfc2-04c8289dc43e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091569","NorthStar Rx LLC","250; 125","mg/1; mg/1","","N","20251231"
"1309","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714029601","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-296","16714-296-01","16714-296_09599f95-761a-4206-bfc2-04c8289dc43e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091569","NorthStar Rx LLC","500; 125","mg/1; mg/1","","N","20251231"
"1310","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714029701","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-297","16714-297-01","16714-297_09599f95-761a-4206-bfc2-04c8289dc43e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","NorthStar Rx LLC","875; 125","mg/1; mg/1","","N","20251231"
"1311","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714029702","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-297","16714-297-02","16714-297_09599f95-761a-4206-bfc2-04c8289dc43e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","NorthStar Rx LLC","875; 125","mg/1; mg/1","","N","20251231"
"1312","AMOXICILLIN","Amoxicillin","16714029801","Penicillin-class Antibacterial [EPC], Penicillins [CS]","16714-298","16714-298-01","16714-298_3fb9b318-8cd3-46e0-bf2d-cf23f8dd58e0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NorthStar Rx LLC","250","mg/1","","N","20251231"
"1313","AMOXICILLIN","Amoxicillin","16714029802","Penicillin-class Antibacterial [EPC], Penicillins [CS]","16714-298","16714-298-02","16714-298_3fb9b318-8cd3-46e0-bf2d-cf23f8dd58e0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NorthStar Rx LLC","250","mg/1","","N","20251231"
"1314","AMOXICILLIN","Amoxicillin","16714029903","Penicillin-class Antibacterial [EPC], Penicillins [CS]","16714-299","16714-299-03","16714-299_3fb9b318-8cd3-46e0-bf2d-cf23f8dd58e0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NorthStar Rx LLC","500","mg/1","","N","20251231"
"1315","AMOXICILLIN","Amoxicillin","16714029904","Penicillin-class Antibacterial [EPC], Penicillins [CS]","16714-299","16714-299-04","16714-299_3fb9b318-8cd3-46e0-bf2d-cf23f8dd58e0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NorthStar Rx LLC","500","mg/1","","N","20251231"
"1316","AMOXICILLIN","Amoxicillin","16714029901","Penicillin-class Antibacterial [EPC], Penicillins [CS]","16714-299","16714-299-01","16714-299_3fb9b318-8cd3-46e0-bf2d-cf23f8dd58e0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NorthStar Rx LLC","500","mg/1","","N","20251231"
"1317","AMOXICILLIN","Amoxicillin","16714029902","Penicillin-class Antibacterial [EPC], Penicillins [CS]","16714-299","16714-299-02","16714-299_3fb9b318-8cd3-46e0-bf2d-cf23f8dd58e0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NorthStar Rx LLC","500","mg/1","","N","20251231"
"1318","MICAFUNGIN SODIUM","Micafungin","16714030110","Echinocandin Antifungal [EPC], Lipopeptides [CS]","16714-301","16714-301-10","16714-301_b96dcf3b-1308-4a44-9dcd-3dc35f9f5bf0","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20221101","","ANDA","ANDA215241","Northstar Rx LLC.","20","mg/mL","","N","20251231"
"1319","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","16714030910","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","16714-309","16714-309-10","16714-309_a42cb3cc-973a-46b7-8f67-35d2fe21a251","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20160331","","ANDA","ANDA205780","NorthStar Rx LLC","1","g/20mL","","N","20251231"
"1320","CEFADROXIL","Cefadroxil","16714038801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","16714-388","16714-388-01","16714-388_f043b17c-7588-4594-904b-056efaea3446","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","NorthStar Rx LLC","500","mg/1","","N","20251231"
"1321","CEFADROXIL","Cefadroxil","16714038802","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","16714-388","16714-388-02","16714-388_f043b17c-7588-4594-904b-056efaea3446","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","NorthStar Rx LLC","500","mg/1","","N","20251231"
"1322","CEFADROXIL","Cefadroxil","16714038901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","16714-389","16714-389-01","16714-389_323b9a4d-c8fc-4fdb-bba4-834468a0a770","HUMAN PRESCRIPTION DRUG","Cefadroxil","","POWDER, FOR SUSPENSION","ORAL","20130425","","ANDA","ANDA065349","NorthStar Rx LLC","250","mg/5mL","","N","20251231"
"1323","CEFADROXIL","Cefadroxil","16714039002","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","16714-390","16714-390-02","16714-390_323b9a4d-c8fc-4fdb-bba4-834468a0a770","HUMAN PRESCRIPTION DRUG","Cefadroxil","","POWDER, FOR SUSPENSION","ORAL","20130425","","ANDA","ANDA065349","NorthStar Rx LLC","500","mg/5mL","","N","20251231"
"1324","CEFADROXIL","Cefadroxil","16714039001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","16714-390","16714-390-01","16714-390_323b9a4d-c8fc-4fdb-bba4-834468a0a770","HUMAN PRESCRIPTION DRUG","Cefadroxil","","POWDER, FOR SUSPENSION","ORAL","20130425","","ANDA","ANDA065349","NorthStar Rx LLC","500","mg/5mL","","N","20251231"
"1325","CEFPODOXIME PROXETIL","CEFPODOXIME PROXETIL","16714039401","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","16714-394","16714-394-01","16714-394_518e9779-a683-436e-a032-c6a0df0a0de2","HUMAN PRESCRIPTION DRUG","CEFPODOXIME PROXETIL","","TABLET, FILM COATED","ORAL","20070611","","ANDA","ANDA065370","NorthStar Rx LLC","100","mg/1","","N","20251231"
"1326","CEFPODOXIME PROXETIL","CEFPODOXIME PROXETIL","16714039501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","16714-395","16714-395-01","16714-395_518e9779-a683-436e-a032-c6a0df0a0de2","HUMAN PRESCRIPTION DRUG","CEFPODOXIME PROXETIL","","TABLET, FILM COATED","ORAL","20070611","","ANDA","ANDA065370","NorthStar Rx LLC","200","mg/1","","N","20251231"
"1327","CEFUROXIME AXETIL","Cefuroxime Axetil","16714040001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","16714-400","16714-400-01","16714-400_c89c84c5-710f-4a4a-8171-c38bee355c1f","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","NorthStar Rx LLC","250","mg/1","","N","20251231"
"1328","CEFUROXIME AXETIL","Cefuroxime Axetil","16714040002","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","16714-400","16714-400-02","16714-400_c89c84c5-710f-4a4a-8171-c38bee355c1f","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","NorthStar Rx LLC","250","mg/1","","N","20251231"
"1329","CEFUROXIME AXETIL","Cefuroxime Axetil","16714040101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","16714-401","16714-401-01","16714-401_c89c84c5-710f-4a4a-8171-c38bee355c1f","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","NorthStar Rx LLC","500","mg/1","","N","20251231"
"1330","CEFUROXIME AXETIL","Cefuroxime Axetil","16714040102","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","16714-401","16714-401-02","16714-401_c89c84c5-710f-4a4a-8171-c38bee355c1f","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","NorthStar Rx LLC","500","mg/1","","N","20251231"
"1331","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","16714040201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","16714-402","16714-402-01","16714-402_3c3d4973-bfda-476f-b094-52ac4648d7f8","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","GRANULE, FOR SUSPENSION","ORAL","20070608","","ANDA","ANDA065409","NorthStar Rx LLC","50","mg/5mL","","N","20251231"
"1332","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","16714040202","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","16714-402","16714-402-02","16714-402_3c3d4973-bfda-476f-b094-52ac4648d7f8","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","GRANULE, FOR SUSPENSION","ORAL","20070608","","ANDA","ANDA065409","NorthStar Rx LLC","50","mg/5mL","","N","20251231"
"1333","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","16714040301","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","16714-403","16714-403-01","16714-403_3c3d4973-bfda-476f-b094-52ac4648d7f8","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","GRANULE, FOR SUSPENSION","ORAL","20070608","","ANDA","ANDA065409","NorthStar Rx LLC","100","mg/5mL","","N","20251231"
"1334","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","16714040302","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","16714-403","16714-403-02","16714-403_3c3d4973-bfda-476f-b094-52ac4648d7f8","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","GRANULE, FOR SUSPENSION","ORAL","20070608","","ANDA","ANDA065409","NorthStar Rx LLC","100","mg/5mL","","N","20251231"
"1335","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","16714043901","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","16714-439","16714-439-01","16714-439_a7a09d9d-f277-40d3-8129-059e86a0ed76","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20141101","20270318","ANDA","ANDA077066","Northstar RxLLC","25; 75","mg/1; mg/1","","N",""
"1336","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","16714043902","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","16714-439","16714-439-02","16714-439_a7a09d9d-f277-40d3-8129-059e86a0ed76","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20141101","20270318","ANDA","ANDA077066","Northstar RxLLC","25; 75","mg/1; mg/1","","N",""
"1337","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714047601","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-476","16714-476-01","16714-476_b27651c4-7ff8-4137-ade1-d445311fa77e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20151101","","ANDA","ANDA065189","Northstar RxLLC","250; 125","mg/1; mg/1","","N","20251231"
"1338","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","16714047701","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","16714-477","16714-477-01","16714-477_b27651c4-7ff8-4137-ade1-d445311fa77e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20151101","","ANDA","ANDA065064","Northstar RxLLC","500; 125","mg/1; mg/1","","N","20251231"
"1339","CLINDAMYCIN PALMITATE HYDROCHLORIDE","Clindamycin Palmitate Hydrochloride (Pediatric)","16714048302","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","16714-483","16714-483-02","16714-483_366c8a71-1c5c-47e8-989d-d04503c65f4b","HUMAN PRESCRIPTION DRUG","Clindamycin Palmitate Hydrochloride (Pediatric)","","SOLUTION","ORAL","20130430","","ANDA","ANDA202409","NorthStar Rx LLC","75","mg/5mL","","N","20251231"
"1340","CLINDAMYCIN PALMITATE HYDROCHLORIDE","Clindamycin Palmitate Hydrochloride (Pediatric)","16714048301","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","16714-483","16714-483-01","16714-483_366c8a71-1c5c-47e8-989d-d04503c65f4b","HUMAN PRESCRIPTION DRUG","Clindamycin Palmitate Hydrochloride (Pediatric)","","SOLUTION","ORAL","20130430","","ANDA","ANDA202409","NorthStar Rx LLC","75","mg/5mL","","N","20251231"
"1341","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","16714049601","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","16714-496","16714-496-01","16714-496_a702b9ac-d29c-4465-b3dd-64576a2c10e2","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20010529","","ANDA","ANDA075673","NORTHSTAR RX LLC",".5; 10","mg/g; mg/g","","N","20251231"
"1342","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","16714049602","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","16714-496","16714-496-02","16714-496_a702b9ac-d29c-4465-b3dd-64576a2c10e2","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20010529","","ANDA","ANDA075673","NORTHSTAR RX LLC",".5; 10","mg/g; mg/g","","N","20251231"
"1343","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","16714051701","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","16714-517","16714-517-01","16714-517_d68b4f89-1f64-4dc4-8fd2-b2fbac14159c","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20160329","","ANDA","ANDA205779","NorthStar Rx LLC","5","g/1","","N","20251231"
"1344","POSACONAZOLE","Posaconazole","16714053501","Azole Antifungal [EPC], Azoles [CS]","16714-535","16714-535-01","16714-535_f00461e3-12cb-3905-e053-2a95a90a4e12","HUMAN PRESCRIPTION DRUG","Posaconazole","","TABLET, DELAYED RELEASE","ORAL","20230402","","ANDA","ANDA214321","NorthStar RxLLC","100","mg/1","","N","20251231"
"1345","METRONIDAZOLE","Metronidazole","16714055701","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","16714-557","16714-557-01","16714-557_d7cc0dfd-2d83-45ac-aef7-d8f5be09238d","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","VAGINAL","20220624","","ANDA","ANDA215794","Northstar Rx LLC","7.5","mg/g","","N","20251231"
"1346","CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE","Ciprofloxacin and Dexamethasone","16714062801","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","16714-628","16714-628-01","16714-628_6fc9db70-e09e-2b14-8c39-98bee524acad","HUMAN PRESCRIPTION DRUG","Ciprofloxacin and Dexamethasone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","20220801","","ANDA","ANDA205548","NorthStar RxLLC","3; 1","mg/mL; mg/mL","","N","20251231"
"1347","MOXIFLOXACIN HYDROCHLORIDE","MOXIFLOXACIN","16714064301","Quinolone Antimicrobial [EPC], Quinolones [CS]","16714-643","16714-643-01","16714-643_c11c970c-ffa6-4661-b515-708bae4eddd6","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN","","SOLUTION/ DROPS","OPHTHALMIC","20171004","","ANDA","ANDA206242","NorthStar Rx LLC","5","mg/mL","","N","20251231"
"1348","FLUCONAZOLE","Fluconazole","16714069101","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","16714-691","16714-691-01","16714-691_06bbf63a-4457-4206-af05-246be0ddb301","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","NorthStar Rx LLC","100","mg/1","","N","20251231"
"1349","FLUCONAZOLE","Fluconazole","16714069102","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","16714-691","16714-691-02","16714-691_06bbf63a-4457-4206-af05-246be0ddb301","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","NorthStar Rx LLC","100","mg/1","","N","20251231"
"1350","FLUCONAZOLE","Fluconazole","16714069211","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","16714-692","16714-692-11","16714-692_06bbf63a-4457-4206-af05-246be0ddb301","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","NorthStar Rx LLC","150","mg/1","","N","20251231"
"1351","FLUCONAZOLE","Fluconazole","16714069302","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","16714-693","16714-693-02","16714-693_06bbf63a-4457-4206-af05-246be0ddb301","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","NorthStar Rx LLC","200","mg/1","","N","20251231"
"1352","FLUCONAZOLE","Fluconazole","16714069301","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","16714-693","16714-693-01","16714-693_06bbf63a-4457-4206-af05-246be0ddb301","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","NorthStar Rx LLC","200","mg/1","","N","20251231"
"1353","FLUCONAZOLE","Fluconazole","16714069401","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","16714-694","16714-694-01","16714-694_06bbf63a-4457-4206-af05-246be0ddb301","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","NorthStar Rx LLC","50","mg/1","","N","20251231"
"1354","FLUCONAZOLE","Fluconazole","16714069501","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","16714-695","16714-695-01","16714-695_95e12350-efed-4dad-8ec3-6aa48fdc1512","HUMAN PRESCRIPTION DRUG","Fluconazole","","POWDER, FOR SUSPENSION","ORAL","20090918","","ANDA","ANDA079150","NorthStar Rx LLC","10","mg/mL","","N","20251231"
"1355","FLUCONAZOLE","Fluconazole","16714069601","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","16714-696","16714-696-01","16714-696_95e12350-efed-4dad-8ec3-6aa48fdc1512","HUMAN PRESCRIPTION DRUG","Fluconazole","","POWDER, FOR SUSPENSION","ORAL","20090918","","ANDA","ANDA079150","NorthStar Rx LLC","40","mg/mL","","N","20251231"
"1356","ITRACONAZOLE","Itraconazole","16714074301","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","16714-743","16714-743-01","16714-743_62530d1a-98c7-4605-a95e-4bdf1b4f3d7c","HUMAN PRESCRIPTION DRUG","Itraconazole","","CAPSULE, COATED PELLETS","ORAL","20170901","","ANDA","ANDA208591","NorthStar RxLLC","100","mg/1","","N","20251231"
"1357","ITRACONAZOLE","Itraconazole","16714074302","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","16714-743","16714-743-02","16714-743_62530d1a-98c7-4605-a95e-4bdf1b4f3d7c","HUMAN PRESCRIPTION DRUG","Itraconazole","","CAPSULE, COATED PELLETS","ORAL","20170901","","ANDA","ANDA208591","NorthStar RxLLC","100","mg/1","","N","20251231"
"1358","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","16714079502","Allylamine Antifungal [EPC], Allylamine [CS]","16714-795","16714-795-02","16714-795_959f3136-b10d-4a73-a11a-1fae5bd72fb6","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","NorthStar Rx LLC","250","mg/1","","N","20251231"
"1359","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","16714079501","Allylamine Antifungal [EPC], Allylamine [CS]","16714-795","16714-795-01","16714-795_959f3136-b10d-4a73-a11a-1fae5bd72fb6","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","NorthStar Rx LLC","250","mg/1","","N","20251231"
"1360","ERTAPENEM SODIUM","Ertapenem","16714088910","Carbapenems [CS], Penem Antibacterial [EPC]","16714-889","16714-889-10","16714-889_e3444dd5-af0d-d362-eadf-e7c6bb9ccd8c","HUMAN PRESCRIPTION DRUG","ERTAPENEM SODIUM","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20210713","","ANDA","ANDA212040","NorthStar RxLLC","1","g/1","","N","20251231"
"1361","DAPTOMYCIN","Daptomycin","16714089201","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","16714-892","16714-892-01","16714-892_92b0bfe9-7694-3806-12c2-9d9b4f6ddfa7","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220613","20260630","ANDA","ANDA208375","NorthStar RxLLC","50","mg/mL","","N",""
"1362","KETOCONAZOLE","Ketoconazole","16714095501","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","16714-955","16714-955-01","16714-955_fb8f0541-bd79-4f25-bc6c-7d75dbba0fe2","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20021218","","ANDA","ANDA075638","NORTHSTAR RX LLC","20","mg/g","","N","20251231"
"1363","KETOCONAZOLE","Ketoconazole","16714095502","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","16714-955","16714-955-02","16714-955_fb8f0541-bd79-4f25-bc6c-7d75dbba0fe2","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20021218","","ANDA","ANDA075638","NORTHSTAR RX LLC","20","mg/g","","N","20251231"
"1364","KETOCONAZOLE","Ketoconazole","16714095503","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","16714-955","16714-955-03","16714-955_fb8f0541-bd79-4f25-bc6c-7d75dbba0fe2","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20021218","","ANDA","ANDA075638","NORTHSTAR RX LLC","20","mg/g","","N","20251231"
"1365","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","clindamycin and benzoyl peroxide","16714098425","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","16714-984","16714-984-25","16714-984_1d40bf0b-022b-445f-95dd-aee2747523f6","HUMAN PRESCRIPTION DRUG","clindamycin and benzoyl peroxide","","GEL","TOPICAL","20190701","","ANDA","ANDA209252","NorthStar RxLLC","50; 10","mg/g; mg/g","","N","20251231"
"1366","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","clindamycin and benzoyl peroxide","16714098450","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","16714-984","16714-984-50","16714-984_1d40bf0b-022b-445f-95dd-aee2747523f6","HUMAN PRESCRIPTION DRUG","clindamycin and benzoyl peroxide","","GEL","TOPICAL","20190701","","ANDA","ANDA209252","NorthStar RxLLC","50; 10","mg/g; mg/g","","N","20251231"
"1367","DAPTOMYCIN","Daptomycin","16729043405","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","16729-434","16729-434-05","16729-434_26404ac9-a349-f997-e063-6394a90a2d12","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190716","","ANDA","ANDA212667","Accord Healthcare, Inc.","350","mg/7mL","","N","20251231"
"1368","DAPTOMYCIN","Daptomycin","16729043445","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","16729-434","16729-434-45","16729-434_26404ac9-a349-f997-e063-6394a90a2d12","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190716","","ANDA","ANDA212667","Accord Healthcare, Inc.","350","mg/7mL","","N","20251231"
"1369","DAPTOMYCIN","Daptomycin","16729043505","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","16729-435","16729-435-05","16729-435_26405b8d-754a-0191-e063-6394a90a0dab","HUMAN PRESCRIPTION DRUG","DAPTOMYCIN","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190624","","ANDA","ANDA211961","Accord Healthcare Inc.","500","mg/10mL","","N","20251231"
"1370","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","16729048501","Antimalarial [EPC], Antirheumatic Agent [EPC]","16729-485","16729-485-01","16729-485_1d63599f-0735-558d-e063-6394a90a2b1f","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET","ORAL","20200512","","ANDA","ANDA213342","Accord Healthcare, Inc.,","200","mg/1","","N","20251231"
"1371","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","16729048516","Antimalarial [EPC], Antirheumatic Agent [EPC]","16729-485","16729-485-16","16729-485_1d63599f-0735-558d-e063-6394a90a2b1f","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET","ORAL","20200512","","ANDA","ANDA213342","Accord Healthcare, Inc.,","200","mg/1","","N","20251231"
"1372","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","16729056101","Antimalarial [EPC], Antirheumatic Agent [EPC]","16729-561","16729-561-01","16729-561_1d63599f-0735-558d-e063-6394a90a2b1f","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET","ORAL","20210928","","ANDA","ANDA213342","Accord Healthcare, Inc.,","100","mg/1","","N","20251231"
"1373","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","16729056201","Antimalarial [EPC], Antirheumatic Agent [EPC]","16729-562","16729-562-01","16729-562_1d63599f-0735-558d-e063-6394a90a2b1f","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET","ORAL","20210928","","ANDA","ANDA213342","Accord Healthcare, Inc.,","300","mg/1","","N","20251231"
"1374","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","16729056301","Antimalarial [EPC], Antirheumatic Agent [EPC]","16729-563","16729-563-01","16729-563_1d63599f-0735-558d-e063-6394a90a2b1f","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET","ORAL","20210928","","ANDA","ANDA213342","Accord Healthcare, Inc.,","400","mg/1","","N","20251231"
"1375","CLINDAMYCIN PHOSPHATE","CLINDAMYCIN","16781046206","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","16781-462","16781-462-06","16781-462_d53a56df-6546-4998-8d39-71a74e73b6fe","HUMAN PRESCRIPTION DRUG","Clindagel","","GEL","TOPICAL","20131125","","NDA","NDA050782","Bausch Health US, LLC","10","mg/mL","","N","20251231"
"1376","CLINDAMYCIN PHOSPHATE","CLINDAMYCIN","16781046275","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","16781-462","16781-462-75","16781-462_d53a56df-6546-4998-8d39-71a74e73b6fe","HUMAN PRESCRIPTION DRUG","Clindagel","","GEL","TOPICAL","20131125","","NDA","NDA050782","Bausch Health US, LLC","10","mg/mL","","N","20251231"
"1377","MICONAZOLE NITRATE","Miconazole Nitrate","16864004002","Azole Antifungal [EPC], Azoles [CS]","16864-040","16864-040-02","16864-040_2914be2e-cf08-8f75-e063-6394a90a01cd","HUMAN OTC DRUG","Triple Antifungal","","OINTMENT","TOPICAL","20210901","","OTC MONOGRAPH DRUG","M005","Advantice Health, LLC","2","g/100g","","N","20251231"
"1378",".ALPHA.-KETOGLUTARIC ACID; AMBERGRIS; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; EPINEPHRINE; FUMARIC ACID; MALIC ACID; MELATONIN; MINERAL OIL; PTERIDIUM AQUILINUM ROOT; PYRIDOXINE HYDROCHLORIDE; QUINHYDRONE; QUININE SALICYLATE; SUS SCROFA ARTERY; SUS SCROFA CEREBELLUM; SUS SCROFA PLACENTA; THIAMINE HYDROCHLORIDE; TOBACCO LEAF",".alpha.-ketoglutaric acid - ambergris - anamirta cocculus seed - conium maculatum flowering top - epinephrine - fumaric acid - malic acid - melatonin - mineral oil - pteridium aquilinum root - pyridoxine hydrochloride - quinhydrone - quinine - sus scrofa artery - sus scrofa cerebellum - sus scrofa placenta - thiamine hydrochloride - tobacco leaf -","17089030618","Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Antimalarial [EPC], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Depigmenting Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]","17089-306","17089-306-18","17089-306_7e7be278-8d19-71c4-e053-2991aa0a377c","HUMAN OTC DRUG","GUNA-DIZZY","","SOLUTION/ DROPS","ORAL","20060523","","UNAPPROVED HOMEOPATHIC","","Guna spa","6; 6; 4; 3; 6; 6; 6; 4; 8; 8; 6; 6; 6; 6; 6; 6; 4; 6","[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL","","N","20251231"
"1379","MUPIROCIN","Mupirocin","17856011201","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","17856-0112","17856-0112-1","17856-0112_3633ac1b-d811-2f7b-e063-6394a90a1227","HUMAN PRESCRIPTION DRUG","mupirocin","","OINTMENT","TOPICAL","20091030","","ANDA","ANDA065123","ATLANTIC BIOLOGICALS CORP.","20","mg/g","","N","20261231"
"1380","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","17856049604","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","17856-0496","17856-0496-4","17856-0496_361f7b6e-a67d-c21a-e063-6394a90ad8ba","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20171004","","ANDA","ANDA091348","ATLANTIC BIOLOGICALS CORP.","200; 40","mg/5mL; mg/5mL","","N","20261231"
"1381","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","17856049605","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","17856-0496","17856-0496-5","17856-0496_361f7b6e-a67d-c21a-e063-6394a90ad8ba","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20171004","","ANDA","ANDA091348","ATLANTIC BIOLOGICALS CORP.","200; 40","mg/5mL; mg/5mL","","N","20261231"
"1382","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","17856049606","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","17856-0496","17856-0496-6","17856-0496_361f7b6e-a67d-c21a-e063-6394a90ad8ba","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20171004","","ANDA","ANDA091348","ATLANTIC BIOLOGICALS CORP.","200; 40","mg/5mL; mg/5mL","","N","20261231"
"1383","NYSTATIN","NYSTATIN","17856050803","Polyene Antifungal [EPC], Polyenes [CS]","17856-0508","17856-0508-3","17856-0508_21eea7cf-eb11-409e-b7f2-209d7a8966dd","HUMAN PRESCRIPTION DRUG","NYSTATIN","","SUSPENSION","ORAL","20221205","","ANDA","ANDA214346","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20251231"
"1384","NYSTATIN","NYSTATIN","17856050807","Polyene Antifungal [EPC], Polyenes [CS]","17856-0508","17856-0508-7","17856-0508_21eea7cf-eb11-409e-b7f2-209d7a8966dd","HUMAN PRESCRIPTION DRUG","NYSTATIN","","SUSPENSION","ORAL","20221205","","ANDA","ANDA214346","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20251231"
"1385","NYSTATIN","NYSTATIN","17856050801","Polyene Antifungal [EPC], Polyenes [CS]","17856-0508","17856-0508-1","17856-0508_21eea7cf-eb11-409e-b7f2-209d7a8966dd","HUMAN PRESCRIPTION DRUG","NYSTATIN","","SUSPENSION","ORAL","20221205","","ANDA","ANDA214346","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20251231"
"1386","NYSTATIN","NYSTATIN","17856050805","Polyene Antifungal [EPC], Polyenes [CS]","17856-0508","17856-0508-5","17856-0508_21eea7cf-eb11-409e-b7f2-209d7a8966dd","HUMAN PRESCRIPTION DRUG","NYSTATIN","","SUSPENSION","ORAL","20221205","","ANDA","ANDA214346","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20251231"
"1387","NYSTATIN","NYSTATIN","17856050903","Polyene Antifungal [EPC], Polyenes [CS]","17856-0509","17856-0509-3","17856-0509_f1be37d2-33ba-416a-8b16-5dbeb4ac04ed","HUMAN PRESCRIPTION DRUG","NYSTATIN","","SUSPENSION","ORAL","20221205","","ANDA","ANDA214346","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20251231"
"1388","NYSTATIN","NYSTATIN","17856050905","Polyene Antifungal [EPC], Polyenes [CS]","17856-0509","17856-0509-5","17856-0509_f1be37d2-33ba-416a-8b16-5dbeb4ac04ed","HUMAN PRESCRIPTION DRUG","NYSTATIN","","SUSPENSION","ORAL","20221205","","ANDA","ANDA214346","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20251231"
"1389","NYSTATIN","NYSTATIN","17856050907","Polyene Antifungal [EPC], Polyenes [CS]","17856-0509","17856-0509-7","17856-0509_f1be37d2-33ba-416a-8b16-5dbeb4ac04ed","HUMAN PRESCRIPTION DRUG","NYSTATIN","","SUSPENSION","ORAL","20221205","","ANDA","ANDA214346","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20251231"
"1390","NYSTATIN","NYSTATIN","17856050901","Polyene Antifungal [EPC], Polyenes [CS]","17856-0509","17856-0509-1","17856-0509_f1be37d2-33ba-416a-8b16-5dbeb4ac04ed","HUMAN PRESCRIPTION DRUG","NYSTATIN","","SUSPENSION","ORAL","20221205","","ANDA","ANDA214346","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20251231"
"1391","NYSTATIN","NYSTATIN","17856050908","Polyene Antifungal [EPC], Polyenes [CS]","17856-0509","17856-0509-8","17856-0509_f1be37d2-33ba-416a-8b16-5dbeb4ac04ed","HUMAN PRESCRIPTION DRUG","NYSTATIN","","SUSPENSION","ORAL","20221205","","ANDA","ANDA214346","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20251231"
"1392","NYSTATIN","Nystatin","17856053805","Polyene Antifungal [EPC], Polyenes [CS]","17856-0538","17856-0538-5","17856-0538_1cdb71e6-f57e-4546-8646-bc6d2ac000f6","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","19950415","","ANDA","ANDA062512","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20251231"
"1393","NYSTATIN","Nystatin","17856053807","Polyene Antifungal [EPC], Polyenes [CS]","17856-0538","17856-0538-7","17856-0538_1cdb71e6-f57e-4546-8646-bc6d2ac000f6","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","19950415","","ANDA","ANDA062512","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20251231"
"1394","NYSTATIN","Nystatin","17856053808","Polyene Antifungal [EPC], Polyenes [CS]","17856-0538","17856-0538-8","17856-0538_1cdb71e6-f57e-4546-8646-bc6d2ac000f6","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","19950415","","ANDA","ANDA062512","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20251231"
"1395","NYSTATIN","Nystatin","17856053809","Polyene Antifungal [EPC], Polyenes [CS]","17856-0538","17856-0538-9","17856-0538_1cdb71e6-f57e-4546-8646-bc6d2ac000f6","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","19950415","","ANDA","ANDA062512","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20251231"
"1396","NYSTATIN","Nystatin","17856053806","Polyene Antifungal [EPC], Polyenes [CS]","17856-0538","17856-0538-6","17856-0538_1cdb71e6-f57e-4546-8646-bc6d2ac000f6","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","19950415","","ANDA","ANDA062512","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20251231"
"1397","NYSTATIN","Nystatin","17856053801","Polyene Antifungal [EPC], Polyenes [CS]","17856-0538","17856-0538-1","17856-0538_1cdb71e6-f57e-4546-8646-bc6d2ac000f6","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","19950415","","ANDA","ANDA062512","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20251231"
"1398","ATOVAQUONE","Atovaquone","17856063101","Antimalarial [EPC], Antiprotozoal [EPC]","17856-0631","17856-0631-1","17856-0631_34f352d5-bdca-df12-e063-6294a90a54bd","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20181011","","ANDA","ANDA210692","ATLANTIC BIOLOGICALS CORP.","750","mg/5mL","","N","20261231"
"1399","NYSTATIN","NYSTATIN","17856104501","Polyene Antifungal [EPC], Polyenes [CS]","17856-1045","17856-1045-1","17856-1045_35ceeae7-4f25-4d5a-e063-6394a90a8ff7","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20240621","","ANDA","ANDA203621","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20261231"
"1400","NYSTATIN","NYSTATIN","17856104503","Polyene Antifungal [EPC], Polyenes [CS]","17856-1045","17856-1045-3","17856-1045_35ceeae7-4f25-4d5a-e063-6394a90a8ff7","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20240621","","ANDA","ANDA203621","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20261231"
"1401","NYSTATIN","NYSTATIN","17856104509","Polyene Antifungal [EPC], Polyenes [CS]","17856-1045","17856-1045-9","17856-1045_35ceeae7-4f25-4d5a-e063-6394a90a8ff7","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20240621","","ANDA","ANDA203621","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20261231"
"1402","NYSTATIN","NYSTATIN","17856104505","Polyene Antifungal [EPC], Polyenes [CS]","17856-1045","17856-1045-5","17856-1045_35ceeae7-4f25-4d5a-e063-6394a90a8ff7","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20240621","","ANDA","ANDA203621","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20261231"
"1403","NYSTATIN","NYSTATIN","17856104507","Polyene Antifungal [EPC], Polyenes [CS]","17856-1045","17856-1045-7","17856-1045_35ceeae7-4f25-4d5a-e063-6394a90a8ff7","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20240621","","ANDA","ANDA203621","ATLANTIC BIOLOGICALS CORP.","100000","[USP'U]/mL","","N","20261231"
"1404","POSACONAZOLE","Posaconazole","17856213301","Azole Antifungal [EPC], Azoles [CS]","17856-2133","17856-2133-1","17856-2133_26452e17-c7c1-4d7d-b44e-0e7906a3809c","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","TABLET, DELAYED RELEASE","ORAL","20190828","","ANDA","ANDA212411","ATLANTIC BIOLOGICALS CORP.","100","mg/1","","N","20251231"
"1405","TIOCONAZOLE","Tioconazole","21130006054","Azole Antifungal [EPC], Azoles [CS]","21130-060","21130-060-54","21130-060_a6c0d30b-1e93-4b4e-bd13-c480eab4aece","HUMAN OTC DRUG","signature care tioconazole 1","","OINTMENT","VAGINAL","20150924","","ANDA","ANDA075915","Safeway","6.5","g/100g","","N","20261231"
"1406","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","21130008002","Allylamine Antifungal [EPC], Allylamine [CS]","21130-080","21130-080-02","21130-080_2be98712-5a71-2119-e063-6394a90ad71e","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Safeway Inc.","1","g/100g","","N","20261231"
"1407","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl","21130012058","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","21130-120","21130-120-58","21130-120_eeaa26fd-5bbc-478a-a9df-c061dc374058","HUMAN OTC DRUG","Signature Care Triple Antibiotic","","OINTMENT","TOPICAL","20170509","","OTC MONOGRAPH DRUG","M004","Safeway","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1408","MICONAZOLE NITRATE","Miconazole nitrate","21130012129","Azole Antifungal [EPC], Azoles [CS]","21130-121","21130-121-29","21130-121_ab7b1901-8aaf-4a6f-bb94-885fb22b941b","HUMAN OTC DRUG","Signature Care Miconazole 7","","CREAM","VAGINAL","20151103","","ANDA","ANDA074760","Safeway","2","g/100g","","N","20251231"
"1409","CLOTRIMAZOLE","Clotrimazole","21130021001","Azole Antifungal [EPC], Azoles [CS]","21130-210","21130-210-01","21130-210_25e03832-0d22-53a7-e063-6294a90ac387","HUMAN OTC DRUG","Signature Care","Jock Itch","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Safeway Inc.","10","mg/g","","N","20251231"
"1410","MICONAZOLE NITRATE","Miconazole Nitrate Antifungal Powder Spray","21130021200","Azole Antifungal [EPC], Azoles [CS]","21130-212","21130-212-00","21130-212_2658fef6-39e9-e2a6-e063-6294a90ac6ad","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, SPRAY","TOPICAL","20210927","","OTC MONOGRAPH DRUG","M005","Better Living Brands","2.6","g/130g","","N","20251231"
"1411","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","21130040958","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","21130-409","21130-409-58","21130-409_083b9108-bd39-4e41-b718-ae7d5240dbb4","HUMAN OTC DRUG","Signature Care Triple Antibiotic","","OINTMENT","TOPICAL","20151014","","OTC MONOGRAPH DRUG","M004","Safeway","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1412","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","21130040964","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","21130-409","21130-409-64","21130-409_083b9108-bd39-4e41-b718-ae7d5240dbb4","HUMAN OTC DRUG","Signature Care Triple Antibiotic","","OINTMENT","TOPICAL","20151014","","OTC MONOGRAPH DRUG","M004","Safeway","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1413","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl","21130044864","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","21130-448","21130-448-64","21130-448_f24a6d8f-d9c7-4df8-8447-3cc7c7f7fa4c","HUMAN OTC DRUG","Signature Care Triple Antibiotic","","OINTMENT","TOPICAL","20150927","","OTC MONOGRAPH DRUG","M004","Safeway","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1414","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin, Polymyxin B, Pramoxine HCl","21130055958","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","21130-559","21130-559-58","21130-559_8504465f-cb55-4a7b-bb82-bfca8641b91d","HUMAN OTC DRUG","Signature Care First Aid Antibiotic","","CREAM","TOPICAL","20151110","","OTC MONOGRAPH DRUG","M004","Safeway","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"1415","MICONAZOLE NITRATE","miconazole nitrate","21130082529","Azole Antifungal [EPC], Azoles [CS]","21130-825","21130-825-29","21130-825_8fb5cd26-54da-4d81-943b-1b029706e77a","HUMAN OTC DRUG","signature care miconazole 7","","CREAM","VAGINAL","20181106","","ANDA","ANDA074760","Safeway","2","g/100g","","N","20251231"
"1416","CLOTRIMAZOLE","Clotrimazole","21130087014","Azole Antifungal [EPC], Azoles [CS]","21130-870","21130-870-14","21130-870_2a442516-fc9b-6e16-e063-6394a90aa100","HUMAN OTC DRUG","Signature Care Athletes Foot","","CREAM","TOPICAL","20220210","","OTC MONOGRAPH DRUG","M005","Safeway","10","mg/g","","N","20251231"
"1417","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","21130096501","Benzylamine Antifungal [EPC], Benzylamines [CS]","21130-965","21130-965-01","21130-965_308fe957-c2ae-e444-e063-6294a90a28fa","HUMAN OTC DRUG","Butenafine Hydrochloride","","CREAM","TOPICAL","20230419","","ANDA","ANDA205181","Albertsons","10","mg/g","","N","20261231"
"1418","CEFOTAXIME SODIUM","cefotaxime injection","21586001102","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","21586-011","21586-011-02","21586-011_425c90b3-5006-427e-95f6-93ee7918fb8b","HUMAN PRESCRIPTION DRUG","Cefotaxime","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20190801","","UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE","","SteriMax Inc.","1","g/1","","N","20251231"
"1419","CEFOTAXIME SODIUM","cefotaxime injection","21586001202","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","21586-012","21586-012-02","21586-012_425c90b3-5006-427e-95f6-93ee7918fb8b","HUMAN PRESCRIPTION DRUG","Cefotaxime","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20190801","","UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE","","SteriMax Inc.","2","g/1","","N","20251231"
"1420","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate Topical Solution USP, 1%","21922000201","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","21922-002","21922-002-01","21922-002_6024e3d1-1e7d-402f-a5c0-8374ec0405f4","HUMAN PRESCRIPTION DRUG","Clindamycin Phoaphate Topical Solution USP, 1%","","SOLUTION","TOPICAL","20190304","","ANDA","ANDA209914","Encube Ethicals Private Limited","10","mg/mL","","N","20251231"
"1421","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate Topical Solution USP, 1%","21922000221","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","21922-002","21922-002-21","21922-002_6024e3d1-1e7d-402f-a5c0-8374ec0405f4","HUMAN PRESCRIPTION DRUG","Clindamycin Phoaphate Topical Solution USP, 1%","","SOLUTION","TOPICAL","20190304","","ANDA","ANDA209914","Encube Ethicals Private Limited","10","mg/mL","","N","20251231"
"1422","TAVABOROLE","TAVABOROLE topical solution, 5%","21922002012","Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]","21922-020","21922-020-12","21922-020_90a6ef7b-ca03-4015-aa28-ab1371bd2119","HUMAN PRESCRIPTION DRUG","Tavaborole","","SOLUTION","TOPICAL","20201019","","ANDA","ANDA211297","Encube Ethicals Private Limited","43.5","mg/mL","","N","20251231"
"1423","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","21922002206","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS]","21922-022","21922-022-06","21922-022_c232b13d-df3f-c875-e053-2a95a90a715c","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","GEL","TOPICAL","20210520","","ANDA","ANDA212433","Encube Ethicals Private Limited","50; 10","mg/g; mg/g","","N","20251231"
"1424","KETOCONAZOLE","Ketoconazole Cream, 2%","21922002504","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","21922-025","21922-025-04","21922-025_a4bede1e-ed28-4c89-92c2-4773d9b6a8b5","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20210527","","ANDA","ANDA212443","Encube Ethicals Private Limited","20","mg/g","","N","20251231"
"1425","KETOCONAZOLE","Ketoconazole Cream, 2%","21922002505","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","21922-025","21922-025-05","21922-025_a4bede1e-ed28-4c89-92c2-4773d9b6a8b5","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20210527","","ANDA","ANDA212443","Encube Ethicals Private Limited","20","mg/g","","N","20251231"
"1426","KETOCONAZOLE","Ketoconazole Cream, 2%","21922002507","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","21922-025","21922-025-07","21922-025_a4bede1e-ed28-4c89-92c2-4773d9b6a8b5","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20210527","","ANDA","ANDA212443","Encube Ethicals Private Limited","20","mg/g","","N","20251231"
"1427","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate Gel USP, 1%","21922002707","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","21922-027","21922-027-07","21922-027_99b7ab00-7b68-41d3-99d8-ecddf57acbb8","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20210315","","ANDA","ANDA212438","Encube Ethicals Private Limited","10","mg/g","","N","20261231"
"1428","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate Gel USP, 1%","21922002705","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","21922-027","21922-027-05","21922-027_99b7ab00-7b68-41d3-99d8-ecddf57acbb8","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20210315","","ANDA","ANDA212438","Encube Ethicals Private Limited","10","mg/g","","N","20261231"
"1429","MUPIROCIN CALCIUM","Mupirocin","21922002905","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","21922-029","21922-029-05","21922-029_b04496f9-f706-40d9-9f1a-9e71d336544c","HUMAN PRESCRIPTION DRUG","Mupirocin","","CREAM","TOPICAL","20210902","","ANDA","ANDA213076","Encube Ethicals Private Limited","2","g/100g","","N","20251231"
"1430","MUPIROCIN CALCIUM","Mupirocin","21922002904","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","21922-029","21922-029-04","21922-029_b04496f9-f706-40d9-9f1a-9e71d336544c","HUMAN PRESCRIPTION DRUG","Mupirocin","","CREAM","TOPICAL","20210902","","ANDA","ANDA213076","Encube Ethicals Private Limited","2","g/100g","","N","20251231"
"1431","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","21922003104","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","21922-031","21922-031-04","21922-031_d5868c2d-5564-6eb1-e053-2a95a90a1a57","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20190928","","ANDA","ANDA207741","Encube Ethicals Private Limited","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"1432","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","21922003105","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","21922-031","21922-031-05","21922-031_d5868c2d-5564-6eb1-e053-2a95a90a1a57","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20190928","","ANDA","ANDA207741","Encube Ethicals Private Limited","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"1433","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","21922003107","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","21922-031","21922-031-07","21922-031_d5868c2d-5564-6eb1-e053-2a95a90a1a57","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20190928","","ANDA","ANDA207741","Encube Ethicals Private Limited","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"1434","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","21922003601","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","21922-036","21922-036-01","21922-036_d603c3a4-08a3-f0ff-e053-2995a90a676b","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","LOTION","TOPICAL","20220119","","ANDA","ANDA215607","Encube Ethicals Private Limited","10","ug/mL","","N","20251231"
"1435","METRONIDAZOLE","Metronidazole","21922003923","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","21922-039","21922-039-23","21922-039_9a88162f-e048-47a4-a512-0ad1fd254774","HUMAN PRESCRIPTION DRUG","Metronidazole Vaginal Gel, 0.75%","","GEL","VAGINAL","20230617","","ANDA","ANDA215610","Encube Ethicals Private Limited","7.5","mg/g","","N","20251231"
"1436","METRONIDAZOLE","Metronidazole vaginal gel, 1.3 %","21922004641","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","21922-046","21922-046-41","21922-046_585d2553-e19f-4227-82db-e4c2034863bf","HUMAN PRESCRIPTION DRUG","Metronidazole Vaginal Gel","","GEL","VAGINAL","20240319","","ANDA","ANDA216795","Encube Ethicals Private Limited","65","mg/5g","","N","20251231"
"1437","CLINDAMYCIN PHOSPHATE; TRETINOIN","Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%","21922005005","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]","21922-050","21922-050-05","21922-050_b192f338-4228-459a-8735-a7f9c6bec447","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%","","GEL","TOPICAL","20230904","","ANDA","ANDA216943","Encube Ethicals Private Limited","10; .25","mg/g; mg/g","","N","20251231"
"1438","CLINDAMYCIN PHOSPHATE; TRETINOIN","Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%","21922005007","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]","21922-050","21922-050-07","21922-050_b192f338-4228-459a-8735-a7f9c6bec447","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%","","GEL","TOPICAL","20230904","","ANDA","ANDA216943","Encube Ethicals Private Limited","10; .25","mg/g; mg/g","","N","20251231"
"1439","METRONIDAZOLE","Metronidazole Topical","21922007006","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","21922-070","21922-070-06","21922-070_05707735-e676-412a-9a77-ebd003afb16c","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","GEL","TOPICAL","20250128","","ANDA","ANDA077547","Encube Ethicals Private Limited","7.5","mg/g","","N","20261231"
"1440","MUPIROCIN","MUPIROCIN","21922007304","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","21922-073","21922-073-04","21922-073_35bb6a29-1c58-f8b1-e063-6394a90a7376","HUMAN PRESCRIPTION DRUG","MUPIROCIN","","OINTMENT","TOPICAL","20250516","","ANDA","ANDA217943","Encube Ethicals Private Limited","20","mg/g","","N","20261231"
"1441","MUPIROCIN","MUPIROCIN","21922007305","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","21922-073","21922-073-05","21922-073_35bb6a29-1c58-f8b1-e063-6394a90a7376","HUMAN PRESCRIPTION DRUG","MUPIROCIN","","OINTMENT","TOPICAL","20250516","","ANDA","ANDA217943","Encube Ethicals Private Limited","20","mg/g","","N","20261231"
"1442","MUPIROCIN","MUPIROCIN","21922007325","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","21922-073","21922-073-25","21922-073_35bb6a29-1c58-f8b1-e063-6394a90a7376","HUMAN PRESCRIPTION DRUG","MUPIROCIN","","OINTMENT","TOPICAL","20250516","","ANDA","ANDA217943","Encube Ethicals Private Limited","20","mg/g","","N","20261231"
"1443","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","21922007440","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","21922-074","21922-074-40","21922-074_977b2395-14ff-4c64-9a1e-77ef75805a83","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","","GEL","TOPICAL","20241201","","ANDA","ANDA207194","Encube Ethicals Private Limited","25; 10","mg/g; mg/g","","N","20261231"
"1444","BACITRACIN ZINC; POLYMYXIN B SULFATE","bacitracin zinc polymyxin b sulfate","21922009205","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","21922-092","21922-092-05","21922-092_31c77e9e-698f-741a-e063-6394a90a1e00","HUMAN OTC DRUG","Double Antibiotic","","OINTMENT","TOPICAL","20250306","","OTC MONOGRAPH DRUG","M004","Encube Ethicals Private Limited","400; 5000","[USP'U]/g; [USP'U]/g","","N","20261231"
"1445","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc neomycin sulfate polymyxin b sulfate","21922009304","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","21922-093","21922-093-04","21922-093_2e985ad0-aa50-4c6b-b0af-1d61489a9fda","HUMAN OTC DRUG","TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20250306","","OTC MONOGRAPH DRUG","M004","Encube Ethicals Private Limited","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"1446","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc neomycin sulfate polymyxin b sulfate","21922009305","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","21922-093","21922-093-05","21922-093_2e985ad0-aa50-4c6b-b0af-1d61489a9fda","HUMAN OTC DRUG","TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20250306","","OTC MONOGRAPH DRUG","M004","Encube Ethicals Private Limited","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"1447","CLOTRIMAZOLE","Clotrimazole","21922009404","Azole Antifungal [EPC], Azoles [CS]","21922-094","21922-094-04","21922-094_afbc28f8-bb76-424d-9d73-136e6c283ead","HUMAN OTC DRUG","ANTIFUNGAL","","CREAM","TOPICAL","20250306","","OTC MONOGRAPH DRUG","M005","Encube Ethicals Private Limited","10","mg/g","","N","20261231"
"1448","CLOTRIMAZOLE","Clotrimazole","21922009405","Azole Antifungal [EPC], Azoles [CS]","21922-094","21922-094-05","21922-094_afbc28f8-bb76-424d-9d73-136e6c283ead","HUMAN OTC DRUG","ANTIFUNGAL","","CREAM","TOPICAL","20250306","","OTC MONOGRAPH DRUG","M005","Encube Ethicals Private Limited","10","mg/g","","N","20261231"
"1449","MICONAZOLE NITRATE","Miconazole Nitrate","21922009506","Azole Antifungal [EPC], Azoles [CS]","21922-095","21922-095-06","21922-095_8be4bbfa-424c-4ccf-b8bc-65b16c126053","HUMAN OTC DRUG","Antifungal Cream","","CREAM","TOPICAL","20250306","","OTC MONOGRAPH DRUG","M005","Encube Ethicals Private Limited","2","g/100g","","N","20261231"
"1450","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin zinc Neomycin sulfate Polymyxin B sulfate Pramoxine Hcl","21922010105","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","21922-101","21922-101-05","21922-101_dfea6b2e-cd76-439d-a3da-64e2d8717163","HUMAN OTC DRUG","TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20250306","","OTC MONOGRAPH DRUG","M004","Encube Ethicals Private Limited","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20261231"
"1451","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin zinc Neomycin sulfate Polymyxin B sulfate Pramoxine Hcl","21922010104","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","21922-101","21922-101-04","21922-101_dfea6b2e-cd76-439d-a3da-64e2d8717163","HUMAN OTC DRUG","TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20250306","","OTC MONOGRAPH DRUG","M004","Encube Ethicals Private Limited","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20261231"
"1452","TETRACYCLINE HYDROCHLORIDE","tetracycline hydrochloride","23155001801","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","23155-018","23155-018-01","23155-018_0d5bebf0-11ec-4572-9728-d8721296b1f4","HUMAN PRESCRIPTION DRUG","tetracycline hydrochloride","","CAPSULE","ORAL","20240915","","NDA","NDA050278","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"1453","NYSTATIN","nystatin","23155005101","Polyene Antifungal [EPC], Polyenes [CS]","23155-051","23155-051-01","23155-051_8239b97f-8c75-4043-94fb-eca90d416b5e","HUMAN PRESCRIPTION DRUG","nystatin","","TABLET, COATED","ORAL","20111031","","ANDA","ANDA062474","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","500000","[USP'U]/1","","N","20251231"
"1454","COLISTIMETHATE SODIUM","COLISTIMETHATE SODIUM","23155019341","Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","23155-193","23155-193-41","23155-193_814f57e1-9ddb-4fbe-a940-051dd3e1e115","HUMAN PRESCRIPTION DRUG","COLISTIMETHATE SODIUM","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20210909","","ANDA","ANDA202359","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","150","mg/4mL","","N","20261231"
"1455","COLISTIMETHATE SODIUM","COLISTIMETHATE SODIUM","23155019331","Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","23155-193","23155-193-31","23155-193_814f57e1-9ddb-4fbe-a940-051dd3e1e115","HUMAN PRESCRIPTION DRUG","COLISTIMETHATE SODIUM","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20210909","","ANDA","ANDA202359","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","150","mg/4mL","","N","20261231"
"1456","AMIKACIN SULFATE","Amikacin Sulfate","23155029041","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","23155-290","23155-290-41","23155-290_fd208d78-8fad-46b3-bfed-d7dacd919f78","HUMAN PRESCRIPTION DRUG","Amikacin Sulfate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20131224","","ANDA","ANDA204040","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","250","mg/mL","","N","20251231"
"1457","AMIKACIN SULFATE","Amikacin Sulfate","23155029042","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","23155-290","23155-290-42","23155-290_fd208d78-8fad-46b3-bfed-d7dacd919f78","HUMAN PRESCRIPTION DRUG","Amikacin Sulfate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20131224","","ANDA","ANDA204040","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","250","mg/mL","","N","20251231"
"1458","AMPHOTERICIN B","Amphotericin B","23155059431","Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]","23155-594","23155-594-31","23155-594_9de2927d-27ac-4890-ad71-a737dd4d3881","HUMAN PRESCRIPTION DRUG","Amphotericin B","","INJECTABLE, LIPOSOMAL","INTRAVENOUS","20250620","","ANDA","ANDA215354","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","50","mg/1","","N","20261231"
"1459","CLINDAMYCIN PALMITATE HYDROCHLORIDE","clindamycin palmitate hydrochloride","23155060351","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","23155-603","23155-603-51","23155-603_6b2e0bbb-397e-49b2-aaea-3ec3896b8beb","HUMAN PRESCRIPTION DRUG","clindamycin palmitate hydrochloride","","GRANULE, FOR SOLUTION","ORAL","20180511","","ANDA","ANDA207047","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","75","mg/5mL","","N","20251231"
"1460","METRONIDAZOLE","METRONIDAZOLE","23155065101","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","23155-651","23155-651-01","23155-651_a144e3b5-1edf-446a-99cd-51f4f8ce8dc5","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20171129","","ANDA","ANDA205245","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"1461","METRONIDAZOLE","METRONIDAZOLE","23155065105","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","23155-651","23155-651-05","23155-651_a144e3b5-1edf-446a-99cd-51f4f8ce8dc5","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20171129","","ANDA","ANDA205245","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"1462","METRONIDAZOLE","METRONIDAZOLE","23155065205","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","23155-652","23155-652-05","23155-652_a144e3b5-1edf-446a-99cd-51f4f8ce8dc5","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20171129","","ANDA","ANDA205245","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"1463","METRONIDAZOLE","METRONIDAZOLE","23155065201","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","23155-652","23155-652-01","23155-652_a144e3b5-1edf-446a-99cd-51f4f8ce8dc5","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20171129","","ANDA","ANDA205245","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"1464","PENTAMIDINE ISETHIONATE","pentamidine isethionate","23155074841","Antiprotozoal [EPC]","23155-748","23155-748-41","23155-748_d0251a47-daa6-431d-9f61-5eafa55d2f85","HUMAN PRESCRIPTION DRUG","pentamidine isethionate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20210108","","ANDA","ANDA213806","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","300","mg/300mg","","N","20251231"
"1465","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","23155076601","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","23155-766","23155-766-01","23155-766_668956fd-53e9-478d-bdff-e93d305c671d","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20200401","","ANDA","ANDA062752","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"1466","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","23155076701","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","23155-767","23155-767-01","23155-767_668956fd-53e9-478d-bdff-e93d305c671d","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20200401","","ANDA","ANDA062752","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"1467","AMIKACIN SULFATE","Amikacin Sulfate","23155078541","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","23155-785","23155-785-41","23155-785_7f946330-e4c6-4643-903d-3695d08df7d6","HUMAN PRESCRIPTION DRUG","Amikacin Sulfate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20201215","","ANDA","ANDA204040","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","500","mg/2mL","","N","20261231"
"1468","AMIKACIN SULFATE","Amikacin Sulfate","23155078641","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","23155-786","23155-786-41","23155-786_7f946330-e4c6-4643-903d-3695d08df7d6","HUMAN PRESCRIPTION DRUG","Amikacin Sulfate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20201215","","ANDA","ANDA204040","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","1","g/4mL","","N","20261231"
"1469","CHLOROQUINE PHOSPHATE","Chloroquine Phosphate","23155085074","Antimalarial [EPC]","23155-850","23155-850-74","23155-850_29ca50e9-6245-3d4a-e063-6394a90ad4b3","HUMAN PRESCRIPTION DRUG","Chloroquine Phosphate","","TABLET, COATED","ORAL","20230320","","ANDA","ANDA214756","Avet Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"1470","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","23155085825","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","23155-858","23155-858-25","23155-858_cc52fc26-1efc-4bb8-af96-6a91f9e7342b","HUMAN PRESCRIPTION DRUG","vancomycin hydrochloride","","CAPSULE","ORAL","20230625","","ANDA","ANDA065490","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","125","mg/1","","N","20261231"
"1471","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","23155085878","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","23155-858","23155-858-78","23155-858_cc52fc26-1efc-4bb8-af96-6a91f9e7342b","HUMAN PRESCRIPTION DRUG","vancomycin hydrochloride","","CAPSULE","ORAL","20230625","","ANDA","ANDA065490","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","125","mg/1","","N","20261231"
"1472","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","23155085925","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","23155-859","23155-859-25","23155-859_cc52fc26-1efc-4bb8-af96-6a91f9e7342b","HUMAN PRESCRIPTION DRUG","vancomycin hydrochloride","","CAPSULE","ORAL","20230625","","ANDA","ANDA065490","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","250","mg/1","","N","20261231"
"1473","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","23155085978","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","23155-859","23155-859-78","23155-859_cc52fc26-1efc-4bb8-af96-6a91f9e7342b","HUMAN PRESCRIPTION DRUG","vancomycin hydrochloride","","CAPSULE","ORAL","20230625","","ANDA","ANDA065490","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","250","mg/1","","N","20261231"
"1474","FLUCYTOSINE","Flucytosine","23155086001","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","23155-860","23155-860-01","23155-860_501b9f97-074d-4a0b-87f5-54fd1ae5cb46","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20230625","","ANDA","ANDA212632","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"1475","FLUCYTOSINE","Flucytosine","23155086003","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","23155-860","23155-860-03","23155-860_501b9f97-074d-4a0b-87f5-54fd1ae5cb46","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20230625","","ANDA","ANDA212632","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"1476","FLUCYTOSINE","Flucytosine","23155086101","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","23155-861","23155-861-01","23155-861_501b9f97-074d-4a0b-87f5-54fd1ae5cb46","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20230625","","ANDA","ANDA212632","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"1477","FLUCYTOSINE","Flucytosine","23155086103","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","23155-861","23155-861-03","23155-861_501b9f97-074d-4a0b-87f5-54fd1ae5cb46","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20230625","","ANDA","ANDA212632","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"1478","NAFCILLIN SODIUM","Nafcillin Sodium","23155090641","Penicillin-class Antibacterial [EPC], Penicillins [CS]","23155-906","23155-906-41","23155-906_45e4c5b2-2a6c-481a-92c6-9ab894df195c","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20250131","","ANDA","ANDA090560","Heritage Pharmaceuticals Inc. d/b/a/ Avet Pharmaceuticals Inc.","1","g/4mL","","N","20261231"
"1479","NAFCILLIN SODIUM","Nafcillin Sodium","23155090741","Penicillin-class Antibacterial [EPC], Penicillins [CS]","23155-907","23155-907-41","23155-907_45e4c5b2-2a6c-481a-92c6-9ab894df195c","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20250131","","ANDA","ANDA090560","Heritage Pharmaceuticals Inc. d/b/a/ Avet Pharmaceuticals Inc.","2","g/8mL","","N","20261231"
"1480","AMPICILLIN SODIUM","Ampicillin Injection","23155091441","Penicillin-class Antibacterial [EPC], Penicillins [CS]","23155-914","23155-914-41","23155-914_bbf4b7d8-bc21-472b-b101-5e9e09618add","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20250131","","ANDA","ANDA090354","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","250","mg/250mg","","N","20251231"
"1481","AMPICILLIN SODIUM","Ampicillin Injection","23155091541","Penicillin-class Antibacterial [EPC], Penicillins [CS]","23155-915","23155-915-41","23155-915_bbf4b7d8-bc21-472b-b101-5e9e09618add","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20250131","","ANDA","ANDA090354","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","500","mg/500mg","","N","20251231"
"1482","AMPICILLIN SODIUM","Ampicillin Injection","23155091641","Penicillin-class Antibacterial [EPC], Penicillins [CS]","23155-916","23155-916-41","23155-916_bbf4b7d8-bc21-472b-b101-5e9e09618add","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20250131","","ANDA","ANDA090354","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","1","g/g","","N","20251231"
"1483","AMPICILLIN SODIUM","Ampicillin Injection","23155091741","Penicillin-class Antibacterial [EPC], Penicillins [CS]","23155-917","23155-917-41","23155-917_bbf4b7d8-bc21-472b-b101-5e9e09618add","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20250131","","ANDA","ANDA090354","Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.","2","g/2g","","N","20251231"
"1484","MICONAZOLE NITRATE","MICONAZOLE NITRATE","23667080401","Azole Antifungal [EPC], Azoles [CS]","23667-804","23667-804-01","23667-804_0b82700a-5ae4-0af6-e063-6394a90a2404","HUMAN OTC DRUG","Good Neighbor Pharmacy Athletes foot Relief Antifungal","","SPRAY","TOPICAL","20170120","","OTC MONOGRAPH DRUG","M005","Formulated Solutions, LLC","20","mg/g","","N","20251231"
"1485","MICONAZOLE NITRATE","MICONAZOLE NITRATE","23667080801","Azole Antifungal [EPC], Azoles [CS]","23667-808","23667-808-01","23667-808_0b587906-d569-e5b7-e063-6294a90a2fc0","HUMAN OTC DRUG","Meijer Jock Itch Relief Antifungal","","SPRAY","TOPICAL","20170120","","OTC MONOGRAPH DRUG","M005","Formulated Solutions, LLC","20","mg/g","","N","20251231"
"1486","MICONAZOLE NITRATE","MICONAZOLE NITRATE","23667081201","Azole Antifungal [EPC], Azoles [CS]","23667-812","23667-812-01","23667-812_0b587f61-d488-f827-e063-6294a90aff19","HUMAN OTC DRUG","Signature Care Athletes Foot","","SPRAY","TOPICAL","20170120","","OTC MONOGRAPH DRUG","M005","Formulated Solutions, LLC","20","mg/g","","N","20251231"
"1487","MICONAZOLE NITRATE","MICONAZOLE NITRATE","23667081701","Azole Antifungal [EPC], Azoles [CS]","23667-817","23667-817-01","23667-817_0b827897-fb61-0f73-e063-6394a90ac59f","HUMAN OTC DRUG","Walgreens Medicated Antifungal Athletes Foot","","SPRAY","TOPICAL","20170123","","OTC MONOGRAPH DRUG","M005","Formulated Solutions, LLC","20","mg/g","","N","20251231"
"1488","MICONAZOLE NITRATE","MICONAZOLE NITRATE","23667081901","Azole Antifungal [EPC], Azoles [CS]","23667-819","23667-819-01","23667-819_0c02e9b6-ff74-c0c7-e063-6294a90adbe3","HUMAN OTC DRUG","Good Neighbor Pharmacy Jock Itch Relief Antifungal","","SPRAY","TOPICAL","20170209","","OTC MONOGRAPH DRUG","M005","Formulated Solutions, LLC","20","mg/g","","N","20251231"
"1489","TOBRAMYCIN","Tobramycin","24208029005","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","24208-290","24208-290-05","24208-290_cab6fed8-0707-482a-9894-33b9846127bb","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","OPHTHALMIC","19931129","","ANDA","ANDA064052","Bausch & Lomb Incorporated","3","mg/mL","","N","20251231"
"1490","DEXAMETHASONE; TOBRAMYCIN","Tobramycin and Dexamethasone","24208029510","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","24208-295","24208-295-10","24208-295_8ef3520d-ac67-4e2d-b0a6-f876e4d1d89f","HUMAN PRESCRIPTION DRUG","Tobramycin and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","19991027","","ANDA","ANDA064134","Bausch & Lomb Incorporated","1; 3","mg/mL; mg/mL","","N","20251231"
"1491","DEXAMETHASONE; TOBRAMYCIN","Tobramycin and Dexamethasone","24208029525","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","24208-295","24208-295-25","24208-295_8ef3520d-ac67-4e2d-b0a6-f876e4d1d89f","HUMAN PRESCRIPTION DRUG","Tobramycin and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","19991027","","ANDA","ANDA064134","Bausch & Lomb Incorporated","1; 3","mg/mL; mg/mL","","N","20251231"
"1492","DEXAMETHASONE; TOBRAMYCIN","Tobramycin and Dexamethasone","24208029505","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","24208-295","24208-295-05","24208-295_8ef3520d-ac67-4e2d-b0a6-f876e4d1d89f","HUMAN PRESCRIPTION DRUG","Tobramycin and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","19991027","","ANDA","ANDA064134","Bausch & Lomb Incorporated","1; 3","mg/mL; mg/mL","","N","20251231"
"1493","POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","Polymyxin B Sulfate and Trimethoprim Sulfate","24208031510","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","24208-315","24208-315-10","24208-315_e9d48b80-02f5-4f7f-83b6-1c9406d30ddb","HUMAN PRESCRIPTION DRUG","Polymyxin B Sulfate and Trimethoprim","","SOLUTION/ DROPS","OPHTHALMIC","19970214","","ANDA","ANDA064120","Bausch & Lomb Incorporated","10000; 1","[USP'U]/mL; mg/mL","","N","20251231"
"1494","PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM","Sulfacetamide Sodium and Prednisolone Sodium Phosphate","24208031710","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","24208-317","24208-317-10","24208-317_06ea3d35-67bf-d0b8-e063-6294a90a5b0c","HUMAN PRESCRIPTION DRUG","Sulfacetamide Sodium and Prednisolone Sodium Phosphate","","SOLUTION/ DROPS","OPHTHALMIC","19951229","","ANDA","ANDA074449","Bausch & Lomb Incoporated","2.3; 100","mg/mL; mg/mL","","N","20251231"
"1495","PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM","Sulfacetamide Sodium and Prednisolone Sodium Phosphate","24208031705","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","24208-317","24208-317-05","24208-317_06ea3d35-67bf-d0b8-e063-6294a90a5b0c","HUMAN PRESCRIPTION DRUG","Sulfacetamide Sodium and Prednisolone Sodium Phosphate","","SOLUTION/ DROPS","OPHTHALMIC","19951229","","ANDA","ANDA074449","Bausch & Lomb Incoporated","2.3; 100","mg/mL; mg/mL","","N","20251231"
"1496","LOTEPREDNOL ETABONATE; TOBRAMYCIN","loteprednol etabonate and tobramycin","24208035801","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","24208-358","24208-358-01","24208-358_4e532599-a607-4047-a600-d3e32fd515a4","HUMAN PRESCRIPTION DRUG","Zylet","","SUSPENSION/ DROPS","OPHTHALMIC","20041214","","NDA","NDA050804","Bausch & Lomb Incorporated","5; 3","mg/mL; mg/mL","","N","20251231"
"1497","LOTEPREDNOL ETABONATE; TOBRAMYCIN","loteprednol etabonate and tobramycin","24208035810","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","24208-358","24208-358-10","24208-358_4e532599-a607-4047-a600-d3e32fd515a4","HUMAN PRESCRIPTION DRUG","Zylet","","SUSPENSION/ DROPS","OPHTHALMIC","20041214","","NDA","NDA050804","Bausch & Lomb Incorporated","5; 3","mg/mL; mg/mL","","N","20251231"
"1498","LOTEPREDNOL ETABONATE; TOBRAMYCIN","loteprednol etabonate and tobramycin","24208035805","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","24208-358","24208-358-05","24208-358_4e532599-a607-4047-a600-d3e32fd515a4","HUMAN PRESCRIPTION DRUG","Zylet","","SUSPENSION/ DROPS","OPHTHALMIC","20041214","","NDA","NDA050804","Bausch & Lomb Incorporated","5; 3","mg/mL; mg/mL","","N","20251231"
"1499","OFLOXACIN","Ofloxacin","24208041010","Quinolone Antimicrobial [EPC], Quinolones [CS]","24208-410","24208-410-10","24208-410_3f88eb9b-9978-4379-b034-92c45b6c259c","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","AURICULAR (OTIC)","20080317","","ANDA","ANDA076128","Bausch & Lomb Incorporated","3","mg/mL","","N","20251231"
"1500","OFLOXACIN","Ofloxacin","24208041005","Quinolone Antimicrobial [EPC], Quinolones [CS]","24208-410","24208-410-05","24208-410_3f88eb9b-9978-4379-b034-92c45b6c259c","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","AURICULAR (OTIC)","20080317","","ANDA","ANDA076128","Bausch & Lomb Incorporated","3","mg/mL","","N","20251231"
"1501","OFLOXACIN","Ofloxacin","24208043410","Quinolone Antimicrobial [EPC], Quinolones [CS]","24208-434","24208-434-10","24208-434_37639b58-1d0f-206e-e063-6294a90a293a","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20040514","","ANDA","ANDA076622","Bausch & Lomb Incorporated","3","mg/mL","","N","20261231"
"1502","OFLOXACIN","Ofloxacin","24208043405","Quinolone Antimicrobial [EPC], Quinolones [CS]","24208-434","24208-434-05","24208-434_37639b58-1d0f-206e-e063-6294a90a293a","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20040514","","ANDA","ANDA076622","Bausch & Lomb Incorporated","3","mg/mL","","N","20261231"
"1503","BESIFLOXACIN","Besifloxacin","24208044605","Quinolone Antimicrobial [EPC], Quinolones [CS]","24208-446","24208-446-05","24208-446_1c4756f2-d92f-af5d-e063-6294a90a9a49","HUMAN PRESCRIPTION DRUG","Besivance","","SUSPENSION","OPHTHALMIC","20090528","","NDA","NDA022308","Bausch & Lomb Incorporated","6","mg/mL","","N","20251231"
"1504","BESIFLOXACIN","Besifloxacin","24208044602","Quinolone Antimicrobial [EPC], Quinolones [CS]","24208-446","24208-446-02","24208-446_1c4756f2-d92f-af5d-e063-6294a90a9a49","HUMAN PRESCRIPTION DRUG","Besivance","","SUSPENSION","OPHTHALMIC","20090528","","NDA","NDA022308","Bausch & Lomb Incorporated","6","mg/mL","","N","20251231"
"1505","GANCICLOVIR","ganciclovir","24208053515","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","24208-535","24208-535-15","24208-535_125fcc15-69c3-3cd0-e063-6394a90a598d","HUMAN PRESCRIPTION DRUG","ZIRGAN","","GEL","OPHTHALMIC","20100430","","NDA","NDA022211","Bausch & Lomb Incorporated","1.5","mg/g","","N","20251231"
"1506","GANCICLOVIR","ganciclovir","24208053535","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","24208-535","24208-535-35","24208-535_125fcc15-69c3-3cd0-e063-6394a90a598d","HUMAN PRESCRIPTION DRUG","ZIRGAN","","GEL","OPHTHALMIC","20100430","","NDA","NDA022211","Bausch & Lomb Incorporated","1.5","mg/g","","N","20251231"
"1507","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc and Polymyxin B Sulfate","24208055555","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","24208-555","24208-555-55","24208-555_24c33b97-e464-feca-e063-6394a90ad7d9","HUMAN PRESCRIPTION DRUG","Bacitracin Zinc and Polymyxin B Sulfate","","OINTMENT","OPHTHALMIC","20080425","","ANDA","ANDA064046","Bausch & Lomb Incorporated","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"1508","GENTAMICIN SULFATE","Gentamicin Sulfate","24208058060","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","24208-580","24208-580-60","24208-580_1dd9fcc1-daec-fa67-e063-6394a90a0139","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","SOLUTION/ DROPS","OPHTHALMIC","19940511","","ANDA","ANDA064048","Bausch & Lomb Incorporated","3","mg/mL","","N","20251231"
"1509","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone","24208063110","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","24208-631","24208-631-10","24208-631_c4177a4a-3251-451f-92fb-5d2e2ad1a670","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SOLUTION/ DROPS","AURICULAR (OTIC)","19951229","","ANDA","ANDA064053","Bausch & Lomb Incoporated","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"1510","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone","24208063562","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","24208-635","24208-635-62","24208-635_33ffdbeb-b85a-25c9-e063-6394a90a05a3","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","19960828","","ANDA","ANDA064065","Bausch & Lomb Incorporated","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20261231"
"1511","SULFACETAMIDE SODIUM","sulfacetamide sodium","24208067004","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","24208-670","24208-670-04","24208-670_39869c1b-2b30-482e-b88e-9177cd85ea16","HUMAN PRESCRIPTION DRUG","Sulfacetamide Sodium","","SOLUTION/ DROPS","OPHTHALMIC","19941228","","ANDA","ANDA040066","Bausch & Lomb Incorporated","100","mg/mL","","N","20251231"
"1512","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc","24208078055","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","24208-780","24208-780-55","24208-780_2abff6dd-ac86-e766-e063-6394a90a9d70","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Bacitracin Zinc","","OINTMENT","OPHTHALMIC","19951030","","ANDA","ANDA064064","Bausch & Lomb Incorporated","400; 3.5; 10000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"1513","BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone","24208078555","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","24208-785","24208-785-55","24208-785_2abffd38-83ff-fdd5-e063-6394a90a2c20","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone","","OINTMENT","OPHTHALMIC","19951030","","ANDA","ANDA064068","Bausch & Lomb Incorporated","400; 10; 3.5; 10000","[USP'U]/g; mg/g; mg/g; [USP'U]/g","","N","20261231"
"1514","GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and gramicidin","24208079062","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","24208-790","24208-790-62","24208-790_2268fd40-b8c0-ed1f-e063-6394a90a8001","HUMAN PRESCRIPTION DRUG","NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN","","SOLUTION/ DROPS","OPHTHALMIC","19960131","","ANDA","ANDA064047","Bausch & Lomb Incorporated",".025; 1.75; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"1515","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone","24208079535","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","24208-795","24208-795-35","24208-795_ec763c42-6065-4d6b-8eb8-7b12c844dac1","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Dexamethasone","","OINTMENT","OPHTHALMIC","19940725","","ANDA","ANDA064063","Bausch & Lomb Incorporated","1; 3.5; 10000","mg/g; mg/g; [USP'U]/g","","N","20251231"
"1516","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone","24208083060","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","24208-830","24208-830-60","24208-830_22348d2e-ed9a-bb62-e063-6394a90aa6df","HUMAN PRESCRIPTION DRUG","Neomycin Polymyxin B Sulfates and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","19950913","","ANDA","ANDA064135","Bausch & Lomb Incorporated","1; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"1517","ERYTHROMYCIN","Erythromycin","24208091055","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24208-910","24208-910-55","24208-910_335e5849-55dc-9d27-e063-6394a90a08a0","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","19940729","","ANDA","ANDA064067","Bausch & Lomb Incorporated","5","mg/g","","N","20261231"
"1518","ERYTHROMYCIN","Erythromycin","24208091019","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24208-910","24208-910-19","24208-910_335e5849-55dc-9d27-e063-6394a90a08a0","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","19940729","","ANDA","ANDA064067","Bausch & Lomb Incorporated","5","mg/g","","N","20261231"
"1519","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","24338010003","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-100","24338-100-03","24338-100_0ca69356-c906-e9a9-e063-6394a90a9395","HUMAN PRESCRIPTION DRUG","E.E.S","400","TABLET","ORAL","20110503","","ANDA","ANDA061905","Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)","400","mg/1","","N","20251231"
"1520","ERYTHROMYCIN","Erythromycin","24338010203","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-102","24338-102-03","24338-102_1afb465a-744a-48a9-a74b-9dad81fee83c","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20110906","","ANDA","ANDA061621","Arbor Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"1521","ERYTHROMYCIN","Erythromycin","24338010213","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-102","24338-102-13","24338-102_1afb465a-744a-48a9-a74b-9dad81fee83c","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20110906","","ANDA","ANDA061621","Arbor Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"1522","ERYTHROMYCIN","Erythromycin","24338010413","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-104","24338-104-13","24338-104_1afb465a-744a-48a9-a74b-9dad81fee83c","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20110906","","ANDA","ANDA061621","Arbor Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"1523","ERYTHROMYCIN","Erythromycin","24338010403","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-104","24338-104-03","24338-104_1afb465a-744a-48a9-a74b-9dad81fee83c","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20110906","","ANDA","ANDA061621","Arbor Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"1524","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","24338011003","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-110","24338-110-03","24338-110_0ca6d238-d01f-04ea-e063-6394a90a7b84","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN ETHYLSUCCINATE","","TABLET","ORAL","20111003","","ANDA","ANDA061904","Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)","400","mg/1","","N","20251231"
"1525","ERYTHROMYCIN","Erythromycin","24338012013","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-120","24338-120-13","24338-120_6f949818-8773-4dfd-96bd-a0d67ffc92c0","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","CAPSULE, DELAYED RELEASE","ORAL","20120110","","ANDA","ANDA062746","Arbor Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"1526","ERYTHROMYCIN","Erythromycin","24338012203","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-122","24338-122-03","24338-122_f7f33758-f601-4397-baa4-30286a9a3a39","HUMAN PRESCRIPTION DRUG","ERY-TAB","","TABLET, DELAYED RELEASE","ORAL","20110418","","ANDA","ANDA062298","Arbor Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"1527","ERYTHROMYCIN","Erythromycin","24338012213","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-122","24338-122-13","24338-122_f7f33758-f601-4397-baa4-30286a9a3a39","HUMAN PRESCRIPTION DRUG","ERY-TAB","","TABLET, DELAYED RELEASE","ORAL","20110418","","ANDA","ANDA062298","Arbor Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"1528","ERYTHROMYCIN","Erythromycin","24338012413","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-124","24338-124-13","24338-124_f7f33758-f601-4397-baa4-30286a9a3a39","HUMAN PRESCRIPTION DRUG","ERY-TAB","","TABLET, DELAYED RELEASE","ORAL","20110418","","ANDA","ANDA062298","Arbor Pharmaceuticals, Inc.","333","mg/1","","N","20251231"
"1529","ERYTHROMYCIN","Erythromycin","24338012403","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-124","24338-124-03","24338-124_f7f33758-f601-4397-baa4-30286a9a3a39","HUMAN PRESCRIPTION DRUG","ERY-TAB","","TABLET, DELAYED RELEASE","ORAL","20110418","","ANDA","ANDA062298","Arbor Pharmaceuticals, Inc.","333","mg/1","","N","20251231"
"1530","ERYTHROMYCIN","Erythromycin","24338012603","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-126","24338-126-03","24338-126_f7f33758-f601-4397-baa4-30286a9a3a39","HUMAN PRESCRIPTION DRUG","ERY-TAB","","TABLET, DELAYED RELEASE","ORAL","20110418","","ANDA","ANDA062298","Arbor Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"1531","ERYTHROMYCIN","Erythromycin","24338012613","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-126","24338-126-13","24338-126_f7f33758-f601-4397-baa4-30286a9a3a39","HUMAN PRESCRIPTION DRUG","ERY-TAB","","TABLET, DELAYED RELEASE","ORAL","20110418","","ANDA","ANDA062298","Arbor Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"1532","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","24338013013","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-130","24338-130-13","24338-130_0ca6c02b-5b9f-39c3-e063-6294a90a4c18","HUMAN PRESCRIPTION DRUG","Ery-Ped","","SUSPENSION","ORAL","20120614","","NDA","NDA050207","Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)","400","mg/5mL","","N","20251231"
"1533","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","24338013213","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-132","24338-132-13","24338-132_0ca6c02b-5b9f-39c3-e063-6294a90a4c18","HUMAN PRESCRIPTION DRUG","Ery-Ped","","SUSPENSION","ORAL","20110705","","NDA","NDA050207","Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)","200","mg/5mL","","N","20251231"
"1534","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","24338013402","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-134","24338-134-02","24338-134_0ca69356-c906-e9a9-e063-6394a90a9395","HUMAN PRESCRIPTION DRUG","E.E.S","","GRANULE, FOR SUSPENSION","ORAL","20110418","","NDA","NDA050207","Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)","200","mg/5mL","","N","20251231"
"1535","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","24338013610","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","24338-136","24338-136-10","24338-136_0ca69356-c906-e9a9-e063-6394a90a9395","HUMAN PRESCRIPTION DRUG","E.E.S","","GRANULE, FOR SUSPENSION","ORAL","20110418","","NDA","NDA050207","Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)","200","mg/5mL","","N","20251231"
"1536","CLOTRIMAZOLE","Clotrimazole","24385011009","Azole Antifungal [EPC], Azoles [CS]","24385-110","24385-110-09","24385-110_08fe560f-f7ac-484c-960e-ee0057bc202d","HUMAN OTC DRUG","Good Neighbor Pharmacy","Clotrimazole 3","CREAM","VAGINAL","20000412","","NDA","NDA021143","AmerisourceBergen","2","g/100g","","N","20251231"
"1537","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride","24385014303","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","24385-143","24385-143-03","24385-143_262f9424-b685-90d5-e063-6294a90a9ffc","HUMAN OTC DRUG","Good Neighbor Pharmacy","Triple Antibiotic Plus Pain Relief","OINTMENT","TOPICAL","20120331","","OTC MONOGRAPH DRUG","M004","Amerisource Bergen","500; 3.5; 10000; 10","[iU]/g; mg/g; [iU]/g; mg/g","","N","20251231"
"1538","CLOTRIMAZOLE","Clotrimazole","24385020501","Azole Antifungal [EPC], Azoles [CS]","24385-205","24385-205-01","24385-205_26ba1bce-4eb7-53e2-e063-6394a90a4347","HUMAN OTC DRUG","Good Neighbor Pharmacy","Clotrimazole","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","AmerisourceBergen","10","mg/g","","N","20251231"
"1539","CLOTRIMAZOLE","Clotrimazole","24385020503","Azole Antifungal [EPC], Azoles [CS]","24385-205","24385-205-03","24385-205_26ba1bce-4eb7-53e2-e063-6394a90a4347","HUMAN OTC DRUG","Good Neighbor Pharmacy","Clotrimazole","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","AmerisourceBergen","10","mg/g","","N","20251231"
"1540","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","24385052405","Allylamine Antifungal [EPC], Allylamine [CS]","24385-524","24385-524-05","24385-524_ff2032fb-2379-49db-918e-b98609fe88af","HUMAN OTC DRUG","Good Neighbor Pharmacy","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","AmerisourceBergen","1","g/100g","","N","20251231"
"1541","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","24385052403","Allylamine Antifungal [EPC], Allylamine [CS]","24385-524","24385-524-03","24385-524_ff2032fb-2379-49db-918e-b98609fe88af","HUMAN OTC DRUG","Good Neighbor Pharmacy","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","AmerisourceBergen","1","g/100g","","N","20251231"
"1542","MICONAZOLE NITRATE","Miconazole nitrate","24385059029","Azole Antifungal [EPC], Azoles [CS]","24385-590","24385-590-29","24385-590_3cecbdc8-ab68-4f0a-a0d0-30a3609be3ad","HUMAN OTC DRUG","Good Neighbor Pharmacy Miconazole 7","","CREAM","VAGINAL","19991011","","ANDA","ANDA074760","Amerisource Bergen","2","g/100g","","N","20251231"
"1543","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","24470092508","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","24470-925","24470-925-08","24470-925_0d1efaac-d62c-41b9-e063-6394a90a94ad","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM, SULFUR","","EMULSION","TOPICAL","20240123","","UNAPPROVED DRUG OTHER","","Cintex Services, LLC","100; 50","mg/g; mg/g","","N","20251231"
"1544","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","24470093201","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","24470-932","24470-932-01","24470-932_0d1f8666-9600-7844-e063-6394a90af412","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM, SULFUR","","LOTION","TOPICAL","20240123","","UNAPPROVED DRUG OTHER","","Cintex Services, LLC","100; 50","mg/g; mg/g","","N","20251231"
"1545","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","24470093301","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","24470-933","24470-933-01","24470-933_0e128306-1358-daad-e063-6294a90a760a","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM, SULFUR","","SUSPENSION","TOPICAL","20240123","","UNAPPROVED DRUG OTHER","","Cintex Services, LLC","100; 50","mg/g; mg/g","","N","20251231"
"1546","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","24470093401","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","24470-934","24470-934-01","24470-934_0fa2c52d-5d4b-4b83-e063-6394a90a5406","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM, SULFUR","","LOTION","TOPICAL","20240123","","UNAPPROVED DRUG OTHER","","Cintex Services, LLC","100; 50","mg/g; mg/g","","N","20251231"
"1547","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","24470093402","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","24470-934","24470-934-02","24470-934_0fa2c52d-5d4b-4b83-e063-6394a90a5406","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM, SULFUR","","LOTION","TOPICAL","20240123","","UNAPPROVED DRUG OTHER","","Cintex Services, LLC","100; 50","mg/g; mg/g","","N","20251231"
"1548","SULFACETAMIDE SODIUM","SULFACETAMIDE SODIUM","24470093512","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","24470-935","24470-935-12","24470-935_0fa3302e-b2b5-6b9b-e063-6394a90abc2c","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM","","GEL","TOPICAL","20240123","","UNAPPROVED DRUG OTHER","","Cintex Services, LLC","100","mg/mL","","N","20251231"
"1549","SULFACETAMIDE SODIUM","SULFACETAMIDE SODIUM","24470093608","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","24470-936","24470-936-08","24470-936_0fa3a441-2d19-977a-e063-6394a90aed99","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM","","SHAMPOO","TOPICAL","20240123","","UNAPPROVED DRUG OTHER","","Cintex Services, LLC","100","mg/mL","","N","20251231"
"1550","SULFACETAMIDE SODIUM","SULFACETAMIDE SODIUM","24470093706","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","24470-937","24470-937-06","24470-937_2150063f-b266-d6ff-e063-6394a90a4eaa","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM","","LIQUID","TOPICAL","20240904","","UNAPPROVED DRUG OTHER","","Cintex Services, LLC","100","mg/mL","","N","20251231"
"1551","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","24470094402","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","24470-944","24470-944-02","24470-944_2f11179d-944f-3161-e063-6394a90a24f2","HUMAN PRESCRIPTION DRUG","Plexion","","LOTION","TOPICAL","20250226","","UNAPPROVED DRUG OTHER","","Cintex Services, LLC","98; 48","mg/g; mg/g","","N","20261231"
"1552","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","24470095602","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","24470-956","24470-956-02","24470-956_2f116ee1-e79e-5581-e063-6394a90ac09f","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM, SULFUR","","CREAM","TOPICAL","20250226","","UNAPPROVED DRUG OTHER","","Cintex Services, LLC","98; 48","mg/g; mg/g","","N","20261231"
"1553","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","24470095702","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","24470-957","24470-957-02","24470-957_2f119797-3be7-6383-e063-6394a90acb11","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM, SULFUR","","LOTION","TOPICAL","20250226","","UNAPPROVED DRUG OTHER","","Cintex Services, LLC","98; 48","mg/g; mg/g","","N","20261231"
"1554","TOBRAMYCIN","Tobramycin","24492085056","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","24492-850","24492-850-56","24492-850_49aa9935-4371-43a5-a681-f7a5725b1b2b","HUMAN PRESCRIPTION DRUG","Kitabis Pak","","SOLUTION","RESPIRATORY (INHALATION)","20150219","","NDA","NDA205433","Pari Respiratory Equipment, Inc.","300","mg/5mL","","N","20251231"
"1555","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN","24658070632","Macrolide Antimicrobial [EPC], Macrolides [CS]","24658-706","24658-706-32","24658-706_63e01689-305e-47f2-b74b-0edeb0069b09","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","POWDER, FOR SUSPENSION","ORAL","20200430","","ANDA","ANDA207531","PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS","200","mg/5mL","","N","20251231"
"1556","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN","24658070834","Macrolide Antimicrobial [EPC], Macrolides [CS]","24658-708","24658-708-34","24658-708_63e01689-305e-47f2-b74b-0edeb0069b09","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","POWDER, FOR SUSPENSION","ORAL","20200430","","ANDA","ANDA207531","PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS","200","mg/5mL","","N","20251231"
"1557","DEMECLOCYCLINE HYDROCHLORIDE","Demeclocycline Hydrochloride","24658071001","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","24658-710","24658-710-01","24658-710_4dd1c0e1-24b8-43e7-8025-c4927d17f814","HUMAN PRESCRIPTION DRUG","Demeclocycline Hydrochloride","","TABLET, FILM COATED","ORAL","20171007","","ANDA","ANDA065447","PuraCap Laboratories LLC","150","mg/1","","N","20251231"
"1558","DEMECLOCYCLINE HYDROCHLORIDE","Demeclocycline Hydrochloride","24658071148","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","24658-711","24658-711-48","24658-711_4dd1c0e1-24b8-43e7-8025-c4927d17f814","HUMAN PRESCRIPTION DRUG","Demeclocycline Hydrochloride","","TABLET, FILM COATED","ORAL","20171007","","ANDA","ANDA065447","PuraCap Laboratories LLC","300","mg/1","","N","20251231"
"1559","RIFAMPIN","rifampin","24658080130","Rifamycin Antibacterial [EPC], Rifamycins [CS]","24658-801","24658-801-30","24658-801_1e50fbd4-91eb-4d25-a90d-1907c3a0ec02","HUMAN PRESCRIPTION DRUG","RIFAMPIN","","CAPSULE","ORAL","20230314","","ANDA","ANDA064150","PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS","150","mg/1","","N","20261231"
"1560","RIFAMPIN","rifampin","24658080260","Rifamycin Antibacterial [EPC], Rifamycins [CS]","24658-802","24658-802-60","24658-802_1e50fbd4-91eb-4d25-a90d-1907c3a0ec02","HUMAN PRESCRIPTION DRUG","RIFAMPIN","","CAPSULE","ORAL","20230314","","ANDA","ANDA064150","PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS","300","mg/1","","N","20261231"
"1561","CLOTRIMAZOLE","Clotrimazole","24909002650","Azole Antifungal [EPC], Azoles [CS]","24909-026","24909-026-50","24909-026_193dda5f-a48b-1939-e063-6294a90a2874","HUMAN OTC DRUG","TerrasilMed ANTIFUNGAL","","OINTMENT","TOPICAL","20230508","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20251231"
"1562","CLOTRIMAZOLE","CLOTRIMAZOLE","24909003775","Azole Antifungal [EPC], Azoles [CS]","24909-037","24909-037-75","24909-037_27ee1758-211f-4f02-e063-6394a90aa618","HUMAN OTC DRUG","terrasil Antifungal Cleansing Bar","","SOAP","TOPICAL","20231002","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20251231"
"1563","CLOTRIMAZOLE","Clotrimazole","24909006450","Azole Antifungal [EPC], Azoles [CS]","24909-064","24909-064-50","24909-064_35d54756-00de-bbe1-e063-6394a90a9e02","HUMAN OTC DRUG","terrasil Folliculitis Cream","Maximum Strength","CREAM","TOPICAL","20250602","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20261231"
"1564","CLOTRIMAZOLE","Clotrimazole","24909006485","Azole Antifungal [EPC], Azoles [CS]","24909-064","24909-064-85","24909-064_35d54756-00de-bbe1-e063-6394a90a9e02","HUMAN OTC DRUG","terrasil Folliculitis Cream","Maximum Strength","CREAM","TOPICAL","20250602","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20261231"
"1565","CLOTRIMAZOLE","Clotrimazole","24909010228","Azole Antifungal [EPC], Azoles [CS]","24909-102","24909-102-28","24909-102_2764150b-187c-5807-e063-6394a90aeb2e","HUMAN OTC DRUG","Terrasil Ringworm Treatment","MAX","OINTMENT","TOPICAL","20140512","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20251231"
"1566","CLOTRIMAZOLE","Clotrimazole","24909010250","Azole Antifungal [EPC], Azoles [CS]","24909-102","24909-102-50","24909-102_2764150b-187c-5807-e063-6394a90aeb2e","HUMAN OTC DRUG","Terrasil Ringworm Treatment","MAX","OINTMENT","TOPICAL","20140512","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20251231"
"1567","CLOTRIMAZOLE","Clotrimazole","24909010215","Azole Antifungal [EPC], Azoles [CS]","24909-102","24909-102-15","24909-102_2764150b-187c-5807-e063-6394a90aeb2e","HUMAN OTC DRUG","Terrasil Ringworm Treatment","MAX","OINTMENT","TOPICAL","20140512","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20251231"
"1568","CLOTRIMAZOLE","Clotrimazole","24909010415","Azole Antifungal [EPC], Azoles [CS]","24909-104","24909-104-15","24909-104_27641d80-1c20-5893-e063-6394a90aa0c3","HUMAN OTC DRUG","Terrasil Tinea Treatment","MAX","OINTMENT","TOPICAL","20140512","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20251231"
"1569","CLOTRIMAZOLE","Clotrimazole","24909010450","Azole Antifungal [EPC], Azoles [CS]","24909-104","24909-104-50","24909-104_27641d80-1c20-5893-e063-6394a90aa0c3","HUMAN OTC DRUG","Terrasil Tinea Treatment","MAX","OINTMENT","TOPICAL","20140512","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20251231"
"1570","CLOTRIMAZOLE","Clotrimazole","24909010428","Azole Antifungal [EPC], Azoles [CS]","24909-104","24909-104-28","24909-104_27641d80-1c20-5893-e063-6394a90aa0c3","HUMAN OTC DRUG","Terrasil Tinea Treatment","MAX","OINTMENT","TOPICAL","20140512","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20251231"
"1571","CLOTRIMAZOLE","Clotrimazole","24909010420","Azole Antifungal [EPC], Azoles [CS]","24909-104","24909-104-20","24909-104_27641d80-1c20-5893-e063-6394a90aa0c3","HUMAN OTC DRUG","Terrasil Tinea Treatment","MAX","OINTMENT","TOPICAL","20140512","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20251231"
"1572","CLOTRIMAZOLE","Clotrimazole","24909010615","Azole Antifungal [EPC], Azoles [CS]","24909-106","24909-106-15","24909-106_35d50caf-99a2-f041-e063-6294a90a1ab9","HUMAN OTC DRUG","Terrasil Anti-Fungal Treatment","MAX","OINTMENT","TOPICAL","20120907","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20261231"
"1573","CLOTRIMAZOLE","Clotrimazole","24909010620","Azole Antifungal [EPC], Azoles [CS]","24909-106","24909-106-20","24909-106_35d50caf-99a2-f041-e063-6294a90a1ab9","HUMAN OTC DRUG","Terrasil Anti-Fungal Treatment","MAX","OINTMENT","TOPICAL","20120907","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20261231"
"1574","CLOTRIMAZOLE","Clotrimazole","24909010650","Azole Antifungal [EPC], Azoles [CS]","24909-106","24909-106-50","24909-106_35d50caf-99a2-f041-e063-6294a90a1ab9","HUMAN OTC DRUG","Terrasil Anti-Fungal Treatment","MAX","OINTMENT","TOPICAL","20120907","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20261231"
"1575","CLOTRIMAZOLE","Clotrimazole","24909010621","Azole Antifungal [EPC], Azoles [CS]","24909-106","24909-106-21","24909-106_35d50caf-99a2-f041-e063-6294a90a1ab9","HUMAN OTC DRUG","Terrasil Anti-Fungal Treatment","MAX","OINTMENT","TOPICAL","20120907","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20261231"
"1576","CLOTRIMAZOLE","Clotrimazole","24909010628","Azole Antifungal [EPC], Azoles [CS]","24909-106","24909-106-28","24909-106_35d50caf-99a2-f041-e063-6294a90a1ab9","HUMAN OTC DRUG","Terrasil Anti-Fungal Treatment","MAX","OINTMENT","TOPICAL","20120907","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20261231"
"1577","MICONAZOLE NITRATE","Miconazole Nitrate","24909020229","Azole Antifungal [EPC], Azoles [CS]","24909-202","24909-202-29","24909-202_193a3ca0-833f-51df-e063-6394a90ac2d7","HUMAN OTC DRUG","Femmesil","Maximum Strength","OINTMENT","TOPICAL","20120907","","OTC MONOGRAPH DRUG","M005","Aidance Skincare & Topical Solutions, LLC","2","g/100g","","N","20251231"
"1578","CLOTRIMAZOLE","Clotrimazole","24909020350","Azole Antifungal [EPC], Azoles [CS]","24909-203","24909-203-50","24909-203_193aaeac-5c4f-3cdc-e063-6394a90a1f02","HUMAN OTC DRUG","Femmesil","","CREAM","TOPICAL","20141130","","OTC MONOGRAPH DRUG","M005","Aidance Skincare & Topical Solutions, LLC","1","g/100g","","N","20251231"
"1579","CLOTRIMAZOLE","Clotrimazole","24909020728","Azole Antifungal [EPC], Azoles [CS]","24909-207","24909-207-28","24909-207_2763d8c0-d3fa-de8d-e063-6394a90ad069","HUMAN OTC DRUG","Terrasil Athletes Foot AntiFungal Treatment Max","","OINTMENT","TOPICAL","20220105","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20251231"
"1580","CLOTRIMAZOLE","Clotrimazole","24909020725","Azole Antifungal [EPC], Azoles [CS]","24909-207","24909-207-25","24909-207_2763d8c0-d3fa-de8d-e063-6394a90ad069","HUMAN OTC DRUG","Terrasil Athletes Foot AntiFungal Treatment Max","","OINTMENT","TOPICAL","20220105","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20251231"
"1581","CLOTRIMAZOLE","Clotrimazole","24909020850","Azole Antifungal [EPC], Azoles [CS]","24909-208","24909-208-50","24909-208_193dfd9a-dfd6-d8dd-e063-6394a90aa2d8","HUMAN OTC DRUG","Terrasil Antifungal Cream Maximum Strength","","CREAM","TOPICAL","20220101","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20251231"
"1582","CLOTRIMAZOLE","Clotrimazole","24909021228","Azole Antifungal [EPC], Azoles [CS]","24909-212","24909-212-28","24909-212_27640b2e-5da2-1a57-e063-6394a90a516b","HUMAN OTC DRUG","Terrasil JockItch Treatment Maximum Strength","","OINTMENT","TOPICAL","20211101","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20251231"
"1583","CLOTRIMAZOLE","Clotrimazole","24909021250","Azole Antifungal [EPC], Azoles [CS]","24909-212","24909-212-50","24909-212_27640b2e-5da2-1a57-e063-6394a90a516b","HUMAN OTC DRUG","Terrasil JockItch Treatment Maximum Strength","","OINTMENT","TOPICAL","20211101","","OTC MONOGRAPH DRUG","M005","Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions","1","g/100g","","N","20251231"
"1584","CLOTRIMAZOLE","Clotrimazole","24909021414","Azole Antifungal [EPC], Azoles [CS]","24909-214","24909-214-14","24909-214_09a92161-51bd-cbf3-e063-6294a90a79b4","HUMAN OTC DRUG","Terrasil Jock Itch Treatment Maximum Strength","","OINTMENT","TOPICAL","20220630","","OTC MONOGRAPH DRUG","M005","Aidance Skincare & Topical Solutions, LLC","1","g/100g","","N","20251231"
"1585","CEFAZOLIN SODIUM","cefazolin sodium","25021010010","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","25021-100","25021-100-10","25021-100_941d9764-bece-4e2b-96de-7581aee8cf72","HUMAN PRESCRIPTION DRUG","cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20090201","","ANDA","ANDA065303","Sagent Pharmaceuticals","500","mg/2.2mL","","N","20251231"
"1586","CEFAZOLIN SODIUM","cefazolin sodium","25021010110","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","25021-101","25021-101-10","25021-101_941d9764-bece-4e2b-96de-7581aee8cf72","HUMAN PRESCRIPTION DRUG","cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20090201","","ANDA","ANDA065303","Sagent Pharmaceuticals","1","g/3mL","","N","20251231"
"1587","CEFAZOLIN SODIUM","cefazolin sodium","25021010299","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","25021-102","25021-102-99","25021-102_b04fdcb7-24fb-4290-9cac-70d7a04ebcd1","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20090401","","ANDA","ANDA065306","Sagent Pharmaceuticals","10","g/1","","N","20251231"
"1588","CEFTRIAXONE SODIUM","ceftriaxone","25021010610","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","25021-106","25021-106-10","25021-106_71bf5ebd-afe1-4906-86ef-76d7e205ec68","HUMAN PRESCRIPTION DRUG","ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20091105","","ANDA","ANDA065329","Sagent Pharmaceuticals","1","g/1","","N","20251231"
"1589","CEFTRIAXONE SODIUM","ceftriaxone","25021010720","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","25021-107","25021-107-20","25021-107_71bf5ebd-afe1-4906-86ef-76d7e205ec68","HUMAN PRESCRIPTION DRUG","ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20091105","","ANDA","ANDA065329","Sagent Pharmaceuticals","2","g/1","","N","20251231"
"1590","CEFOXITIN SODIUM","cefoxitin","25021010910","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","25021-109","25021-109-10","25021-109_b43cf6e8-a0e4-4f66-9559-6fcc65c40532","HUMAN PRESCRIPTION DRUG","Cefoxitin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20091105","","ANDA","ANDA065414","Sagent Pharmaceuticals","1","g/1","","N","20251231"
"1591","CEFOXITIN SODIUM","cefoxitin","25021011020","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","25021-110","25021-110-20","25021-110_b43cf6e8-a0e4-4f66-9559-6fcc65c40532","HUMAN PRESCRIPTION DRUG","Cefoxitin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20091105","","ANDA","ANDA065414","Sagent Pharmaceuticals","2","g/1","","N","20251231"
"1592","CEFOXITIN SODIUM","cefoxitin","25021011199","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","25021-111","25021-111-99","25021-111_79813968-4f6f-49a9-9a94-18607a1bcfbf","HUMAN PRESCRIPTION DRUG","Cefoxitin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20100812","","ANDA","ANDA065415","Sagent Pharmaceuticals","10","g/1","","N","20251231"
"1593","CIPROFLOXACIN","ciprofloxacin","25021011482","Quinolone Antimicrobial [EPC], Quinolones [CS]","25021-114","25021-114-82","25021-114_c30953aa-a1e5-45b5-97a5-6bb9d0b0bd6f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","INJECTION, SOLUTION","INTRAVENOUS","20080324","","ANDA","ANDA078252","Sagent Pharmaceuticals","2","mg/mL","","N","20251231"
"1594","CIPROFLOXACIN","ciprofloxacin","25021011487","Quinolone Antimicrobial [EPC], Quinolones [CS]","25021-114","25021-114-87","25021-114_c30953aa-a1e5-45b5-97a5-6bb9d0b0bd6f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","INJECTION, SOLUTION","INTRAVENOUS","20080324","","ANDA","ANDA078252","Sagent Pharmaceuticals","2","mg/mL","","N","20251231"
"1595","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","25021011502","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","25021-115","25021-115-02","25021-115_4662502b-ce7c-4278-854d-cf8632ac9b83","HUMAN PRESCRIPTION DRUG","Clindamycin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120515","","ANDA","ANDA090108","Sagent Pharmaceuticals","150","mg/mL","","N","20251231"
"1596","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","25021011504","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","25021-115","25021-115-04","25021-115_4662502b-ce7c-4278-854d-cf8632ac9b83","HUMAN PRESCRIPTION DRUG","Clindamycin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120515","","ANDA","ANDA090108","Sagent Pharmaceuticals","150","mg/mL","","N","20251231"
"1597","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","25021011506","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","25021-115","25021-115-06","25021-115_4662502b-ce7c-4278-854d-cf8632ac9b83","HUMAN PRESCRIPTION DRUG","Clindamycin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120515","","ANDA","ANDA090108","Sagent Pharmaceuticals","150","mg/mL","","N","20251231"
"1598","CEFUROXIME SODIUM","Cefuroxime sodium","25021011810","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","25021-118","25021-118-10","25021-118_244117cb-7dfb-44fd-a670-323aae6b51f7","HUMAN PRESCRIPTION DRUG","Cefuroxime sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20160901","","ANDA","ANDA064125","Sagent Pharmaceuticals","750","mg/1","","N","20261231"
"1599","CEFUROXIME SODIUM","Cefuroxime sodium","25021011920","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","25021-119","25021-119-20","25021-119_244117cb-7dfb-44fd-a670-323aae6b51f7","HUMAN PRESCRIPTION DRUG","Cefuroxime sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20160901","","ANDA","ANDA064125","Sagent Pharmaceuticals","1.5","g/16mL","","N","20261231"
"1600","CEFEPIME HYDROCHLORIDE","cefepime hydrochloride","25021012120","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","25021-121","25021-121-20","25021-121_a980a9e1-16f8-41c8-a8e4-31101948966c","HUMAN PRESCRIPTION DRUG","cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20080501","","ANDA","ANDA065441","Sagent Pharmaceuticals","1","g/1","","N","20251231"
"1601","CEFEPIME HYDROCHLORIDE","cefepime hydrochloride","25021012250","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","25021-122","25021-122-50","25021-122_a980a9e1-16f8-41c8-a8e4-31101948966c","HUMAN PRESCRIPTION DRUG","cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20080501","","ANDA","ANDA065441","Sagent Pharmaceuticals","2","g/1","","N","20251231"
"1602","CEFTAZIDIME","ceftazidime","25021012720","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","25021-127","25021-127-20","25021-127_6b34b5ad-001f-4c39-8415-a223eb692b46","HUMAN PRESCRIPTION DRUG","Ceftazidime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20080515","","ANDA","ANDA062640","Sagent Pharmaceuticals","1","g/1","","N","20251231"
"1603","CEFTAZIDIME","ceftazidime","25021012850","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","25021-128","25021-128-50","25021-128_6b34b5ad-001f-4c39-8415-a223eb692b46","HUMAN PRESCRIPTION DRUG","Ceftazidime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20080515","","ANDA","ANDA062640","Sagent Pharmaceuticals","2","g/1","","N","20251231"
"1604","CEFTAZIDIME","ceftazidime","25021012999","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","25021-129","25021-129-99","25021-129_c6b97c07-4742-4c33-8266-a154bd634da5","HUMAN PRESCRIPTION DRUG","Ceftazidime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20080515","","ANDA","ANDA062640","Sagent Pharmaceuticals","6","g/30mL","","N","20251231"
"1605","METRONIDAZOLE","Metronidazole","25021013182","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","25021-131","25021-131-82","25021-131_cad111bb-2009-422a-b16e-87d75ade4e4c","HUMAN PRESCRIPTION DRUG","Metronidazole","","INJECTION, SOLUTION","INTRAVENOUS","20091115","","ANDA","ANDA206191","Sagent Pharmaceuticals","500","mg/100mL","","N","20261231"
"1606","AMPICILLIN SODIUM","ampicillin","25021013610","Penicillin-class Antibacterial [EPC], Penicillins [CS]","25021-136","25021-136-10","25021-136_c3bd533d-1831-4030-8fc0-97c93f4803b6","HUMAN PRESCRIPTION DRUG","ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20140701","","ANDA","ANDA090354","Sagent Pharmaceuticals","1","g/1","","N","20251231"
"1607","AMPICILLIN SODIUM","ampicillin","25021013720","Penicillin-class Antibacterial [EPC], Penicillins [CS]","25021-137","25021-137-20","25021-137_c3bd533d-1831-4030-8fc0-97c93f4803b6","HUMAN PRESCRIPTION DRUG","ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20140701","","ANDA","ANDA090354","Sagent Pharmaceuticals","2","g/1","","N","20251231"
"1608","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin and sulbactam","25021014220","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","25021-142","25021-142-20","25021-142_6ea0f274-201c-4a5a-947e-6a94bbfcda30","HUMAN PRESCRIPTION DRUG","ampicillin and sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20100630","","ANDA","ANDA065406","Sagent Pharmaceuticals","1; .5","g/1; g/1","","N","20261231"
"1609","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin and sulbactam","25021014330","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","25021-143","25021-143-30","25021-143_6ea0f274-201c-4a5a-947e-6a94bbfcda30","HUMAN PRESCRIPTION DRUG","ampicillin and sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20100630","","ANDA","ANDA065406","Sagent Pharmaceuticals","2; 1","g/1; g/1","","N","20261231"
"1610","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin and sulbactam","25021014499","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","25021-144","25021-144-99","25021-144_6be243c8-0de8-4b13-972f-9300db172339","HUMAN PRESCRIPTION DRUG","ampicillin and sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20100812","","ANDA","ANDA065403","Sagent Pharmaceuticals","100; 50","mg/mL; mg/mL","","N","20251231"
"1611","OXACILLIN SODIUM","oxacillin sodium","25021014610","Penicillin-class Antibacterial [EPC], Penicillins [CS]","25021-146","25021-146-10","25021-146_bfe80588-e805-420a-af34-6bd5e8635525","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120601","20251231","ANDA","ANDA091246","Sagent Pharmaceuticals","1","g/1","","N",""
"1612","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","25021014720","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","25021-147","25021-147-20","25021-147_a05d9267-0d03-44f5-ae26-e7a523b5b862","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20250601","","ANDA","ANDA218140","Sagent Pharmaceuticals","750","mg/15mL","","N","20261231"
"1613","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","25021014830","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","25021-148","25021-148-30","25021-148_a05d9267-0d03-44f5-ae26-e7a523b5b862","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20250601","","ANDA","ANDA218140","Sagent Pharmaceuticals","1.25","g/25mL","","N","20261231"
"1614","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","25021014930","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","25021-149","25021-149-30","25021-149_a05d9267-0d03-44f5-ae26-e7a523b5b862","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20250601","","ANDA","ANDA218140","Sagent Pharmaceuticals","1.5","g/30mL","","N","20261231"
"1615","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","25021015010","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","25021-150","25021-150-10","25021-150_9421f884-7b57-4a9a-8389-a45a70dd4598","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230715","","ANDA","ANDA205694","Sagent Pharmaceuticals","500","mg/10mL","","N","20251231"
"1616","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","25021015120","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","25021-151","25021-151-20","25021-151_9421f884-7b57-4a9a-8389-a45a70dd4598","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230715","","ANDA","ANDA205694","Sagent Pharmaceuticals","1","g/20mL","","N","20251231"
"1617","PENICILLIN G POTASSIUM","penicillin g potassium","25021015320","Penicillin-class Antibacterial [EPC], Penicillins [CS]","25021-153","25021-153-20","25021-153_0474a791-61f5-4da7-96db-63fa6541f87e","HUMAN PRESCRIPTION DRUG","Penicillin G Potassium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20241201","","ANDA","ANDA065448","Sagent Pharmaceuticals","5000000","[iU]/1","","N","20251231"
"1618","PENICILLIN G POTASSIUM","penicillin g potassium","25021015451","Penicillin-class Antibacterial [EPC], Penicillins [CS]","25021-154","25021-154-51","25021-154_0474a791-61f5-4da7-96db-63fa6541f87e","HUMAN PRESCRIPTION DRUG","Penicillin G Potassium","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20241101","","ANDA","ANDA065448","Sagent Pharmaceuticals","20000000","[iU]/1","","N","20251231"
"1619","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","25021015799","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","25021-157","25021-157-99","25021-157_9b6f6171-cd0c-4468-a018-ebec650749ab","HUMAN PRESCRIPTION DRUG","Vancomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20120920","","ANDA","ANDA200837","Sagent Pharmaceuticals","5","g/100mL","","N","20251231"
"1620","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","25021015899","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","25021-158","25021-158-99","25021-158_9b6f6171-cd0c-4468-a018-ebec650749ab","HUMAN PRESCRIPTION DRUG","Vancomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20120920","","ANDA","ANDA200837","Sagent Pharmaceuticals","10","g/100mL","","N","20251231"
"1621","OXACILLIN SODIUM","oxacillin sodium","25021016224","Penicillin-class Antibacterial [EPC], Penicillins [CS]","25021-162","25021-162-24","25021-162_bfe80588-e805-420a-af34-6bd5e8635525","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120601","20251130","ANDA","ANDA091246","Sagent Pharmaceuticals","2","g/1","","N",""
"1622","OXACILLIN SODIUM","oxacillin sodium","25021016268","Penicillin-class Antibacterial [EPC], Penicillins [CS]","25021-162","25021-162-68","25021-162_bfe80588-e805-420a-af34-6bd5e8635525","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120601","20251130","ANDA","ANDA091246","Sagent Pharmaceuticals","2","g/1","","N",""
"1623","OXACILLIN SODIUM","oxacillin sodium","25021016368","Penicillin-class Antibacterial [EPC], Penicillins [CS]","25021-163","25021-163-68","25021-163_ead45fae-c703-40fd-8dca-912fca402254","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20181015","20250630","ANDA","ANDA091245","Sagent Pharmaceuticals","10","g/100mL","","N",""
"1624","OXACILLIN SODIUM","oxacillin sodium","25021016399","Penicillin-class Antibacterial [EPC], Penicillins [CS]","25021-163","25021-163-99","25021-163_ead45fae-c703-40fd-8dca-912fca402254","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20181015","20250630","ANDA","ANDA091245","Sagent Pharmaceuticals","10","g/100mL","","N",""
"1625","AMIKACIN SULFATE","amikacin sulfate","25021017302","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","25021-173","25021-173-02","25021-173_628539d5-fc0d-44a8-a854-b1e78382e78d","HUMAN PRESCRIPTION DRUG","amikacin sulfate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20160615","","ANDA","ANDA203323","Sagent Pharmaceuticals","250","mg/mL","","N","20251231"
"1626","AMIKACIN SULFATE","amikacin sulfate","25021017304","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","25021-173","25021-173-04","25021-173_628539d5-fc0d-44a8-a854-b1e78382e78d","HUMAN PRESCRIPTION DRUG","amikacin sulfate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20160615","","ANDA","ANDA203323","Sagent Pharmaceuticals","250","mg/mL","","N","20251231"
"1627","DAPTOMYCIN","daptomycin","25021017416","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","25021-174","25021-174-16","25021-174_a3f62ffc-f089-4f4c-bad1-99f60f1d88b0","HUMAN PRESCRIPTION DRUG","daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20191115","","ANDA","ANDA207104","Sagent Pharmaceuticals","50","mg/mL","","N","20251231"
"1628","DAPTOMYCIN","daptomycin","25021017415","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","25021-174","25021-174-15","25021-174_a3f62ffc-f089-4f4c-bad1-99f60f1d88b0","HUMAN PRESCRIPTION DRUG","daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20191115","","ANDA","ANDA207104","Sagent Pharmaceuticals","50","mg/mL","","N","20251231"
"1629","DAPTOMYCIN","Daptomycin","25021017915","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","25021-179","25021-179-15","25021-179_bd554c4f-8286-4db5-bb82-681d17bd4884","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200201","","NDA","NDA208385","Sagent Pharmaceuticals","350","mg/7mL","","N","20251231"
"1630","DAPTOMYCIN","Daptomycin","25021017916","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","25021-179","25021-179-16","25021-179_bd554c4f-8286-4db5-bb82-681d17bd4884","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200201","","NDA","NDA208385","Sagent Pharmaceuticals","350","mg/7mL","","N","20251231"
"1631","DAPTOMYCIN","Daptomycin","25021017966","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","25021-179","25021-179-66","25021-179_bd554c4f-8286-4db5-bb82-681d17bd4884","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200201","","NDA","NDA208385","Sagent Pharmaceuticals","350","mg/7mL","","N","20251231"
"1632","DAPTOMYCIN","Daptomycin","25021017967","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","25021-179","25021-179-67","25021-179_bd554c4f-8286-4db5-bb82-681d17bd4884","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200201","","NDA","NDA208385","Sagent Pharmaceuticals","350","mg/7mL","","N","20251231"
"1633","AZITHROMYCIN MONOHYDRATE","azithromycin monohydrate","25021018066","Macrolide Antimicrobial [EPC], Macrolides [CS]","25021-180","25021-180-66","25021-180_b0e66ff2-e3f0-4c89-9eb9-8122d1020d29","HUMAN PRESCRIPTION DRUG","Azithromycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20240915","","ANDA","ANDA065501","Sagent Pharmaceuticals","500","mg/5mL","","N","20251231"
"1634","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin Sodium, Tazobactam Sodium","25021018199","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","25021-181","25021-181-99","25021-181_a6724256-14c5-4408-83a5-a964f146f0d5","HUMAN PRESCRIPTION DRUG","Piperacillin, Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210228","","ANDA","ANDA208675","Sagent Pharmaceuticals","36; 4.5","g/152mL; g/152mL","","N","20251231"
"1635","FLUCONAZOLE","Fluconazole","25021018466","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","25021-184","25021-184-66","25021-184_bd560fcb-5efc-48d3-8d2c-e21f2d072215","HUMAN PRESCRIPTION DRUG","Fluconazole","","INJECTION, SOLUTION","INTRAVENOUS","20191015","","ANDA","ANDA079104","Sagent Pharmaceuticals","2","mg/mL","","N","20251231"
"1636","FLUCONAZOLE","Fluconazole","25021018482","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","25021-184","25021-184-82","25021-184_bd560fcb-5efc-48d3-8d2c-e21f2d072215","HUMAN PRESCRIPTION DRUG","Fluconazole","","INJECTION, SOLUTION","INTRAVENOUS","20191015","","ANDA","ANDA079104","Sagent Pharmaceuticals","2","mg/mL","","N","20251231"
"1637","FLUCONAZOLE","Fluconazole","25021018487","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","25021-184","25021-184-87","25021-184_bd560fcb-5efc-48d3-8d2c-e21f2d072215","HUMAN PRESCRIPTION DRUG","Fluconazole","","INJECTION, SOLUTION","INTRAVENOUS","20191015","","ANDA","ANDA079104","Sagent Pharmaceuticals","2","mg/mL","","N","20251231"
"1638","FLUCONAZOLE","Fluconazole","25021018467","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","25021-184","25021-184-67","25021-184_bd560fcb-5efc-48d3-8d2c-e21f2d072215","HUMAN PRESCRIPTION DRUG","Fluconazole","","INJECTION, SOLUTION","INTRAVENOUS","20191015","","ANDA","ANDA079104","Sagent Pharmaceuticals","2","mg/mL","","N","20251231"
"1639","GANCICLOVIR SODIUM","ganciclovir sodium","25021018510","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","25021-185","25021-185-10","25021-185_696f706f-39d7-4647-a506-2ebf7b956cc1","HUMAN PRESCRIPTION DRUG","ganciclovir","","INJECTION, SOLUTION","INTRAVENOUS","20180215","","ANDA","ANDA207645","Sagent Pharmaceuticals","50","mg/mL","","N","20251231"
"1640","MICAFUNGIN SODIUM","Micafungin Sodium","25021019011","Echinocandin Antifungal [EPC], Lipopeptides [CS]","25021-190","25021-190-11","25021-190_390d8b41-041f-41ac-a437-de877bf562be","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210615","","ANDA","ANDA213363","Sagent Pharmaceuticals","50","mg/5mL","","N","20251231"
"1641","MICAFUNGIN SODIUM","Micafungin Sodium","25021019010","Echinocandin Antifungal [EPC], Lipopeptides [CS]","25021-190","25021-190-10","25021-190_390d8b41-041f-41ac-a437-de877bf562be","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210615","","ANDA","ANDA213363","Sagent Pharmaceuticals","50","mg/5mL","","N","20251231"
"1642","MICAFUNGIN SODIUM","Micafungin Sodium","25021019110","Echinocandin Antifungal [EPC], Lipopeptides [CS]","25021-191","25021-191-10","25021-191_390d8b41-041f-41ac-a437-de877bf562be","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210615","","ANDA","ANDA213363","Sagent Pharmaceuticals","100","mg/5mL","","N","20251231"
"1643","MICAFUNGIN SODIUM","Micafungin Sodium","25021019111","Echinocandin Antifungal [EPC], Lipopeptides [CS]","25021-191","25021-191-11","25021-191_390d8b41-041f-41ac-a437-de877bf562be","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210615","","ANDA","ANDA213363","Sagent Pharmaceuticals","100","mg/5mL","","N","20251231"
"1644","CIPROFLOXACIN","ciprofloxacin","25021019287","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","25021-192","25021-192-87","25021-192_4f039d85-dab5-4f6e-8a0f-087a4c47b089","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","INJECTION, SOLUTION","INTRAVENOUS","20221215","","ANDA","ANDA078252","Sagent Pharmaceuticals","2","mg/mL","","N","20251231"
"1645","CIPROFLOXACIN","ciprofloxacin","25021019282","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","25021-192","25021-192-82","25021-192_4f039d85-dab5-4f6e-8a0f-087a4c47b089","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","INJECTION, SOLUTION","INTRAVENOUS","20221215","","ANDA","ANDA078252","Sagent Pharmaceuticals","2","mg/mL","","N","20251231"
"1646","CASPOFUNGIN ACETATE","Caspofungin Acetate","25021019410","Echinocandin Antifungal [EPC], Lipopeptides [CS]","25021-194","25021-194-10","25021-194_3a261cef-2cc8-457f-977b-56c21d865caf","HUMAN PRESCRIPTION DRUG","Caspofungin Acetate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230715","","ANDA","ANDA207092","Sagent Pharmaceuticals","5","mg/mL","","N","20251231"
"1647","CASPOFUNGIN ACETATE","Caspofungin Acetate","25021019510","Echinocandin Antifungal [EPC], Lipopeptides [CS]","25021-195","25021-195-10","25021-195_3a261cef-2cc8-457f-977b-56c21d865caf","HUMAN PRESCRIPTION DRUG","Caspofungin Acetate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230715","","ANDA","ANDA207092","Sagent Pharmaceuticals","7","mg/mL","","N","20251231"
"1648","AMPICILLIN SODIUM","Ampicillin Sodium","25021019799","Penicillin-class Antibacterial [EPC], Penicillins [CS]","25021-197","25021-197-99","25021-197_0e1963ba-9650-44ba-9ba0-1817b0e73512","HUMAN PRESCRIPTION DRUG","Ampicillin Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20250115","","ANDA","ANDA201404","Sagent Pharmaceuticals","10","g/100mL","","N","20261231"
"1649","NAFCILLIN SODIUM","Nafcillin Sodium","25021019899","Penicillin-class Antibacterial [EPC], Penicillins [CS]","25021-198","25021-198-99","25021-198_f50e7f65-8bca-4df1-bff1-8069b33def90","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20250415","","ANDA","ANDA090005","Sagent Pharmaceuticals","10","g/100mL","","N","20261231"
"1650","VORICONAZOLE","Voriconazole","27241006303","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","27241-063","27241-063-03","27241-063_c53722b1-d12e-4132-91db-ac576859fcdc","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET","ORAL","20160531","","ANDA","ANDA206181","Ajanta Pharma USA Inc.","200","mg/1","","N","20261231"
"1651","CLARITHROMYCIN","Clarithromycin","27241006406","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","27241-064","27241-064-06","27241-064_e6fc5858-56af-49e1-871d-f1e733dc9a23","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20190425","","ANDA","ANDA206714","Ajanta Pharma USA Inc.","250","mg/1","","N","20251231"
"1652","CLARITHROMYCIN","Clarithromycin","27241006506","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","27241-065","27241-065-06","27241-065_e6fc5858-56af-49e1-871d-f1e733dc9a23","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20190425","","ANDA","ANDA206714","Ajanta Pharma USA Inc.","500","mg/1","","N","20251231"
"1653","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir","27241015860","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","27241-158","27241-158-60","27241-158_7a7e79d7-afc4-4675-9067-dc823b8a653e","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET","ORAL","20191226","","ANDA","ANDA212234","Ajanta Pharma USA Inc.","450","mg/1","","N","20251231"
"1654","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir hydrochloride","27241015919","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","27241-159","27241-159-19","27241-159_9b16302a-f8e7-4fa0-8d04-a5d5c2071cc6","HUMAN PRESCRIPTION DRUG","Valganciclovir hydrochloride","","POWDER, FOR SOLUTION","ORAL","20200113","","ANDA","ANDA212890","Ajanta Pharma USA Inc.","50","mg/mL","","N","20251231"
"1655","SECNIDAZOLE","secnidazole","27437005102","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","27437-051","27437-051-02","27437-051_fe8dadfb-2b46-433c-b3fa-9d9c3d0548b5","HUMAN PRESCRIPTION DRUG","SOLOSEC","","GRANULE","ORAL","20171030","","NDA","NDA209363","Lupin Pharmaceuticals, Inc.","2","g/4.8g","","N","20251231"
"1656","SECNIDAZOLE","secnidazole","27437005101","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","27437-051","27437-051-01","27437-051_fe8dadfb-2b46-433c-b3fa-9d9c3d0548b5","HUMAN PRESCRIPTION DRUG","SOLOSEC","","GRANULE","ORAL","20171030","","NDA","NDA209363","Lupin Pharmaceuticals, Inc.","2","g/4.8g","","N","20251231"
"1657","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","28595024036","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","28595-240","28595-240-36","28595-240_2b3a0935-2cc7-095d-e063-6394a90a043a","HUMAN PRESCRIPTION DRUG","Augmentin","","FOR SUSPENSION","ORAL","20230223","","NDA","NDA050575","Allegis Pharmaceuticals, LLC","125; 31.25","mg/5mL; mg/5mL","","N","20261231"
"1658","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","28595024035","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","28595-240","28595-240-35","28595-240_2b3a0935-2cc7-095d-e063-6394a90a043a","HUMAN PRESCRIPTION DRUG","Augmentin","","FOR SUSPENSION","ORAL","20230223","","NDA","NDA050575","Allegis Pharmaceuticals, LLC","125; 31.25","mg/5mL; mg/5mL","","N","20261231"
"1659","SULFACETAMIDE SODIUM; SULFUR","sulfacetamide sodium and sulfur","28595050108","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","28595-501","28595-501-08","28595-501_1b2c4d92-36ab-e2f3-e063-6294a90a77a2","HUMAN PRESCRIPTION DRUG","sulfacetamide sodium and sulfur","Sodium Sulfacetamide - Sulfur","SUSPENSION","TOPICAL","20240618","","UNAPPROVED DRUG OTHER","","Allegis Pharmaceuticals, LLC","90; 42.5","mg/mL; mg/mL","","N","20251231"
"1660","METRONIDAZOLE","Metronidazole","29300022605","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","29300-226","29300-226-05","29300-226_afe0fa12-6438-4bd6-9a71-1f248bc9c54d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Unichem Pharmaceuticals (USA), Inc.","250","mg/1","","N","20251231"
"1661","METRONIDAZOLE","Metronidazole","29300022610","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","29300-226","29300-226-10","29300-226_afe0fa12-6438-4bd6-9a71-1f248bc9c54d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Unichem Pharmaceuticals (USA), Inc.","250","mg/1","","N","20251231"
"1662","METRONIDAZOLE","Metronidazole","29300022601","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","29300-226","29300-226-01","29300-226_afe0fa12-6438-4bd6-9a71-1f248bc9c54d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Unichem Pharmaceuticals (USA), Inc.","250","mg/1","","N","20251231"
"1663","METRONIDAZOLE","Metronidazole","29300022646","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","29300-226","29300-226-46","29300-226_afe0fa12-6438-4bd6-9a71-1f248bc9c54d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Unichem Pharmaceuticals (USA), Inc.","250","mg/1","","N","20251231"
"1664","METRONIDAZOLE","Metronidazole","29300022652","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","29300-226","29300-226-52","29300-226_afe0fa12-6438-4bd6-9a71-1f248bc9c54d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Unichem Pharmaceuticals (USA), Inc.","250","mg/1","","N","20251231"
"1665","METRONIDAZOLE","Metronidazole","29300022701","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","29300-227","29300-227-01","29300-227_afe0fa12-6438-4bd6-9a71-1f248bc9c54d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Unichem Pharmaceuticals (USA), Inc.","500","mg/1","","N","20251231"
"1666","METRONIDAZOLE","Metronidazole","29300022705","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","29300-227","29300-227-05","29300-227_afe0fa12-6438-4bd6-9a71-1f248bc9c54d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Unichem Pharmaceuticals (USA), Inc.","500","mg/1","","N","20251231"
"1667","METRONIDAZOLE","Metronidazole","29300022710","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","29300-227","29300-227-10","29300-227_afe0fa12-6438-4bd6-9a71-1f248bc9c54d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Unichem Pharmaceuticals (USA), Inc.","500","mg/1","","N","20251231"
"1668","METRONIDAZOLE","Metronidazole","29300022746","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","29300-227","29300-227-46","29300-227_afe0fa12-6438-4bd6-9a71-1f248bc9c54d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Unichem Pharmaceuticals (USA), Inc.","500","mg/1","","N","20251231"
"1669","CLOTRIMAZOLE","Clotrimazole","29978091860","Azole Antifungal [EPC], Azoles [CS]","29978-918","29978-918-60","29978-918_0df96321-505c-7f42-e063-6394a90a404a","HUMAN OTC DRUG","Alevazol","","OINTMENT","TOPICAL","20140901","","UNAPPROVED DRUG OTHER","","Capital Pharmaceutical, LLC","10","mg/g","","N","20251231"
"1670","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","30142003764","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","30142-037","30142-037-64","30142-037_94c0d3b7-00b1-4971-b246-526ba3890542","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20170503","","OTC MONOGRAPH DRUG","M004","Kroger Company","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1671","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","30142008001","Allylamine Antifungal [EPC], Allylamine [CS]","30142-080","30142-080-01","30142-080_42c428de-a4af-4e91-9314-ca79a575623e","HUMAN OTC DRUG","Kroger","Antifungal","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Kroger Company","1","g/100g","","N","20251231"
"1672","MICONAZOLE NITRATE","Jock Itch Spray","30142008946","Azole Antifungal [EPC], Azoles [CS]","30142-089","30142-089-46","30142-089_2900ffa1-32a6-01a2-e063-6394a90a5396","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, SPRAY","TOPICAL","20180401","","OTC MONOGRAPH DRUG","M005","Kroger Co.","1.3","g/130g","","N","20251231"
"1673","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","30142021002","Benzylamine Antifungal [EPC], Benzylamines [CS]","30142-210","30142-210-02","30142-210_f48462c5-4628-4207-bcdc-f7ccd33d9077","HUMAN OTC DRUG","Butenafine Hydrochloride","Athletes Foot","CREAM","TOPICAL","20171116","","ANDA","ANDA205181","Kroger Company","10","mg/g","","N","20251231"
"1674","CLOTRIMAZOLE","Clotrimazole","30142030501","Azole Antifungal [EPC], Azoles [CS]","30142-305","30142-305-01","30142-305_262e4d94-4e6c-df4c-e063-6394a90aa8b4","HUMAN OTC DRUG","Kroger","ATHLETES FOOT","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Kroger Company","10","mg/g","","N","20251231"
"1675","CLOTRIMAZOLE","Clotrimazole","30142051001","Azole Antifungal [EPC], Azoles [CS]","30142-510","30142-510-01","30142-510_15d823aa-7ae5-3bbd-e063-6394a90abc1b","HUMAN OTC DRUG","Kroger","Jock Itch","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Kroger Company","10","mg/g","","N","20251231"
"1676","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl","30142067964","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","30142-679","30142-679-64","30142-679_64ed7cef-be19-41a4-a541-ebf298316d8c","HUMAN OTC DRUG","Triple Antibiotic plus pain relief","","OINTMENT","TOPICAL","20170427","","OTC MONOGRAPH DRUG","M004","Kroger Company","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1677","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin, Polymyxin B, Pramoxine Hydrochloride","30142079058","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","30142-790","30142-790-58","30142-790_0fe7e7ba-4a5f-40b7-a1f2-c9778deb7db5","HUMAN OTC DRUG","antibiotic plus pain relief","","CREAM","TOPICAL","20190214","","OTC MONOGRAPH DRUG","M004","Kroger Company","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"1678","MICONAZOLE NITRATE","Miconazole nitrate","30142082529","Azole Antifungal [EPC], Azoles [CS]","30142-825","30142-825-29","30142-825_4f5abe8d-92ee-4fdc-bd96-95049a2f1076","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20020715","","ANDA","ANDA074760","Kroger Company","2","g/100g","","N","20251231"
"1679","MICONAZOLE NITRATE","Anti-fungal Powder Miconazole Nitrate Talc Free","30142084001","Azole Antifungal [EPC], Azoles [CS]","30142-840","30142-840-01","30142-840_2900d8d7-ecfa-6aae-e063-6294a90a9000","HUMAN OTC DRUG","Miconazole Nitrate","","POWDER","TOPICAL","20220411","20260530","OTC MONOGRAPH DRUG","M005","Kroger Co.","1.42","g/71g","","N",""
"1680","MICONAZOLE NITRATE","Miconazole Nitrate","30142094771","Azole Antifungal [EPC], Azoles [CS]","30142-947","30142-947-71","30142-947_2656150a-52d7-c50f-e063-6394a90aa6ac","HUMAN OTC DRUG","Anti-Fungal Powder","","POWDER","TOPICAL","20241001","","OTC MONOGRAPH DRUG","M005","The Kroger Co.","20","mg/g","","N","20251231"
"1681","ITRACONAZOLE","Itraconazole","31722000631","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","31722-006","31722-006-31","31722-006_2cd3622f-a50f-ec9c-e063-6294a90a3a30","HUMAN PRESCRIPTION DRUG","Itraconazole","","SOLUTION","ORAL","20200901","","ANDA","ANDA212239","Camber Pharmaceuticals, Inc.","10","mg/mL","","N","20261231"
"1682","DAPTOMYCIN","Daptomycin","31722010210","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","31722-102","31722-102-10","31722-102_774368a9-067c-4071-a397-2153d1a90242","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210104","","ANDA","ANDA212513","Camber Pharmaceuticals Inc.","500","mg/10mL","","N","20251231"
"1683","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","31722021010","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","31722-210","31722-210-10","31722-210_e449bca2-14c8-ae21-e053-2a95a90a942b","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220706","","ANDA","ANDA216591","Camber Pharmaceuticals, Inc.","500","mg/10mL","","N","20251231"
"1684","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","31722021032","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","31722-210","31722-210-32","31722-210_e449bca2-14c8-ae21-e053-2a95a90a942b","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220706","","ANDA","ANDA216591","Camber Pharmaceuticals, Inc.","500","mg/10mL","","N","20251231"
"1685","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","31722021110","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","31722-211","31722-211-10","31722-211_e449bca2-14c8-ae21-e053-2a95a90a942b","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220706","","ANDA","ANDA216591","Camber Pharmaceuticals, Inc.","1","g/20mL","","N","20251231"
"1686","DAPTOMYCIN","Daptomycin","31722021510","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","31722-215","31722-215-10","31722-215_f16ae2ef-72ac-19ba-e053-2995a90a629b","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20221223","","ANDA","ANDA216445","Camber Pharmaceuticals, Inc.","350","mg/7mL","","N","20251231"
"1687","DAPTOMYCIN","Daptomycin","31722021501","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","31722-215","31722-215-01","31722-215_f16ae2ef-72ac-19ba-e053-2995a90a629b","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20221223","","ANDA","ANDA216445","Camber Pharmaceuticals, Inc.","350","mg/7mL","","N","20251231"
"1688","DAPTOMYCIN","Daptomycin","31722021601","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","31722-216","31722-216-01","31722-216_ec153388-c19e-e94d-e053-2a95a90a6387","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220923","","ANDA","ANDA216413","Camber Pharmaceuticals, Inc.","500","mg/10mL","","N","20251231"
"1689","VORICONAZOLE","Voriconazole","31722022431","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","31722-224","31722-224-31","31722-224_1817cf18-51b4-b1d4-e063-6294a90ab549","HUMAN PRESCRIPTION DRUG","Voriconazole","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20240403","","ANDA","ANDA218533","Camber Pharmaceuticals, Inc.","10","mg/mL","","N","20251231"
"1690","POSACONAZOLE","POSACONAZOLE","31722037031","Azole Antifungal [EPC], Azoles [CS]","31722-370","31722-370-31","31722-370_2cfdafa2-b1b9-0758-e063-6394a90ac7f9","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","SOLUTION","INTRAVENOUS","20241223","","ANDA","ANDA219057","Camber Pharmaceuticals, Inc.","18","mg/mL","","N","20261231"
"1691","ATOVAQUONE","Atovaquone","31722062921","Antimalarial [EPC], Antiprotozoal [EPC]","31722-629","31722-629-21","31722-629_151b9723-5db4-ac2b-e063-6294a90af073","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20181011","","ANDA","ANDA210692","Camber Pharmaceuticals, Inc.","750","mg/5mL","","N","20251231"
"1692","POSACONAZOLE","Posaconazole","31722067760","Azole Antifungal [EPC], Azoles [CS]","31722-677","31722-677-60","31722-677_f00382d7-d652-18a4-e053-2995a90a58d1","HUMAN PRESCRIPTION DRUG","Posaconazole","","TABLET, DELAYED RELEASE","ORAL","20221208","","ANDA","ANDA214321","Camber Pharmaceuticals, Inc.","100","mg/1","","N","20251231"
"1693","LINEZOLID","Linezolid","31722074920","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","31722-749","31722-749-20","31722-749_2b439d9f-d081-c988-e063-6394a90af390","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151221","","ANDA","ANDA204239","Camber Pharmaceuticals, Inc.","600","mg/1","","N","20261231"
"1694","LINEZOLID","Linezolid","31722074931","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","31722-749","31722-749-31","31722-749_2b439d9f-d081-c988-e063-6394a90af390","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151221","","ANDA","ANDA204239","Camber Pharmaceuticals, Inc.","600","mg/1","","N","20261231"
"1695","LINEZOLID","Linezolid","31722074901","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","31722-749","31722-749-01","31722-749_2b439d9f-d081-c988-e063-6394a90af390","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151221","","ANDA","ANDA204239","Camber Pharmaceuticals, Inc.","600","mg/1","","N","20261231"
"1696","LINEZOLID","Linezolid","31722074930","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","31722-749","31722-749-30","31722-749_2b439d9f-d081-c988-e063-6394a90af390","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151221","","ANDA","ANDA204239","Camber Pharmaceuticals, Inc.","600","mg/1","","N","20261231"
"1697","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir","31722083231","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","31722-832","31722-832-31","31722-832_2b44d151-5b10-9250-e063-6294a90a53c2","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET, FILM COATED","ORAL","20160318","","ANDA","ANDA205166","Camber Pharmaceuticals, Inc.","450","mg/1","","N","20261231"
"1698","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir","31722083232","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","31722-832","31722-832-32","31722-832_2b44d151-5b10-9250-e063-6294a90a53c2","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET, FILM COATED","ORAL","20160318","","ANDA","ANDA205166","Camber Pharmaceuticals, Inc.","450","mg/1","","N","20261231"
"1699","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir","31722083260","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","31722-832","31722-832-60","31722-832_2b44d151-5b10-9250-e063-6294a90a53c2","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET, FILM COATED","ORAL","20160318","","ANDA","ANDA205166","Camber Pharmaceuticals, Inc.","450","mg/1","","N","20261231"
"1700","VALGANCICLOVIR HYDROCHLORIDE","VALGANCICLOVIR HYDROCHLORIDE","31722083710","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","31722-837","31722-837-10","31722-837_eaad537e-d8e5-24a2-e053-2a95a90ad075","HUMAN PRESCRIPTION DRUG","VALGANCICLOVIR","","POWDER, FOR SOLUTION","ORAL","20221004","","ANDA","ANDA211475","Camber Pharmaceuticals, Inc.","50","mg/mL","","N","20251231"
"1701","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin","31722084530","Quinolone Antimicrobial [EPC], Quinolones [CS]","31722-845","31722-845-30","31722-845_f6e9a43c-e301-ff1f-e053-6394a90a1458","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","TABLET, FILM COATED","ORAL","20230302","","ANDA","ANDA204836","Camber Pharmaceuticals, Inc.","400","mg/1","","N","20251231"
"1702","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin","31722084505","Quinolone Antimicrobial [EPC], Quinolones [CS]","31722-845","31722-845-05","31722-845_f6e9a43c-e301-ff1f-e053-6394a90a1458","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","TABLET, FILM COATED","ORAL","20230302","","ANDA","ANDA204836","Camber Pharmaceuticals, Inc.","400","mg/1","","N","20251231"
"1703","LINEZOLID","Linezolid","31722086525","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","31722-865","31722-865-25","31722-865_05657697-e108-9eaf-e063-6294a90a5d97","HUMAN PRESCRIPTION DRUG","Linezolid","","GRANULE, FOR SUSPENSION","ORAL","20221031","","ANDA","ANDA211813","Camber Pharmaceuticals, Inc.","100","mg/5mL","","N","20251231"
"1704","LINEZOLID","Linezolid","33342035232","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","33342-352","33342-352-32","33342-352_90dd8c13-c428-4472-91e5-5b1fcdc4fce3","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, COATED","ORAL","20241010","","ANDA","ANDA210378","Macleods Pharmaceuticals Limited","600","mg/1","","N","20251231"
"1705","LINEZOLID","Linezolid","33342035211","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","33342-352","33342-352-11","33342-352_90dd8c13-c428-4472-91e5-5b1fcdc4fce3","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, COATED","ORAL","20241010","","ANDA","ANDA210378","Macleods Pharmaceuticals Limited","600","mg/1","","N","20251231"
"1706","LINEZOLID","Linezolid","33342035231","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","33342-352","33342-352-31","33342-352_90dd8c13-c428-4472-91e5-5b1fcdc4fce3","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, COATED","ORAL","20241010","","ANDA","ANDA210378","Macleods Pharmaceuticals Limited","600","mg/1","","N","20251231"
"1707","NYSTATIN","Nystatin","33342046930","Polyene Antifungal [EPC], Polyenes [CS]","33342-469","33342-469-30","33342-469_d8ebb61a-a326-4f0d-a346-c3db045c3fb0","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20210825","","ANDA","ANDA213566","Macleods Pharmaceuticals Limited","100000","1/g","","N","20251231"
"1708","NYSTATIN","Nystatin","33342046915","Polyene Antifungal [EPC], Polyenes [CS]","33342-469","33342-469-15","33342-469_d8ebb61a-a326-4f0d-a346-c3db045c3fb0","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20210825","","ANDA","ANDA213566","Macleods Pharmaceuticals Limited","100000","1/g","","N","20251231"
"1709","NYSTATIN","Nystatin","33342048130","Polyene Antifungal [EPC], Polyenes [CS]","33342-481","33342-481-30","33342-481_fe3db8b2-9de4-4f9e-b763-8536a1e4cea8","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20210129","","ANDA","ANDA213826","Macleods Pharmaceuticals Limited","100000","1/g","","N","20251231"
"1710","NYSTATIN","Nystatin","33342048115","Polyene Antifungal [EPC], Polyenes [CS]","33342-481","33342-481-15","33342-481_fe3db8b2-9de4-4f9e-b763-8536a1e4cea8","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20210129","","ANDA","ANDA213826","Macleods Pharmaceuticals Limited","100000","1/g","","N","20251231"
"1711","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and triamcinolone acetonide","33342048230","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","33342-482","33342-482-30","33342-482_f23f4207-1d1b-4eb2-9b7f-a70ced65192a","HUMAN PRESCRIPTION DRUG","Nystatin and triamcinolone acetonide","","CREAM","TOPICAL","20220831","","ANDA","ANDA214181","Macleods Pharmaceuticals Limited","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"1712","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and triamcinolone acetonide","33342048260","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","33342-482","33342-482-60","33342-482_f23f4207-1d1b-4eb2-9b7f-a70ced65192a","HUMAN PRESCRIPTION DRUG","Nystatin and triamcinolone acetonide","","CREAM","TOPICAL","20220831","","ANDA","ANDA214181","Macleods Pharmaceuticals Limited","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"1713","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and triamcinolone acetonide","33342048215","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","33342-482","33342-482-15","33342-482_f23f4207-1d1b-4eb2-9b7f-a70ced65192a","HUMAN PRESCRIPTION DRUG","Nystatin and triamcinolone acetonide","","CREAM","TOPICAL","20220831","","ANDA","ANDA214181","Macleods Pharmaceuticals Limited","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"1714","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and triamcinolone acetonide","33342048360","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","33342-483","33342-483-60","33342-483_15bf2ff1-510e-4f0e-9817-8af28790e01b","HUMAN PRESCRIPTION DRUG","Nystatin and triamcinolone acetonide","","OINTMENT","TOPICAL","20210901","","ANDA","ANDA214751","Macleods Pharmaceuticals Limited","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"1715","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and triamcinolone acetonide","33342048330","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","33342-483","33342-483-30","33342-483_15bf2ff1-510e-4f0e-9817-8af28790e01b","HUMAN PRESCRIPTION DRUG","Nystatin and triamcinolone acetonide","","OINTMENT","TOPICAL","20210901","","ANDA","ANDA214751","Macleods Pharmaceuticals Limited","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"1716","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and triamcinolone acetonide","33342048315","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","33342-483","33342-483-15","33342-483_15bf2ff1-510e-4f0e-9817-8af28790e01b","HUMAN PRESCRIPTION DRUG","Nystatin and triamcinolone acetonide","","OINTMENT","TOPICAL","20210901","","ANDA","ANDA214751","Macleods Pharmaceuticals Limited","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"1717","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN and TAZOBACTAM","35369050102","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","35369-0501","35369-0501-2","35369-0501_83e081fa-7103-403a-b275-7d7205835a91","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20180810","","ANDA","ANDA204959","Shandong Anxin Pharmaceutical Co., Ltd.","4; .5","g/20mL; g/20mL","","N","20251231"
"1718","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN and TAZOBACTAM","35369050202","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","35369-0502","35369-0502-2","35369-0502_83e081fa-7103-403a-b275-7d7205835a91","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20180810","","ANDA","ANDA204959","Shandong Anxin Pharmaceutical Co., Ltd.","2; .25","g/10mL; g/10mL","","N","20251231"
"1719","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN and TAZOBACTAM","35369050302","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","35369-0503","35369-0503-2","35369-0503_83e081fa-7103-403a-b275-7d7205835a91","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20180810","","ANDA","ANDA204959","Shandong Anxin Pharmaceutical Co., Ltd.","3; .375","g/15mL; g/15mL","","N","20251231"
"1720","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","35369050401","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","35369-0504","35369-0504-1","35369-0504_7557a940-1967-4f48-8c56-d494b793d934","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230414","","ANDA","ANDA217243","Shandong Anxin Pharmaceutical Co., Ltd.","36; 4.5","g/180mL; g/180mL","","N","20251231"
"1721","KETOCONAZOLE","ketoconazole","35573043302","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","35573-433","35573-433-02","35573-433_748e48d8-09d3-413c-b724-883b6b47f01e","HUMAN PRESCRIPTION DRUG","KETOCONAZOLE","","TABLET","ORAL","20200410","","ANDA","ANDA075912","Burel Pharmaceuticals, LLC","200","mg/1","","N","20251231"
"1722","KETOCONAZOLE","ketoconazole","35573043330","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","35573-433","35573-433-30","35573-433_748e48d8-09d3-413c-b724-883b6b47f01e","HUMAN PRESCRIPTION DRUG","KETOCONAZOLE","","TABLET","ORAL","20200410","","ANDA","ANDA075912","Burel Pharmaceuticals, LLC","200","mg/1","","N","20251231"
"1723","TOBRAMYCIN SULFATE","Tobramycin","36000024201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","36000-242","36000-242-01","36000-242_159010d8-a23b-482b-a55f-3fe7b0f5e907","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION","INTRAMUSCULAR; INTRAVENOUS","20160715","","ANDA","ANDA206965","Baxter Healthcare Corporation","40","mg/mL","","N","20251231"
"1724","TOBRAMYCIN SULFATE","Tobramycin","36000024425","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","36000-244","36000-244-25","36000-244_159010d8-a23b-482b-a55f-3fe7b0f5e907","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION","INTRAMUSCULAR; INTRAVENOUS","20160715","","ANDA","ANDA206965","Baxter Healthcare Corporation","40","mg/mL","","N","20251231"
"1725","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","36800004901","Benzylamine Antifungal [EPC], Benzylamines [CS]","36800-049","36800-049-01","36800-049_a0c731ca-4dec-4150-9732-a3320468ac12","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","TOPCO ASSOCIATES LLC","10","mg/g","","N","20251231"
"1726","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride","36800005624","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","36800-056","36800-056-24","36800-056_2630bfec-db5a-290a-e063-6394a90a82c7","HUMAN OTC DRUG","TopCare","Triple Antibiotic Plus Pain Relief","OINTMENT","TOPICAL","20120331","","OTC MONOGRAPH DRUG","M004","Topco Associates LLC","500; 3.5; 10000; 10","[iU]/g; mg/g; [iU]/g; mg/g","","N","20251231"
"1727","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","36800008001","Allylamine Antifungal [EPC], Allylamine [CS]","36800-080","36800-080-01","36800-080_a7a50c80-4e9a-41b0-ab6d-44c03ed2449d","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Topco Associates LLC","1","g/100g","","N","20251231"
"1728","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","36800038101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","36800-381","36800-381-01","36800-381_25dde4fa-5a72-8322-e063-6294a90afdf0","HUMAN OTC DRUG","TopCare","Antibiotic Plus Pain Relief","CREAM","TOPICAL","20120321","","OTC MONOGRAPH DRUG","M017","Topco Associates LLC","3.5; 10000; 10","mg/g; [iU]/g; mg/g","","N","20251231"
"1729","MICONAZOLE NITRATE","Athletes Foot Powder Spray Talc Free","36800038446","Azole Antifungal [EPC], Azoles [CS]","36800-384","36800-384-46","36800-384_2905f032-1923-fede-e063-6294a90a5377","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, POWDER","TOPICAL","20171207","","OTC MONOGRAPH DRUG","M005","Topco Associates LLC","2.6","g/130g","","N","20251231"
"1730","MICONAZOLE NITRATE","Anti-fungal Powder Miconazole Nitrate Talc Free","36800038525","Azole Antifungal [EPC], Azoles [CS]","36800-385","36800-385-25","36800-385_2655afa6-4595-89ba-e063-6394a90a22c5","HUMAN OTC DRUG","Miconazole Nitrate","","POWDER","TOPICAL","20171207","20260930","OTC MONOGRAPH DRUG","M005","Topco Associates LLC","1.42","g/71g","","N",""
"1731","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","36800041626","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","36800-416","36800-416-26","36800-416_ad03114a-7d22-43d3-9e2f-dc62936cd5d1","HUMAN OTC DRUG","topcare triple antibiotic","","OINTMENT","TOPICAL","20200226","","OTC MONOGRAPH DRUG","M004","Topco Associates LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1732","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","36800041664","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","36800-416","36800-416-64","36800-416_ad03114a-7d22-43d3-9e2f-dc62936cd5d1","HUMAN OTC DRUG","topcare triple antibiotic","","OINTMENT","TOPICAL","20200226","","OTC MONOGRAPH DRUG","M004","Topco Associates LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1733","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","36800041658","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","36800-416","36800-416-58","36800-416_ad03114a-7d22-43d3-9e2f-dc62936cd5d1","HUMAN OTC DRUG","topcare triple antibiotic","","OINTMENT","TOPICAL","20200226","","OTC MONOGRAPH DRUG","M004","Topco Associates LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1734","TIOCONAZOLE","Tioconazole","36800042654","Azole Antifungal [EPC], Azoles [CS]","36800-426","36800-426-54","36800-426_d24c0ab3-4644-4b60-90a5-dc1aac6eb6f3","HUMAN OTC DRUG","Topcare Tioconazole 1","","OINTMENT","VAGINAL","20080303","","ANDA","ANDA075915","Topco Associates LLC","6.5","g/100g","","N","20251231"
"1735","CLOTRIMAZOLE","Clotrimazole","36800049569","Azole Antifungal [EPC], Azoles [CS]","36800-495","36800-495-69","36800-495_26ba6aeb-ef0c-8f68-e063-6394a90aa47c","HUMAN OTC DRUG","TopCare","Antifungal","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Topco Associates LLC","10","mg/g","","N","20251231"
"1736","CLOTRIMAZOLE","Clotrimazole","36800050801","Azole Antifungal [EPC], Azoles [CS]","36800-508","36800-508-01","36800-508_b5f02aa7-e582-40f1-a912-b43c32b64bd6","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","20210930","20260530","OTC MONOGRAPH DRUG","M005","TOP CARE (Topco Associates LLC)","10","mg/g","","N",""
"1737","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","36800056402","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","36800-564","36800-564-02","36800-564_262f4a54-d15f-6d5a-e063-6394a90ae10b","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","","OTC MONOGRAPH DRUG","M004","Topco Associates LLC","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1738","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","36800056401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","36800-564","36800-564-01","36800-564_262f4a54-d15f-6d5a-e063-6394a90ae10b","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","","OTC MONOGRAPH DRUG","M004","Topco Associates LLC","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1739","MICONAZOLE NITRATE","Miconazole Nitrate","36800061301","Azole Antifungal [EPC], Azoles [CS]","36800-613","36800-613-01","36800-613_2655e323-30a9-a2a2-e063-6294a90a486a","HUMAN OTC DRUG","Anti-Fungal Powder","","POWDER","TOPICAL","20240603","","OTC MONOGRAPH DRUG","M005","TopCo Associates","20","mg/g","","N","20251231"
"1740","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, neomycin, polymyxin B, pramoxine hydrochloride","36800078064","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","36800-780","36800-780-64","36800-780_05358cf0-75b2-4ea0-af54-5aaba75c8923","HUMAN OTC DRUG","topcare triple antibiotic","","OINTMENT","TOPICAL","20200315","","OTC MONOGRAPH DRUG","M004","Topco Associates LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1741","MICONAZOLE NITRATE","miconazole nitrate","36800078214","Azole Antifungal [EPC], Azoles [CS]","36800-782","36800-782-14","36800-782_6381c9e2-ff95-42f8-8b4f-0031692f5931","HUMAN OTC DRUG","Topco Miconazole 3","","CREAM","VAGINAL","20200427","","ANDA","ANDA091366","Topco Associates LLC","40","mg/g","","N","20251231"
"1742","MICONAZOLE NITRATE","Miconazole nitrate","36800082529","Azole Antifungal [EPC], Azoles [CS]","36800-825","36800-825-29","36800-825_887383d2-df39-4e9f-9b11-4fa83dc578ce","HUMAN OTC DRUG","Topcare Miconazole 7","","CREAM","VAGINAL","20000229","","ANDA","ANDA074760","Topco Associates LLC","2","g/100g","","N","20251231"
"1743","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","neomycin, polymyxin B, pramoxine hydrochloride","36800097658","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","36800-976","36800-976-58","36800-976_cc235da2-c30c-4192-a5e7-5956c5981d72","HUMAN OTC DRUG","Topcare Antibiotic","","CREAM","TOPICAL","20200403","","OTC MONOGRAPH DRUG","M017","Topco Associates LLC","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"1744","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride","37012002701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","37012-027","37012-027-01","37012-027_26309a7a-2fb2-99f7-e063-6294a90a0b12","HUMAN OTC DRUG","Shopko","Triple Antibiotic plus Pain Relief","OINTMENT","TOPICAL","20120331","","OTC MONOGRAPH DRUG","M004","Shopko Stores Operating Co., LLC","500; 3.5; 10000; 10","[iU]/g; mg/g; [iU]/g; mg/g","","N","20251231"
"1745","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride","37012002702","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","37012-027","37012-027-02","37012-027_26309a7a-2fb2-99f7-e063-6294a90a0b12","HUMAN OTC DRUG","Shopko","Triple Antibiotic plus Pain Relief","OINTMENT","TOPICAL","20120331","","OTC MONOGRAPH DRUG","M004","Shopko Stores Operating Co., LLC","500; 3.5; 10000; 10","[iU]/g; mg/g; [iU]/g; mg/g","","N","20251231"
"1746","QUININE SULFATE","Chininum Sulphuricum","37662025001","Antimalarial [EPC]","37662-0250","37662-0250-1","37662-0250_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","6","[hp_C]/1","","N","20251231"
"1747","QUININE SULFATE","Chininum Sulphuricum","37662025002","Antimalarial [EPC]","37662-0250","37662-0250-2","37662-0250_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","6","[hp_C]/1","","N","20251231"
"1748","QUININE SULFATE","Chininum Sulphuricum","37662025003","Antimalarial [EPC]","37662-0250","37662-0250-3","37662-0250_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","6","[hp_C]/1","","N","20251231"
"1749","QUININE SULFATE","Chininum Sulphuricum","37662025102","Antimalarial [EPC]","37662-0251","37662-0251-2","37662-0251_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","12","[hp_C]/1","","N","20251231"
"1750","QUININE SULFATE","Chininum Sulphuricum","37662025103","Antimalarial [EPC]","37662-0251","37662-0251-3","37662-0251_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","12","[hp_C]/1","","N","20251231"
"1751","QUININE SULFATE","Chininum Sulphuricum","37662025101","Antimalarial [EPC]","37662-0251","37662-0251-1","37662-0251_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","12","[hp_C]/1","","N","20251231"
"1752","QUININE SULFATE","Chininum Sulphuricum","37662025201","Antimalarial [EPC]","37662-0252","37662-0252-1","37662-0252_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","30","[hp_C]/1","","N","20251231"
"1753","QUININE SULFATE","Chininum Sulphuricum","37662025203","Antimalarial [EPC]","37662-0252","37662-0252-3","37662-0252_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","30","[hp_C]/1","","N","20251231"
"1754","QUININE SULFATE","Chininum Sulphuricum","37662025204","Antimalarial [EPC]","37662-0252","37662-0252-4","37662-0252_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","30","[hp_C]/1","","N","20251231"
"1755","QUININE SULFATE","Chininum Sulphuricum","37662025202","Antimalarial [EPC]","37662-0252","37662-0252-2","37662-0252_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","30","[hp_C]/1","","N","20251231"
"1756","QUININE SULFATE","Chininum Sulphuricum","37662025301","Antimalarial [EPC]","37662-0253","37662-0253-1","37662-0253_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","100","[hp_C]/1","","N","20251231"
"1757","QUININE SULFATE","Chininum Sulphuricum","37662025303","Antimalarial [EPC]","37662-0253","37662-0253-3","37662-0253_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","100","[hp_C]/1","","N","20251231"
"1758","QUININE SULFATE","Chininum Sulphuricum","37662025304","Antimalarial [EPC]","37662-0253","37662-0253-4","37662-0253_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","100","[hp_C]/1","","N","20251231"
"1759","QUININE SULFATE","Chininum Sulphuricum","37662025302","Antimalarial [EPC]","37662-0253","37662-0253-2","37662-0253_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","100","[hp_C]/1","","N","20251231"
"1760","QUININE SULFATE","Chininum Sulphuricum","37662025401","Antimalarial [EPC]","37662-0254","37662-0254-1","37662-0254_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","200","[hp_C]/1","","N","20251231"
"1761","QUININE SULFATE","Chininum Sulphuricum","37662025404","Antimalarial [EPC]","37662-0254","37662-0254-4","37662-0254_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","200","[hp_C]/1","","N","20251231"
"1762","QUININE SULFATE","Chininum Sulphuricum","37662025403","Antimalarial [EPC]","37662-0254","37662-0254-3","37662-0254_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","200","[hp_C]/1","","N","20251231"
"1763","QUININE SULFATE","Chininum Sulphuricum","37662025402","Antimalarial [EPC]","37662-0254","37662-0254-2","37662-0254_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","200","[hp_C]/1","","N","20251231"
"1764","QUININE SULFATE","Chininum Sulphuricum","37662025501","Antimalarial [EPC]","37662-0255","37662-0255-1","37662-0255_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","500","[hp_C]/1","","N","20251231"
"1765","QUININE SULFATE","Chininum Sulphuricum","37662025502","Antimalarial [EPC]","37662-0255","37662-0255-2","37662-0255_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","500","[hp_C]/1","","N","20251231"
"1766","QUININE SULFATE","Chininum Sulphuricum","37662025504","Antimalarial [EPC]","37662-0255","37662-0255-4","37662-0255_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","500","[hp_C]/1","","N","20251231"
"1767","QUININE SULFATE","Chininum Sulphuricum","37662025503","Antimalarial [EPC]","37662-0255","37662-0255-3","37662-0255_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","500","[hp_C]/1","","N","20251231"
"1768","QUININE SULFATE","Chininum Sulphuricum","37662025601","Antimalarial [EPC]","37662-0256","37662-0256-1","37662-0256_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","1","[hp_M]/1","","N","20251231"
"1769","QUININE SULFATE","Chininum Sulphuricum","37662025602","Antimalarial [EPC]","37662-0256","37662-0256-2","37662-0256_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","1","[hp_M]/1","","N","20251231"
"1770","QUININE SULFATE","Chininum Sulphuricum","37662025604","Antimalarial [EPC]","37662-0256","37662-0256-4","37662-0256_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","1","[hp_M]/1","","N","20251231"
"1771","QUININE SULFATE","Chininum Sulphuricum","37662025603","Antimalarial [EPC]","37662-0256","37662-0256-3","37662-0256_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","1","[hp_M]/1","","N","20251231"
"1772","QUININE SULFATE","Chininum Sulphuricum","37662025701","Antimalarial [EPC]","37662-0257","37662-0257-1","37662-0257_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","10","[hp_M]/1","","N","20251231"
"1773","QUININE SULFATE","Chininum Sulphuricum","37662025702","Antimalarial [EPC]","37662-0257","37662-0257-2","37662-0257_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","10","[hp_M]/1","","N","20251231"
"1774","QUININE SULFATE","Chininum Sulphuricum","37662025703","Antimalarial [EPC]","37662-0257","37662-0257-3","37662-0257_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","10","[hp_M]/1","","N","20251231"
"1775","QUININE SULFATE","Chininum Sulphuricum","37662025704","Antimalarial [EPC]","37662-0257","37662-0257-4","37662-0257_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","10","[hp_M]/1","","N","20251231"
"1776","QUININE SULFATE","Chininum Sulphuricum","37662025801","Antimalarial [EPC]","37662-0258","37662-0258-1","37662-0258_e066fe81-39e1-3e40-e053-2a95a90ac0cf","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","1","[hp_Q]/1","","N","20251231"
"1777","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662026601","Antimalarial [EPC]","37662-0266","37662-0266-1","37662-0266_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","6","[hp_C]/1","","N","20251231"
"1778","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662026602","Antimalarial [EPC]","37662-0266","37662-0266-2","37662-0266_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","6","[hp_C]/1","","N","20251231"
"1779","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662026603","Antimalarial [EPC]","37662-0266","37662-0266-3","37662-0266_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","6","[hp_C]/1","","N","20251231"
"1780","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662026702","Antimalarial [EPC]","37662-0267","37662-0267-2","37662-0267_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","12","[hp_C]/1","","N","20251231"
"1781","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662026703","Antimalarial [EPC]","37662-0267","37662-0267-3","37662-0267_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","12","[hp_C]/1","","N","20251231"
"1782","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662026701","Antimalarial [EPC]","37662-0267","37662-0267-1","37662-0267_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","12","[hp_C]/1","","N","20251231"
"1783","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662026801","Antimalarial [EPC]","37662-0268","37662-0268-1","37662-0268_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","30","[hp_C]/1","","N","20251231"
"1784","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662026803","Antimalarial [EPC]","37662-0268","37662-0268-3","37662-0268_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","30","[hp_C]/1","","N","20251231"
"1785","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662026804","Antimalarial [EPC]","37662-0268","37662-0268-4","37662-0268_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","30","[hp_C]/1","","N","20251231"
"1786","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662026802","Antimalarial [EPC]","37662-0268","37662-0268-2","37662-0268_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","30","[hp_C]/1","","N","20251231"
"1787","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662026901","Antimalarial [EPC]","37662-0269","37662-0269-1","37662-0269_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","100","[hp_C]/1","","N","20251231"
"1788","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662026904","Antimalarial [EPC]","37662-0269","37662-0269-4","37662-0269_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","100","[hp_C]/1","","N","20251231"
"1789","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662026903","Antimalarial [EPC]","37662-0269","37662-0269-3","37662-0269_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","100","[hp_C]/1","","N","20251231"
"1790","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662026902","Antimalarial [EPC]","37662-0269","37662-0269-2","37662-0269_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","100","[hp_C]/1","","N","20251231"
"1791","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027001","Antimalarial [EPC]","37662-0270","37662-0270-1","37662-0270_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","200","[hp_C]/1","","N","20251231"
"1792","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027002","Antimalarial [EPC]","37662-0270","37662-0270-2","37662-0270_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","200","[hp_C]/1","","N","20251231"
"1793","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027003","Antimalarial [EPC]","37662-0270","37662-0270-3","37662-0270_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","200","[hp_C]/1","","N","20251231"
"1794","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027004","Antimalarial [EPC]","37662-0270","37662-0270-4","37662-0270_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","200","[hp_C]/1","","N","20251231"
"1795","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027101","Antimalarial [EPC]","37662-0271","37662-0271-1","37662-0271_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","500","[hp_C]/1","","N","20251231"
"1796","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027102","Antimalarial [EPC]","37662-0271","37662-0271-2","37662-0271_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","500","[hp_C]/1","","N","20251231"
"1797","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027103","Antimalarial [EPC]","37662-0271","37662-0271-3","37662-0271_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","500","[hp_C]/1","","N","20251231"
"1798","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027104","Antimalarial [EPC]","37662-0271","37662-0271-4","37662-0271_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","500","[hp_C]/1","","N","20251231"
"1799","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027202","Antimalarial [EPC]","37662-0272","37662-0272-2","37662-0272_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","1","[hp_M]/1","","N","20251231"
"1800","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027203","Antimalarial [EPC]","37662-0272","37662-0272-3","37662-0272_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","1","[hp_M]/1","","N","20251231"
"1801","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027201","Antimalarial [EPC]","37662-0272","37662-0272-1","37662-0272_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","1","[hp_M]/1","","N","20251231"
"1802","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027204","Antimalarial [EPC]","37662-0272","37662-0272-4","37662-0272_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","1","[hp_M]/1","","N","20251231"
"1803","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027302","Antimalarial [EPC]","37662-0273","37662-0273-2","37662-0273_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","10","[hp_M]/1","","N","20251231"
"1804","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027303","Antimalarial [EPC]","37662-0273","37662-0273-3","37662-0273_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","10","[hp_M]/1","","N","20251231"
"1805","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027304","Antimalarial [EPC]","37662-0273","37662-0273-4","37662-0273_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","10","[hp_M]/1","","N","20251231"
"1806","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027301","Antimalarial [EPC]","37662-0273","37662-0273-1","37662-0273_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","10","[hp_M]/1","","N","20251231"
"1807","CHLOROQUINE PHOSPHATE","Chloroquinum Phos.","37662027401","Antimalarial [EPC]","37662-0274","37662-0274-1","37662-0274_e06a5ca9-e6f0-8803-e053-2a95a90a7277","HUMAN OTC DRUG","Chloroquinum Phos.","","PELLET","ORAL","20220601","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","1","[hp_Q]/1","","N","20251231"
"1808","RIBAVIRIN","Ribavirinum","37662413602","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4136","37662-4136-2","37662-4136_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","6","[hp_C]/1","","N","20251231"
"1809","RIBAVIRIN","Ribavirinum","37662413601","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4136","37662-4136-1","37662-4136_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","6","[hp_C]/1","","N","20251231"
"1810","RIBAVIRIN","Ribavirinum","37662413603","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4136","37662-4136-3","37662-4136_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","6","[hp_C]/1","","N","20251231"
"1811","RIBAVIRIN","Ribavirinum","37662413701","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4137","37662-4137-1","37662-4137_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","12","[hp_C]/1","","N","20251231"
"1812","RIBAVIRIN","Ribavirinum","37662413702","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4137","37662-4137-2","37662-4137_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","12","[hp_C]/1","","N","20251231"
"1813","RIBAVIRIN","Ribavirinum","37662413703","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4137","37662-4137-3","37662-4137_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","12","[hp_C]/1","","N","20251231"
"1814","RIBAVIRIN","Ribavirinum","37662413802","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4138","37662-4138-2","37662-4138_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","30","[hp_C]/1","","N","20251231"
"1815","RIBAVIRIN","Ribavirinum","37662413803","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4138","37662-4138-3","37662-4138_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","30","[hp_C]/1","","N","20251231"
"1816","RIBAVIRIN","Ribavirinum","37662413801","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4138","37662-4138-1","37662-4138_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","30","[hp_C]/1","","N","20251231"
"1817","RIBAVIRIN","Ribavirinum","37662413804","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4138","37662-4138-4","37662-4138_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","30","[hp_C]/1","","N","20251231"
"1818","RIBAVIRIN","Ribavirinum","37662413901","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4139","37662-4139-1","37662-4139_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","100","[hp_C]/1","","N","20251231"
"1819","RIBAVIRIN","Ribavirinum","37662413903","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4139","37662-4139-3","37662-4139_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","100","[hp_C]/1","","N","20251231"
"1820","RIBAVIRIN","Ribavirinum","37662413904","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4139","37662-4139-4","37662-4139_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","100","[hp_C]/1","","N","20251231"
"1821","RIBAVIRIN","Ribavirinum","37662413902","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4139","37662-4139-2","37662-4139_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","100","[hp_C]/1","","N","20251231"
"1822","RIBAVIRIN","Ribavirinum","37662414003","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4140","37662-4140-3","37662-4140_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","200","[hp_C]/1","","N","20251231"
"1823","RIBAVIRIN","Ribavirinum","37662414004","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4140","37662-4140-4","37662-4140_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","200","[hp_C]/1","","N","20251231"
"1824","RIBAVIRIN","Ribavirinum","37662414001","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4140","37662-4140-1","37662-4140_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","200","[hp_C]/1","","N","20251231"
"1825","RIBAVIRIN","Ribavirinum","37662414002","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4140","37662-4140-2","37662-4140_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","200","[hp_C]/1","","N","20251231"
"1826","RIBAVIRIN","Ribavirinum","37662414103","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4141","37662-4141-3","37662-4141_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","500","[hp_C]/1","","N","20251231"
"1827","RIBAVIRIN","Ribavirinum","37662414104","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4141","37662-4141-4","37662-4141_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","500","[hp_C]/1","","N","20251231"
"1828","RIBAVIRIN","Ribavirinum","37662414101","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4141","37662-4141-1","37662-4141_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","500","[hp_C]/1","","N","20251231"
"1829","RIBAVIRIN","Ribavirinum","37662414102","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4141","37662-4141-2","37662-4141_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","500","[hp_C]/1","","N","20251231"
"1830","RIBAVIRIN","Ribavirinum","37662414202","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4142","37662-4142-2","37662-4142_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","1","[hp_M]/1","","N","20251231"
"1831","RIBAVIRIN","Ribavirinum","37662414204","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4142","37662-4142-4","37662-4142_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","1","[hp_M]/1","","N","20251231"
"1832","RIBAVIRIN","Ribavirinum","37662414201","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4142","37662-4142-1","37662-4142_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","1","[hp_M]/1","","N","20251231"
"1833","RIBAVIRIN","Ribavirinum","37662414203","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4142","37662-4142-3","37662-4142_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","1","[hp_M]/1","","N","20251231"
"1834","RIBAVIRIN","Ribavirinum","37662414301","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","37662-4143","37662-4143-1","37662-4143_078e2ef1-2e1e-f8c3-e063-6394a90a145e","HUMAN OTC DRUG","Ribavirinum","","PELLET","ORAL","20231012","","UNAPPROVED HOMEOPATHIC","","Hahnemann Laboratories, INC.","1","[hp_Q]/1","","N","20251231"
"1835","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin, Polymyxin B, Pramoxine HCl","37808000558","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","37808-005","37808-005-58","37808-005_9fd3e906-9a3a-4640-aff6-8237eb1c5980","HUMAN OTC DRUG","antibiotic","","CREAM","TOPICAL","20150914","","OTC MONOGRAPH DRUG","M004","H E B","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"1836","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","37808001302","Benzylamine Antifungal [EPC], Benzylamines [CS]","37808-013","37808-013-02","37808-013_e3972ebb-3fa2-446c-b72b-c218753cd5eb","HUMAN OTC DRUG","Athletes Foot Ultra","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","H E B","10","mg/g","","N","20251231"
"1837","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","37808008001","Allylamine Antifungal [EPC], Allylamine [CS]","37808-080","37808-080-01","37808-080_864a75dd-8000-40be-9070-cc919b6b9fda","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","H E B","1","g/100g","","N","20251231"
"1838","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","37808026364","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","37808-263","37808-263-64","37808-263_be02d97b-a643-4cb8-8038-7ffe68aa4096","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20141014","","OTC MONOGRAPH DRUG","M004","H E B","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1839","CLOTRIMAZOLE","Clotrimazole","37808030501","Azole Antifungal [EPC], Azoles [CS]","37808-305","37808-305-01","37808-305_26ba3ab5-25b4-5e33-e063-6394a90ac5d9","HUMAN OTC DRUG","HEB","Antifungal","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","H E B","10","mg/g","","N","20251231"
"1840","TIOCONAZOLE","Tioconazole","37808042654","Azole Antifungal [EPC], Azoles [CS]","37808-426","37808-426-54","37808-426_0c72d07d-86cc-443d-96a8-8ec00e1cfa7c","HUMAN OTC DRUG","Tioconazole 1","","OINTMENT","VAGINAL","20160509","","ANDA","ANDA075915","H E B","6.5","g/100g","","N","20251231"
"1841","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl","37808067964","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","37808-679","37808-679-64","37808-679_1ae76431-f5da-4248-b405-a18cba20439e","HUMAN OTC DRUG","triple antibiotic plus","maximum strength","OINTMENT","TOPICAL","20101105","","OTC MONOGRAPH DRUG","M004","H E B","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1842","MICONAZOLE NITRATE","Miconazole nitrate","37808082526","Azole Antifungal [EPC], Azoles [CS]","37808-825","37808-825-26","37808-825_154b2a8e-966f-4dd9-8ce8-30a5adb3aab5","HUMAN OTC DRUG","miconazole 7","","CREAM","VAGINAL","20060109","","ANDA","ANDA074760","H E B","2","g/100g","","N","20251231"
"1843","MICONAZOLE NITRATE","miconazole nitrate","37808092814","Azole Antifungal [EPC], Azoles [CS]","37808-928","37808-928-14","37808-928_6b7d09f4-b857-4e61-9541-2a143bd5a8ee","HUMAN OTC DRUG","Miconazole","","CREAM","VAGINAL","20200317","","ANDA","ANDA091366","H E B","40","mg/g","","N","20251231"
"1844","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate","37835090301","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","37835-903","37835-903-01","37835-903_2813b0ae-5c5a-e0bb-e063-6394a90a5e15","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20240701","","OTC MONOGRAPH DRUG","M004","Bi-Mart","400; 5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1845","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride","37835090401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","37835-904","37835-904-01","37835-904_28136828-782b-87b3-e063-6394a90a2876","HUMAN OTC DRUG","Triple Antibiotic Plus Pain Relief","","OINTMENT","TOPICAL","20240701","","OTC MONOGRAPH DRUG","M004","Bi-Mart","400; 5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1846","NEOMYCIN SULFATE","Neomycin Sulfate","39822031005","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","39822-0310","39822-0310-5","39822-0310_19871fb5-6718-b186-e063-6394a90a9f93","HUMAN PRESCRIPTION DRUG","Neomycin Sulfate","","TABLET","ORAL","20100312","","ANDA","ANDA065220","XGen Pharmaceuticals DJB, Inc.","500","mg/1","","N","20251231"
"1847","TOBRAMYCIN SULFATE","Tobramycin","39822041206","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","39822-0412","39822-0412-6","39822-0412_f7047d2d-2b45-7a75-e053-6294a90a49a0","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20010817","","ANDA","ANDA065013","XGen Pharmaceuticals DJB, Inc.","1.2","g/30mL","","N","20251231"
"1848","TOBRAMYCIN SULFATE","Tobramycin","39822041201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","39822-0412","39822-0412-1","39822-0412_f7047d2d-2b45-7a75-e053-6294a90a49a0","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20010817","","ANDA","ANDA065013","XGen Pharmaceuticals DJB, Inc.","1.2","g/30mL","","N","20251231"
"1849","STREPTOMYCIN SULFATE","Streptomycin","39822070602","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Antimycobacterial [EPC]","39822-0706","39822-0706-2","39822-0706_02f9e270-6046-83b6-e063-6394a90afc27","HUMAN PRESCRIPTION DRUG","Streptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR","19980630","","ANDA","ANDA064210","XGen Pharmaceuticals DJB, Inc.","1","g/1","","N","20251231"
"1850","NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin and Polymyxin B Sulfates","39822120105","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","39822-1201","39822-1201-5","39822-1201_0cc9b11c-90cb-c93a-e063-6294a90ab1eb","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates","","SOLUTION","IRRIGATION","20060119","","ANDA","ANDA065106","XGen Pharmaceuticals DJB, Inc.","40; 200000","mg/mL; [USP'U]/mL","","N","20251231"
"1851","NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin and Polymyxin B Sulfates","39822120102","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","39822-1201","39822-1201-2","39822-1201_0cc9b11c-90cb-c93a-e063-6294a90ab1eb","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates","","SOLUTION","IRRIGATION","20060119","","ANDA","ANDA065106","XGen Pharmaceuticals DJB, Inc.","40; 200000","mg/mL; [USP'U]/mL","","N","20251231"
"1852","NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin and Polymyxin B Sulfates","39822122001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","39822-1220","39822-1220-1","39822-1220_0cc9b11c-90cb-c93a-e063-6294a90ab1eb","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates","","SOLUTION","IRRIGATION","20060131","","ANDA","ANDA065108","XGen Pharmaceuticals DJB, Inc.","40; 200000","mg/mL; [USP'U]/mL","","N","20251231"
"1853","PENTAMIDINE ISETHIONATE","PENTAMIDINE ISETHIONATE","39822303002","Antiprotozoal [EPC]","39822-3030","39822-3030-2","39822-3030_13f0833c-208d-be41-e063-6294a90a627b","HUMAN PRESCRIPTION DRUG","Pentamidine Isethionate","","INHALANT","RESPIRATORY (INHALATION)","20230404","","ANDA","ANDA206983","XGen Pharmaceuticals DJB, Inc.","300","mg/6mL","","N","20251231"
"1854","PENTAMIDINE ISETHIONATE","PENTAMIDINE ISETHIONATE","39822305002","Antiprotozoal [EPC]","39822-3050","39822-3050-2","39822-3050_0fcb7bdf-013e-a77c-e063-6394a90ad20f","HUMAN PRESCRIPTION DRUG","PENTAMIDINE ISETHIONATE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20230404","","ANDA","ANDA206982","XGen Pharmaceuticals DJB, Inc.","300","mg/3mL","","N","20251231"
"1855","BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin","39892083001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","39892-0830","39892-0830-1","39892-0830_0c1083e3-bad3-7844-e063-6394a90a440b","HUMAN OTC DRUG","MediChoice Triple Antibiotic","","OINTMENT","TOPICAL","20150327","","OTC MONOGRAPH DRUG","M004","Owens & Minor Inc.","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1856","VORICONAZOLE","voriconazole","40032003860","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","40032-038","40032-038-60","40032-038_55941af1-d7bf-494a-b90f-9ef19bc76eba","HUMAN PRESCRIPTION DRUG","VORICONAZOLE","","SUSPENSION","ORAL","20160601","","ANDA","ANDA206799","Novel Laboratories, Inc.","40","mg/mL","","N","20251231"
"1857","TRIMETHOPRIM","Trimethoprim","40032033024","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]","40032-330","40032-330-24","40032-330_63ba2637-37db-4f1e-b488-6e53466a5028","HUMAN PRESCRIPTION DRUG","Trimethoprim","","TABLET","ORAL","20140304","","ANDA","ANDA091437","Novel Laboratories, Inc.","100","mg/1","","N","20251231"
"1858","NITROFURANTOIN","Nitrofurantoin","40032045011","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","40032-450","40032-450-11","40032-450_f62f5875-c0f1-4892-95c4-a811d8b6f1de","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","SUSPENSION","ORAL","20140908","","ANDA","ANDA201693","Novel Laboratories, Inc.","25","mg/5mL","","N","20251231"
"1859","FLUCYTOSINE","Flucytosine","40032077003","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","40032-770","40032-770-03","40032-770_6e35eb2f-b8be-422e-adcd-c11a2a6e3cb4","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170707","","ANDA","ANDA204652","Novel Laboratories, Inc.","500","mg/1","","N","20251231"
"1860","FLUCYTOSINE","Flucytosine","40032077001","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","40032-770","40032-770-01","40032-770_6e35eb2f-b8be-422e-adcd-c11a2a6e3cb4","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170707","","ANDA","ANDA204652","Novel Laboratories, Inc.","500","mg/1","","N","20251231"
"1861","FLUCYTOSINE","Flucytosine","40032077103","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","40032-771","40032-771-03","40032-771_6e35eb2f-b8be-422e-adcd-c11a2a6e3cb4","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170707","","ANDA","ANDA204652","Novel Laboratories, Inc.","250","mg/1","","N","20251231"
"1862","FLUCYTOSINE","Flucytosine","40032077101","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","40032-771","40032-771-01","40032-771_6e35eb2f-b8be-422e-adcd-c11a2a6e3cb4","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170707","","ANDA","ANDA204652","Novel Laboratories, Inc.","250","mg/1","","N","20251231"
"1863","TIOCONAZOLE","Tioconazole","41163003254","Azole Antifungal [EPC], Azoles [CS]","41163-032","41163-032-54","41163-032_07a00775-6625-48de-9963-5626755d3a04","HUMAN OTC DRUG","Equaline Tioconazole 1","","OINTMENT","VAGINAL","20160308","","ANDA","ANDA075915","United Natural Foods, Inc. dba UNFI","6.5","g/100g","","N","20251231"
"1864","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl","41163004064","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","41163-040","41163-040-64","41163-040_d0967fa7-fac5-49b8-8e63-7968c56fccc7","HUMAN OTC DRUG","equaline first aid antibiotic","","OINTMENT","TOPICAL","20150402","","OTC MONOGRAPH DRUG","M004","United Natural Foods, Inc. dba UNFI","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1865","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","41163020964","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","41163-209","41163-209-64","41163-209_a8bebda7-32f6-460c-9be2-f17337c09694","HUMAN OTC DRUG","equaline first aid antibiotic","","OINTMENT","TOPICAL","20141124","","OTC MONOGRAPH DRUG","M004","United Natural Foods, Inc. dba UNFI","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1866","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","41163020958","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","41163-209","41163-209-58","41163-209_a8bebda7-32f6-460c-9be2-f17337c09694","HUMAN OTC DRUG","equaline first aid antibiotic","","OINTMENT","TOPICAL","20141124","","OTC MONOGRAPH DRUG","M004","United Natural Foods, Inc. dba UNFI","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1867","MICONAZOLE NITRATE","Miconazole nitrate","41163082529","Azole Antifungal [EPC], Azoles [CS]","41163-825","41163-825-29","41163-825_4c7ab517-750f-4479-adaf-ed5e04765a52","HUMAN OTC DRUG","Equaline Miconazole 7","","CREAM","VAGINAL","20041110","","ANDA","ANDA074760","United Natural Foods, Inc. dba UNFI","2","g/100g","","N","20251231"
"1868","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","41250006758","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","41250-067","41250-067-58","41250-067_f9920f43-f0a7-44df-98c0-0738be3f3eda","HUMAN OTC DRUG","triple antibiotic","","OINTMENT","TOPICAL","20150402","","OTC MONOGRAPH DRUG","M004","Meijer Distribution Inc","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1869","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","41250006764","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","41250-067","41250-067-64","41250-067_f9920f43-f0a7-44df-98c0-0738be3f3eda","HUMAN OTC DRUG","triple antibiotic","","OINTMENT","TOPICAL","20150402","","OTC MONOGRAPH DRUG","M004","Meijer Distribution Inc","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1870","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","41250006716","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","41250-067","41250-067-16","41250-067_f9920f43-f0a7-44df-98c0-0738be3f3eda","HUMAN OTC DRUG","triple antibiotic","","OINTMENT","TOPICAL","20150402","","OTC MONOGRAPH DRUG","M004","Meijer Distribution Inc","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1871","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","41250008002","Allylamine Antifungal [EPC], Allylamine [CS]","41250-080","41250-080-02","41250-080_2b483c18-3a33-1701-e063-6294a90a3f49","HUMAN OTC DRUG","Antifungal","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Meijer Distribution Inc","1","g/100g","","N","20261231"
"1872","MICONAZOLE NITRATE","Antifungal Miconazole Liquid Continuous Spray","41250009853","Azole Antifungal [EPC], Azoles [CS]","41250-098","41250-098-53","41250-098_24748eb1-8920-cb66-e063-6394a90aac0e","HUMAN OTC DRUG","Miconazole nitrate","","AEROSOL, SPRAY","TOPICAL","20120413","20270531","OTC MONOGRAPH DRUG","M005","Meijer Distribution Inc","3","g/150g","","N",""
"1873","MICONAZOLE NITRATE","Athletes Foot Powder Spray Talc Free","41250019646","Azole Antifungal [EPC], Azoles [CS]","41250-196","41250-196-46","41250-196_2474d4ae-87b7-2b9e-e063-6394a90a67bf","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, POWDER","TOPICAL","20180404","20260831","OTC MONOGRAPH DRUG","M005","Meijer Distribution Inc","2.6","g/130g","","N",""
"1874","CLOTRIMAZOLE","Clotrimazole","41250030503","Azole Antifungal [EPC], Azoles [CS]","41250-305","41250-305-03","41250-305_2de2fecf-096e-f04c-e063-6294a90adc25","HUMAN OTC DRUG","meijer","Athletes Foot","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Meijer Distribution Inc","10","mg/g","","N","20261231"
"1875","CLOTRIMAZOLE","Clotrimazole","41250030502","Azole Antifungal [EPC], Azoles [CS]","41250-305","41250-305-02","41250-305_2de2fecf-096e-f04c-e063-6294a90adc25","HUMAN OTC DRUG","meijer","Athletes Foot","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Meijer Distribution Inc","10","mg/g","","N","20261231"
"1876","TIOCONAZOLE","Tioconazole","41250042654","Azole Antifungal [EPC], Azoles [CS]","41250-426","41250-426-54","41250-426_ccef57e6-1a04-4a66-95d7-afe3e1f54902","HUMAN OTC DRUG","tioconazole 1","","OINTMENT","VAGINAL","20080109","","ANDA","ANDA075915","Meijer Distribution Inc","6.5","g/100g","","N","20251231"
"1877","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl","41250043358","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","41250-433","41250-433-58","41250-433_6839f211-f184-4ae6-8dfe-c7eb21d79b00","HUMAN OTC DRUG","triple antibiotic","","OINTMENT","TOPICAL","20171003","","OTC MONOGRAPH DRUG","M004","Meijer Distribution Inc","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1878","MICONAZOLE NITRATE","Jock Itch Powder Spray","41250056256","Azole Antifungal [EPC], Azoles [CS]","41250-562","41250-562-56","41250-562_247abca7-e996-ad69-e063-6394a90aeeef","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, SPRAY","TOPICAL","20200801","20260430","OTC MONOGRAPH DRUG","M005","Meijer Distribution Inc.","2.6","g/130g","","N",""
"1879","MICONAZOLE NITRATE","Anti-fungal Powder Miconazole Nitrate Talc Free","41250057525","Azole Antifungal [EPC], Azoles [CS]","41250-575","41250-575-25","41250-575_21b29ec4-99e6-31cf-e063-6394a90aeb2e","HUMAN OTC DRUG","Miconazole Nitrate","","POWDER","TOPICAL","20171201","20260531","OTC MONOGRAPH DRUG","M005","Meijer Distribution Inc","1.42","g/71g","","N",""
"1880","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl","41250067916","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","41250-679","41250-679-16","41250-679_cb2359ef-f85b-49ed-9376-3da78eb6c9f4","HUMAN OTC DRUG","triple antibiotic","plus pain relief","OINTMENT","TOPICAL","20100317","","OTC MONOGRAPH DRUG","M004","Meijer Distribution Inc","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1881","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl","41250067958","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","41250-679","41250-679-58","41250-679_cb2359ef-f85b-49ed-9376-3da78eb6c9f4","HUMAN OTC DRUG","triple antibiotic","plus pain relief","OINTMENT","TOPICAL","20100317","","OTC MONOGRAPH DRUG","M004","Meijer Distribution Inc","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1882","MICONAZOLE NITRATE","Miconazole nitrate","41250082529","Azole Antifungal [EPC], Azoles [CS]","41250-825","41250-825-29","41250-825_a045e703-1c48-4efe-b2b3-37d9eb40839c","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20000204","","ANDA","ANDA074760","Meijer Distribution Inc","2","g/100g","","N","20251231"
"1883","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride","41415005075","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","41415-050","41415-050-75","41415-050_308ff3de-fd29-8383-e063-6394a90ad11a","HUMAN OTC DRUG","Publix","antibiotic plus pain relief","OINTMENT","TOPICAL","20120331","","OTC MONOGRAPH DRUG","M004","Publix Super Markets Inc","500; 3.5; 10000; 10","[iU]/g; mg/g; [iU]/g; mg/g","","N","20261231"
"1884","CLOTRIMAZOLE","Clotrimazole","41415005675","Azole Antifungal [EPC], Azoles [CS]","41415-056","41415-056-75","41415-056_25e00efc-5f42-14ec-e063-6294a90ae6d4","HUMAN OTC DRUG","Publix","athletic foot","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Publix Super Markets Inc","10","mg/g","","N","20251231"
"1885","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride","41415007675","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","41415-076","41415-076-75","41415-076_26e252dc-4e30-1989-e063-6394a90a9aed","HUMAN OTC DRUG","Publix","antibiotic plus Pain Relief","CREAM","TOPICAL","20120321","","OTC MONOGRAPH DRUG","M004","Publix Super Markets Inc","3.5; 10000; 10","mg/g; [iU]/g; mg/g","","N","20251231"
"1886","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B","41415012002","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","41415-120","41415-120-02","41415-120_262f24d0-9fd6-566c-e063-6294a90a344d","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","","OTC MONOGRAPH DRUG","M004","Publix Super Markets Inc","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"1887","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin B sulfate","41520006758","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","41520-067","41520-067-58","41520-067_412fbcf7-fe57-4d68-98f5-55887274ca67","HUMAN OTC DRUG","careone triple antibiotic","","OINTMENT","TOPICAL","20191001","","OTC MONOGRAPH DRUG","M004","American Sales Company","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1888","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin B sulfate","41520006764","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","41520-067","41520-067-64","41520-067_412fbcf7-fe57-4d68-98f5-55887274ca67","HUMAN OTC DRUG","careone triple antibiotic","","OINTMENT","TOPICAL","20191001","","OTC MONOGRAPH DRUG","M004","American Sales Company","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"1889","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","41520008002","Allylamine Antifungal [EPC], Allylamine [CS]","41520-080","41520-080-02","41520-080_2423035d-6c72-595a-e063-6294a90a3d4c","HUMAN OTC DRUG","Antifungal Foot","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","American Sales Company","1","g/100g","","N","20251231"
"1890","CLOTRIMAZOLE","Clotrimazole","41520030502","Azole Antifungal [EPC], Azoles [CS]","41520-305","41520-305-02","41520-305_25dff1a5-0649-388c-e063-6294a90ad290","HUMAN OTC DRUG","CAREONE","Clotrimazole","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","American Sales Company","10","mg/g","","N","20251231"
"1891","TIOCONAZOLE","Tioconazole","41520042654","Azole Antifungal [EPC], Azoles [CS]","41520-426","41520-426-54","41520-426_765f1ed8-68e3-4902-b0db-4959632dcdd6","HUMAN OTC DRUG","CareOne Tioconazole 1","","OINTMENT","VAGINAL","20080107","","ANDA","ANDA075915","American Sales Company","6.5","g/100g","","N","20251231"
"1892","MICONAZOLE NITRATE","Anti-fungal Miconazole Athletes Foot Spray Talc Free","41520056546","Azole Antifungal [EPC], Azoles [CS]","41520-565","41520-565-46","41520-565_26558760-2f04-7e4e-e063-6394a90a1b19","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, POWDER","TOPICAL","20171020","","OTC MONOGRAPH DRUG","M005","Foodhold USA","2.6","g/130g","","N","20251231"
"1893","MICONAZOLE NITRATE","Jock Itch Spray Talc Free","41520056646","Azole Antifungal [EPC], Azoles [CS]","41520-566","41520-566-46","41520-566_26557c46-516a-7674-e063-6294a90a6830","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, SPRAY","TOPICAL","20171020","","OTC MONOGRAPH DRUG","M005","American Sales Company","1.3","g/130g","","N","20251231"
"1894","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, Pramoxine Hydrochloride","41520067964","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","41520-679","41520-679-64","41520-679_e7ac2499-f4cf-4328-a238-79f63e9bfaf6","HUMAN OTC DRUG","careone triple antibiotic","","OINTMENT","TOPICAL","20190926","","OTC MONOGRAPH DRUG","M004","American Sales Company","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"1895","MICONAZOLE NITRATE","Miconazole nitrate","41520082529","Azole Antifungal [EPC], Azoles [CS]","41520-825","41520-825-29","41520-825_dd6f9159-8c07-49f6-a043-99222a327cba","HUMAN OTC DRUG","Careone miconazole 7","","CREAM","VAGINAL","20190529","","ANDA","ANDA074760","American Sales Company","2","g/100g","","N","20251231"
"1896","COLISTIMETHATE SODIUM","colistimethate","42023010701","Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","42023-107","42023-107-01","42023-107_f647cf6d-c5bd-4cb2-9992-e43bda0bee31","HUMAN PRESCRIPTION DRUG","Coly-Mycin","M","INJECTION","INTRAMUSCULAR; INTRAVENOUS","20071101","","NDA","NDA050108","Endo USA, Inc.","150","mg/2mL","","N","20251231"
"1897","GANCICLOVIR SODIUM","Ganciclovir","42023017325","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","42023-173","42023-173-25","42023-173_f04cdda8-4829-4fa1-8cf2-503479c89b1e","HUMAN PRESCRIPTION DRUG","Ganciclovir","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20161206","","ANDA","ANDA204950","Endo USA, Inc.","500","mg/10mL","","N","20251231"
"1898","POSACONAZOLE","Posaconazole","42023019501","Azole Antifungal [EPC], Azoles [CS]","42023-195","42023-195-01","42023-195_1d3cec9f-0d1a-4095-b12f-623c1ba1deb2","HUMAN PRESCRIPTION DRUG","Posaconazole","","INJECTION","INTRAVENOUS","20230101","","ANDA","ANDA208768","ENDO USA, Inc.","18","mg/mL","","N","20251231"
"1899","ERTAPENEM SODIUM","ertapenem sodium","42023022185","Carbapenems [CS], Penem Antibacterial [EPC]","42023-221","42023-221-85","42023-221_97203e37-2288-4da2-90cb-e810795ec8c9","HUMAN PRESCRIPTION DRUG","ERTAPENEM","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20181101","","NDA","NDA021337","ENDO USA, Inc.","1","g/1","","N","20251231"
"1900","ERTAPENEM SODIUM","ertapenem sodium","42023022110","Carbapenems [CS], Penem Antibacterial [EPC]","42023-221","42023-221-10","42023-221_97203e37-2288-4da2-90cb-e810795ec8c9","HUMAN PRESCRIPTION DRUG","ERTAPENEM","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20181101","","NDA","NDA021337","ENDO USA, Inc.","1","g/1","","N","20251231"
"1901","MICAFUNGIN SODIUM","Micafungin","42023022910","Echinocandin Antifungal [EPC], Lipopeptides [CS]","42023-229","42023-229-10","42023-229_6322266c-5be3-40c9-84c8-5f86e9635826","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210801","","NDA","NDA212156","Endo USA, Inc.","10","mg/mL","","N","20251231"
"1902","MICAFUNGIN SODIUM","Micafungin","42023023010","Echinocandin Antifungal [EPC], Lipopeptides [CS]","42023-230","42023-230-10","42023-230_6322266c-5be3-40c9-84c8-5f86e9635826","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210801","","NDA","NDA212156","Endo USA, Inc.","20","mg/mL","","N","20251231"
"1903","SULFACETAMIDE SODIUM; SULFUR","SODIUM SULFACETAMIDE and SULFUR","42192010406","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","42192-104","42192-104-06","42192-104_0e76cbc6-8cf0-7dc8-e063-6294a90a815a","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE and SULFUR","Wash","LIQUID","TOPICAL","20080604","","UNAPPROVED DRUG OTHER","","Acella Pharmaceuticals, LLC","100; 10","mg/g; mg/g","","N","20251231"
"1904","SULFACETAMIDE; SULFUR","SODIUM SULFACETAMIDE, SULFUR","42192012116","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","42192-121","42192-121-16","42192-121_5f0c9397-a5f3-44d6-933e-10eda34274c2","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE - SULFUR WASH","","LIQUID","TOPICAL","20100916","","UNAPPROVED DRUG OTHER","","ACELLA PHARMACEUTICALS","90; 40","mg/473.2mL; mg/473.2mL","","N","20251231"
"1905","SULFACETAMIDE SODIUM","SODIUM SULFACETAMIDE","42192012916","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","42192-129","42192-129-16","42192-129_49b06fdb-fd90-439d-b6a9-0a7c2a5951d1","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE","","LIQUID","TOPICAL","20110104","","UNAPPROVED DRUG OTHER","","Acella Pharmaceuticals, LLC","100","mg/mL","","N","20251231"
"1906","SULFACETAMIDE SODIUM; SULFUR","Sodium Sulfacetamide and Sulfur","42192013316","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","42192-133","42192-133-16","42192-133_888fce7d-dc47-4d1b-9c39-9dfcaa051607","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide and Sulfur","","SOLUTION","TOPICAL","20110513","","UNAPPROVED DRUG OTHER","","Acella Pharmaceuticals, LLC","80; 40","mg/mL; mg/mL","","N","20251231"
"1907","SULFACETAMIDE SODIUM; SULFUR","Sulfacetamide Sodium and Sulfur","42192013606","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","42192-136","42192-136-06","42192-136_679caef9-ee89-4c41-abfb-1987997729fc","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10 Sulfur 5 Cleanser","","RINSE","TOPICAL","20120420","","UNAPPROVED DRUG OTHER","","Acella Pharmaceuticals, LLC","10; 5","mg/g; mg/g","","N","20251231"
"1908","SULFACETAMIDE SODIUM; SULFUR","Sulfacetamide Sodium and Sulfur","42192013612","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","42192-136","42192-136-12","42192-136_679caef9-ee89-4c41-abfb-1987997729fc","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10 Sulfur 5 Cleanser","","RINSE","TOPICAL","20120420","","UNAPPROVED DRUG OTHER","","Acella Pharmaceuticals, LLC","10; 5","mg/g; mg/g","","N","20251231"
"1909","SULFACETAMIDE SODIUM; SULFUR","Sulfacetamide Sodium and Sulfur","42192013608","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","42192-136","42192-136-08","42192-136_679caef9-ee89-4c41-abfb-1987997729fc","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10 Sulfur 5 Cleanser","","RINSE","TOPICAL","20120420","","UNAPPROVED DRUG OTHER","","Acella Pharmaceuticals, LLC","10; 5","mg/g; mg/g","","N","20251231"
"1910","SULFACETAMIDE SODIUM; SULFUR","Sodium Sulfacetamide and Sulfur","42192013901","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","42192-139","42192-139-01","42192-139_db2b5db3-6b73-4292-874e-d1893b647429","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE, SULFUR","","CREAM","TOPICAL","20140611","","UNAPPROVED DRUG OTHER","","Acella Pharmaceuticals, LLC","100; 50","mg/g; mg/g","","N","20251231"
"1911","SULFACETAMIDE SODIUM; SULFUR","Sulfacetamide Sodium and Sulfur","42192014360","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","42192-143","42192-143-60","42192-143_611118dd-dbf5-489a-95ec-761a0d8f8cb4","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam","","AEROSOL, FOAM","TOPICAL","20130416","20250831","UNAPPROVED DRUG OTHER","","Acella Pharmaceuticals, LLC","10; 5","mg/g; mg/g","","N",""
"1912","SULFACETAMIDE SODIUM; SULFUR","Sulfacetamide Sodium and Sulfur","42192014416","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","42192-144","42192-144-16","42192-144_f3d0bdef-7a45-458c-b5f7-f6b43c2a7deb","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 9 Sulfur 4.5 Wash","","RINSE","TOPICAL","20130320","","UNAPPROVED DRUG OTHER","","Acella Pharmaceuticals, LLC","9; 4.5","mg/g; mg/g","","N","20251231"
"1913","SULFACETAMIDE SODIUM","Sodium Sulfacetamide","42192014612","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","42192-146","42192-146-12","42192-146_7340c3e1-44c3-4dd8-a75d-1af4b614fd44","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide","","GEL","TOPICAL","20141010","","UNAPPROVED DRUG OTHER","","Acella Pharmaceuticals, LLC","100","mg/mL","","N","20251231"
"1914","SULFACETAMIDE SODIUM; SULFUR","Sulfacetamide Sodium and Sulfur","42192014708","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","42192-147","42192-147-08","42192-147_b08cb1fa-01aa-46a5-88a5-4892ecec02da","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10 Sulfur 2 Cleanser","","SOLUTION","TOPICAL","20140814","","UNAPPROVED DRUG OTHER","","Acella Pharmaceuticals, LLC","100; 20","mg/g; mg/g","","N","20251231"
"1915","SULFACETAMIDE SODIUM; SULFUR","Sodium Sulfacetamide and Sulfur","42192014902","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","42192-149","42192-149-02","42192-149_db2b5db3-6b73-4292-874e-d1893b647429","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE, SULFUR","","CREAM","TOPICAL","20140814","","UNAPPROVED DRUG OTHER","","Acella Pharmaceuticals, LLC","100; 50","mg/g; mg/g","","N","20251231"
"1916","SULFACETAMIDE SODIUM; SULFUR","Sulfacetamide Sodium and Sulfur","42192015002","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","42192-150","42192-150-02","42192-150_04ebb5f9-8352-433f-9b8a-5b7e7ead6a18","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10 Sulfur 2 cream","","CREAM","TOPICAL","20140821","","UNAPPROVED DRUG OTHER","","Acella Pharmaceuticals, LLC","100; 20","mg/g; mg/g","","N","20261231"
"1917","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","42192015610","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","42192-156","42192-156-10","42192-156_95f45cf0-cdf3-4755-85b4-b2de8bf5735b","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser","","LIQUID","TOPICAL","20161212","","UNAPPROVED DRUG OTHER","","Acella Pharmaceuticals, LLC","98; 48","mg/g; mg/g","","N","20251231"
"1918","CIPROFLOXACIN; FLUOCINOLONE ACETONIDE","ciprofloxacin and fluocinolone acetonide","42195012814","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","42195-128","42195-128-14","42195-128_2413ec85-b490-0f70-e063-6394a90aaca8","HUMAN PRESCRIPTION DRUG","Ciprofloxacin and Fluocinolone Acetonide","","SOLUTION","AURICULAR (OTIC)","20211004","","NDA AUTHORIZED GENERIC","NDA208251","Xspire Pharma, LLC",".75; .0625","mg/.25mL; mg/.25mL","","N","20251231"
"1919","CIPROFLOXACIN HYDROCHLORIDE","CIPROFLOXACIN","42195055014","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","42195-550","42195-550-14","42195-550_2413e537-63a6-14e9-e063-6394a90a3096","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Otic","","SOLUTION/ DROPS","AURICULAR (OTIC)","20120827","","NDA","NDA021918","Xspire Pharma, Llc",".5","mg/.25mL","","N","20251231"
"1920","ATOVAQUONE","Atovaquone","42239000108","Antimalarial [EPC], Antiprotozoal [EPC]","42239-001","42239-001-08","42239-001_34f67d35-7080-d493-e063-6294a90a5cc9","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20231114","","ANDA","ANDA214272","Abon Pharmaceuticals, LLC","750","mg/5mL","","N","20261231"
"1921","ATOVAQUONE","Atovaquone","42239000166","Antimalarial [EPC], Antiprotozoal [EPC]","42239-001","42239-001-66","42239-001_34f67d35-7080-d493-e063-6294a90a5cc9","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20231114","","ANDA","ANDA214272","Abon Pharmaceuticals, LLC","750","mg/5mL","","N","20261231"
"1922","CEFDINIR","Cefdinir","42291004360","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","42291-043","42291-043-60","42291-043_1acc4326-dea5-fe18-e063-6294a90aad7d","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20240613","","ANDA","ANDA065368","AvKARE","300","mg/1","","N","20251231"
"1923","AZITHROMYCIN MONOHYDRATE","Azithromycin","42291004430","Macrolide Antimicrobial [EPC], Macrolides [CS]","42291-044","42291-044-30","42291-044_16da421a-bae2-b709-e063-6394a90a58df","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20240424","","ANDA","ANDA065218","AvKARE","600","mg/1","","N","20251231"
"1924","CHLOROQUINE PHOSPHATE","CHLOROQUINE PHOSPHATE","42291004725","Antimalarial [EPC]","42291-047","42291-047-25","42291-047_0a341d0e-791b-85dd-e063-6294a90a42cb","HUMAN PRESCRIPTION DRUG","Chloroquine Phosphate","","TABLET","ORAL","20231115","","ANDA","ANDA040516","AvKARE","500","mg/1","","N","20251231"
"1925","AZITHROMYCIN DIHYDRATE","Azithromycin","42291008230","Macrolide Antimicrobial [EPC], Macrolides [CS]","42291-082","42291-082-30","42291-082_0e8b3994-a062-af6e-e063-6294a90a60ad","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20220411","","ANDA","ANDA210000","AvKARE","250","mg/1","","N","20251231"
"1926","AZITHROMYCIN DIHYDRATE","Azithromycin","42291008206","Macrolide Antimicrobial [EPC], Macrolides [CS]","42291-082","42291-082-06","42291-082_0e8b3994-a062-af6e-e063-6294a90a60ad","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20220411","","ANDA","ANDA210000","AvKARE","250","mg/1","","N","20251231"
"1927","AZITHROMYCIN DIHYDRATE","Azithromycin","42291008303","Macrolide Antimicrobial [EPC], Macrolides [CS]","42291-083","42291-083-03","42291-083_0e8b3994-a062-af6e-e063-6294a90a60ad","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20220411","","ANDA","ANDA210001","AvKARE","500","mg/1","","N","20251231"
"1928","AZITHROMYCIN DIHYDRATE","Azithromycin","42291008330","Macrolide Antimicrobial [EPC], Macrolides [CS]","42291-083","42291-083-30","42291-083_0e8b3994-a062-af6e-e063-6294a90a60ad","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20220411","","ANDA","ANDA210001","AvKARE","500","mg/1","","N","20251231"
"1929","CEPHALEXIN","Cephalexin","42291020850","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","42291-208","42291-208-50","42291-208_0e8c522a-7694-54c7-e063-6294a90a7e9d","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110811","","ANDA","ANDA062713","AvKARE","250","mg/1","","N","20251231"
"1930","CEPHALEXIN","Cephalexin","42291020950","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","42291-209","42291-209-50","42291-209_0e8c522a-7694-54c7-e063-6294a90a7e9d","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110811","","ANDA","ANDA062713","AvKARE","500","mg/1","","N","20251231"
"1931","PRIMAQUINE PHOSPHATE","PRIMAQUINE PHOSPHATE","42291051001","Antimalarial [EPC]","42291-510","42291-510-01","42291-510_0e902405-2b11-fc76-e063-6394a90ad984","HUMAN PRESCRIPTION DRUG","PRIMAQUINE PHOSPHATE","","TABLET, FILM COATED","ORAL","20190221","","ANDA","ANDA206043","AvKARE","15","mg/1","","N","20251231"
"1932","NYSTATIN","Nystatin","42291065190","Polyene Antifungal [EPC], Polyenes [CS]","42291-651","42291-651-90","42291-651_0e99334f-dd13-5853-e063-6294a90ad0f2","HUMAN PRESCRIPTION DRUG","Nystatin","","TABLET, FILM COATED","ORAL","20140120","","ANDA","ANDA062506","AvKARE","500000","[USP'U]/1","","N","20251231"
"1933","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","42291075801","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","42291-758","42291-758-01","42291-758_0e9aacfd-d4d3-be6c-e063-6394a90a430b","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20150805","","ANDA","ANDA076899","AvKARE","400; 80","mg/1; mg/1","","N","20251231"
"1934","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","42291075850","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","42291-758","42291-758-50","42291-758_0e9aacfd-d4d3-be6c-e063-6394a90a430b","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20150805","","ANDA","ANDA076899","AvKARE","400; 80","mg/1; mg/1","","N","20251231"
"1935","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","42291075901","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","42291-759","42291-759-01","42291-759_0e9aacfd-d4d3-be6c-e063-6394a90a430b","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20150805","","ANDA","ANDA076899","AvKARE","800; 160","mg/1; mg/1","","N","20251231"
"1936","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","42291075950","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","42291-759","42291-759-50","42291-759_0e9aacfd-d4d3-be6c-e063-6394a90a430b","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20150805","","ANDA","ANDA076899","AvKARE","800; 160","mg/1; mg/1","","N","20251231"
"1937","POSACONAZOLE","Posaconazole","42291091960","Azole Antifungal [EPC], Azoles [CS]","42291-919","42291-919-60","42291-919_fa293151-c70c-bbf0-e053-6294a90a77aa","HUMAN PRESCRIPTION DRUG","Posaconazole","","TABLET, DELAYED RELEASE","ORAL","20230420","","ANDA","ANDA216626","AvKARE","100","mg/1","","N","20251231"
"1938","MICONAZOLE NITRATE","Miconazole Nitrate","42291093885","Azole Antifungal [EPC], Azoles [CS]","42291-938","42291-938-85","42291-938_1a264e31-3305-6e3f-e063-6294a90adff1","HUMAN OTC DRUG","Miconazole Nitrate","","POWDER","TOPICAL","20240605","","OTC MONOGRAPH DRUG","M005","AvKARE","2","g/100g","","N","20251231"
"1939","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir hydrochloride","42291097201","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","42291-972","42291-972-01","42291-972_07eb7119-b679-5570-e063-6394a90a8038","HUMAN PRESCRIPTION DRUG","Valganciclovir hydrochloride for Oral","","POWDER, FOR SOLUTION","ORAL","20231017","","ANDA","ANDA205220","AvKARE","50","mg/mL","","N","20251231"
"1940","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir hydrochloride","42291097360","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","42291-973","42291-973-60","42291-973_0d0b8a06-8587-2cfe-e063-6294a90af7a0","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET, FILM COATED","ORAL","20231221","","ANDA","ANDA200790","AvKARE","450","mg/1","","N","20251231"
"1941","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","42385097101","Antimalarial [EPC], Antirheumatic Agent [EPC]","42385-971","42385-971-01","42385-971_5db4ef8e-532f-4bbe-94ec-489704e93be7","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET, FILM COATED","ORAL","20230306","","ANDA","ANDA210959","Laurus Labs Limited","200","mg/1","","N","20251231"
"1942","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","42385097111","Antimalarial [EPC], Antirheumatic Agent [EPC]","42385-971","42385-971-11","42385-971_5db4ef8e-532f-4bbe-94ec-489704e93be7","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET, FILM COATED","ORAL","20230306","","ANDA","ANDA210959","Laurus Labs Limited","200","mg/1","","N","20251231"
"1943","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","42385097105","Antimalarial [EPC], Antirheumatic Agent [EPC]","42385-971","42385-971-05","42385-971_5db4ef8e-532f-4bbe-94ec-489704e93be7","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET, FILM COATED","ORAL","20230306","","ANDA","ANDA210959","Laurus Labs Limited","200","mg/1","","N","20251231"
"1944","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","42385097160","Antimalarial [EPC], Antirheumatic Agent [EPC]","42385-971","42385-971-60","42385-971_5db4ef8e-532f-4bbe-94ec-489704e93be7","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET, FILM COATED","ORAL","20230306","","ANDA","ANDA210959","Laurus Labs Limited","200","mg/1","","N","20251231"
"1945","FLUCYTOSINE","Flucytosine","42494033901","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","42494-339","42494-339-01","42494-339_2a26a9f9-9188-4608-a587-77f76ec22b56","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170726","","NDA AUTHORIZED GENERIC","NDA017001","Cameron Pharmaceuticals, LLC","250","mg/1","","N","20251231"
"1946","FLUCYTOSINE","Flucytosine","42494033903","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","42494-339","42494-339-03","42494-339_2a26a9f9-9188-4608-a587-77f76ec22b56","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170726","","NDA AUTHORIZED GENERIC","NDA017001","Cameron Pharmaceuticals, LLC","250","mg/1","","N","20251231"
"1947","FLUCYTOSINE","Flucytosine","42494034001","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","42494-340","42494-340-01","42494-340_2a26a9f9-9188-4608-a587-77f76ec22b56","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170726","","NDA AUTHORIZED GENERIC","NDA017001","Cameron Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"1948","FLUCYTOSINE","Flucytosine","42494034003","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","42494-340","42494-340-03","42494-340_2a26a9f9-9188-4608-a587-77f76ec22b56","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170726","","NDA AUTHORIZED GENERIC","NDA017001","Cameron Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"1949","RIBAVIRIN","Ribavirin","42494042301","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","42494-423","42494-423-01","42494-423_48e8b38f-e794-438f-bf24-66d0363e4829","HUMAN PRESCRIPTION DRUG","Ribavirin","","POWDER, FOR SOLUTION","RESPIRATORY (INHALATION)","20200415","","NDA","NDA018859","Cameron Pharmaceuticals","6","g/1","","N","20251231"
"1950","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","42494045050","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","42494-450","42494-450-50","42494-450_afc558cf-0125-4291-879b-2695781d83aa","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","CAPSULE","ORAL","20240115","","ANDA","ANDA210729","Cameron Pharmaceuticals","125","mg/1","","N","20251231"
"1951","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","42494045020","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","42494-450","42494-450-20","42494-450_afc558cf-0125-4291-879b-2695781d83aa","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","CAPSULE","ORAL","20240115","","ANDA","ANDA210729","Cameron Pharmaceuticals","125","mg/1","","N","20251231"
"1952","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","42494045150","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","42494-451","42494-451-50","42494-451_afc558cf-0125-4291-879b-2695781d83aa","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","CAPSULE","ORAL","20240115","","ANDA","ANDA210729","Cameron Pharmaceuticals","250","mg/1","","N","20251231"
"1953","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","42494045120","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","42494-451","42494-451-20","42494-451_afc558cf-0125-4291-879b-2695781d83aa","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","CAPSULE","ORAL","20240115","","ANDA","ANDA210729","Cameron Pharmaceuticals","250","mg/1","","N","20251231"
"1954","BACITRACIN ZINC; POLYMYXIN B SULFATE","BACITRACIN ZINC, POLYMYXIN B SULFATE","42523011575","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","42523-115","42523-115-75","42523-115_37b88f6e-726a-eb56-e063-6294a90a072d","HUMAN OTC DRUG","POLVO DE SULFA FIRST AID ANTIBIOTIC","","POWDER","TOPICAL","20250526","","OTC MONOGRAPH DRUG","M004","Coastal Contract Packaging, Inc.","500; 10000","[USP'U]/g; [USP'U]/g","","N","20261231"
"1955","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","42571016001","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","42571-160","42571-160-01","42571-160_22fed4a2-f386-635e-e063-6394a90ae634","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","Micro Labs Limited","250; 125","mg/1; mg/1","","N","20251231"
"1956","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","42571016030","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","42571-160","42571-160-30","42571-160_22fed4a2-f386-635e-e063-6394a90ae634","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","Micro Labs Limited","250; 125","mg/1; mg/1","","N","20251231"
"1957","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","42571016011","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","42571-160","42571-160-11","42571-160_22fed4a2-f386-635e-e063-6394a90ae634","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","Micro Labs Limited","250; 125","mg/1; mg/1","","N","20251231"
"1958","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","42571016111","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","42571-161","42571-161-11","42571-161_22fed4a2-f386-635e-e063-6394a90ae634","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","Micro Labs Limited","500; 125","mg/1; mg/1","","N","20251231"
"1959","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","42571016142","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","42571-161","42571-161-42","42571-161_22fed4a2-f386-635e-e063-6394a90ae634","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","Micro Labs Limited","500; 125","mg/1; mg/1","","N","20251231"
"1960","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","42571016101","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","42571-161","42571-161-01","42571-161_22fed4a2-f386-635e-e063-6394a90ae634","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","Micro Labs Limited","500; 125","mg/1; mg/1","","N","20251231"
"1961","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","42571016244","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","42571-162","42571-162-44","42571-162_22fed4a2-f386-635e-e063-6394a90ae634","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","Micro Labs Limited","875; 125","mg/1; mg/1","","N","20251231"
"1962","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","42571016201","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","42571-162","42571-162-01","42571-162_22fed4a2-f386-635e-e063-6394a90ae634","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","Micro Labs Limited","875; 125","mg/1; mg/1","","N","20251231"
"1963","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","42571016242","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","42571-162","42571-162-42","42571-162_22fed4a2-f386-635e-e063-6394a90ae634","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","Micro Labs Limited","875; 125","mg/1; mg/1","","N","20251231"
"1964","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","42571016347","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","42571-163","42571-163-47","42571-163_22ff093e-19eb-7dd4-e063-6394a90ac20d","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20210701","","ANDA","ANDA205187","Micro Labs Limited","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"1965","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","42571016447","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","42571-164","42571-164-47","42571-164_22ff093e-19eb-7dd4-e063-6394a90ac20d","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20210701","","ANDA","ANDA205187","Micro Labs Limited","400; 57","mg/5mL; mg/5mL","","N","20251231"
"1966","AMOXICILLIN","Amoxicillin","42571023310","Penicillin-class Antibacterial [EPC], Penicillins [CS]","42571-233","42571-233-10","42571-233_238f9a44-0678-eb7c-e063-6394a90a4c73","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20221101","","ANDA","ANDA207471","Micro Labs Limited","250","mg/1","","N","20251231"
"1967","AMOXICILLIN","Amoxicillin","42571023330","Penicillin-class Antibacterial [EPC], Penicillins [CS]","42571-233","42571-233-30","42571-233_238f9a44-0678-eb7c-e063-6394a90a4c73","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20221101","","ANDA","ANDA207471","Micro Labs Limited","250","mg/1","","N","20251231"
"1968","AMOXICILLIN","Amoxicillin","42571023301","Penicillin-class Antibacterial [EPC], Penicillins [CS]","42571-233","42571-233-01","42571-233_238f9a44-0678-eb7c-e063-6394a90a4c73","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20221101","","ANDA","ANDA207471","Micro Labs Limited","250","mg/1","","N","20251231"
"1969","AMOXICILLIN","Amoxicillin","42571023305","Penicillin-class Antibacterial [EPC], Penicillins [CS]","42571-233","42571-233-05","42571-233_238f9a44-0678-eb7c-e063-6394a90a4c73","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20221101","","ANDA","ANDA207471","Micro Labs Limited","250","mg/1","","N","20251231"
"1970","AMOXICILLIN","Amoxicillin","42571023410","Penicillin-class Antibacterial [EPC], Penicillins [CS]","42571-234","42571-234-10","42571-234_238f9a44-0678-eb7c-e063-6394a90a4c73","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20221101","","ANDA","ANDA207471","Micro Labs Limited","500","mg/1","","N","20251231"
"1971","AMOXICILLIN","Amoxicillin","42571023430","Penicillin-class Antibacterial [EPC], Penicillins [CS]","42571-234","42571-234-30","42571-234_238f9a44-0678-eb7c-e063-6394a90a4c73","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20221101","","ANDA","ANDA207471","Micro Labs Limited","500","mg/1","","N","20251231"
"1972","AMOXICILLIN","Amoxicillin","42571023405","Penicillin-class Antibacterial [EPC], Penicillins [CS]","42571-234","42571-234-05","42571-234_238f9a44-0678-eb7c-e063-6394a90a4c73","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20221101","","ANDA","ANDA207471","Micro Labs Limited","500","mg/1","","N","20251231"
"1973","AMOXICILLIN","Amoxicillin","42571023401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","42571-234","42571-234-01","42571-234_238f9a44-0678-eb7c-e063-6394a90a4c73","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20221101","","ANDA","ANDA207471","Micro Labs Limited","500","mg/1","","N","20251231"
"1974","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","42571025001","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","42571-250","42571-250-01","42571-250_35016f15-e9fa-01d9-e063-6394a90a13c1","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Micro Labs Limited","75","mg/1","","N","20261231"
"1975","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","42571025067","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","42571-250","42571-250-67","42571-250_35016f15-e9fa-01d9-e063-6394a90a13c1","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Micro Labs Limited","75","mg/1","","N","20261231"
"1976","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","42571025110","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","42571-251","42571-251-10","42571-251_35016f15-e9fa-01d9-e063-6394a90a13c1","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Micro Labs Limited","150","mg/1","","N","20261231"
"1977","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","42571025123","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","42571-251","42571-251-23","42571-251_35016f15-e9fa-01d9-e063-6394a90a13c1","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Micro Labs Limited","150","mg/1","","N","20261231"
"1978","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","42571025105","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","42571-251","42571-251-05","42571-251_35016f15-e9fa-01d9-e063-6394a90a13c1","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Micro Labs Limited","150","mg/1","","N","20261231"
"1979","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","42571025101","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","42571-251","42571-251-01","42571-251_35016f15-e9fa-01d9-e063-6394a90a13c1","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Micro Labs Limited","150","mg/1","","N","20261231"
"1980","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","42571025201","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","42571-252","42571-252-01","42571-252_35016f15-e9fa-01d9-e063-6394a90a13c1","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Micro Labs Limited","300","mg/1","","N","20261231"
"1981","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","42571025210","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","42571-252","42571-252-10","42571-252_35016f15-e9fa-01d9-e063-6394a90a13c1","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Micro Labs Limited","300","mg/1","","N","20261231"
"1982","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","42571025205","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","42571-252","42571-252-05","42571-252_35016f15-e9fa-01d9-e063-6394a90a13c1","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Micro Labs Limited","300","mg/1","","N","20261231"
"1983","ERYTHROMYCIN","erythromycin","42571038425","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","42571-384","42571-384-25","42571-384_2a48007e-8455-66af-e063-6294a90afbbd","HUMAN PRESCRIPTION DRUG","erythromycin","","SOLUTION","TOPICAL","20210604","","ANDA","ANDA062687","MICRO LABS LIMITED","20","mg/mL","","N","20251231"
"1984","NITROFURANTOIN","Nitrofurantoin","42571039305","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","42571-393","42571-393-05","42571-393_35155f61-5d28-d364-e063-6294a90aa4c6","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20240401","","ANDA","ANDA217073","Micro Labs Limited","100","mg/1","","N","20261231"
"1985","NITROFURANTOIN","Nitrofurantoin","42571039390","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","42571-393","42571-393-90","42571-393_35155f61-5d28-d364-e063-6294a90aa4c6","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20240401","","ANDA","ANDA217073","Micro Labs Limited","100","mg/1","","N","20261231"
"1986","NITROFURANTOIN","Nitrofurantoin","42571039301","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","42571-393","42571-393-01","42571-393_35155f61-5d28-d364-e063-6294a90aa4c6","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20240401","","ANDA","ANDA217073","Micro Labs Limited","100","mg/1","","N","20261231"
"1987","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and clavulanate potassium","42571039570","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","42571-395","42571-395-70","42571-395_2bd14acf-1437-ec8d-e063-6394a90adc4f","HUMAN PRESCRIPTION DRUG","Amoxicillin and clavulanate potassium","","FOR SUSPENSION","ORAL","20240401","","ANDA","ANDA217805","Micro Labs Limited","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"1988","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and clavulanate potassium","42571039577","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","42571-395","42571-395-77","42571-395_2bd14acf-1437-ec8d-e063-6394a90adc4f","HUMAN PRESCRIPTION DRUG","Amoxicillin and clavulanate potassium","","FOR SUSPENSION","ORAL","20240401","","ANDA","ANDA217805","Micro Labs Limited","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"1989","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and clavulanate potassium","42571039546","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","42571-395","42571-395-46","42571-395_2bd14acf-1437-ec8d-e063-6394a90adc4f","HUMAN PRESCRIPTION DRUG","Amoxicillin and clavulanate potassium","","FOR SUSPENSION","ORAL","20240401","","ANDA","ANDA217805","Micro Labs Limited","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"1990","TOBRAMYCIN","Tobramycin solution","42571040892","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","42571-408","42571-408-92","42571-408_23008774-ec12-93b1-e063-6394a90ac97c","HUMAN PRESCRIPTION DRUG","Tobramycin","","INHALANT","RESPIRATORY (INHALATION)","20240101","","ANDA","ANDA217344","Micro Labs Limited","300","mg/5mL","","N","20251231"
"1991","DAPTOMYCIN","daptomycin","42658001101","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","42658-011","42658-011-01","42658-011_2b63c556-af83-7aa5-e063-6294a90a8dff","HUMAN PRESCRIPTION DRUG","daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20250101","","ANDA","ANDA212250","Hisun Pharmaceuticals USA, Inc.","500","mg/10mL","","N","20261231"
"1992","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","42708000214","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","42708-002","42708-002-14","42708-002_27611515-e689-228b-e063-6294a90a7709","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20061101","","ANDA","ANDA076794","QPharma Inc","500","mg/1","","N","20251231"
"1993","AMOXICILLIN","Amoxicillin","42708001030","Penicillin-class Antibacterial [EPC], Penicillins [CS]","42708-010","42708-010-30","42708-010_357d8682-acdb-c640-e063-6294a90a4c09","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","QPharma, Inc.","500","mg/1","","N","20261231"
"1994","CEPHALEXIN","Cephalexin","42708001728","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","42708-017","42708-017-28","42708-017_2760ef8f-55e5-aa1c-e063-6394a90a69f0","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","QPharma Inc","500","mg/1","","N","20251231"
"1995","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","42708005320","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","42708-053","42708-053-20","42708-053_357dfe45-0cc8-5890-e063-6294a90aae15","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","QPharma, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"1996","CEPHALEXIN","Cephalexin","42708007028","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","42708-070","42708-070-28","42708-070_2760fbbc-eca8-4df8-e063-6394a90a15f5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","QPharma Inc","500","mg/1","","N","20251231"
"1997","AMOXICILLIN","Amoxicillin","42708007630","Penicillin-class Antibacterial [EPC], Penicillins [CS]","42708-076","42708-076-30","42708-076_176c1251-92ea-2cce-e063-6394a90a0998","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","QPharma Inc","500","mg/1","","N","20251231"
"1998","AMOXICILLIN","Amoxicillin","42708007820","Penicillin-class Antibacterial [EPC], Penicillins [CS]","42708-078","42708-078-20","42708-078_357e3e68-dd25-abee-e063-6394a90afda5","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","QPharma, Inc.","875","mg/1","","N","20261231"
"1999","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","42708008814","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","42708-088","42708-088-14","42708-088_2760fb34-95ea-e201-e063-6294a90aa69c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","QPharma Inc","500","mg/1","","N","20251231"
"2000","PENICILLIN V POTASSIUM","Penicillin V Potassium","42708009814","Penicillin-class Antibacterial [EPC], Penicillins [CS]","42708-098","42708-098-14","42708-098_276122db-5464-05cc-e063-6394a90af46d","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","QPharma Inc","500","mg/1","","N","20251231"
"2001","CEPHALEXIN","Cephalexin","42708010028","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","42708-100","42708-100-28","42708-100_27613960-8ab5-ddd8-e063-6294a90a80e4","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","QPharma Inc","250","mg/1","","N","20251231"
"2002","AMOXICILLIN","Amoxicillin","42708011220","Penicillin-class Antibacterial [EPC], Penicillins [CS]","42708-112","42708-112-20","42708-112_35a5f114-ba14-cde1-e063-6294a90a7840","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20000926","","ANDA","ANDA065056","QPharma, Inc.","875","mg/1","","N","20261231"
"2003","CEPHALEXIN","Cephalexin","42708014528","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","42708-145","42708-145-28","42708-145_2761184d-994f-e421-e063-6394a90a69b8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","QPharma Inc","250","mg/1","","N","20251231"
"2004","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","42708014614","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","42708-146","42708-146-14","42708-146_276146a3-9ce5-4c4d-e063-6294a90ab4b8","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","QPharma Inc","500","mg/1","","N","20251231"
"2005","AMOXICILLIN","Amoxicillin","42708015330","Penicillin-class Antibacterial [EPC], Penicillins [CS]","42708-153","42708-153-30","42708-153_3591b831-319a-efa5-e063-6294a90ad3fe","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","QPharma, Inc.","500","mg/1","","N","20261231"
"2006","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","42708017828","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","42708-178","42708-178-28","42708-178_27744b73-57ac-7ee6-e063-6394a90abcc1","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","QPharma, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"2007","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","42708018428","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","42708-184","42708-184-28","42708-184_357f18fd-663f-8d08-e063-6294a90a22a1","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","QPharma, Inc.","25; 75","mg/1; mg/1","","N","20261231"
"2008","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","42708018814","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","42708-188","42708-188-14","42708-188_2c39e702-ca76-941d-e063-6394a90a3bcc","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","QPharma, Inc.","500","mg/1","","N","20261231"
"2009","FLUCYTOSINE","Flucytosine","42794000908","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","42794-009","42794-009-08","42794-009_f1f1b263-dcab-60e7-e053-2995a90ae493","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20180601","","ANDA","ANDA201566","Sigmapharm Laboratories, LLC","250","mg/1","","N","20251231"
"2010","FLUCYTOSINE","Flucytosine","42794001008","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","42794-010","42794-010-08","42794-010_f1f1b263-dcab-60e7-e053-2995a90ae493","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20180601","","ANDA","ANDA201566","Sigmapharm Laboratories, LLC","500","mg/1","","N","20251231"
"2011","TINIDAZOLE","Tinidazole","42799020701","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","42799-207","42799-207-01","42799-207_cacd17f5-c956-4f21-bdf9-822f52c66f36","HUMAN PRESCRIPTION DRUG","Tinidazole","","TABLET","ORAL","20191220","","ANDA","ANDA203808","Edenbridge Pharmaceuticals LLC.","250","mg/1","","N","20261231"
"2012","TINIDAZOLE","Tinidazole","42799020802","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","42799-208","42799-208-02","42799-208_cacd17f5-c956-4f21-bdf9-822f52c66f36","HUMAN PRESCRIPTION DRUG","Tinidazole","","TABLET","ORAL","20191220","","ANDA","ANDA203808","Edenbridge Pharmaceuticals LLC.","500","mg/1","","N","20261231"
"2013","TINIDAZOLE","Tinidazole","42799020801","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","42799-208","42799-208-01","42799-208_cacd17f5-c956-4f21-bdf9-822f52c66f36","HUMAN PRESCRIPTION DRUG","Tinidazole","","TABLET","ORAL","20191220","","ANDA","ANDA203808","Edenbridge Pharmaceuticals LLC.","500","mg/1","","N","20261231"
"2014","DEMECLOCYCLINE HYDROCHLORIDE","Demeclocycline Hydrochloride","42806014301","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","42806-143","42806-143-01","42806-143_b84008e7-52db-4b3e-a12e-cb939852ff0f","HUMAN PRESCRIPTION DRUG","Demeclocycline Hydrochloride","","TABLET, FILM COATED","ORAL","20150202","","ANDA","ANDA065447","Epic Pharma, LLC","150","mg/1","","N","20251231"
"2015","DEMECLOCYCLINE HYDROCHLORIDE","Demeclocycline Hydrochloride","42806014305","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","42806-143","42806-143-05","42806-143_b84008e7-52db-4b3e-a12e-cb939852ff0f","HUMAN PRESCRIPTION DRUG","Demeclocycline Hydrochloride","","TABLET, FILM COATED","ORAL","20150202","","ANDA","ANDA065447","Epic Pharma, LLC","150","mg/1","","N","20251231"
"2016","DEMECLOCYCLINE HYDROCHLORIDE","Demeclocycline Hydrochloride","42806014330","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","42806-143","42806-143-30","42806-143_b84008e7-52db-4b3e-a12e-cb939852ff0f","HUMAN PRESCRIPTION DRUG","Demeclocycline Hydrochloride","","TABLET, FILM COATED","ORAL","20150202","","ANDA","ANDA065447","Epic Pharma, LLC","150","mg/1","","N","20251231"
"2017","DEMECLOCYCLINE HYDROCHLORIDE","Demeclocycline Hydrochloride","42806014430","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","42806-144","42806-144-30","42806-144_b84008e7-52db-4b3e-a12e-cb939852ff0f","HUMAN PRESCRIPTION DRUG","Demeclocycline Hydrochloride","","TABLET, FILM COATED","ORAL","20150202","","ANDA","ANDA065447","Epic Pharma, LLC","300","mg/1","","N","20251231"
"2018","DEMECLOCYCLINE HYDROCHLORIDE","Demeclocycline Hydrochloride","42806014448","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","42806-144","42806-144-48","42806-144_b84008e7-52db-4b3e-a12e-cb939852ff0f","HUMAN PRESCRIPTION DRUG","Demeclocycline Hydrochloride","","TABLET, FILM COATED","ORAL","20150202","","ANDA","ANDA065447","Epic Pharma, LLC","300","mg/1","","N","20251231"
"2019","DEMECLOCYCLINE HYDROCHLORIDE","Demeclocycline Hydrochloride","42806014401","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","42806-144","42806-144-01","42806-144_b84008e7-52db-4b3e-a12e-cb939852ff0f","HUMAN PRESCRIPTION DRUG","Demeclocycline Hydrochloride","","TABLET, FILM COATED","ORAL","20150202","","ANDA","ANDA065447","Epic Pharma, LLC","300","mg/1","","N","20251231"
"2020","AZITHROMYCIN MONOHYDRATE","azithromycin","42806014731","Macrolide Antimicrobial [EPC], Macrolides [CS]","42806-147","42806-147-31","42806-147_8982f18b-d818-43db-acbd-4ca06d36b967","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","POWDER, FOR SUSPENSION","ORAL","20180410","","ANDA","ANDA207531","Epic Pharma, LLC","100","mg/5mL","","N","20251231"
"2021","AZITHROMYCIN MONOHYDRATE","azithromycin","42806014932","Macrolide Antimicrobial [EPC], Macrolides [CS]","42806-149","42806-149-32","42806-149_8982f18b-d818-43db-acbd-4ca06d36b967","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","POWDER, FOR SUSPENSION","ORAL","20180410","","ANDA","ANDA207531","Epic Pharma, LLC","200","mg/5mL","","N","20251231"
"2022","AZITHROMYCIN MONOHYDRATE","azithromycin","42806015033","Macrolide Antimicrobial [EPC], Macrolides [CS]","42806-150","42806-150-33","42806-150_8982f18b-d818-43db-acbd-4ca06d36b967","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","POWDER, FOR SUSPENSION","ORAL","20180410","","ANDA","ANDA207531","Epic Pharma, LLC","200","mg/5mL","","N","20251231"
"2023","AZITHROMYCIN MONOHYDRATE","azithromycin","42806015134","Macrolide Antimicrobial [EPC], Macrolides [CS]","42806-151","42806-151-34","42806-151_8982f18b-d818-43db-acbd-4ca06d36b967","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","POWDER, FOR SUSPENSION","ORAL","20180410","","ANDA","ANDA207531","Epic Pharma, LLC","200","mg/5mL","","N","20251231"
"2024","NYSTATIN","Nystatin Topical Powder","42806017815","Polyene Antifungal [EPC], Polyenes [CS]","42806-178","42806-178-15","42806-178_eb386427-9b1d-4b13-9e18-0f9cc00b4cb7","HUMAN PRESCRIPTION DRUG","Nystatin Topical Powder","","POWDER","TOPICAL","20180502","","ANDA","ANDA210532","Epic Pharma, LLC","100000","U/g","","N","20251231"
"2025","NYSTATIN","Nystatin Topical Powder","42806017860","Polyene Antifungal [EPC], Polyenes [CS]","42806-178","42806-178-60","42806-178_eb386427-9b1d-4b13-9e18-0f9cc00b4cb7","HUMAN PRESCRIPTION DRUG","Nystatin Topical Powder","","POWDER","TOPICAL","20180502","","ANDA","ANDA210532","Epic Pharma, LLC","100000","U/g","","N","20251231"
"2026","NYSTATIN","Nystatin Topical Powder","42806017830","Polyene Antifungal [EPC], Polyenes [CS]","42806-178","42806-178-30","42806-178_eb386427-9b1d-4b13-9e18-0f9cc00b4cb7","HUMAN PRESCRIPTION DRUG","Nystatin Topical Powder","","POWDER","TOPICAL","20180502","","ANDA","ANDA210532","Epic Pharma, LLC","100000","U/g","","N","20251231"
"2027","NYSTATIN","Nystatin Topical Powder","42806018530","Polyene Antifungal [EPC], Polyenes [CS]","42806-185","42806-185-30","42806-185_8723c280-f501-46c5-8be5-8a3e9cbd28b9","HUMAN PRESCRIPTION DRUG","Nystatin Topical Powder","","POWDER","TOPICAL","20230414","","ANDA","ANDA210532","Epic Pharma, LLC","100000","U/g","","N","20251231"
"2028","NYSTATIN","Nystatin Topical Powder","42806018515","Polyene Antifungal [EPC], Polyenes [CS]","42806-185","42806-185-15","42806-185_8723c280-f501-46c5-8be5-8a3e9cbd28b9","HUMAN PRESCRIPTION DRUG","Nystatin Topical Powder","","POWDER","TOPICAL","20230414","","ANDA","ANDA210532","Epic Pharma, LLC","100000","U/g","","N","20251231"
"2029","NYSTATIN","Nystatin Topical Powder","42806018560","Polyene Antifungal [EPC], Polyenes [CS]","42806-185","42806-185-60","42806-185_8723c280-f501-46c5-8be5-8a3e9cbd28b9","HUMAN PRESCRIPTION DRUG","Nystatin Topical Powder","","POWDER","TOPICAL","20230414","","ANDA","ANDA210532","Epic Pharma, LLC","100000","U/g","","N","20251231"
"2030","NYSTATIN","Nystatin Topical Powder","42806018615","Polyene Antifungal [EPC], Polyenes [CS]","42806-186","42806-186-15","42806-186_9370d48a-ca85-41a4-8038-6f170f7db42c","HUMAN PRESCRIPTION DRUG","KLAYESTA","","POWDER","TOPICAL","20230414","","ANDA","ANDA210532","Epic Pharma, LLC","100000","U/g","","N","20251231"
"2031","NYSTATIN","Nystatin Topical Powder","42806018660","Polyene Antifungal [EPC], Polyenes [CS]","42806-186","42806-186-60","42806-186_9370d48a-ca85-41a4-8038-6f170f7db42c","HUMAN PRESCRIPTION DRUG","KLAYESTA","","POWDER","TOPICAL","20230414","","ANDA","ANDA210532","Epic Pharma, LLC","100000","U/g","","N","20251231"
"2032","NYSTATIN","Nystatin Topical Powder","42806018630","Polyene Antifungal [EPC], Polyenes [CS]","42806-186","42806-186-30","42806-186_9370d48a-ca85-41a4-8038-6f170f7db42c","HUMAN PRESCRIPTION DRUG","KLAYESTA","","POWDER","TOPICAL","20230414","","ANDA","ANDA210532","Epic Pharma, LLC","100000","U/g","","N","20251231"
"2033","SULFADIAZINE","sulfadiazine","42806075760","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","42806-757","42806-757-60","42806-757_69f2d77c-8279-4524-93c2-f199e7973400","HUMAN PRESCRIPTION DRUG","SULFADIAZINE","","TABLET","ORAL","20211215","","ANDA","ANDA040091","EPIC PHARMA, LLC","500","mg/1","","N","20251231"
"2034","RIFAMPIN","rifampin","42806079930","Rifamycin Antibacterial [EPC], Rifamycins [CS]","42806-799","42806-799-30","42806-799_a4ac02e8-68ac-4e79-8ca5-0939dd002c87","HUMAN PRESCRIPTION DRUG","RIFAMPIN","","CAPSULE","ORAL","20211215","","ANDA","ANDA064150","EPIC PHARMA, LLC","300","mg/1","","N","20251231"
"2035","RIFAMPIN","rifampin","42806079960","Rifamycin Antibacterial [EPC], Rifamycins [CS]","42806-799","42806-799-60","42806-799_a4ac02e8-68ac-4e79-8ca5-0939dd002c87","HUMAN PRESCRIPTION DRUG","RIFAMPIN","","CAPSULE","ORAL","20211215","","ANDA","ANDA064150","EPIC PHARMA, LLC","300","mg/1","","N","20251231"
"2036","RIFAMPIN","rifampin","42806079905","Rifamycin Antibacterial [EPC], Rifamycins [CS]","42806-799","42806-799-05","42806-799_a4ac02e8-68ac-4e79-8ca5-0939dd002c87","HUMAN PRESCRIPTION DRUG","RIFAMPIN","","CAPSULE","ORAL","20211215","","ANDA","ANDA064150","EPIC PHARMA, LLC","300","mg/1","","N","20251231"
"2037","RIFAMPIN","rifampin","42806079901","Rifamycin Antibacterial [EPC], Rifamycins [CS]","42806-799","42806-799-01","42806-799_a4ac02e8-68ac-4e79-8ca5-0939dd002c87","HUMAN PRESCRIPTION DRUG","RIFAMPIN","","CAPSULE","ORAL","20211215","","ANDA","ANDA064150","EPIC PHARMA, LLC","300","mg/1","","N","20251231"
"2038","RIFAMPIN","rifampin","42806080101","Rifamycin Antibacterial [EPC], Rifamycins [CS]","42806-801","42806-801-01","42806-801_a4ac02e8-68ac-4e79-8ca5-0939dd002c87","HUMAN PRESCRIPTION DRUG","RIFAMPIN","","CAPSULE","ORAL","20211215","","ANDA","ANDA064150","EPIC PHARMA, LLC","150","mg/1","","N","20251231"
"2039","RIFAMPIN","rifampin","42806080130","Rifamycin Antibacterial [EPC], Rifamycins [CS]","42806-801","42806-801-30","42806-801_a4ac02e8-68ac-4e79-8ca5-0939dd002c87","HUMAN PRESCRIPTION DRUG","RIFAMPIN","","CAPSULE","ORAL","20211215","","ANDA","ANDA064150","EPIC PHARMA, LLC","150","mg/1","","N","20251231"
"2040","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate and polymyxin b sulfate","42961022201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","42961-222","42961-222-01","42961-222_fb1b966b-d9ec-4acd-a3ba-277c745bed7f","HUMAN OTC DRUG","Xpect Triple Antibiotic","","OINTMENT","TOPICAL","20220512","","OTC MONOGRAPH DRUG","M004","Cintas Corporation","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"2041","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate and polymyxin b sulfate","42961022204","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","42961-222","42961-222-04","42961-222_fb1b966b-d9ec-4acd-a3ba-277c745bed7f","HUMAN OTC DRUG","Xpect Triple Antibiotic","","OINTMENT","TOPICAL","20220512","","OTC MONOGRAPH DRUG","M004","Cintas Corporation","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"2042","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate and polymyxin b sulfate","42961022203","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","42961-222","42961-222-03","42961-222_fb1b966b-d9ec-4acd-a3ba-277c745bed7f","HUMAN OTC DRUG","Xpect Triple Antibiotic","","OINTMENT","TOPICAL","20220512","","OTC MONOGRAPH DRUG","M004","Cintas Corporation","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"2043","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate and polymyxin b sulfate","42961022202","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","42961-222","42961-222-02","42961-222_fb1b966b-d9ec-4acd-a3ba-277c745bed7f","HUMAN OTC DRUG","Xpect Triple Antibiotic","","OINTMENT","TOPICAL","20220512","","OTC MONOGRAPH DRUG","M004","Cintas Corporation","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"2044","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","42961023602","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","42961-236","42961-236-02","42961-236_e6f96b7e-f0be-4dc9-ae36-89d8d9ec9630","HUMAN OTC DRUG","Xpect Triple Antibiotic","","OINTMENT","TOPICAL","20230913","","OTC MONOGRAPH DRUG","M004","Cintas Corporation","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"2045","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","42961023603","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","42961-236","42961-236-03","42961-236_e6f96b7e-f0be-4dc9-ae36-89d8d9ec9630","HUMAN OTC DRUG","Xpect Triple Antibiotic","","OINTMENT","TOPICAL","20230913","","OTC MONOGRAPH DRUG","M004","Cintas Corporation","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"2046","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","43063007703","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","43063-077","43063-077-03","43063-077_1f0a506a-8862-3564-e063-6394a90aea7e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065096","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"2047","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","43063007706","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","43063-077","43063-077-06","43063-077_1f0a506a-8862-3564-e063-6394a90aea7e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065096","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"2048","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","43063007704","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","43063-077","43063-077-04","43063-077_1f0a506a-8862-3564-e063-6394a90aea7e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065096","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"2049","DICLOXACILLIN SODIUM","Dicloxacillin Sodium","43063018006","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-180","43063-180-06","43063-180_24255d3b-67ed-67fa-e063-6394a90a151d","HUMAN PRESCRIPTION DRUG","Dicloxacillin Sodium","","CAPSULE","ORAL","19900930","","ANDA","ANDA062286","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2050","AMOXICILLIN","Amoxicillin","43063034104","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-341","43063-341-04","43063-341_22937c6f-a08b-e39c-e063-6394a90a64ff","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","19930101","","ANDA","ANDA064013","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2051","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","43063037702","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","43063-377","43063-377-02","43063-377_1f1ee5de-2c73-b842-e063-6394a90a2f9c","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065096","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"2052","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","Atovaquone and Proguanil Hydrochloride","43063039320","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","43063-393","43063-393-20","43063-393_24260b8b-6dc3-71ee-e063-6394a90ade50","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil Hydrochloride","","TABLET, FILM COATED","ORAL","20110915","","ANDA","ANDA091211","PD-Rx Pharmaceuticals, Inc.","250; 100","mg/1; mg/1","","N","20251231"
"2053","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","Atovaquone and Proguanil Hydrochloride","43063039314","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","43063-393","43063-393-14","43063-393_24260b8b-6dc3-71ee-e063-6394a90ade50","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil Hydrochloride","","TABLET, FILM COATED","ORAL","20110915","","ANDA","ANDA091211","PD-Rx Pharmaceuticals, Inc.","250; 100","mg/1; mg/1","","N","20251231"
"2054","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","43063041006","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-410","43063-410-06","43063-410_36b0c0b6-8368-77aa-e063-6394a90a0cc7","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"2055","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","43063041010","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-410","43063-410-10","43063-410_36b0c0b6-8368-77aa-e063-6394a90a0cc7","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"2056","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","43063041020","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-410","43063-410-20","43063-410_36b0c0b6-8368-77aa-e063-6394a90a0cc7","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"2057","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","43063041014","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-410","43063-410-14","43063-410_36b0c0b6-8368-77aa-e063-6394a90a0cc7","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"2058","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","43063041012","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-410","43063-410-12","43063-410_36b0c0b6-8368-77aa-e063-6394a90a0cc7","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"2059","DICLOXACILLIN SODIUM","Dicloxacillin Sodium","43063047330","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-473","43063-473-30","43063-473_243754c3-fb3f-2610-e063-6394a90a1406","HUMAN PRESCRIPTION DRUG","Dicloxacillin Sodium","","CAPSULE","ORAL","19900930","","ANDA","ANDA062286","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2060","DICLOXACILLIN SODIUM","Dicloxacillin Sodium","43063047320","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-473","43063-473-20","43063-473_243754c3-fb3f-2610-e063-6394a90a1406","HUMAN PRESCRIPTION DRUG","Dicloxacillin Sodium","","CAPSULE","ORAL","19900930","","ANDA","ANDA062286","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2061","CEPHALEXIN","Cephalexin","43063049704","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-497","43063-497-04","43063-497_1d8c6ce0-2d85-2993-e063-6294a90a897b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2062","CEPHALEXIN","Cephalexin","43063049706","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-497","43063-497-06","43063-497_1d8c6ce0-2d85-2993-e063-6294a90a897b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2063","CEPHALEXIN","Cephalexin","43063049710","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-497","43063-497-10","43063-497_1d8c6ce0-2d85-2993-e063-6294a90a897b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2064","CEPHALEXIN","Cephalexin","43063049715","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-497","43063-497-15","43063-497_1d8c6ce0-2d85-2993-e063-6294a90a897b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2065","CEPHALEXIN","Cephalexin","43063049720","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-497","43063-497-20","43063-497_1d8c6ce0-2d85-2993-e063-6294a90a897b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2066","CEPHALEXIN","Cephalexin","43063049709","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-497","43063-497-09","43063-497_1d8c6ce0-2d85-2993-e063-6294a90a897b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2067","CEPHALEXIN","Cephalexin","43063049730","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-497","43063-497-30","43063-497_1d8c6ce0-2d85-2993-e063-6294a90a897b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2068","CEPHALEXIN","Cephalexin","43063049740","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-497","43063-497-40","43063-497_1d8c6ce0-2d85-2993-e063-6294a90a897b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2069","CEPHALEXIN","Cephalexin","43063049728","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-497","43063-497-28","43063-497_1d8c6ce0-2d85-2993-e063-6294a90a897b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2070","CEPHALEXIN","Cephalexin","43063049708","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-497","43063-497-08","43063-497_1d8c6ce0-2d85-2993-e063-6294a90a897b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2071","CLARITHROMYCIN","Clarithromycin","43063053020","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","43063-530","43063-530-20","43063-530_11ff3fd5-ad00-8eb5-e063-6294a90a9372","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2072","CLARITHROMYCIN","Clarithromycin","43063053014","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","43063-530","43063-530-14","43063-530_11ff3fd5-ad00-8eb5-e063-6294a90a9372","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2073","CEPHALEXIN","Cephalexin","43063053606","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-536","43063-536-06","43063-536_24381665-427d-31c5-e063-6394a90aceb5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2074","CEPHALEXIN","Cephalexin","43063053608","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-536","43063-536-08","43063-536_24381665-427d-31c5-e063-6394a90aceb5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2075","CEPHALEXIN","Cephalexin","43063053609","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-536","43063-536-09","43063-536_24381665-427d-31c5-e063-6394a90aceb5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2076","CEPHALEXIN","Cephalexin","43063053614","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-536","43063-536-14","43063-536_24381665-427d-31c5-e063-6394a90aceb5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2077","CEPHALEXIN","Cephalexin","43063053620","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-536","43063-536-20","43063-536_24381665-427d-31c5-e063-6394a90aceb5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2078","CEPHALEXIN","Cephalexin","43063053621","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-536","43063-536-21","43063-536_24381665-427d-31c5-e063-6394a90aceb5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2079","CEPHALEXIN","Cephalexin","43063053624","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-536","43063-536-24","43063-536_24381665-427d-31c5-e063-6394a90aceb5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2080","CEPHALEXIN","Cephalexin","43063053628","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-536","43063-536-28","43063-536_24381665-427d-31c5-e063-6394a90aceb5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2081","CEPHALEXIN","Cephalexin","43063053630","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-536","43063-536-30","43063-536_24381665-427d-31c5-e063-6394a90aceb5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2082","CEPHALEXIN","Cephalexin","43063053640","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-536","43063-536-40","43063-536_24381665-427d-31c5-e063-6394a90aceb5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2083","CEPHALEXIN","Cephalexin","43063053656","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-536","43063-536-56","43063-536_24381665-427d-31c5-e063-6394a90aceb5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2084","CEPHALEXIN","Cephalexin","43063053604","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-536","43063-536-04","43063-536_24381665-427d-31c5-e063-6394a90aceb5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2085","CEPHALEXIN","Cephalexin","43063053610","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-536","43063-536-10","43063-536_24381665-427d-31c5-e063-6394a90aceb5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2086","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","43063054701","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-547","43063-547-01","43063-547_2f3a7ef3-c294-3acb-e063-6294a90ad47f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2087","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","43063054702","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-547","43063-547-02","43063-547_2f3a7ef3-c294-3acb-e063-6294a90ad47f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2088","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","43063054704","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-547","43063-547-04","43063-547_2f3a7ef3-c294-3acb-e063-6294a90ad47f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2089","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","43063054706","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-547","43063-547-06","43063-547_2f3a7ef3-c294-3acb-e063-6294a90ad47f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2090","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","43063054710","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-547","43063-547-10","43063-547_2f3a7ef3-c294-3acb-e063-6294a90ad47f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2091","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","43063054720","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-547","43063-547-20","43063-547_2f3a7ef3-c294-3acb-e063-6294a90ad47f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2092","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","43063054728","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-547","43063-547-28","43063-547_2f3a7ef3-c294-3acb-e063-6294a90ad47f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2093","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","43063054730","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-547","43063-547-30","43063-547_2f3a7ef3-c294-3acb-e063-6294a90ad47f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2094","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","43063054779","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-547","43063-547-79","43063-547_2f3a7ef3-c294-3acb-e063-6294a90ad47f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2095","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","43063054782","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-547","43063-547-82","43063-547_2f3a7ef3-c294-3acb-e063-6294a90ad47f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2096","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","43063054714","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-547","43063-547-14","43063-547_2f3a7ef3-c294-3acb-e063-6294a90ad47f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2097","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","43063054703","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-547","43063-547-03","43063-547_2f3a7ef3-c294-3acb-e063-6294a90ad47f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2098","CEFADROXIL","Cefadroxil","43063055314","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-553","43063-553-14","43063-553_2f3a95a9-25cd-d525-e063-6394a90a460f","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20080423","","ANDA","ANDA065392","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2099","CEFADROXIL","Cefadroxil","43063055320","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-553","43063-553-20","43063-553_2f3a95a9-25cd-d525-e063-6394a90a460f","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20080423","","ANDA","ANDA065392","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2100","CEFADROXIL","Cefadroxil","43063055328","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-553","43063-553-28","43063-553_2f3a95a9-25cd-d525-e063-6394a90a460f","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20080423","","ANDA","ANDA065392","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2101","CEFADROXIL","Cefadroxil","43063055310","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-553","43063-553-10","43063-553_2f3a95a9-25cd-d525-e063-6394a90a460f","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20080423","","ANDA","ANDA065392","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2102","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063055715","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-557","43063-557-15","43063-557_24b28d19-4bc9-e350-e063-6394a90ac146","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2103","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063055720","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-557","43063-557-20","43063-557_24b28d19-4bc9-e350-e063-6394a90ac146","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2104","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063055728","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-557","43063-557-28","43063-557_24b28d19-4bc9-e350-e063-6394a90ac146","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2105","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063055706","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-557","43063-557-06","43063-557_24b28d19-4bc9-e350-e063-6394a90ac146","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2106","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063055740","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-557","43063-557-40","43063-557_24b28d19-4bc9-e350-e063-6394a90ac146","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2107","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063055730","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-557","43063-557-30","43063-557_24b28d19-4bc9-e350-e063-6394a90ac146","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2108","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063055704","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-557","43063-557-04","43063-557_24b28d19-4bc9-e350-e063-6394a90ac146","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2109","AMOXICILLIN","Amoxicillin","43063056306","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-563","43063-563-06","43063-563_17de878e-e608-6d2d-e063-6394a90a5990","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2110","AMOXICILLIN","Amoxicillin","43063056308","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-563","43063-563-08","43063-563_17de878e-e608-6d2d-e063-6394a90a5990","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2111","AMOXICILLIN","Amoxicillin","43063056314","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-563","43063-563-14","43063-563_17de878e-e608-6d2d-e063-6394a90a5990","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2112","AMOXICILLIN","Amoxicillin","43063056315","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-563","43063-563-15","43063-563_17de878e-e608-6d2d-e063-6394a90a5990","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2113","AMOXICILLIN","Amoxicillin","43063056321","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-563","43063-563-21","43063-563_17de878e-e608-6d2d-e063-6394a90a5990","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2114","AMOXICILLIN","Amoxicillin","43063056330","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-563","43063-563-30","43063-563_17de878e-e608-6d2d-e063-6394a90a5990","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2115","AMOXICILLIN","Amoxicillin","43063056340","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-563","43063-563-40","43063-563_17de878e-e608-6d2d-e063-6394a90a5990","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2116","AMOXICILLIN","Amoxicillin","43063056356","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-563","43063-563-56","43063-563_17de878e-e608-6d2d-e063-6394a90a5990","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2117","AMOXICILLIN","Amoxicillin","43063056360","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-563","43063-563-60","43063-563_17de878e-e608-6d2d-e063-6394a90a5990","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2118","AMOXICILLIN","Amoxicillin","43063056363","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-563","43063-563-63","43063-563_17de878e-e608-6d2d-e063-6394a90a5990","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2119","AMOXICILLIN","Amoxicillin","43063056309","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-563","43063-563-09","43063-563_17de878e-e608-6d2d-e063-6394a90a5990","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2120","AMOXICILLIN","Amoxicillin","43063056328","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-563","43063-563-28","43063-563_17de878e-e608-6d2d-e063-6394a90a5990","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2121","ERYTHROMYCIN","Erythromycin","43063056930","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","43063-569","43063-569-30","43063-569_243896df-eedc-bfac-e063-6394a90a906f","HUMAN PRESCRIPTION DRUG","ERY-TAB","","TABLET, DELAYED RELEASE","ORAL","20110418","","ANDA","ANDA062298","PD-Rx Pharmaceuticals, Inc.","333","mg/1","","N","20251231"
"2122","AMOXICILLIN","Amoxicillin","43063057415","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-574","43063-574-15","43063-574_32fbc384-f6a4-23ce-e063-6394a90af1e6","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"2123","AMOXICILLIN","Amoxicillin","43063057421","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-574","43063-574-21","43063-574_32fbc384-f6a4-23ce-e063-6394a90af1e6","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"2124","AMOXICILLIN","Amoxicillin","43063057430","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-574","43063-574-30","43063-574_32fbc384-f6a4-23ce-e063-6394a90af1e6","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"2125","AMOXICILLIN","Amoxicillin","43063057406","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-574","43063-574-06","43063-574_32fbc384-f6a4-23ce-e063-6394a90af1e6","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"2126","AMOXICILLIN","Amoxicillin","43063057404","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-574","43063-574-04","43063-574_32fbc384-f6a4-23ce-e063-6394a90af1e6","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"2127","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063057628","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-576","43063-576-28","43063-576_24387623-5bb9-a6bd-e063-6394a90a0fb4","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2128","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063057640","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-576","43063-576-40","43063-576_24387623-5bb9-a6bd-e063-6394a90a0fb4","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2129","CEFADROXIL","Cefadroxil","43063059528","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-595","43063-595-28","43063-595_17dfd29a-9b42-0f7d-e063-6394a90ae4fd","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2130","CEFADROXIL","Cefadroxil","43063059520","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-595","43063-595-20","43063-595_17dfd29a-9b42-0f7d-e063-6394a90ae4fd","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2131","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063061440","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-614","43063-614-40","43063-614_2439a316-fe8f-ec31-e063-6394a90a4d46","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2132","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063062240","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-622","43063-622-40","43063-622_2439ae6d-efc5-429b-e063-6394a90aa759","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2133","CEFUROXIME AXETIL","Cefuroxime Axetil","43063062320","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-623","43063-623-20","43063-623_24217658-9d12-7b32-e063-6394a90a1dbe","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2134","CEFUROXIME AXETIL","Cefuroxime Axetil","43063062330","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-623","43063-623-30","43063-623_24217658-9d12-7b32-e063-6394a90a1dbe","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2135","CEFUROXIME AXETIL","Cefuroxime Axetil","43063062314","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-623","43063-623-14","43063-623_24217658-9d12-7b32-e063-6394a90a1dbe","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2136","CEPHALEXIN","Cephalexin","43063063428","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-634","43063-634-28","43063-634_13785daa-6182-3206-e063-6294a90a036c","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2137","CEPHALEXIN","Cephalexin","43063063440","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-634","43063-634-40","43063-634_13785daa-6182-3206-e063-6294a90a036c","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2138","FLUCONAZOLE","Fluconazole","43063064202","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","43063-642","43063-642-02","43063-642_22ca6e3a-ad9a-8713-e063-6394a90a41b9","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","PD-Rx Pharmaceuticals, Inc.","150","mg/1","","N","20251231"
"2139","FLUCONAZOLE","Fluconazole","43063064510","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","43063-645","43063-645-10","43063-645_22ca7a64-145e-868f-e063-6394a90a82fc","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","PD-Rx Pharmaceuticals, Inc.","100","mg/1","","N","20251231"
"2140","CEFUROXIME AXETIL","Cefuroxime axetil","43063065614","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-656","43063-656-14","43063-656_1cbd707d-3df0-9d86-e063-6294a90aa7d6","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2141","CEFUROXIME AXETIL","Cefuroxime axetil","43063065620","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-656","43063-656-20","43063-656_1cbd707d-3df0-9d86-e063-6294a90aa7d6","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2142","CEFUROXIME AXETIL","Cefuroxime axetil","43063065760","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-657","43063-657-60","43063-657_2473fb44-71f5-a936-e063-6394a90aed89","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2143","CEFUROXIME AXETIL","Cefuroxime axetil","43063065720","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-657","43063-657-20","43063-657_2473fb44-71f5-a936-e063-6394a90aed89","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2144","CEPHALEXIN","Cephalexin","43063067828","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-678","43063-678-28","43063-678_13787305-de64-3bae-e063-6294a90a4520","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2145","CEPHALEXIN","Cephalexin","43063067840","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-678","43063-678-40","43063-678_13787305-de64-3bae-e063-6294a90a4520","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2146","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063068040","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-680","43063-680-40","43063-680_2474ed29-3b3e-5db1-e063-6394a90a84c9","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2147","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063070406","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-704","43063-704-06","43063-704_2475185d-eab4-958e-e063-6394a90a3bd4","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2148","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063070420","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-704","43063-704-20","43063-704_2475185d-eab4-958e-e063-6394a90a3bd4","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2149","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063070428","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-704","43063-704-28","43063-704_2475185d-eab4-958e-e063-6394a90a3bd4","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2150","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063070440","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-704","43063-704-40","43063-704_2475185d-eab4-958e-e063-6394a90a3bd4","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2151","METRONIDAZOLE","Metronidazole","43063071921","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","43063-719","43063-719-21","43063-719_1f9671d9-2318-5b45-e063-6294a90a9d8e","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2152","METRONIDAZOLE","Metronidazole","43063071928","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","43063-719","43063-719-28","43063-719_1f9671d9-2318-5b45-e063-6294a90a9d8e","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2153","METRONIDAZOLE","Metronidazole","43063071930","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","43063-719","43063-719-30","43063-719_1f9671d9-2318-5b45-e063-6294a90a9d8e","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2154","METRONIDAZOLE","Metronidazole","43063071906","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","43063-719","43063-719-06","43063-719_1f9671d9-2318-5b45-e063-6294a90a9d8e","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2155","METRONIDAZOLE","Metronidazole","43063071956","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","43063-719","43063-719-56","43063-719_1f9671d9-2318-5b45-e063-6294a90a9d8e","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2156","PRIMAQUINE PHOSPHATE","Primaquine Phosphate","43063072114","Antimalarial [EPC]","43063-721","43063-721-14","43063-721_36c0e266-7161-2887-e063-6294a90a9fc1","HUMAN PRESCRIPTION DRUG","Primaquine Phosphate","","TABLET","ORAL","20140801","","ANDA","ANDA204476","PD-Rx Pharmaceuticals, Inc.","15","mg/1","","N","20261231"
"2157","PRIMAQUINE PHOSPHATE","Primaquine Phosphate","43063072128","Antimalarial [EPC]","43063-721","43063-721-28","43063-721_36c0e266-7161-2887-e063-6294a90a9fc1","HUMAN PRESCRIPTION DRUG","Primaquine Phosphate","","TABLET","ORAL","20140801","","ANDA","ANDA204476","PD-Rx Pharmaceuticals, Inc.","15","mg/1","","N","20261231"
"2158","METRONIDAZOLE","Metronidazole","43063073814","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","43063-738","43063-738-14","43063-738_200aca84-c8f0-ed51-e063-6394a90a8343","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2159","METRONIDAZOLE","Metronidazole","43063073860","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","43063-738","43063-738-60","43063-738_200aca84-c8f0-ed51-e063-6394a90a8343","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2160","METRONIDAZOLE","Metronidazole","43063073830","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","43063-738","43063-738-30","43063-738_200aca84-c8f0-ed51-e063-6394a90a8343","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2161","METRONIDAZOLE","Metronidazole","43063073820","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","43063-738","43063-738-20","43063-738_200aca84-c8f0-ed51-e063-6394a90a8343","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2162","CLARITHROMYCIN","Clarithromycin","43063075214","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","43063-752","43063-752-14","43063-752_1a3d0aef-6486-bfa1-e063-6294a90aac45","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20191123","","ANDA","ANDA203584","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2163","CLARITHROMYCIN","Clarithromycin","43063075220","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","43063-752","43063-752-20","43063-752_1a3d0aef-6486-bfa1-e063-6294a90aac45","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20191123","","ANDA","ANDA203584","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2164","CLARITHROMYCIN","Clarithromycin","43063075228","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","43063-752","43063-752-28","43063-752_1a3d0aef-6486-bfa1-e063-6294a90aac45","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20191123","","ANDA","ANDA203584","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2165","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","43063076728","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-767","43063-767-28","43063-767_36c1792e-ec69-ff9a-e063-6294a90a325b","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","PD-Rx Pharmaceuticals, Inc.","750","mg/1","","N","20261231"
"2166","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063078006","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-780","43063-780-06","43063-780_2c25446b-961e-ee26-e063-6394a90a7385","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2167","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063078020","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-780","43063-780-20","43063-780_2c25446b-961e-ee26-e063-6394a90a7385","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2168","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063078028","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-780","43063-780-28","43063-780_2c25446b-961e-ee26-e063-6394a90a7385","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2169","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063078030","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-780","43063-780-30","43063-780_2c25446b-961e-ee26-e063-6394a90a7385","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2170","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063078040","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-780","43063-780-40","43063-780_2c25446b-961e-ee26-e063-6394a90a7385","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2171","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063078015","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-780","43063-780-15","43063-780_2c25446b-961e-ee26-e063-6394a90a7385","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2172","AMOXICILLIN","Amoxicillin","43063082004","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-820","43063-820-04","43063-820_1c357c04-3f57-a942-e063-6294a90a1a22","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2173","AMOXICILLIN","Amoxicillin","43063082014","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-820","43063-820-14","43063-820_1c357c04-3f57-a942-e063-6294a90a1a22","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2174","AMOXICILLIN","Amoxicillin","43063082015","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-820","43063-820-15","43063-820_1c357c04-3f57-a942-e063-6294a90a1a22","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2175","AMOXICILLIN","Amoxicillin","43063082020","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-820","43063-820-20","43063-820_1c357c04-3f57-a942-e063-6294a90a1a22","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2176","AMOXICILLIN","Amoxicillin","43063082008","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-820","43063-820-08","43063-820_1c357c04-3f57-a942-e063-6294a90a1a22","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2177","AMOXICILLIN","Amoxicillin","43063082028","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-820","43063-820-28","43063-820_1c357c04-3f57-a942-e063-6294a90a1a22","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2178","AMOXICILLIN","Amoxicillin","43063082030","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-820","43063-820-30","43063-820_1c357c04-3f57-a942-e063-6294a90a1a22","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2179","AMOXICILLIN","Amoxicillin","43063082040","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-820","43063-820-40","43063-820_1c357c04-3f57-a942-e063-6294a90a1a22","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2180","AMOXICILLIN","Amoxicillin","43063082050","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-820","43063-820-50","43063-820_1c357c04-3f57-a942-e063-6294a90a1a22","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2181","AMOXICILLIN","Amoxicillin","43063082056","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-820","43063-820-56","43063-820_1c357c04-3f57-a942-e063-6294a90a1a22","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2182","AMOXICILLIN","Amoxicillin","43063082006","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-820","43063-820-06","43063-820_1c357c04-3f57-a942-e063-6294a90a1a22","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2183","AMOXICILLIN","Amoxicillin","43063082021","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-820","43063-820-21","43063-820_1c357c04-3f57-a942-e063-6294a90a1a22","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2184","CLARITHROMYCIN","Clarithromycin","43063082320","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","43063-823","43063-823-20","43063-823_1c35c84d-13ea-16a1-e063-6294a90a0e09","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2185","CLARITHROMYCIN","Clarithromycin","43063082328","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","43063-823","43063-823-28","43063-823_1c35c84d-13ea-16a1-e063-6294a90a0e09","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2186","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","43063086906","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-869","43063-869-06","43063-869_36c1922f-56d3-9a55-e063-6294a90a5571","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2187","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","43063086910","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-869","43063-869-10","43063-869_36c1922f-56d3-9a55-e063-6294a90a5571","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2188","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","43063086920","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-869","43063-869-20","43063-869_36c1922f-56d3-9a55-e063-6294a90a5571","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2189","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","43063086930","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-869","43063-869-30","43063-869_36c1922f-56d3-9a55-e063-6294a90a5571","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2190","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","43063086908","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-869","43063-869-08","43063-869_36c1922f-56d3-9a55-e063-6294a90a5571","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2191","AMOXICILLIN","Amoxicillin","43063088520","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-885","43063-885-20","43063-885_2cf156b1-81d6-05eb-e063-6394a90aa475","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, COATED","ORAL","20060329","","ANDA","ANDA065255","PD-Rx Pharmaceuticals, Inc.","875","mg/1","","N","20261231"
"2192","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","43063090620","Allylamine Antifungal [EPC], Allylamine [CS]","43063-906","43063-906-20","43063-906_1c5d7aea-f0b6-420a-e063-6394a90a8b22","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2193","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","43063090642","Allylamine Antifungal [EPC], Allylamine [CS]","43063-906","43063-906-42","43063-906_1c5d7aea-f0b6-420a-e063-6394a90a8b22","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2194","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","43063090690","Allylamine Antifungal [EPC], Allylamine [CS]","43063-906","43063-906-90","43063-906_1c5d7aea-f0b6-420a-e063-6394a90a8b22","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"2195","AMOXICILLIN","Amoxicillin","43063091530","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-915","43063-915-30","43063-915_1c5da052-9cee-8d0f-e063-6294a90aac84","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2196","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","43063092304","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-923","43063-923-04","43063-923_302b5697-b550-7973-e063-6294a90a78c6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2197","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","43063092306","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-923","43063-923-06","43063-923_302b5697-b550-7973-e063-6294a90a78c6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2198","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","43063092302","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-923","43063-923-02","43063-923_302b5697-b550-7973-e063-6294a90a78c6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2199","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","43063092320","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-923","43063-923-20","43063-923_302b5697-b550-7973-e063-6294a90a78c6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2200","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","43063092328","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-923","43063-923-28","43063-923_302b5697-b550-7973-e063-6294a90a78c6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2201","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","43063092310","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-923","43063-923-10","43063-923_302b5697-b550-7973-e063-6294a90a78c6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2202","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","43063092314","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-923","43063-923-14","43063-923_302b5697-b550-7973-e063-6294a90a78c6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2203","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","43063092330","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43063-923","43063-923-30","43063-923_302b5697-b550-7973-e063-6294a90a78c6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"2204","CLARITHROMYCIN","Clarithromycin","43063094214","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","43063-942","43063-942-14","43063-942_1c5dd872-3205-9aa3-e063-6394a90a6c5b","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED, EXTENDED RELEASE","ORAL","20190910","","ANDA","ANDA208987","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2205","CEFDINIR","Cefdinir","43063095920","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-959","43063-959-20","43063-959_1cd197fe-059c-b5b9-e063-6394a90a93f8","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"2206","CEFDINIR","Cefdinir","43063095914","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-959","43063-959-14","43063-959_1cd197fe-059c-b5b9-e063-6394a90a93f8","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"2207","CEFDINIR","Cefdinir","43063096420","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-964","43063-964-20","43063-964_1cd2d244-5839-592e-e063-6294a90a17de","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"2208","CEFDINIR","Cefdinir","43063096414","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43063-964","43063-964-14","43063-964_1cd2d244-5839-592e-e063-6294a90a17de","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"2209","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063099540","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-995","43063-995-40","43063-995_1cd58a6d-52a1-adb4-e063-6394a90a7a37","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2210","PENICILLIN V POTASSIUM","Penicillin V Potassium","43063099528","Penicillin-class Antibacterial [EPC], Penicillins [CS]","43063-995","43063-995-28","43063-995_1cd58a6d-52a1-adb4-e063-6394a90a7a37","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"2211","CLINDAMYCIN PHOSPHATE","Clindamycin phosphate","43066099324","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","43066-993","43066-993-24","43066-993_a0176463-4969-45bd-b2ab-cbf0e2dfe05e","HUMAN PRESCRIPTION DRUG","Clindamycin phosphate","","INJECTION, SOLUTION","INTRAVENOUS","20170628","","ANDA","ANDA208084","Baxter Healthcare Corporation","600","mg/50mL","","N","20261231"
"2212","CLINDAMYCIN PHOSPHATE","Clindamycin phosphate","43066099524","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","43066-995","43066-995-24","43066-995_a0176463-4969-45bd-b2ab-cbf0e2dfe05e","HUMAN PRESCRIPTION DRUG","Clindamycin phosphate","","INJECTION, SOLUTION","INTRAVENOUS","20170628","","ANDA","ANDA208084","Baxter Healthcare Corporation","900","mg/50mL","","N","20261231"
"2213","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCl","43136010001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","43136-100","43136-100-01","43136-100_2aab1069-ce32-f92b-e063-6294a90a879d","HUMAN OTC DRUG","AVON HeXashield Triple Antibiotic with Pain Relief","","OINTMENT","TOPICAL","20190731","","OTC MONOGRAPH DRUG","M004","Tai Guk Pharm. Co., Ltd.","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20261231"
"2214","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","43353089316","Allylamine Antifungal [EPC], Allylamine [CS]","43353-893","43353-893-16","43353-893_280bbc43-14a1-47e0-a702-8cd8117c2978","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20120822","","ANDA","ANDA077714","Aphena Pharma Solutions - Tennessee, LLC","250","mg/1","","N","20251231"
"2215","VORICONAZOLE","voriconazole","43386003860","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","43386-038","43386-038-60","43386-038_63e8113a-a13c-4a3d-b611-5a2c602a49a5","HUMAN PRESCRIPTION DRUG","VORICONAZOLE","","POWDER, FOR SUSPENSION","ORAL","20160601","","ANDA","ANDA206799","Lupin Pharmaceuticals,Inc.","40","mg/mL","","N","20251231"
"2216","VORICONAZOLE","voriconazole","43386008803","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","43386-088","43386-088-03","43386-088_56ca1aed-0ee1-4afa-8bc3-a6d5f503ba6e","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20160524","","ANDA","ANDA207371","Lupin Pharmaceuticals,Inc.","50","mg/1","","N","20251231"
"2217","VORICONAZOLE","voriconazole","43386008903","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","43386-089","43386-089-03","43386-089_56ca1aed-0ee1-4afa-8bc3-a6d5f503ba6e","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20160524","","ANDA","ANDA207371","Lupin Pharmaceuticals,Inc.","200","mg/1","","N","20251231"
"2218","TRIMETHOPRIM","Trimethoprim","43386033001","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]","43386-330","43386-330-01","43386-330_6a57562b-424f-40ef-9b86-fa0e66c1c344","HUMAN PRESCRIPTION DRUG","Trimethoprim","","TABLET","ORAL","20110624","","ANDA","ANDA091437","Lupin Pharmaceuticals,Inc.","100","mg/1","","N","20251231"
"2219","NITROFURANTOIN","Nitrofurantoin","43386045011","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","43386-450","43386-450-11","43386-450_361dd255-19ba-453f-9b68-ade3185ff390","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","SUSPENSION","ORAL","20150521","","ANDA","ANDA201693","Lupin Pharmaceuticals,Inc.","25","mg/5mL","","N","20251231"
"2220","NYSTATIN","Nystatin","43386053002","Polyene Antifungal [EPC], Polyenes [CS]","43386-530","43386-530-02","43386-530_d26973cb-9e26-4a33-a4c0-4ea368d0666f","HUMAN PRESCRIPTION DRUG","Nystatin","","POWDER","TOPICAL","20140926","","ANDA","ANDA065138","Lupin Pharmaceuticals,Inc.","100000","U/g","","N","20251231"
"2221","NYSTATIN","Nystatin","43386053006","Polyene Antifungal [EPC], Polyenes [CS]","43386-530","43386-530-06","43386-530_d26973cb-9e26-4a33-a4c0-4ea368d0666f","HUMAN PRESCRIPTION DRUG","Nystatin","","POWDER","TOPICAL","20140926","","ANDA","ANDA065138","Lupin Pharmaceuticals,Inc.","100000","U/g","","N","20251231"
"2222","NYSTATIN","Nystatin","43386053001","Polyene Antifungal [EPC], Polyenes [CS]","43386-530","43386-530-01","43386-530_d26973cb-9e26-4a33-a4c0-4ea368d0666f","HUMAN PRESCRIPTION DRUG","Nystatin","","POWDER","TOPICAL","20140926","","ANDA","ANDA065138","Lupin Pharmaceuticals,Inc.","100000","U/g","","N","20251231"
"2223","TINIDAZOLE","Tinidazole","43386055004","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","43386-550","43386-550-04","43386-550_98a66e10-fb32-46ce-a68b-c21d615f6621","HUMAN PRESCRIPTION DRUG","Tinidazole","","TABLET","ORAL","20120430","","ANDA","ANDA202044","Lupin Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"2224","TINIDAZOLE","Tinidazole","43386055106","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","43386-551","43386-551-06","43386-551_98a66e10-fb32-46ce-a68b-c21d615f6621","HUMAN PRESCRIPTION DRUG","Tinidazole","","TABLET","ORAL","20120430","","ANDA","ANDA202044","Lupin Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"2225","TINIDAZOLE","Tinidazole","43386055102","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","43386-551","43386-551-02","43386-551_98a66e10-fb32-46ce-a68b-c21d615f6621","HUMAN PRESCRIPTION DRUG","Tinidazole","","TABLET","ORAL","20120430","","ANDA","ANDA202044","Lupin Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"2226","NITROFURANTOIN","Nitrofurantoin macrocrystals","43386064101","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","43386-641","43386-641-01","43386-641_2e7ec48f-d605-4e97-8620-299e5f143026","HUMAN PRESCRIPTION DRUG","Nitrofurantoin macrocrystals","","CAPSULE","ORAL","20180709","","ANDA","ANDA203233","Lupin Pharmaceuticals,Inc.","50","mg/1","","N","20251231"
"2227","NITROFURANTOIN","Nitrofurantoin macrocrystals","43386064201","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","43386-642","43386-642-01","43386-642_2e7ec48f-d605-4e97-8620-299e5f143026","HUMAN PRESCRIPTION DRUG","Nitrofurantoin macrocrystals","","CAPSULE","ORAL","20180709","","ANDA","ANDA203233","Lupin Pharmaceuticals,Inc.","100","mg/1","","N","20251231"
"2228","FLUCYTOSINE","Flucytosine","43386077001","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","43386-770","43386-770-01","43386-770_be28385c-7f27-4092-b87f-076a166e1e8a","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170707","","ANDA","ANDA204652","Lupin Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"2229","FLUCYTOSINE","Flucytosine","43386077101","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","43386-771","43386-771-01","43386-771_be28385c-7f27-4092-b87f-076a166e1e8a","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170707","","ANDA","ANDA204652","Lupin Pharmaceuticals,Inc.","250","mg/1","","N","20261231"
"2230","ANAMIRTA COCCULUS SEED; ARNICA MONTANA; BRYONIA ALBA ROOT; CONIUM MACULATUM FLOWERING TOP; IPECAC; POTASSIUM CARBONATE; QUININE SULFATE; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; VERATRUM ALBUM ROOT","Arnica Montana, Bryonia Alba Root, Quinine Sulfate, Anamirta Cocculus Seed, Conium Maculatum Flowering Top, Strychnos Ignatii Seed, Ipecac, Potassium Carbonate, Strychnos Nux-Vomica Seed, Sepia Officinalis Juice, Tobacco Leaf, Veratrum Album Root","43406009901","Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]","43406-0099","43406-0099-1","43406-0099_2779f075-075c-413a-b4a9-e8e0f4c2d586","HUMAN OTC DRUG","MOTION SICKNESS HP","","LIQUID","ORAL","20070529","","UNAPPROVED HOMEOPATHIC","","Natural Creations, Inc.","30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30","[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL","","N","20251231"
"2231","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","43473001201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","43473-012","43473-012-01","43473-012_07b3bb16-6261-e661-e063-6394a90a6eec","HUMAN OTC DRUG","EVERLIT CARE Triple Antibiotic","","OINTMENT","TOPICAL","20231014","","OTC MONOGRAPH DRUG","M004","Nantong Health & Beyond Hygienic Products Inc.","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20251231"
"2232","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","43473001401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","43473-014","43473-014-01","43473-014_0814d789-8b7d-0be7-e063-6294a90a1e10","HUMAN OTC DRUG","GENUINE FIRST AID Antibiotic","","OINTMENT","TOPICAL","20231018","","OTC MONOGRAPH DRUG","M004","Nantong Health & Beyond Hygienic Products Inc.","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20251231"
"2233","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","43473001601","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","43473-016","43473-016-01","43473-016_0a755b30-1d1a-b11f-e063-6394a90ab80f","HUMAN OTC DRUG","FIRSTAR TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20231118","","OTC MONOGRAPH DRUG","M004","Nantong Health & Beyond Hygienic Products Inc.","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20251231"
"2234","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","43473005301","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","43473-053","43473-053-01","43473-053_22fe43ad-5108-caa6-e063-6394a90a04e2","HUMAN OTC DRUG","AOSI HEALTHCARE TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20240924","","OTC MONOGRAPH DRUG","M004","Nantong Health & Beyond Hygienic Products Inc.","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20251231"
"2235","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","43473006101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","43473-061","43473-061-01","43473-061_288e3925-8f7c-10f5-e063-6394a90a92db","HUMAN OTC DRUG","OP First Aid Series TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20241205","","OTC MONOGRAPH DRUG","M004","Nantong Health & Beyond Hygienic Products Inc.","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20251231"
"2236","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","43473006301","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","43473-063","43473-063-01","43473-063_2af0d53b-2a41-0bdc-e063-6294a90a2874","HUMAN OTC DRUG","health and beyond TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20250104","","OTC MONOGRAPH DRUG","M004","Nantong Health & Beyond Hygienic Products Inc.","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20261231"
"2237","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","43473006701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","43473-067","43473-067-01","43473-067_2c1c9ba3-ecbd-3ad1-e063-6394a90a1ea3","HUMAN OTC DRUG","PROHEAL TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20250117","","OTC MONOGRAPH DRUG","M004","Nantong Health & Beyond Hygienic Products Inc.","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20261231"
"2238","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","43473006801","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","43473-068","43473-068-01","43473-068_2e794e36-4fb0-14ef-e063-6394a90ad1f0","HUMAN OTC DRUG","The Life Safety Pro Triple Antibiotic","","OINTMENT","TOPICAL","20250218","","OTC MONOGRAPH DRUG","M004","Nantong Health & Beyond Hygienic Products Inc.","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20261231"
"2239","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B sulfate","43473030101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","43473-301","43473-301-01","43473-301_0e66af91-e0b5-827f-e063-6294a90a9847","HUMAN OTC DRUG","Lightning X Triple Antibiotic","","OINTMENT","TOPICAL","20240108","","OTC MONOGRAPH DRUG","M004","Nantong Health & Beyond Hygienic Products Inc.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"2240","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","43473031001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","43473-310","43473-310-01","43473-310_0f0d1ba7-fe9d-8e0b-e063-6394a90a3081","HUMAN OTC DRUG","MyMedic Triple Antibiotic","","OINTMENT","TOPICAL","20240116","","OTC MONOGRAPH DRUG","M003","Nantong Health & Beyond Hygienic Products Inc.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"2241","SULFACETAMIDE SODIUM; SULFUR","sulfacetamide sodium and Sulfur","43538010060","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","43538-100","43538-100-60","43538-100_10983826-2970-4ff2-87f6-6633c093843f","HUMAN PRESCRIPTION DRUG","Sumaxin","Cleansing Pads","CLOTH","TOPICAL","20090101","","UNAPPROVED DRUG OTHER","","Medimetriks Pharmaceuticals, Inc.","100; 40","mg/g; mg/g","","N","20251231"
"2242","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","43538017069","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","43538-170","43538-170-69","43538-170_46465f9a-1b07-4044-9598-55a211b95297","HUMAN PRESCRIPTION DRUG","Clindacin P","","SOLUTION","TOPICAL","20110220","","ANDA","ANDA065049","Medimetriks Pharmaceuticals, Inc.","10","mg/mL","","N","20251231"
"2243","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","43538017260","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","43538-172","43538-172-60","43538-172_f5e860a1-3132-4e98-aea7-bfa65d478bf6","HUMAN PRESCRIPTION DRUG","Clindacin ETZ","","SWAB","TOPICAL","20130615","","ANDA","ANDA065049","Medimetriks Pharmaceuticals, Inc.","10","mg/1","","N","20251231"
"2244","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","clindamycin phosphate and benzoyl peroxide","43538017645","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","43538-176","43538-176-45","43538-176_ea93a8c5-1172-4b62-9a28-33783fbca9fd","HUMAN PRESCRIPTION DRUG","Neuac","","GEL","TOPICAL","20140615","","ANDA","ANDA090979","Medimetriks Pharmaceuticals","50; 10","mg/g; mg/g","","N","20251231"
"2245","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","43538017910","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","43538-179","43538-179-10","43538-179_391b4472-8468-4d6f-bab0-406d83655cd0","HUMAN PRESCRIPTION DRUG","Clindacin","","AEROSOL, FOAM","TOPICAL","20100321","","ANDA","ANDA090785","Medimetriks Pharmaceuticals, Inc.","10","mg/g","","N","20251231"
"2246","KETOCONAZOLE","ketoconazole","43538053010","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","43538-530","43538-530-10","43538-530_354d4926-b665-4e7e-a86a-5baae165a470","HUMAN PRESCRIPTION DRUG","Ketodan","","AEROSOL, FOAM","TOPICAL","20120615","","ANDA","ANDA091550","Medimetriks Pharmaceuticals, Inc.","20","mg/g","","N","20251231"
"2247","VANCOMYCIN HYDROCHLORIDE","Vancomycin hydrochloride","43538080510","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","43538-805","43538-805-10","43538-805_1ad6b244-4759-43d1-aae0-81580193759e","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20080630","","ANDA","ANDA065401","Medimetriks Pharmaceuticals, Inc.","500","mg/10mL","","N","20261231"
"2248","VANCOMYCIN HYDROCHLORIDE","Vancomycin hydrochloride","43538081010","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","43538-810","43538-810-10","43538-810_1ad6b244-4759-43d1-aae0-81580193759e","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20080630","","ANDA","ANDA065401","Medimetriks Pharmaceuticals, Inc.","1","g/20mL","","N","20261231"
"2249","FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE","neomycin sulfate and fluocinolone acetonide","43538094099","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","43538-940","43538-940-99","43538-940_4b6c5088-fd92-4793-8010-f2b20f9fe44a","HUMAN PRESCRIPTION DRUG","Neo-Synalar","","CREAM","TOPICAL","19630611","","ANDA","ANDA060700","Medimetriks Pharmaceuticals",".25; 3.5","mg/g; mg/g","","N","20251231"
"2250","FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE","neomycin sulfate and fluocinolone acetonide","43538094060","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","43538-940","43538-940-60","43538-940_4b6c5088-fd92-4793-8010-f2b20f9fe44a","HUMAN PRESCRIPTION DRUG","Neo-Synalar","","CREAM","TOPICAL","19630611","","ANDA","ANDA060700","Medimetriks Pharmaceuticals",".25; 3.5","mg/g; mg/g","","N","20251231"
"2251","VORICONAZOLE","Voriconazole","43547037750","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","43547-377","43547-377-50","43547-377_dc47845f-067b-42a7-b140-51898cb35b0c","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, COATED","ORAL","20161028","","ANDA","ANDA206654","Solco Healthcare U.S., LLC","50","mg/1","","N","20251231"
"2252","VORICONAZOLE","Voriconazole","43547037703","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","43547-377","43547-377-03","43547-377_dc47845f-067b-42a7-b140-51898cb35b0c","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, COATED","ORAL","20161028","","ANDA","ANDA206654","Solco Healthcare U.S., LLC","50","mg/1","","N","20251231"
"2253","VORICONAZOLE","Voriconazole","43547037850","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","43547-378","43547-378-50","43547-378_dc47845f-067b-42a7-b140-51898cb35b0c","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, COATED","ORAL","20161028","","ANDA","ANDA206654","Solco Healthcare U.S., LLC","200","mg/1","","N","20251231"
"2254","VORICONAZOLE","Voriconazole","43547037803","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","43547-378","43547-378-03","43547-378_dc47845f-067b-42a7-b140-51898cb35b0c","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, COATED","ORAL","20161028","","ANDA","ANDA206654","Solco Healthcare U.S., LLC","200","mg/1","","N","20251231"
"2255","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","43547068810","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43547-688","43547-688-10","43547-688_b6dcfcef-d4ec-4463-a6b5-192cd8c7c0c3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Solco Healthcare US, LLC","250","mg/1","","N","20251231"
"2256","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","43547068910","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43547-689","43547-689-10","43547-689_b6dcfcef-d4ec-4463-a6b5-192cd8c7c0c3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Solco Healthcare US, LLC","500","mg/1","","N","20251231"
"2257","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","43547068950","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43547-689","43547-689-50","43547-689_b6dcfcef-d4ec-4463-a6b5-192cd8c7c0c3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Solco Healthcare US, LLC","500","mg/1","","N","20251231"
"2258","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","43598013101","Antimalarial [EPC], Antirheumatic Agent [EPC]","43598-131","43598-131-01","43598-131_0e271b0d-e217-4651-a2ae-98c64fd0b98e","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20221024","","ANDA","ANDA210441","Dr. Reddy's Laboratories Inc.","400","mg/1","","N","20251231"
"2259","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","43598013105","Antimalarial [EPC], Antirheumatic Agent [EPC]","43598-131","43598-131-05","43598-131_0e271b0d-e217-4651-a2ae-98c64fd0b98e","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20221024","","ANDA","ANDA210441","Dr. Reddy's Laboratories Inc.","400","mg/1","","N","20251231"
"2260","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","43598013201","Antimalarial [EPC], Antirheumatic Agent [EPC]","43598-132","43598-132-01","43598-132_0e271b0d-e217-4651-a2ae-98c64fd0b98e","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20221024","","ANDA","ANDA210441","Dr. Reddy's Laboratories Inc.","300","mg/1","","N","20251231"
"2261","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","43598013205","Antimalarial [EPC], Antirheumatic Agent [EPC]","43598-132","43598-132-05","43598-132_0e271b0d-e217-4651-a2ae-98c64fd0b98e","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20221024","","ANDA","ANDA210441","Dr. Reddy's Laboratories Inc.","300","mg/1","","N","20251231"
"2262","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","43598013301","Antimalarial [EPC], Antirheumatic Agent [EPC]","43598-133","43598-133-01","43598-133_0e271b0d-e217-4651-a2ae-98c64fd0b98e","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20221024","","ANDA","ANDA210441","Dr. Reddy's Laboratories Inc.","100","mg/1","","N","20251231"
"2263","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","43598013305","Antimalarial [EPC], Antirheumatic Agent [EPC]","43598-133","43598-133-05","43598-133_0e271b0d-e217-4651-a2ae-98c64fd0b98e","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20221024","","ANDA","ANDA210441","Dr. Reddy's Laboratories Inc.","100","mg/1","","N","20251231"
"2264","SILVER SULFADIAZINE","Silver Sulfadiazine","43598021040","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","43598-210","43598-210-40","43598-210_13bd26c4-522e-3253-d05e-d48c367a800c","HUMAN PRESCRIPTION DRUG","SSD Cream","","CREAM","TOPICAL","20110504","","NDA","NDA018578","Dr Reddys Laboratories Inc","10","g/1000g","","N","20251231"
"2265","SILVER SULFADIAZINE","Silver Sulfadiazine","43598021050","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","43598-210","43598-210-50","43598-210_13bd26c4-522e-3253-d05e-d48c367a800c","HUMAN PRESCRIPTION DRUG","SSD Cream","","CREAM","TOPICAL","20110504","","NDA","NDA018578","Dr Reddys Laboratories Inc","10","g/1000g","","N","20251231"
"2266","SILVER SULFADIAZINE","Silver Sulfadiazine","43598021055","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","43598-210","43598-210-55","43598-210_13bd26c4-522e-3253-d05e-d48c367a800c","HUMAN PRESCRIPTION DRUG","SSD Cream","","CREAM","TOPICAL","20110504","","NDA","NDA018578","Dr Reddys Laboratories Inc","10","g/1000g","","N","20251231"
"2267","SILVER SULFADIAZINE","Silver Sulfadiazine","43598021025","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","43598-210","43598-210-25","43598-210_13bd26c4-522e-3253-d05e-d48c367a800c","HUMAN PRESCRIPTION DRUG","SSD Cream","","CREAM","TOPICAL","20110504","","NDA","NDA018578","Dr Reddys Laboratories Inc","10","g/1000g","","N","20251231"
"2268","SILVER SULFADIAZINE","Silver Sulfadiazine","43598021085","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","43598-210","43598-210-85","43598-210_13bd26c4-522e-3253-d05e-d48c367a800c","HUMAN PRESCRIPTION DRUG","SSD Cream","","CREAM","TOPICAL","20110504","","NDA","NDA018578","Dr Reddys Laboratories Inc","10","g/1000g","","N","20251231"
"2269","CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE","Ciprofloxacin and Dexamethasone","43598032675","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","43598-326","43598-326-75","43598-326_0fb2c386-6a61-7ae1-9cab-a71e05073685","HUMAN PRESCRIPTION DRUG","Ciprofloxacin and Dexamethasone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","20200810","","ANDA","ANDA205548","Dr. Reddy's Laboratories, Inc.","3; 1","mg/mL; mg/mL","","N","20251231"
"2270","VALGANCICLOVIR HYDROCHLORIDE","valganciclovir hydrochloride","43598035630","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","43598-356","43598-356-30","43598-356_2fbdd00d-733b-49f9-70b4-c1aefa75d6a4","HUMAN PRESCRIPTION DRUG","valganciclovir hydrochloride","","TABLET","ORAL","20171212","","ANDA","ANDA206876","Dr. Reddy's Laboratories Inc","450","mg/1","","N","20251231"
"2271","VALGANCICLOVIR HYDROCHLORIDE","valganciclovir hydrochloride","43598035660","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","43598-356","43598-356-60","43598-356_2fbdd00d-733b-49f9-70b4-c1aefa75d6a4","HUMAN PRESCRIPTION DRUG","valganciclovir hydrochloride","","TABLET","ORAL","20171212","","ANDA","ANDA206876","Dr. Reddy's Laboratories Inc","450","mg/1","","N","20251231"
"2272","DAPTOMYCIN","Daptomycin","43598041311","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","43598-413","43598-413-11","43598-413_607d5de5-52c5-3cb7-0707-7535e1791027","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190501","","ANDA","ANDA208375","Dr.Reddy's Laboratories Inc.,","500","mg/10mL","","N","20251231"
"2273","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","43598043130","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","43598-431","43598-431-30","43598-431_19bf5993-943a-b384-9639-c93bff9aea5c","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20161115","","ANDA","ANDA208326","Dr. Reddy's Laboratories, Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"2274","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","43598043160","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","43598-431","43598-431-60","43598-431_19bf5993-943a-b384-9639-c93bff9aea5c","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20161115","","ANDA","ANDA208326","Dr. Reddy's Laboratories, Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"2275","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","43598043144","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","43598-431","43598-431-44","43598-431_19bf5993-943a-b384-9639-c93bff9aea5c","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20161115","","ANDA","ANDA208326","Dr. Reddy's Laboratories, Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"2276","POSACONAZOLE","Posaconazole","43598047060","Azole Antifungal [EPC], Azoles [CS]","43598-470","43598-470-60","43598-470_46386e60-8ac3-4620-b163-e1637a0f8bbf","HUMAN PRESCRIPTION DRUG","Posaconazole","","TABLET, DELAYED RELEASE","ORAL","20220407","","ANDA","ANDA212500","Dr.Reddys Laboratories Inc","100","mg/1","","N","20251231"
"2277","DAPTOMYCIN","Daptomycin","43598047611","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","43598-476","43598-476-11","43598-476_29677998-337b-a026-92f5-1a3958dec926","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20211004","","ANDA","ANDA211403","Dr. Reddy's Laboratories Inc.,","350","mg/7mL","","N","20251231"
"2278","DAPTOMYCIN","Daptomycin","43598047658","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","43598-476","43598-476-58","43598-476_29677998-337b-a026-92f5-1a3958dec926","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20211004","","ANDA","ANDA211403","Dr. Reddy's Laboratories Inc.,","350","mg/7mL","","N","20251231"
"2279","TOBRAMYCIN","Tobramycin Inhalation Solution","43598060556","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","43598-605","43598-605-56","43598-605_946d18e8-ea8f-97c0-f49b-ec4e286beede","HUMAN PRESCRIPTION DRUG","Tobramycin Inhalation Solution","","INHALANT","RESPIRATORY (INHALATION)","20190514","","ANDA","ANDA207080","Dr. Reddy's Laboratories Inc.","300","mg/5mL","","N","20251231"
"2280","TOBRAMYCIN","Tobramycin Inhalation Solution","43598060558","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","43598-605","43598-605-58","43598-605_946d18e8-ea8f-97c0-f49b-ec4e286beede","HUMAN PRESCRIPTION DRUG","Tobramycin Inhalation Solution","","INHALANT","RESPIRATORY (INHALATION)","20190514","","ANDA","ANDA207080","Dr. Reddy's Laboratories Inc.","300","mg/5mL","","N","20251231"
"2281","PYRIMETHAMINE","pyrimethamine","43598067201","Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]","43598-672","43598-672-01","43598-672_eaf69850-6d69-7178-e1b9-0897caf031da","HUMAN PRESCRIPTION DRUG","Pyrimethamine","","TABLET","ORAL","20200316","","ANDA","ANDA207127","DR.REDDYS LABORATORIES INC","25","mg/1","","N","20251231"
"2282","PYRIMETHAMINE","pyrimethamine","43598067230","Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]","43598-672","43598-672-30","43598-672_eaf69850-6d69-7178-e1b9-0897caf031da","HUMAN PRESCRIPTION DRUG","Pyrimethamine","","TABLET","ORAL","20200316","","ANDA","ANDA207127","DR.REDDYS LABORATORIES INC","25","mg/1","","N","20251231"
"2283","CEFIXIME","Cefixime","43598067350","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43598-673","43598-673-50","43598-673_06f95483-707f-8e4b-e063-6294a90a1992","HUMAN PRESCRIPTION DRUG","Cefixime","","POWDER, FOR SUSPENSION","ORAL","20170803","","ANDA","ANDA206938","Dr. Reddy’s Laboratories, Inc","100","mg/5mL","","N","20251231"
"2284","CEFIXIME","Cefixime","43598067451","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43598-674","43598-674-51","43598-674_06f95483-707f-8e4b-e063-6294a90a1992","HUMAN PRESCRIPTION DRUG","Cefixime","","POWDER, FOR SUSPENSION","ORAL","20170803","","ANDA","ANDA206938","Dr. Reddy’s Laboratories, Inc","200","mg/5mL","","N","20251231"
"2285","CEFIXIME","Cefixime","43598067450","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","43598-674","43598-674-50","43598-674_06f95483-707f-8e4b-e063-6294a90a1992","HUMAN PRESCRIPTION DRUG","Cefixime","","POWDER, FOR SUSPENSION","ORAL","20170803","","ANDA","ANDA206938","Dr. Reddy’s Laboratories, Inc","200","mg/5mL","","N","20251231"
"2286","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","43598072105","Antimalarial [EPC], Antirheumatic Agent [EPC]","43598-721","43598-721-05","43598-721_0e271b0d-e217-4651-a2ae-98c64fd0b98e","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20180501","","ANDA","ANDA210441","Dr. Reddy's Laboratories Inc.","200","mg/1","","N","20251231"
"2287","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","43598072101","Antimalarial [EPC], Antirheumatic Agent [EPC]","43598-721","43598-721-01","43598-721_0e271b0d-e217-4651-a2ae-98c64fd0b98e","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20180501","","ANDA","ANDA210441","Dr. Reddy's Laboratories Inc.","200","mg/1","","N","20251231"
"2288","ERTAPENEM SODIUM","Ertapenem","43598090158","Carbapenems [CS], Penem Antibacterial [EPC]","43598-901","43598-901-58","43598-901_39078864-5998-878d-b70d-8f46a61bbf02","HUMAN PRESCRIPTION DRUG","ERTAPENEM SODIUM","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20210429","","ANDA","ANDA212040","Dr.Reddys Laboratories Inc.,","1","g/1","","N","20251231"
"2289","MICONAZOLE NITRATE","MICONAZOLE NITRATE","43689002501","Azole Antifungal [EPC], Azoles [CS]","43689-0025","43689-0025-1","43689-0025_08854bfe-b2c1-e134-e063-6394a90a773f","HUMAN OTC DRUG","DB Antifungal foot","","CREAM","TOPICAL","20170427","","OTC MONOGRAPH DRUG","M005","The Magni Group Inc","20","mg/g","","N","20251231"
"2290","MICONAZOLE NITRATE","MICONAZOLE NITRATE","43689002502","Azole Antifungal [EPC], Azoles [CS]","43689-0025","43689-0025-2","43689-0025_08854bfe-b2c1-e134-e063-6394a90a773f","HUMAN OTC DRUG","DB Antifungal foot","","CREAM","TOPICAL","20170427","","OTC MONOGRAPH DRUG","M005","The Magni Group Inc","20","mg/g","","N","20251231"
"2291","CHAMAELIRIUM LUTEUM ROOT; CORTISONE ACETATE; DIBASIC POTASSIUM PHOSPHATE; ENTEROBACTER CLOACAE; EPINEPHRINE; GOLD; HYPERICUM PERFORATUM WHOLE; QUININE ARSENATE; SELENIUM; STRYCHNOS NUX-VOMICA SEED","Cortisone Aceticum, Adrenalinum, Chininum Arsenicosum, Helonias Dioica, Hypericum Perforatum, Kali Phosphoricum, Nux Vomica, Selenium Metallicum, Aurum Metallicum, Bacillus 7 (Enterobacter Cloacae)","43742125801","Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Antimalarial [EPC], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]","43742-1258","43742-1258-1","43742-1258_d75fc007-3071-4114-9cb5-4aa4686778a3","HUMAN OTC DRUG","Bio Mood Phase","","LIQUID","ORAL","20180911","","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","10; 8; 10; 30; 8; 10; 10; 10; 10; 10","[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL","","N","20251231"
"2292","ACETIC ACID; ALOE; ARSENIC TRIOXIDE; BOTULINUM TOXIN TYPE A; BRUGIA MALAYI; CITRULLUS COLOCYNTHIS FRUIT PULP; CLOSTRIDIUM DIFFICILE; COLCHICUM AUTUMNALE BULB; ECHINACEA ANGUSTIFOLIA; ESCHERICHIA COLI; HELICOBACTER PYLORI; MERCURIC CHLORIDE; PROTEUS VULGARIS; QUININE SULFATE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; STRYCHNOS NUX-VOMICA SEED; VIBRIO CHOLERAE; YERSINIA ENTEROCOLITICA","Echinacea (Angustifolia), Aloe, Colchicum Autumnale, Colocynthis, Mercurius Corrosivus, Nux Vomica, Arsenicum Album, Clostridium Difficile, Aceticum Acidum, Chininum Sulphuricum, Cholera Nosode, Proteus (Vulgaris), Colibacillinum Cum Natrum Muriaticum, Helicobacter Pylori, Yersinia Enterocolitica, Botulinum Nosode, Salmonella Typhi Nosode, Brugia Malayi","43742142101","Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]","43742-1421","43742-1421-1","43742-1421_f7a18cc2-4492-4561-b393-4e00164fbcbe","HUMAN OTC DRUG","DysBio Plus","","LIQUID","ORAL","20190103","20251111","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","12; 6; 8; 30; 39; 8; 8; 8; 3; 30; 30; 8; 16; 12; 33; 8; 12; 30","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N",""
"2293","ACETYL COENZYME A; ADENOSINE TRIPHOSPHATE DISODIUM; ARTEMISIA CINA PRE-FLOWERING TOP; BACOPA MONNIERI WHOLE; DOPAMINE HYDROCHLORIDE; EQUOL, (+/-)-; GAMBOGE; IODINE; LYCOPODIUM CLAVATUM SPORE; OXYTOCIN ACETATE; PHOSPHORUS; QUININE SULFATE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SEDUM ROSEUM ROOT; SEROTONIN HYDROCHLORIDE; SUS SCROFA ADRENAL CORTEX; SUS SCROFA STOMACH; SUS SCROFA THYROID","Acetyl Coenzyme A, Adenosinum Triphosphoricum Dinatrum, Adrenal Cortex (Suis), Bacopa Speciosa, Equol, Gambogia, Oxytocin Acetate, Rhodiola, Stomach (Suis), Chininum Sulphuricum, Iodium, Lycopodium Clavatum, Phosphorus, Dopamine Hydrochloride, Thyroidinum (Suis), Cina, Serotonin (Hydrochloride), Morgan Gaertner","43742148401","Antimalarial [EPC], Catecholamine [EPC], Catecholamines [CS], Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]","43742-1484","43742-1484-1","43742-1484_a2f76ef9-6c60-415e-a6a8-cbf46772debe","HUMAN OTC DRUG","Appetite Control","","LIQUID","ORAL","20190507","20250706","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","6; 6; 8; 6; 8; 6; 14; 6; 6; 6; 6; 6; 30; 6; 8; 6; 6; 8","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N",""
"2294","ADENOSINE TRIPHOSPHATE DISODIUM; ARTEMISIA CINA PRE-FLOWERING TOP; BACOPA MONNIERI WHOLE; DOPAMINE HYDROCHLORIDE; EQUOL, (+/-)-; GAMBOGE; IODINE; LYCOPODIUM CLAVATUM SPORE; OXYTOCIN; PANTOTHENIC ACID; PHOSPHORUS; QUININE SULFATE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SEDUM ROSEUM ROOT; SEROTONIN HYDROCHLORIDE; SUS SCROFA ADRENAL CORTEX; SUS SCROFA STOMACH; THYROID","Adenosinum Triphosphoricum Dinatrum, Adrenal Cortex (Suis), Bacopa Speciosa, Equol, Pantothenic Acid, Gambogia, Oxytocin, Rhodiola, Stomach (Suis), Chininum Sulphuricum, Iodium, Lycopodium Clavatum, Phosphorus, Dopamine Hydrochloride, Thyroidinum (Suis), Cina, Serotonin (Hydrochloride), Morgan Gaertner","43742153401","Antimalarial [EPC], Catecholamine [EPC], Catecholamines [CS], Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]","43742-1534","43742-1534-1","43742-1534_cfe44bd2-bd78-4987-803a-b2f3b70d9ffe","HUMAN OTC DRUG","Appetite Control","","LIQUID","ORAL","20190822","20280512","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","6; 8; 6; 8; 6; 14; 6; 6; 12; 6; 6; 6; 30; 6; 8; 6; 6; 8","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N",""
"2295","ACETIC ACID; ALOE; ARSENIC TRIOXIDE; BOTULINUM TOXIN TYPE A; BRUGIA MALAYI; CITRULLUS COLOCYNTHIS FRUIT PULP; CLOSTRIDIUM DIFFICILE; COLCHICUM AUTUMNALE BULB; ECHINACEA ANGUSTIFOLIA; ESCHERICHIA COLI; HELICOBACTER PYLORI; MERCURIC CHLORIDE; PROTEUS VULGARIS; QUININE SULFATE; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; STRYCHNOS NUX-VOMICA SEED; VIBRIO CHOLERAE","Echinacea (Angustifolia), Aloe, Colchicum Autumnale, Colocynthis, Mercurius Corrosivus, Nux Vomica, Arsenicum Album, Aceticum Acidum, Chininum Sulphuricum, Cholera Nosode, Proteus (Vulgaris), Colibacillinum Cum Natrum Muriaticum, Helicobacter Pylori, Botulinum, Salmonella Typhi Nosode, Morgan Gaertner, Clostridium Difficile, Brugia Malayi","43742159501","Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]","43742-1595","43742-1595-1","43742-1595_77f20218-fa8a-4a9b-a642-a134ff0fbd9a","HUMAN OTC DRUG","DysBio Plus","","LIQUID","ORAL","20191029","20260406","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","12; 6; 8; 30; 39; 8; 30; 8; 3; 30; 30; 8; 16; 12; 30; 33; 8; 12","[hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N",""
"2296","ALUMINUM OXIDE; ANTIMONY TRISULFIDE; BARIUM CARBONATE; CONIUM MACULATUM FLOWERING TOP; DIOSCOREA VILLOSA TUBER; EGG PHOSPHOLIPIDS; EPINEPHRINE; GOLD MONOSULFIDE; GRAPHITE; GUAIACUM OFFICINALE RESIN; LILIUM LANCIFOLIUM WHOLE FLOWERING; LITHIUM CARBONATE; QUININE SULFATE; SELENIUM; SEPIA OFFICINALIS JUICE; SOLANUM TUBEROSUM WHOLE; SUS SCROFA PLACENTA; THYROID, BOVINE; TOXICODENDRON VERNIX LEAFY TWIG; VIOLA ODORATA WHOLE","Dioscorea Villosa, Lecithin, sepia, Viola Odorata, Adrenalinum, Lithium Carbonicum, Thyroidinum (Bovine), Placenta Totalis Suis, Guaiacum, Solanum Tuberosum, Antimonium Crudum, Aurum Sulphuratum, Baryta Carbonica, Chininum Sulphuricum, Conium Maculatum, Graphites, Lilium Tigrinum, Rhus Venenata, Selenium Metallicum, Alumina","43742162801","Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Antimalarial [EPC], Catecholamine [EPC], Catecholamines [CS], Mood Stabilizer [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]","43742-1628","43742-1628-1","43742-1628_163c3448-f07c-4ea7-a4d9-0610e4a05f21","HUMAN OTC DRUG","Motivation","","LIQUID","ORAL","20200317","","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","12; 12; 12; 12; 6; 6; 8; 12; 12; 10; 12; 8; 12; 12; 6; 10; 8; 8; 12; 6","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"2297","ADENOSINE TRIPHOSPHATE DISODIUM; ASCORBIC ACID; ASPARAGINE MONOHYDRATE; EGG; FERROUS IODIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHENYLALANINE; PROTEUS MORGANII; QUERCETIN; SUS SCROFA ILEUM; SUS SCROFA JEJUNUM; SUS SCROFA STOMACH; TETRACYCLINE","Adenosinum Triphosphoricum Dinatrum, L-Asparagine (Monohydrate), L-Phenylalanine, Quercetin, Ileum (Suis), Jejunum (Suis), Stomach (Suis), Ascorbicum Acidum, Calcarea Carbonica, Ferrum Iodatum, Tetracycline, Egg (Hen Whole), Proteus (Morgani)","43742164401","Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Egg Proteins, Dietary [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS], Vitamin C [EPC]","43742-1644","43742-1644-1","43742-1644_1563fd0a-84b1-4b12-9eb3-79bcfc411061","HUMAN OTC DRUG","Egg Allergen Mix","","LIQUID","ORAL","20200511","","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","4; 6; 6; 28; 6; 6; 6; 30; 6; 8; 8; 8; 6","[hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL","","N","20251231"
"2298","ACTIVATED CHARCOAL; ASARUM CANADENSE ROOT; CARBON DISULFIDE; CYCLAMEN PURPURASCENS TUBER; DYSPHANIA AMBROSIOIDES WHOLE; GINKGO; GOSSYPIUM HERBACEUM ROOT BARK; GRAPHITE; LEAD; ONION; ONOSMODIUM VIRGINIANUM; PHOSPHORUS; QUININE SULFATE; SILVER NITRATE; SODIUM SALICYLATE; SOLANUM DULCAMARA TOP; SUS SCROFA CARTILAGE; SUS SCROFA NASAL MUCOSA; THERIDION CURASSAVICUM; WOOD CREOSOTE; ZINC","Allium Cepa, Argentum Nitricum, Chenopodium Anthelminticum, Dulcamara, Ginkgo Biloba, Chininum Sulphuricum, Cartilago Suis, Mucosa Nasalis Suis, Asarum Canadense, Onosmodium Virginianum, Natrum Salicylicum, Carbo Vegetabilis, Carboneum Sulphuratum, Cyclamen Europaeum, Gossypium Herbaceum, Graphites, Kreosotum, Phosphorus, Plumbum Metallicum, Theridion, Zincum Metallicum","43742164601","Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]","43742-1646","43742-1646-1","43742-1646_65c8fd27-99d4-42dc-9108-f3442df82afb","HUMAN OTC DRUG","TinitX","","LIQUID","ORAL","20200529","20251014","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","12; 9; 12; 12; 6; 6; 12; 12; 12; 6; 10; 12; 6; 6; 10; 6; 8; 8; 12; 12; 12","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N",""
"2299","ACTIVATED CHARCOAL; ANTIMONY ARSENATE; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); CHELIDONIUM MAJUS WHOLE; COPPER; GELSEMIUM SEMPERVIRENS ROOT; HAEMOPHILUS INFLUENZAE TYPE B; IPECAC; MYCOPLASMA PNEUMONIAE; OXYGEN; PHOSPHORUS; POLYGALA SENEGA ROOT; POTASSIUM CHLORIDE; PRATIA PURPURASCENS; QUININE HYDROCHLORIDE; STREPTOCOCCUS PNEUMONIAE; SUS SCROFA LUNG; TIN; VERATRUM VIRIDE ROOT","Kali Muriaticum, Carbo Vegetabilis, Lung (Suis), Mycoplasma Pneumoniae, Bryonia (Alba), Gelsemium Sempervirens, Haemophilus Influenzae B, Pneumococcinum, Oxygenium, Antimonium Arsenicicum, Camphora, Chelidonium Majus, Chininum Muriaticum, Cuprum Metallicum, Ipecacuanha, Lobelia Purpurescens, Phosphorus, Senega Officinalis, Stannum Metallicum, Veratrum Viride","43742164901","Antimalarial [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]","43742-1649","43742-1649-1","43742-1649_88a60fdb-2df6-4215-a955-8f3ae0bd5b98","HUMAN OTC DRUG","Lung Drainage","","LIQUID","ORAL","20200626","20280919","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","8; 30; 12; 30; 30; 30; 12; 16; 30; 12; 16; 30; 30; 6; 30; 30; 16; 8; 30; 30","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N",""
"2300","AMBERGRIS; ANAMIRTA COCCULUS SEED; ASARUM CANADENSE ROOT; BRYONIA ALBA ROOT; CALCIUM SULFATE ANHYDROUS; CARBON DISULFIDE; CONIUM MACULATUM FLOWERING TOP; CYCLAMEN PURPURASCENS TUBER; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; KEROSENE; MACROPIPER METHYSTICUM ROOT; PHOSPHORUS; QUININE SULFATE; SILICON DIOXIDE; SILVER NITRATE; SODIUM SALICYLATE; SUS SCROFA CEREBRUM; THERIDION CURASSAVICUM; TOBACCO LEAF","Cerebellum (Suis), Bryonia (Alba), Petroleum, Tabacum, Ambra Grisea, Cyclamen Europaeum, Natrum Salicylicum, Argentum Nitricum, Asarum Canadense, Calcarea Sulphurica, Carboneum Sulphuratum, Chininum Sulphuricum, Cocculus Indicus, Conium Maculatum, Digitalis Purpurea, Gelsemium Sempervirens, Phosphorus, Piper Methysticum, Silicea, Theridion","43742167501","Allergens [CS], Antimalarial [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS]","43742-1675","43742-1675-1","43742-1675_7581a689-8459-41c1-8546-c99d733347ad","HUMAN OTC DRUG","Dizzy","","LIQUID","ORAL","20200922","","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","9; 12; 12; 8; 12; 12; 12; 9; 12; 12; 8; 12; 12; 12; 12; 12; 10; 6; 12; 8","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"2301","ACTIVATED CHARCOAL; ASARUM CANADENSE ROOT; CARBON DISULFIDE; CYCLAMEN PURPURASCENS TUBER; DYSPHANIA AMBROSIOIDES WHOLE; GINKGO; GOSSYPIUM HERBACEUM ROOT BARK; GRAPHITE; LEAD; ONION; ONOSMODIUM VIRGINIANUM; PHOSPHORUS; QUININE SULFATE; SILVER NITRATE; SODIUM SALICYLATE; SOLANUM DULCAMARA TOP; SUS SCROFA CARTILAGE; SUS SCROFA NASAL MUCOSA; THERIDION CURASSAVICUM; WOOD CREOSOTE; ZINC","Allium Cepa, Argentum Nitricum, Chenopodium Anthelminticum, Dulcamara, Ginkgo Biloba, Chininum Sulphuricum, Cartilago Suis, Mucosa Nasalis Suis, Asarum Canadense, Onosmodium Virginianum, Natrum Salicylicum, Carbo Vegetabilis, Carboneum Sulphuratum, Cyclamen Europaeum, Gossypium Herbaceum, Graphites, Kreosotum, Phosphorus, Plumbum Metallicum, Theridion, Zincum Metallicum","43742200101","Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]","43742-2001","43742-2001-1","43742-2001_a3e74730-e480-4316-b20c-3b570c0b688d","HUMAN OTC DRUG","Ear Ring","","LIQUID","ORAL","20201221","20281201","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","12; 9; 12; 12; 6; 6; 12; 12; 12; 6; 10; 12; 6; 6; 10; 6; 8; 8; 12; 12; 12","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N",""
"2302","ACETIC ACID; ALOE; ARSENIC TRIOXIDE; BOTULINUM TOXIN TYPE A; BRUGIA MALAYI; CITRULLUS COLOCYNTHIS FRUIT PULP; CLOSTRIDIUM DIFFICILE; COLCHICUM AUTUMNALE BULB; ECHINACEA ANGUSTIFOLIA WHOLE; ESCHERICHIA COLI; HELICOBACTER PYLORI; MERCURIC CHLORIDE; PROTEUS VULGARIS; QUININE SULFATE; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; STRYCHNOS NUX-VOMICA SEED; VIBRIO CHOLERAE","Echinacea (Angustifolia), Aloe, Colchicum Autumnale, Colocynthis, Mercurius Corrosivus, Nux Vomica, Arsenicum Album, Aceticum Acidum, Chininum Sulphuricum, Cholera Nosode, Proteus (Vulgaris), Colibacillinum Cum Natrum Muriaticum, Helicobacter Pylori, Botulinum, Salmonella Typhi Nosode, Morgan Gaertner, Clostridium Difficile, Brugia Malayi","43742202101","Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]","43742-2021","43742-2021-1","43742-2021_644e91cf-eaa3-431e-81b9-81815e3e2a50","HUMAN OTC DRUG","DysBio Plus","","LIQUID","ORAL","20210628","20270926","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","12; 7; 8; 30; 39; 8; 30; 8; 3; 30; 30; 8; 16; 12; 30; 33; 8; 12","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N",""
"2303","ACETIC ACID; ALOE; ARSENIC TRIOXIDE; BRUGIA MALAYI; CITRULLUS COLOCYNTHIS FRUIT PULP; CLOSTRIDIUM BOTULINUM; CLOSTRIDIUM DIFFICILE; COLCHICUM AUTUMNALE BULB; ECHINACEA ANGUSTIFOLIA WHOLE; ESCHERICHIA COLI; HELICOBACTER PYLORI; MERCURIC CHLORIDE; PROTEUS VULGARIS; QUININE SULFATE; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; SALMONELLA ENTERICA ENTERICA SEROVAR TYPHI; STRYCHNOS NUX-VOMICA SEED; VIBRIO CHOLERAE","Echinacea (Angustifolia), Aloe, Colchicum Autumnale, Colocynthis, Mercurius Corrosivus, Nux Vomica, Arsenicum Album, Aceticum Acidum, Chininum Sulphuricum, Cholera Nosode, Proteus (Vulgaris), Colibacillinum Cum Natrum Muriaticum, Helicobacter Pylori, Botulinum, Salmonella Typhi Nosode, Morgan Gaertner, Clostridium Difficile, Brugia Malayi","43742208401","Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]","43742-2084","43742-2084-1","43742-2084_7287390d-e064-4ee5-b8d9-9d72d33f6a8d","HUMAN OTC DRUG","Dysbio Plus","","LIQUID","ORAL","20230418","20280922","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","12; 7; 8; 39; 8; 30; 30; 8; 3; 30; 30; 8; 16; 12; 30; 33; 8; 16","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N",""
"2304","ADENOSINE TRIPHOSPHATE DISODIUM; ARTEMISIA CINA PRE-FLOWERING TOP; BACOPA MONNIERA LEAF; DOPAMINE HYDROCHLORIDE; EQUOL; GAMBOGE; IODINE; LYCOPODIUM CLAVATUM SPORE; OXYTOCIN; PANTOTHENIC ACID; PHOSPHORUS; QUININE SULFATE; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; SEDUM ROSEUM ROOT; SEROTONIN HYDROCHLORIDE; SUS SCROFA ADRENAL CORTEX; SUS SCROFA STOMACH; THYROID","Adenosinum Triphosphoricum Dinatrum, Adrenal Cortex (Suis), Bacopa Speciosa, Chininum Sulphuricum, Cina, Dopamine Hydrochloride, Equol, Gambogia, Iodium, Lycopodium Clavatum, Morgan Gaertner, Oxytocin, Pantothenic Acid, Phosphorus, Rhodiola, Serotonin (Hydrochloride), Stomach (Suis), Thyroidinum (Suis)","43742209401","Antimalarial [EPC], Catecholamine [EPC], Catecholamines [CS], Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]","43742-2094","43742-2094-1","43742-2094_be07c45e-1f9e-43ed-8d52-c2eddf5fb3bc","HUMAN OTC DRUG","Appetite Control","","LIQUID","ORAL","20231026","20290124","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","6; 8; 6; 8; 6; 14; 6; 6; 12; 6; 6; 6; 30; 6; 8; 6; 6; 8","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N",""
"2305","ACTIVATED CHARCOAL; ANTIMONY ARSENATE; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); CHELIDONIUM MAJUS WHOLE; COPPER; GELSEMIUM SEMPERVIRENS ROOT; HAEMOPHILUS INFLUENZAE TYPE B; IPECAC; MYCOPLASMA PNEUMONIAE; MYCOPLASMA PNEUMONIAE DNA; OXYGEN; PHOSPHORUS; POLYGALA SENEGA ROOT; POTASSIUM CHLORIDE; PRATIA PURPURASCENS; QUININE HYDROCHLORIDE; STREPTOCOCCUS PNEUMONIAE; SUS SCROFA LUNG; TIN; VERATRUM VIRIDE ROOT","Antimonium Arsenicicum, Bryonia (Alba), Camphora, Carbo Vegetabilis, Chelidonium Majus, Chininum Muriaticum, Cuprum Metallicum, Gelsemium Sempervirens, Haemophilus Influenzae B, Ipecacuanha, Kali Muriaticum, Lobelia Purpurescens, Lung (Suis), Mycoplasma Pneumoniae, Mycoplasma Pneumoniae DNA, Oxygenium, Phosphorus, Pneumococcinum, Senega Officinalis, Stannum Metallicum, Veratrum Viride","43742211601","Antimalarial [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]","43742-2116","43742-2116-1","43742-2116_2977b724-9f83-4525-9147-4a0fca498654","HUMAN OTC DRUG","Lung Drainage","","LIQUID","ORAL","20240202","","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","8; 30; 12; 30; 30; 30; 12; 16; 30; 12; 30; 16; 30; 30; 6; 30; 30; 16; 8; 30; 30","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"2306","ACETIC ACID; ALOE; ARSENIC TRIOXIDE; BRUGIA MALAYI; CITRULLUS COLOCYNTHIS FRUIT PULP; CLOSTRIDIUM BOTULINUM; CLOSTRIDIUM DIFFICILE; COLCHICUM AUTUMNALE BULB; ECHINACEA ANGUSTIFOLIA WHOLE; ESCHERICHIA COLI; HELICOBACTER PYLORI; HELICOBACTER PYLORI DNA; MERCURIC CHLORIDE; PROTEUS VULGARIS; QUININE SULFATE; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; SALMONELLA ENTERICA ENTERICA SEROVAR TYPHI; STRYCHNOS NUX-VOMICA SEED; VIBRIO CHOLERAE","Aceticum Acidum, Aloe, Arsenicum Album, Botulinum, Brugia Malayi, Chininum Sulphuricum, Cholera Nosode, Clostridium Difficile, Colchicum Autumnale, Colibacillinum Cum Natrum Muriaticum, Colocynthis, Echinacea (Angustifolia), Helicobacter Pylori, Helicobacter Pylori DNA, Mercurius Corrosivus, Morgan Gaertner, Nux Vomica, Proteus (Vulgaris), Salmonella Typhi Nosode","43742212001","Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]","43742-2120","43742-2120-1","43742-2120_132cec85-45c1-45cc-9acf-dbf426cbfd9b","HUMAN OTC DRUG","Dysbio Plus","","LIQUID","ORAL","20240207","","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","12; 7; 8; 39; 8; 30; 30; 8; 3; 30; 30; 16; 8; 16; 12; 30; 33; 8; 16","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"2307","ADENOSINE TRIPHOSPHATE DISODIUM; ARTEMISIA CINA PRE-FLOWERING TOP; BACOPA MONNIERA LEAF; DOPAMINE HYDROCHLORIDE; EQUOL; GAMBOGE; IODINE; LYCOPODIUM CLAVATUM SPORE; OXYTOCIN; PANTOTHENIC ACID; PHOSPHORUS; QUININE SULFATE; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; SEDUM ROSEUM ROOT; SEROTONIN HYDROCHLORIDE; SUS SCROFA ADRENAL CORTEX; SUS SCROFA STOMACH; THYROID","Adenosinum Triphosphoricum Dinatrum, Adrenal Cortex (Suis), Bacopa Speciosa, Chininum Sulphuricum, Cina, Dopamine Hydrochloride, Equol, Gambogia, Iodium, Lycopodium Clavatum, Morgan Gaertner, Oxytocin, Pantothenic Acid, Phosphorus, Rhodiola, Serotonin (Hydrochloride), Stomach (Suis), Thyroidinum (Suis)","43742214401","Antimalarial [EPC], Catecholamine [EPC], Catecholamines [CS], Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]","43742-2144","43742-2144-1","43742-2144_78aaef20-b610-4071-8204-433d2f30dd63","HUMAN OTC DRUG","Appetite Control","","LIQUID","ORAL","20240312","","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","6; 8; 6; 8; 6; 14; 6; 6; 34; 6; 6; 6; 30; 6; 8; 6; 6; 8","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"2308","ADENOSINE TRIPHOSPHATE DISODIUM; AMBER; APIS MELLIFERA; CASTANEA SATIVA LEAF; CEANOTHUS AMERICANUS LEAF; HELIANTHUS ANNUUS FLOWERING TOP; IRON; JUNIPER BERRY; MYOSOTIS ARVENSIS WHOLE; PHYTOLACCA AMERICANA ROOT; QUERCUS ROBUR NUT; QUININE ARSENITE; SODIUM CHLORIDE; SODIUM SULFATE; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; UBIDECARENONE","Adenosinum Triphosphoricum Dinatrum, Apis Mellifica, Castanea Vesca, Ceanothus Americanus, Chininum Arsenicosum, Ferrum Metallicum, Helianthus Annuus, Juniperus Communis, Lymph Node (Suis), Myosotis Arvensis, Natrum Muriaticum, Natrum Sulphuricum, Phytolacca Decandra, Quercus Glandium Spiritus, Spleen (Suis), Succinum, Thymus (Suis), Ubidecarenonum","43742217601","Allergens [CS], Allergens [CS], Antimalarial [EPC], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]","43742-2176","43742-2176-1","43742-2176_072b8a81-c032-4ab3-952d-b61d1d3870f5","HUMAN OTC DRUG","Lymph/Spleen Combo","","LIQUID","ORAL","20240731","","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","12; 30; 200; 6; 6; 30; 30; 3; 9; 8; 6; 12; 6; 6; 8; 8; 8; 12","[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"2309","ACTIVATED CHARCOAL; ASARUM CANADENSE ROOT; CARBON DISULFIDE; CYCLAMEN PURPURASCENS TUBER; DYSPHANIA AMBROSIOIDES WHOLE; GINKGO; GOSSYPIUM HERBACEUM ROOT BARK; GRAPHITE; LEAD; ONION; PHOSPHORUS; QUININE SULFATE; SILVER NITRATE; SODIUM SALICYLATE; SOLANUM DULCAMARA TOP; SUS SCROFA CARTILAGE; SUS SCROFA NASAL MUCOSA; THERIDION CURASSAVICUM; WOOD CREOSOTE; ZINC","Allium Cepa, Argentum Nitricum, Asarum Canadense, Carbo Vegetabilis, Carboneum Sulphuratum, Cartilago Suis, Chenopodium Anthelminticum, Chininum Sulphuricum, Cyclamen Europaeum, Dulcamara, Ginkgo Biloba, Gossypium Herbaceum, Graphites, Kreosotum, Mucosa Nasalis Suis, Natrum Salicylicum, Phosphorus, Plumbum Metallicum, Theridion, Zincum Metallicum","43742217801","Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]","43742-2178","43742-2178-1","43742-2178_64b7dac4-3d20-41ce-8a1a-84923e5fb6bb","HUMAN OTC DRUG","Ear Ring","","LIQUID","ORAL","20240513","20290724","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","12; 9; 12; 12; 6; 6; 12; 12; 12; 6; 12; 6; 6; 10; 6; 8; 8; 12; 12; 12","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N",""
"2310","ACTIVATED CHARCOAL; ASARUM CANADENSE ROOT; CARBON DISULFIDE; CYCLAMEN PURPURASCENS TUBER; DYSPHANIA AMBROSIOIDES WHOLE; GINKGO; GRAPHITE; LEAD; ONION; PHOSPHORUS; QUININE SULFATE; SILVER NITRATE; SODIUM SALICYLATE; SOLANUM DULCAMARA TOP; SUS SCROFA CARTILAGE; SUS SCROFA NASAL MUCOSA; THERIDION CURASSAVICUM; WOOD CREOSOTE; ZINC","Allium Cepa, Argentum Nitricum, Asarum Canadense, Carbo Vegetabilis, Carboneum Sulphuratum, Cartilago Suis, Chenopodium Anthelminticum, Chininum Sulphuricum, Cyclamen Europaeum, Dulcamara, Ginkgo Biloba, Graphites, Kreosotum, Mucosa Nasalis Suis, Natrum Salicylicum, Phosphorus, Plumbum Metallicum, Theridion, Zincum Metallicum","43742226401","Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]","43742-2264","43742-2264-1","43742-2264_2fb50204-f6e9-4d7a-a79e-21aaa81f8096","HUMAN OTC DRUG","Ear Ring","","LIQUID","ORAL","20250414","","UNAPPROVED HOMEOPATHIC","","Deseret Biologicals, Inc.","12; 9; 12; 12; 6; 6; 12; 12; 6; 12; 6; 6; 10; 6; 8; 8; 12; 12; 12","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20261231"
"2311","ARSENIC TRIOXIDE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; CITHARACANTHUS SPINICRUS; CLAVICEPS PURPUREA SCLEROTIUM; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA WHOLE; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LOXOSCELES RECLUSA; QUININE SULFATE","Baptisia Tinctoria, Echinacea (Angustifolia), Arsenicum Album, Chininum Sulphuricum, Crotalus Horridus, Lachesis Mutus, Secale Cornutum, Tarentula Cubensis, Latrodectus Mactans, Anthracinum, Loxosceles Reclusa","43857062001","Antimalarial [EPC]","43857-0620","43857-0620-1","43857-0620_5d5310a2-7ea8-4a68-aa0e-bc7bcc142504","HUMAN PRESCRIPTION DRUG","Septaforce","","LIQUID","ORAL","20211119","","UNAPPROVED HOMEOPATHIC","","BioActive Nutritional, Inc.","12; 33; 3; 12; 12; 12; 3; 12; 12; 15; 12","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL","","N","20251231"
"2312","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","44118070010","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44118-700","44118-700-10","44118-700_d91769aa-ca47-567f-e053-2a95a90a664b","HUMAN PRESCRIPTION DRUG","Plexion","","LIQUID","TOPICAL","20220228","","UNAPPROVED DRUG OTHER","","Eckson Labs, LLC","98; 48","mg/g; mg/g","","N","20251231"
"2313","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","44118070102","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44118-701","44118-701-02","44118-701_db71ee55-bbde-0996-e053-2a95a90a5687","HUMAN PRESCRIPTION DRUG","Plexion","","CREAM","TOPICAL","20220330","","UNAPPROVED DRUG OTHER","","Eckson Labs LLC","98; 48","mg/g; mg/g","","N","20251231"
"2314","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","44118070302","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44118-703","44118-703-02","44118-703_db747368-d45e-64e3-e053-2995a90a1fb8","HUMAN PRESCRIPTION DRUG","Plexion","","LOTION","TOPICAL","20220330","","UNAPPROVED DRUG OTHER","","Eckson Labs LLC","98; 48","mg/g; mg/g","","N","20251231"
"2315","SULFACETAMIDE SODIUM","SULFACETAMIDE SODIUM","44118071208","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44118-712","44118-712-08","44118-712_d7af39fc-190c-6c97-e053-2995a90adc80","HUMAN PRESCRIPTION DRUG","PLEXION NS","","SHAMPOO","TOPICAL","20211006","","UNAPPROVED DRUG OTHER","","Eckson Labs, LLC","98","mg/mL","","N","20251231"
"2316","TINIDAZOLE","tinidazole","44523045012","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","44523-450","44523-450-12","44523-450_36d804aa-0040-15a6-e063-6294a90abc0f","HUMAN PRESCRIPTION DRUG","Tinidazole","","TABLET, FILM COATED","ORAL","20250320","","NDA AUTHORIZED GENERIC","NDA021618","BioComp Pharma, Inc.","500","mg/1","","N","20261231"
"2317","TINIDAZOLE","tinidazole","44523045020","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","44523-450","44523-450-20","44523-450_36d804aa-0040-15a6-e063-6294a90abc0f","HUMAN PRESCRIPTION DRUG","Tinidazole","","TABLET, FILM COATED","ORAL","20250320","","NDA AUTHORIZED GENERIC","NDA021618","BioComp Pharma, Inc.","500","mg/1","","N","20261231"
"2318","SULFACETAMIDE SODIUM","Sodium Sulfacetamide","44523051008","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-510","44523-510-08","44523-510_f7e4da5a-b00f-c32c-e053-6294a90a74aa","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide","","SHAMPOO","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100","mg/mL","","N","20251231"
"2319","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","44523052002","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-520","44523-520-02","44523-520_2d7f2b22-c0bb-6b29-e063-6394a90aae2e","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide, Sulfur","","CREAM","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100; 50","mg/g; mg/g","","N","20261231"
"2320","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","44523053502","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-535","44523-535-02","44523-535_2d7f1cbd-1ec1-50f3-e063-6394a90ab966","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide, Sulfur","","CREAM","TOPICAL","20110915","20251031","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100; 20","mg/g; mg/g","","N",""
"2321","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM","44523054202","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-542","44523-542-02","44523-542_f7986b08-7653-ebba-e053-6294a90a0206","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide, Sulfur","","CREAM","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100; 50","mg/g; mg/g","","N","20251231"
"2322","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","44523055008","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-550","44523-550-08","44523-550_f798f8d7-639f-2a12-e053-6294a90a00fb","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide, Sulfur","","EMULSION","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100; 20","mg/g; mg/g","","N","20251231"
"2323","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","44523056006","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-560","44523-560-06","44523-560_09910b22-d48a-4d9b-e063-6394a90a50ea","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM, SULFUR","","EMULSION","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100; 50","mg/g; mg/g","","N","20251231"
"2324","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","44523056008","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-560","44523-560-08","44523-560_09910b22-d48a-4d9b-e063-6394a90a50ea","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM, SULFUR","","EMULSION","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100; 50","mg/g; mg/g","","N","20251231"
"2325","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","44523056012","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-560","44523-560-12","44523-560_09910b22-d48a-4d9b-e063-6394a90a50ea","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM, SULFUR","","EMULSION","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100; 50","mg/g; mg/g","","N","20251231"
"2326","SULFACETAMIDE SODIUM","SULFACETAMIDE SODIUM","44523056812","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-568","44523-568-12","44523-568_f79829b8-9eab-703f-e053-6294a90aaf15","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM","","LIQUID","TOPICAL","20110915","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100","mg/mL","","N","20251231"
"2327","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","44523060002","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-600","44523-600-02","44523-600_2c6307dd-ff18-0654-e063-6294a90afc15","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE AND SULFUR","","LOTION","TOPICAL","20250123","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","98; 48","mg/g; mg/g","","N","20261231"
"2328","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","44523060201","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-602","44523-602-01","44523-602_f7993689-bf1d-56b7-e053-6394a90af46b","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE AND SULFUR","","LOTION","TOPICAL","20110430","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100; 50","mg/g; mg/g","","N","20251231"
"2329","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","44523060301","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-603","44523-603-01","44523-603_f7992356-ed95-ad2f-e053-6294a90a8281","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE AND SULFUR","","CREAM","TOPICAL","20110430","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100; 50","mg/g; mg/g","","N","20251231"
"2330","SULFACETAMIDE SODIUM; SULFUR","sulfacetamide sodium, sulfur","44523060401","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-604","44523-604-01","44523-604_f79914d3-c3c4-8601-e053-6294a90aefb3","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE, SULFUR","","SUSPENSION","TOPICAL","20110604","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100; 50","mg/g; mg/g","","N","20251231"
"2331","SULFACETAMIDE SODIUM; SULFUR","sodium sulfacetamide, sulfur","44523060516","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-605","44523-605-16","44523-605_f7e45f8b-a93c-26b4-e053-6394a90a841e","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE AND SULFUR","","LOTION","TOPICAL","20110415","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","90; 45","mg/g; mg/g","","N","20251231"
"2332","SULFACETAMIDE SODIUM","SODIUM SULFACETAMIDE","44523060612","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-606","44523-606-12","44523-606_130061d9-9da2-8409-e063-6294a90af310","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE","","LIQUID","TOPICAL","20130107","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100","mg/mL","","N","20251231"
"2333","SULFACETAMIDE SODIUM","SODIUM SULFACETAMIDE","44523060616","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-606","44523-606-16","44523-606_130061d9-9da2-8409-e063-6294a90af310","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE","","LIQUID","TOPICAL","20130107","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100","mg/mL","","N","20251231"
"2334","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","44523060702","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-607","44523-607-02","44523-607_13008a88-c5f4-b52f-e063-6294a90a577b","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE AND SULFUR","","LOTION","TOPICAL","20110604","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100; 50","mg/g; mg/g","","N","20251231"
"2335","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","44523060701","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-607","44523-607-01","44523-607_13008a88-c5f4-b52f-e063-6294a90a577b","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE AND SULFUR","","LOTION","TOPICAL","20110604","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100; 50","mg/g; mg/g","","N","20251231"
"2336","SULFACETAMIDE SODIUM","SODIUM SULFACETAMIDE","44523061306","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-613","44523-613-06","44523-613_f7e4cac5-e0b3-b203-e053-6294a90ac08b","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE","","LIQUID","TOPICAL","20110907","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","100","mg/mL","","N","20251231"
"2337","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","44523062416","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-624","44523-624-16","44523-624_36d7ebf4-3712-9d8b-e063-6394a90ae579","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE AND SULFUR","","SUSPENSION","TOPICAL","20250127","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","80; 40","mg/mL; mg/mL","","N","20261231"
"2338","SULFACETAMIDE SODIUM; SULFUR","Sodium Sulfacetamide 9.8% and Sulfur 4.8%","44523074810","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","44523-748","44523-748-10","44523-748_36d7f15d-0115-a647-e063-6394a90ab97d","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE AND SULFUR","","EMULSION","TOPICAL","20241217","","UNAPPROVED DRUG OTHER","","BioComp Pharma, Inc.","98; 48","mg/g; mg/g","","N","20261231"
"2339","AMPICILLIN SODIUM","Ampicillin","44567010010","Penicillin-class Antibacterial [EPC], Penicillins [CS]","44567-100","44567-100-10","44567-100_ea730793-1874-42cf-85fe-46b49000a8a0","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120510","","ANDA","ANDA062772","WG Critical Care, LLC","250","mg/1","","N","20261231"
"2340","AMPICILLIN SODIUM","Ampicillin","44567010110","Penicillin-class Antibacterial [EPC], Penicillins [CS]","44567-101","44567-101-10","44567-101_ea730793-1874-42cf-85fe-46b49000a8a0","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120510","","ANDA","ANDA062772","WG Critical Care, LLC","500","mg/1","","N","20261231"
"2341","AMPICILLIN SODIUM","Ampicillin","44567010210","Penicillin-class Antibacterial [EPC], Penicillins [CS]","44567-102","44567-102-10","44567-102_ea730793-1874-42cf-85fe-46b49000a8a0","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120510","","ANDA","ANDA062772","WG Critical Care, LLC","1","g/1","","N","20261231"
"2342","AMPICILLIN SODIUM","Ampicillin","44567010310","Penicillin-class Antibacterial [EPC], Penicillins [CS]","44567-103","44567-103-10","44567-103_ea730793-1874-42cf-85fe-46b49000a8a0","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120510","","ANDA","ANDA062772","WG Critical Care, LLC","2","g/1","","N","20261231"
"2343","AMPICILLIN SODIUM","Ampicillin","44567010410","Penicillin-class Antibacterial [EPC], Penicillins [CS]","44567-104","44567-104-10","44567-104_6b3c9300-bd54-4c73-b7ea-ad2813f6b8e0","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20120510","","ANDA","ANDA063142","WG Critical Care, LLC","10","g/100mL","","N","20251231"
"2344","AMPICILLIN SODIUM","Ampicillin","44567010401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","44567-104","44567-104-01","44567-104_6b3c9300-bd54-4c73-b7ea-ad2813f6b8e0","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20120510","","ANDA","ANDA063142","WG Critical Care, LLC","10","g/100mL","","N","20251231"
"2345","AMPICILLIN SODIUM","Ampicillin","44567010510","Penicillin-class Antibacterial [EPC], Penicillins [CS]","44567-105","44567-105-10","44567-105_ea730793-1874-42cf-85fe-46b49000a8a0","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120510","","ANDA","ANDA062772","WG Critical Care, LLC","125","mg/1","","N","20261231"
"2346","CEFAZOLIN SODIUM","Cefazolin","44567012025","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-120","44567-120-25","44567-120_9ccb8f46-5ebd-47c1-a401-811db9860c23","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20190423","","ANDA","ANDA065303","WG Critical Care, LLC","1","g/1","","N","20261231"
"2347","CEFEPIME HYDROCHLORIDE","Cefepime","44567013010","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-130","44567-130-10","44567-130_a58c99bd-b70a-4a7f-be6c-d08c36104899","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20210331","","ANDA","ANDA065441","WG Critical Care, LLC","1","g/20mL","","N","20251231"
"2348","CEFEPIME HYDROCHLORIDE","Cefepime","44567013110","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-131","44567-131-10","44567-131_a58c99bd-b70a-4a7f-be6c-d08c36104899","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210331","","ANDA","ANDA065441","WG Critical Care, LLC","2","g/20mL","","N","20251231"
"2349","MEROPENEM","Meropenem","44567014510","Carbapenems [CS], Penem Antibacterial [EPC]","44567-145","44567-145-10","44567-145_174553b5-2586-46de-95d4-bc87f9e46e4f","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210630","","ANDA","ANDA210773","WG Critical Care, LLC","500","mg/1","","N","20261231"
"2350","MEROPENEM","Meropenem","44567014610","Carbapenems [CS], Penem Antibacterial [EPC]","44567-146","44567-146-10","44567-146_174553b5-2586-46de-95d4-bc87f9e46e4f","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210630","","ANDA","ANDA210773","WG Critical Care, LLC","1","g/1","","N","20261231"
"2351","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin and Sulbactam","44567015010","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","44567-150","44567-150-10","44567-150_439e3c85-4ac9-4aaa-a234-f906059f7b9e","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20211130","","ANDA","ANDA201406","WG Critical Care, LLC","2; 1","g/20mL; g/20mL","","N","20261231"
"2352","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin and Sulbactam","44567021010","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","44567-210","44567-210-10","44567-210_aa550f01-5c9e-4d9c-b463-4930b2c1e5e7","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20051130","","ANDA","ANDA065176","WG Critical Care, LLC","1; .5","g/10mL; g/10mL","","N","20261231"
"2353","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin and Sulbactam","44567021110","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","44567-211","44567-211-10","44567-211_aa550f01-5c9e-4d9c-b463-4930b2c1e5e7","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20051130","","ANDA","ANDA065176","WG Critical Care, LLC","2; 1","g/20mL; g/20mL","","N","20261231"
"2354","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin and Sulbactam","44567021201","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","44567-212","44567-212-01","44567-212_6db840e0-7805-4daa-b8b9-aa6f1f46fd10","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20051125","","ANDA","ANDA065188","WG Critical Care, LLC","10; 5","g/100mL; g/100mL","","N","20251231"
"2355","NAFCILLIN SODIUM","Nafcillin","44567022110","Penicillin-class Antibacterial [EPC], Penicillins [CS]","44567-221","44567-221-10","44567-221_1d3972eb-3c35-4e3f-81b7-0a28b58c75a4","HUMAN PRESCRIPTION DRUG","Nafcillin","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20130118","","ANDA","ANDA090560","WG Critical Care, LLC","1","g/1","","N","20251231"
"2356","NAFCILLIN SODIUM","Nafcillin","44567022210","Penicillin-class Antibacterial [EPC], Penicillins [CS]","44567-222","44567-222-10","44567-222_1d3972eb-3c35-4e3f-81b7-0a28b58c75a4","HUMAN PRESCRIPTION DRUG","Nafcillin","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20130118","","ANDA","ANDA090560","WG Critical Care, LLC","2","g/1","","N","20251231"
"2357","NAFCILLIN SODIUM","NAFCILLIN","44567022301","Penicillin-class Antibacterial [EPC], Penicillins [CS]","44567-223","44567-223-01","44567-223_c7d4ca5b-202d-4ba3-adfa-4eccf19d2d47","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20110427","","ANDA","ANDA090005","WG Critical Care, LLC","10","g/100mL","","N","20251231"
"2358","CEFTAZIDIME","Ceftazidime","44567023525","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-235","44567-235-25","44567-235_c1a9149a-efde-4f1c-a5f9-72a369d72c0e","HUMAN PRESCRIPTION DRUG","Ceftazidime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20130131","","ANDA","ANDA062640","WG Critical Care, LLC","1","g/1","","N","20251231"
"2359","CEFTAZIDIME","Ceftazidime","44567023610","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-236","44567-236-10","44567-236_c1a9149a-efde-4f1c-a5f9-72a369d72c0e","HUMAN PRESCRIPTION DRUG","Ceftazidime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20130131","","ANDA","ANDA062640","WG Critical Care, LLC","2","g/1","","N","20251231"
"2360","CEFTAZIDIME","Ceftazidime","44567023706","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-237","44567-237-06","44567-237_a225696b-a8e8-45cc-a329-9f312e03ea1a","HUMAN PRESCRIPTION DRUG","Ceftazidime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20130131","","ANDA","ANDA062640","WG Critical Care, LLC","6","g/100mL","","N","20251231"
"2361","CEFEPIME HYDROCHLORIDE","Cefepime","44567024010","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-240","44567-240-10","44567-240_bb74bbf9-bb0c-417b-949f-1fe5f995e956","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20141010","","ANDA","ANDA065441","WG Critical Care, LLC","1","g/20mL","","N","20251231"
"2362","CEFEPIME HYDROCHLORIDE","Cefepime","44567024110","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-241","44567-241-10","44567-241_bb74bbf9-bb0c-417b-949f-1fe5f995e956","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20141010","","ANDA","ANDA065441","WG Critical Care, LLC","2","g/20mL","","N","20251231"
"2363","CEFOXITIN SODIUM","Cefoxitin","44567024525","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-245","44567-245-25","44567-245_fa6d5377-af57-45a8-aa38-685877c809a7","HUMAN PRESCRIPTION DRUG","Cefoxitin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20150218","","ANDA","ANDA065414","WG Critical Care, LLC","1","g/1","","N","20251231"
"2364","CEFOXITIN SODIUM","Cefoxitin","44567024585","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-245","44567-245-85","44567-245_fa6d5377-af57-45a8-aa38-685877c809a7","HUMAN PRESCRIPTION DRUG","Cefoxitin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20150218","","ANDA","ANDA065414","WG Critical Care, LLC","1","g/1","","N","20251231"
"2365","CEFOXITIN SODIUM","Cefoxitin","44567024625","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-246","44567-246-25","44567-246_fa6d5377-af57-45a8-aa38-685877c809a7","HUMAN PRESCRIPTION DRUG","Cefoxitin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20150218","","ANDA","ANDA065414","WG Critical Care, LLC","2","g/1","","N","20251231"
"2366","CEFOXITIN SODIUM","Cefoxitin","44567024685","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-246","44567-246-85","44567-246_fa6d5377-af57-45a8-aa38-685877c809a7","HUMAN PRESCRIPTION DRUG","Cefoxitin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20150218","","ANDA","ANDA065414","WG Critical Care, LLC","2","g/1","","N","20251231"
"2367","CEFOXITIN SODIUM","Cefoxitin","44567024710","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-247","44567-247-10","44567-247_eaa65075-3ed9-4a2c-9aa5-2f24a34bf5b2","HUMAN PRESCRIPTION DRUG","Cefoxitin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20131001","","ANDA","ANDA065415","WG Critical Care, LLC","10","g/1","","N","20251231"
"2368","PENICILLIN G POTASSIUM","Penicillin G Potassium","44567031010","Penicillin-class Antibacterial [EPC], Penicillins [CS]","44567-310","44567-310-10","44567-310_7f68ffb1-7d79-47ed-afe1-a9489bf42973","HUMAN PRESCRIPTION DRUG","Penicillin G Potassium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120510","","ANDA","ANDA065149","WG Critical Care, LLC","1000000","[iU]/1","","N","20261231"
"2369","PENICILLIN G POTASSIUM","Penicillin G Potassium","44567031110","Penicillin-class Antibacterial [EPC], Penicillins [CS]","44567-311","44567-311-10","44567-311_7f68ffb1-7d79-47ed-afe1-a9489bf42973","HUMAN PRESCRIPTION DRUG","Penicillin G Potassium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120510","","ANDA","ANDA065149","WG Critical Care, LLC","5000000","[iU]/1","","N","20261231"
"2370","PENICILLIN G POTASSIUM","Penicillin G Potassium","44567031210","Penicillin-class Antibacterial [EPC], Penicillins [CS]","44567-312","44567-312-10","44567-312_7f68ffb1-7d79-47ed-afe1-a9489bf42973","HUMAN PRESCRIPTION DRUG","Penicillin G Potassium","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20120510","","ANDA","ANDA065149","WG Critical Care, LLC","20000000","[iU]/1","","N","20261231"
"2371","MEROPENEM","Meropenem","44567040010","Carbapenems [CS], Penem Antibacterial [EPC]","44567-400","44567-400-10","44567-400_b1a7606e-81b5-4e9e-be8c-b0e50b3cbde8","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20200109","","ANDA","ANDA210773","WG Critical Care, LLC","500","mg/1","","N","20261231"
"2372","MEROPENEM","Meropenem","44567040110","Carbapenems [CS], Penem Antibacterial [EPC]","44567-401","44567-401-10","44567-401_b1a7606e-81b5-4e9e-be8c-b0e50b3cbde8","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20200109","","ANDA","ANDA210773","WG Critical Care, LLC","1","g/1","","N","20261231"
"2373","MEROPENEM","Meropenem","44567040206","Carbapenems [CS], Penem Antibacterial [EPC]","44567-402","44567-402-06","44567-402_d0522d6b-aceb-4cc9-8b25-0dd563930d47","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20230908","","NDA","NDA215212","WG Critical Care, LLC","2","g/1","","N","20251231"
"2374","CEFTRIAXONE SODIUM","Ceftriaxone","44567070025","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-700","44567-700-25","44567-700_eb48063c-c656-42d9-8733-841cd1b39a82","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20080724","","ANDA","ANDA065329","WG Critical Care, LLC","500","mg/1","","N","20261231"
"2375","CEFTRIAXONE SODIUM","Ceftriaxone","44567070125","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-701","44567-701-25","44567-701_eb48063c-c656-42d9-8733-841cd1b39a82","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20080724","","ANDA","ANDA065329","WG Critical Care, LLC","1","g/1","","N","20261231"
"2376","CEFTRIAXONE SODIUM","Ceftriaxone","44567070195","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-701","44567-701-95","44567-701_eb48063c-c656-42d9-8733-841cd1b39a82","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20080724","","ANDA","ANDA065329","WG Critical Care, LLC","1","g/1","","N","20261231"
"2377","CEFTRIAXONE SODIUM","Ceftriaxone","44567070225","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-702","44567-702-25","44567-702_8a67f12f-d687-4596-956a-f58681d646ed","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20080724","","ANDA","ANDA065329","WG Critical Care, LLC","2","g/1","","N","20261231"
"2378","CEFTRIAXONE SODIUM","Ceftriaxone","44567070295","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-702","44567-702-95","44567-702_8a67f12f-d687-4596-956a-f58681d646ed","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20080724","","ANDA","ANDA065329","WG Critical Care, LLC","2","g/1","","N","20261231"
"2379","CEFTRIAXONE SODIUM","Ceftriaxone","44567070301","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-703","44567-703-01","44567-703_25b246f3-2324-45b8-94f3-657774b7cb62","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20080724","","ANDA","ANDA065328","WG Critical Care, LLC","10","g/100mL","","N","20251231"
"2380","CILASTATIN SODIUM; IMIPENEM ANHYDROUS","Imipenem and Cilastatin","44567070510","Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]","44567-705","44567-705-10","44567-705_6bfcc077-8c32-4c7e-abaa-f17eb2084231","HUMAN PRESCRIPTION DRUG","Imipenem and Cilastatin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210309","","ANDA","ANDA207594","WG Critical Care, LLC","500; 500","mg/1; mg/1","","N","20261231"
"2381","CEFAZOLIN SODIUM","Cefazolin","44567070625","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-706","44567-706-25","44567-706_7333fedf-6410-4d9a-9a9b-329f98ed0934","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20150306","","ANDA","ANDA065303","WG Critical Care, LLC","500","mg/1","","N","20261231"
"2382","CEFAZOLIN SODIUM","Cefazolin","44567070725","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-707","44567-707-25","44567-707_7333fedf-6410-4d9a-9a9b-329f98ed0934","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20150306","","ANDA","ANDA065303","WG Critical Care, LLC","1","g/1","","N","20261231"
"2383","CEFAZOLIN SODIUM","Cefazolin","44567070810","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-708","44567-708-10","44567-708_d94c6e64-269c-4cbb-b5e5-77a338d8c7f3","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20150306","","ANDA","ANDA065306","WG Critical Care, LLC","10","g/1","","N","20251231"
"2384","METRONIDAZOLE","Metronidazole","44567075024","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","44567-750","44567-750-24","44567-750_e4ea0c09-cdd1-4708-962c-6ba28b989df3","HUMAN PRESCRIPTION DRUG","Metronidazole","","INJECTION, SOLUTION","INTRAVENOUS","20250131","","ANDA","ANDA206191","WG Critical Care, LLC","500","mg/100mL","","N","20261231"
"2385","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN SODIUM,TAZOBACTAM SODIUM","44567080110","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","44567-801","44567-801-10","44567-801_2eb617c2-c198-4e3a-bccd-68616e26a5d5","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20091013","","ANDA","ANDA065523","WG Critical Care, LLC","2; .25","g/1; g/1","","N","20251231"
"2386","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN SODIUM,TAZOBACTAM SODIUM","44567080210","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","44567-802","44567-802-10","44567-802_2eb617c2-c198-4e3a-bccd-68616e26a5d5","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20091013","","ANDA","ANDA065523","WG Critical Care, LLC","3; .375","g/1; g/1","","N","20251231"
"2387","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN SODIUM,TAZOBACTAM SODIUM","44567080310","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","44567-803","44567-803-10","44567-803_2eb617c2-c198-4e3a-bccd-68616e26a5d5","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20091013","","ANDA","ANDA065523","WG Critical Care, LLC","4; .5","g/1; g/1","","N","20251231"
"2388","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","44567080401","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","44567-804","44567-804-01","44567-804_0f49832c-2b7f-4852-9088-fedb9bf19029","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20091020","","ANDA","ANDA090498","WG Critical Care, LLC","36; 4.5","g/1; g/1","","N","20251231"
"2389","ERTAPENEM SODIUM","ertapenem","44567082010","Carbapenems [CS], Penem Antibacterial [EPC]","44567-820","44567-820-10","44567-820_befbf704-5aae-474b-8457-c77b2ab7835e","HUMAN PRESCRIPTION DRUG","ertapenem","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20200107","","ANDA","ANDA208790","WG Critical Care, LLC","1","g/1","","N","20251231"
"2390","CEFAZOLIN SODIUM","Cefazolin","44567084025","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-840","44567-840-25","44567-840_f295b581-42f2-4a83-bd35-58d21fa32dda","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20230518","","NDA","NDA211413","WG Critical Care, LLC","2","g/1","","N","20261231"
"2391","CEFAZOLIN SODIUM","Cefazolin","44567084525","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","44567-845","44567-845-25","44567-845_f295b581-42f2-4a83-bd35-58d21fa32dda","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20240510","","NDA","NDA211413","WG Critical Care, LLC","3","g/1","","N","20261231"
"2392","MICONAZOLE NITRATE","MICONAZOLE NITRATE","44577020556","Azole Antifungal [EPC], Azoles [CS]","44577-205","44577-205-56","44577-205_0973aae6-55b5-5f1a-e063-6394a90a9848","HUMAN OTC DRUG","MacerRx Web","","CREAM","TOPICAL","20130606","","OTC MONOGRAPH DRUG","M005","Clinical Therapeutic Solutions","2","g/100g","","N","20251231"
"2393","ERTAPENEM SODIUM","Ertapenem Sodium","44647005110","Carbapenems [CS], Penem Antibacterial [EPC]","44647-051","44647-051-10","44647-051_0b211a36-8d30-fb5e-e063-6294a90af3de","HUMAN PRESCRIPTION DRUG","Ertapenem","","INJECTION","INTRAMUSCULAR; INTRAVENOUS","20190319","","ANDA","ANDA207647","Savior Lifetec Corporation","1","g/20mL","","N","20251231"
"2394","ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; CEANOTHUS AMERICANUS LEAF; IODINE; NITRIC ACID; PHOSPHORIC ACID; PHOSPHORUS; QUININE SULFATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; SUS SCROFA SPLEEN","Spleen (Suis), Arsenicum Album, Carbo Vegetabilis, Ceanothus Americanus, Chininum Sulphuricum, Ignatia Amara, Iodium, Natrum Muriaticum, Nitricum Acidum, Phosphoricum Acidum, Phosphorus","44911026101","Antimalarial [EPC]","44911-0261","44911-0261-1","44911-0261_9cdb1036-89a8-455a-ac56-be6742001ba4","HUMAN OTC DRUG","Spleenpar","","LIQUID","ORAL","20150904","","UNAPPROVED HOMEOPATHIC","","Energique, Inc.","12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 6","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"2395","ALLYLTHIOUREA; CINCHONA OFFICINALIS BARK; GINKGO; GRAPHITE; LEAD; QUININE SULFATE; SALICYLIC ACID; SODIUM SALICYLATE; SPIGELIA ANTHELMIA WHOLE","Ginkgo Biloba, Chininum Sulphuricum, Cinchona Officinalis, Graphites, Natrum Salicylicum, Plumbum Metallicum, Salicylicum acidum, Spigelia Anthelmia, Thiosinaminum","44911062601","Antimalarial [EPC]","44911-0626","44911-0626-1","44911-0626_dfb88b6d-ce5b-4ee0-9fca-6a7946664679","HUMAN OTC DRUG","Ring HP","","LIQUID","ORAL","20201221","","UNAPPROVED HOMEOPATHIC","","Energique, Inc.","30; 30; 6; 30; 30; 30; 30; 30; 30","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"2396","ERYTHROMYCIN","erythromycin","45802003846","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","45802-038","45802-038-46","45802-038_22fd6fa6-2fdf-4e0d-b51a-89bd44e4ecf0","HUMAN PRESCRIPTION DRUG","erythromycin","","SOLUTION","TOPICAL","20111219","","ANDA","ANDA063038","Padagis Israel Pharmaceuticals Ltd","20","mg/mL","","N","20251231"
"2397","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","45802004202","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","45802-042","45802-042-02","45802-042_6ac971cb-6d92-4cc1-9e03-cb10dad6439c","HUMAN PRESCRIPTION DRUG","Clindesse","","CREAM","VAGINAL","20150703","","NDA","NDA050793","Padagis Israel Pharmaceuticals Ltd","100","mg/5g","","N","20261231"
"2398","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","45802004201","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","45802-042","45802-042-01","45802-042_6ac971cb-6d92-4cc1-9e03-cb10dad6439c","HUMAN PRESCRIPTION DRUG","Clindesse","","CREAM","VAGINAL","20150703","","NDA","NDA050793","Padagis Israel Pharmaceuticals Ltd","100","mg/5g","","N","20261231"
"2399","GENTAMICIN SULFATE","Gentamicin Sulfate","45802004635","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","45802-046","45802-046-35","45802-046_551f1c2e-36a3-4229-b70f-38b6a3faa1d5","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","OINTMENT","TOPICAL","20060710","","ANDA","ANDA062351","Padagis Israel Pharmaceuticals Ltd","1","mg/g","","N","20261231"
"2400","GENTAMICIN SULFATE","Gentamicin Sulfate","45802004611","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","45802-046","45802-046-11","45802-046_551f1c2e-36a3-4229-b70f-38b6a3faa1d5","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","OINTMENT","TOPICAL","20060710","","ANDA","ANDA062351","Padagis Israel Pharmaceuticals Ltd","1","mg/g","","N","20261231"
"2401","NYSTATIN","Nystatin","45802004811","Polyene Antifungal [EPC], Polyenes [CS]","45802-048","45802-048-11","45802-048_d0882d4c-19ef-45d3-99c2-2697b1d213d4","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20060915","","ANDA","ANDA062472","Padagis Israel Pharmaceuticals Ltd","100000","[USP'U]/g","","N","20261231"
"2402","GENTAMICIN SULFATE","Gentamicin Sulfate","45802005635","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","45802-056","45802-056-35","45802-056_11688357-e569-4785-a313-18115f24c5bb","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","CREAM","TOPICAL","20060823","","ANDA","ANDA062307","Padagis Israel Pharmaceuticals Ltd","1","mg/g","","N","20261231"
"2403","GENTAMICIN SULFATE","Gentamicin Sulfate","45802005611","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","45802-056","45802-056-11","45802-056_11688357-e569-4785-a313-18115f24c5bb","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","CREAM","TOPICAL","20060823","","ANDA","ANDA062307","Padagis Israel Pharmaceuticals Ltd","1","mg/g","","N","20261231"
"2404","NYSTATIN","Nystatin","45802005935","Polyene Antifungal [EPC], Polyenes [CS]","45802-059","45802-059-35","45802-059_e2839c50-5b8f-4e7b-9636-d22687038a89","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20060921","","ANDA","ANDA062225","Padagis Israel Pharmaceuticals Ltd","100000","[USP'U]/g","","N","20251231"
"2405","MUPIROCIN","Mupirocin","45802011222","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","45802-112","45802-112-22","45802-112_d51e7348-2495-41d4-93c1-bfaef2dac375","HUMAN PRESCRIPTION DRUG","mupirocin","","OINTMENT","TOPICAL","20091030","","ANDA","ANDA065123","Padagis Israel Pharmaceuticals Ltd","20","mg/g","","N","20251231"
"2406","MUPIROCIN","Mupirocin","45802011214","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","45802-112","45802-112-14","45802-112_d51e7348-2495-41d4-93c1-bfaef2dac375","HUMAN PRESCRIPTION DRUG","mupirocin","","OINTMENT","TOPICAL","20091030","","ANDA","ANDA065123","Padagis Israel Pharmaceuticals Ltd","20","mg/g","","N","20251231"
"2407","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","45802012801","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","45802-128","45802-128-01","45802-128_073ff89e-39d5-4061-9af6-7fa356b2fce5","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","LOTION","TOPICAL","20210331","","ANDA","ANDA214604","Padagis Israel Pharmaceuticals Ltd","10","mg/mL","","N","20251231"
"2408","METRONIDAZOLE","metronidazole","45802013970","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","45802-139","45802-139-70","45802-139_ac51fedf-e650-40c6-a92f-d33d6f32e54b","HUMAN PRESCRIPTION DRUG","metronidazole vaginal","","GEL","VAGINAL","20190708","","ANDA","ANDA211786","Padagis Israel Pharmaceuticals Ltd","7.5","mg/g","","N","20251231"
"2409","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","45802014370","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","45802-143","45802-143-70","45802-143_007b5d54-72af-4d4e-a893-c6a79396b9b3","HUMAN OTC DRUG","triple antibiotic","","OINTMENT","TOPICAL","20140520","","OTC MONOGRAPH DRUG","M004","Padagis Israel Pharmaceuticals Ltd","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"2410","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","45802014303","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","45802-143","45802-143-03","45802-143_007b5d54-72af-4d4e-a893-c6a79396b9b3","HUMAN OTC DRUG","triple antibiotic","","OINTMENT","TOPICAL","20140520","","OTC MONOGRAPH DRUG","M004","Padagis Israel Pharmaceuticals Ltd","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"2411","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","45802014301","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","45802-143","45802-143-01","45802-143_007b5d54-72af-4d4e-a893-c6a79396b9b3","HUMAN OTC DRUG","triple antibiotic","","OINTMENT","TOPICAL","20140520","","OTC MONOGRAPH DRUG","M004","Padagis Israel Pharmaceuticals Ltd","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"2412","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin and triamcinolone acetonide","45802024496","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","45802-244","45802-244-96","45802-244_5797c2ea-37cd-4a6f-87ce-030df00cb949","HUMAN PRESCRIPTION DRUG","nystatin and triamcinolone acetonide","","OINTMENT","TOPICAL","20171018","","ANDA","ANDA207380","Padagis Israel Pharmaceuticals Ltd","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"2413","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin and triamcinolone acetonide","45802024414","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","45802-244","45802-244-14","45802-244_5797c2ea-37cd-4a6f-87ce-030df00cb949","HUMAN PRESCRIPTION DRUG","nystatin and triamcinolone acetonide","","OINTMENT","TOPICAL","20171018","","ANDA","ANDA207380","Padagis Israel Pharmaceuticals Ltd","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"2414","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin and triamcinolone acetonide","45802024494","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","45802-244","45802-244-94","45802-244_5797c2ea-37cd-4a6f-87ce-030df00cb949","HUMAN PRESCRIPTION DRUG","nystatin and triamcinolone acetonide","","OINTMENT","TOPICAL","20171018","","ANDA","ANDA207380","Padagis Israel Pharmaceuticals Ltd","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"2415","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","45802026337","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","45802-263","45802-263-37","45802-263_e92b0367-c4ed-4147-b5f5-0c6afa71b1bd","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20060531","","ANDA","ANDA065049","Padagis Israel Pharmaceuticals Ltd","10","mg/mL","","N","20251231"
"2416","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate and Benzoyl Peroxide","45802038301","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","45802-383","45802-383-01","45802-383_2dfc025a-8eac-4e05-a1fe-dc22914002bb","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Benzoyl Peroxide","","GEL","TOPICAL","20240920","","ANDA","ANDA209610","Padagis Israel Pharmaceuticals Ltd","37.5; 10","mg/g; mg/g","","N","20251231"
"2417","BUTOCONAZOLE NITRATE","butoconazole nitrate","45802039601","Azole Antifungal [EPC], Azoles [CS]","45802-396","45802-396-01","45802-396_3953738b-1476-4a24-9e07-a7d3866d76a8","HUMAN PRESCRIPTION DRUG","gynazole 1","","CREAM","VAGINAL","20150429","","ANDA","ANDA200923","Padagis Israel Pharmaceuticals Ltd","100","mg/5g","","N","20251231"
"2418","BUTOCONAZOLE NITRATE","butoconazole nitrate","45802039602","Azole Antifungal [EPC], Azoles [CS]","45802-396","45802-396-02","45802-396_3953738b-1476-4a24-9e07-a7d3866d76a8","HUMAN PRESCRIPTION DRUG","gynazole 1","","CREAM","VAGINAL","20150429","","ANDA","ANDA200923","Padagis Israel Pharmaceuticals Ltd","100","mg/5g","","N","20251231"
"2419","CLOTRIMAZOLE","Clotrimazole","45802043401","Azole Antifungal [EPC], Azoles [CS]","45802-434","45802-434-01","45802-434_5ec69d48-9aa8-4f80-bbb0-403781f2fe57","HUMAN OTC DRUG","clotrimazole","","CREAM","TOPICAL","20110603","20260228","OTC MONOGRAPH DRUG","M005","Padagis Israel Pharmaceuticals Ltd","1","g/100g","","N",""
"2420","CLOTRIMAZOLE","Clotrimazole","45802043411","Azole Antifungal [EPC], Azoles [CS]","45802-434","45802-434-11","45802-434_5ec69d48-9aa8-4f80-bbb0-403781f2fe57","HUMAN OTC DRUG","clotrimazole","","CREAM","TOPICAL","20110603","20260228","OTC MONOGRAPH DRUG","M005","Padagis Israel Pharmaceuticals Ltd","1","g/100g","","N",""
"2421","KETOCONAZOLE","Ketoconazole","45802046564","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","45802-465","45802-465-64","45802-465_85a7e4b1-78a5-41e9-996c-026c58e487c2","HUMAN PRESCRIPTION DRUG","Ketoconazole","","SHAMPOO, SUSPENSION","TOPICAL","20100119","","ANDA","ANDA076419","Padagis Israel Pharmaceuticals Ltd","20","mg/mL","","N","20261231"
"2422","ECONAZOLE NITRATE","Econazole Nitrate","45802046653","Azole Antifungal [EPC], Azoles [CS]","45802-466","45802-466-53","45802-466_a926c9d7-1215-47b9-a0ed-462941c209fc","HUMAN PRESCRIPTION DRUG","Econazole Nitrate","","CREAM","TOPICAL","20060808","","ANDA","ANDA076479","Padagis Israel Pharmaceuticals Ltd","10","mg/g","","N","20251231"
"2423","ECONAZOLE NITRATE","Econazole Nitrate","45802046635","Azole Antifungal [EPC], Azoles [CS]","45802-466","45802-466-35","45802-466_a926c9d7-1215-47b9-a0ed-462941c209fc","HUMAN PRESCRIPTION DRUG","Econazole Nitrate","","CREAM","TOPICAL","20060808","","ANDA","ANDA076479","Padagis Israel Pharmaceuticals Ltd","10","mg/g","","N","20251231"
"2424","ECONAZOLE NITRATE","Econazole Nitrate","45802046611","Azole Antifungal [EPC], Azoles [CS]","45802-466","45802-466-11","45802-466_a926c9d7-1215-47b9-a0ed-462941c209fc","HUMAN PRESCRIPTION DRUG","Econazole Nitrate","","CREAM","TOPICAL","20060808","","ANDA","ANDA076479","Padagis Israel Pharmaceuticals Ltd","10","mg/g","","N","20251231"
"2425","KETOCONAZOLE","ketoconazole","45802053232","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","45802-532","45802-532-32","45802-532_f9768109-216c-49f3-be2a-d0c3eac142b9","HUMAN PRESCRIPTION DRUG","ketoconazole","","AEROSOL, FOAM","TOPICAL","20110830","","ANDA","ANDA091550","Padagis Israel Pharmaceuticals Ltd","2","g/100g","","N","20251231"
"2426","KETOCONAZOLE","ketoconazole","45802053233","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","45802-532","45802-532-33","45802-532_f9768109-216c-49f3-be2a-d0c3eac142b9","HUMAN PRESCRIPTION DRUG","ketoconazole","","AEROSOL, FOAM","TOPICAL","20110830","","ANDA","ANDA091550","Padagis Israel Pharmaceuticals Ltd","2","g/100g","","N","20251231"
"2427","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","45802056201","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","45802-562","45802-562-01","45802-562_e9efa7c9-d611-4ff9-a05e-868a68018d08","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20130917","","ANDA","ANDA064050","Padagis Israel Pharmaceuticals Ltd","10","mg/mL","","N","20251231"
"2428","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","45802056202","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","45802-562","45802-562-02","45802-562_e9efa7c9-d611-4ff9-a05e-868a68018d08","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20130917","","ANDA","ANDA064050","Padagis Israel Pharmaceuticals Ltd","10","mg/mL","","N","20251231"
"2429","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate, Benzoyl Peroxide","45802059701","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","45802-597","45802-597-01","45802-597_fc3fe08e-5d69-42c0-bbdd-887ff1d944a6","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Benzoyl Peroxide","","GEL","TOPICAL","20190912","","ANDA","ANDA205397","Padagis Israel Pharmaceuticals Ltd","25; 10","mg/g; mg/g","","N","20251231"
"2430","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","45802066033","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","45802-660","45802-660-33","45802-660_5c4e6dd8-1cba-471e-ae54-220717472f41","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","AEROSOL, FOAM","TOPICAL","20100331","","ANDA","ANDA090785","Padagis Israel Pharmaceuticals Ltd","10","mg/g","","N","20251231"
"2431","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","45802066032","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","45802-660","45802-660-32","45802-660_5c4e6dd8-1cba-471e-ae54-220717472f41","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","AEROSOL, FOAM","TOPICAL","20100331","","ANDA","ANDA090785","Padagis Israel Pharmaceuticals Ltd","10","mg/g","","N","20251231"
"2432","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin, Benzoyl Peroxide","45802073684","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","45802-736","45802-736-84","45802-736_4934962f-c507-4b32-9196-dded1e01eed1","HUMAN PRESCRIPTION DRUG","clindamycin phosphate and benzoyl peroxide","","GEL","TOPICAL","20120626","","ANDA","ANDA090979","Padagis Israel Pharmaceuticals Ltd","50; 10","mg/g; mg/g","","N","20251231"
"2433","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin, triamcinolone acetonide","45802088096","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","45802-880","45802-880-96","45802-880_3f4fba52-76cc-4ac5-aee1-e562d5c37a64","HUMAN PRESCRIPTION DRUG","NYSTATIN AND TRIAMCINOLONE ACETONIDE","","CREAM","TOPICAL","20171127","","ANDA","ANDA208479","Padagis Israel Pharmaceuticals Ltd","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"2434","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin, triamcinolone acetonide","45802088094","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","45802-880","45802-880-94","45802-880_3f4fba52-76cc-4ac5-aee1-e562d5c37a64","HUMAN PRESCRIPTION DRUG","NYSTATIN AND TRIAMCINOLONE ACETONIDE","","CREAM","TOPICAL","20171127","","ANDA","ANDA208479","Padagis Israel Pharmaceuticals Ltd","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"2435","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin, triamcinolone acetonide","45802088014","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","45802-880","45802-880-14","45802-880_3f4fba52-76cc-4ac5-aee1-e562d5c37a64","HUMAN PRESCRIPTION DRUG","NYSTATIN AND TRIAMCINOLONE ACETONIDE","","CREAM","TOPICAL","20171127","","ANDA","ANDA208479","Padagis Israel Pharmaceuticals Ltd","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"2436","SULFACETAMIDE SODIUM","Sulfacetamide Sodium","45802089626","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","45802-896","45802-896-26","45802-896_691b3713-2516-4b03-bac5-85aa430dee0b","HUMAN PRESCRIPTION DRUG","Sulfacetamide Sodium","","LOTION","TOPICAL","20121017","","ANDA","ANDA078649","Padagis Israel Pharmaceuticals Ltd","100","mg/mL","","N","20251231"
"2437","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","45802090096","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","45802-900","45802-900-96","45802-900_435a43c6-e6a0-447c-bd8e-a072fd096120","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PHOSPHATE","","GEL","TOPICAL","20210120","","ANDA","ANDA212104","Padagis Israel Pharmaceuticals Ltd","10","mg/g","","N","20251231"
"2438","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","45802090094","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","45802-900","45802-900-94","45802-900_435a43c6-e6a0-447c-bd8e-a072fd096120","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PHOSPHATE","","GEL","TOPICAL","20210120","","ANDA","ANDA212104","Padagis Israel Pharmaceuticals Ltd","10","mg/g","","N","20251231"
"2439","ERYTHROMYCIN","Erythromycin","45802096272","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","45802-962","45802-962-72","45802-962_02f703fe-50b5-45dc-bfbb-fb0ef4784bcc","HUMAN PRESCRIPTION DRUG","Ery","","SWAB","TOPICAL","20080707","","ANDA","ANDA064126","Padagis Israel Pharmaceuticals Ltd","20","mg/mL","","N","20251231"
"2440","ERYTHROMYCIN","Erythromycin","45802096696","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","45802-966","45802-966-96","45802-966_4dc0587a-23b1-43b0-a1a5-18a8acbbede1","HUMAN PRESCRIPTION DRUG","Erythromycin","","GEL","TOPICAL","20080612","","ANDA","ANDA063211","Padagis Israel Pharmaceuticals Ltd","20","mg/g","","N","20251231"
"2441","ERYTHROMYCIN","Erythromycin","45802096694","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","45802-966","45802-966-94","45802-966_4dc0587a-23b1-43b0-a1a5-18a8acbbede1","HUMAN PRESCRIPTION DRUG","Erythromycin","","GEL","TOPICAL","20080612","","ANDA","ANDA063211","Padagis Israel Pharmaceuticals Ltd","20","mg/g","","N","20251231"
"2442","MICONAZOLE NITRATE","MICONAZOLE NITRATE","45861007803","Azole Antifungal [EPC], Azoles [CS]","45861-078","45861-078-03","45861-078_304cdd96-e633-803f-e063-6394a90a1ade","HUMAN OTC DRUG","Miconazole Nitrate 2%","","CREAM","TOPICAL","20250201","","OTC MONOGRAPH DRUG","M017","Pharmaceutica North America, Inc.","2","g/100g","","N","20261231"
"2443","CLOTRIMAZOLE","Clotrimazole","45861009907","Azole Antifungal [EPC], Azoles [CS]","45861-099","45861-099-07","45861-099_2f257e0d-8cad-9325-e063-6394a90ab8db","HUMAN OTC DRUG","Clotrimazole Cream, 1%","","CREAM","TOPICAL","20241210","","OTC MONOGRAPH DRUG","M005","Pharmaceutica North America, Inc","1","g/100g","","N","20261231"
"2444","CLOTRIMAZOLE","Clotrimazole","45861009909","Azole Antifungal [EPC], Azoles [CS]","45861-099","45861-099-09","45861-099_2f257e0d-8cad-9325-e063-6394a90ab8db","HUMAN OTC DRUG","Clotrimazole Cream, 1%","","CREAM","TOPICAL","20241210","","OTC MONOGRAPH DRUG","M005","Pharmaceutica North America, Inc","1","g/100g","","N","20261231"
"2445","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","45865013118","Macrolide Antimicrobial [EPC], Macrolides [CS]","45865-131","45865-131-18","45865-131_13026860-1545-2203-e063-6394a90a4b87","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","","ANDA","ANDA208250","Medsource Pharmaceuticals","250","mg/1","","N","20251231"
"2446","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","45865013106","Macrolide Antimicrobial [EPC], Macrolides [CS]","45865-131","45865-131-06","45865-131_13026860-1545-2203-e063-6394a90a4b87","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","","ANDA","ANDA208250","Medsource Pharmaceuticals","250","mg/1","","N","20251231"
"2447","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","45865017128","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","45865-171","45865-171-28","45865-171_1496f044-d232-f7d5-e063-6394a90a6125","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Medsource Pharmaceuticals","500","mg/1","","N","20251231"
"2448","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","45865022720","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","45865-227","45865-227-20","45865-227_129fed5d-6ad6-dc43-e063-6294a90abe1a","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","Medsource Pharmaceuticals","875; 125","mg/1; mg/1","","N","20251231"
"2449","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","45865023020","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","45865-230","45865-230-20","45865-230_1275ba9e-689e-104c-e063-6394a90a2b15","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","Medsource Pharmaceuticals","500; 125","mg/1; mg/1","","N","20251231"
"2450","AZITHROMYCIN DIHYDRATE","Azithromycin","45865024906","Macrolide Antimicrobial [EPC], Macrolides [CS]","45865-249","45865-249-06","45865-249_14bbd718-00e1-5aca-e063-6294a90a26c3","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20051114","","ANDA","ANDA065211","Medsource Pharmaceuticals","250","mg/1","","N","20251231"
"2451","CEPHALEXIN","Cephalexin","45865028030","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","45865-280","45865-280-30","45865-280_14823c33-a8b0-47e5-e063-6394a90a4935","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","Medsource Pharmaceuticals","500","mg/1","","N","20251231"
"2452","MICONAZOLE NITRATE","Miconazole Nitrate","46063055212","Azole Antifungal [EPC], Azoles [CS]","46063-552","46063-552-12","46063-552_4aca3928-9552-426f-8384-6c0abcaa7cb9","HUMAN OTC DRUG","Relispray Antifungal Powder","","AEROSOL, SPRAY","TOPICAL","20220301","","OTC MONOGRAPH DRUG","M005","Midas-Care Pharmaceuticals Pvt. Ltd.",".02","g/g","","N","20251231"
"2453","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin, Polymyxin B, Pramoxine HCl","46122024403","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","46122-244","46122-244-03","46122-244_e90b8285-ca61-4537-93e1-915c38f1c0b9","HUMAN OTC DRUG","Good Neighbor Pharmacy Antibiotic and Pain Relief","","CREAM","TOPICAL","20140211","","OTC MONOGRAPH DRUG","M004","Amerisource Bergen","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"2454","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","46122041405","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","46122-414","46122-414-05","46122-414_262ec27f-2227-2cec-e063-6394a90a4025","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","","OTC MONOGRAPH DRUG","M004","AmerisourceBergen","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"2455","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","46122041403","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","46122-414","46122-414-03","46122-414_262ec27f-2227-2cec-e063-6394a90a4025","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","","OTC MONOGRAPH DRUG","M004","AmerisourceBergen","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"2456","MICONAZOLE NITRATE","Anti-fungal Powder Miconazole Nitrate Talc Free","46122044427","Azole Antifungal [EPC], Azoles [CS]","46122-444","46122-444-27","46122-444_28a13243-f896-18a8-e063-6394a90a2dfb","HUMAN OTC DRUG","Miconazole Nitrate","","POWDER","TOPICAL","20170808","20260531","OTC MONOGRAPH DRUG","M005","AmerisourceBergen Drug Corporation","1.42","g/71g","","N",""
"2457","MICONAZOLE NITRATE","Miconazole Nitrate","46122078929","Azole Antifungal [EPC], Azoles [CS]","46122-789","46122-789-29","46122-789_27744bc9-9f30-6344-e063-6394a90a1b65","HUMAN OTC DRUG","Miconazorb AF","","POWDER","TOPICAL","20240405","","OTC MONOGRAPH DRUG","M005","AmerisourceBergen Drug Corporation","20","mg/g","","N","20251231"
"2458","METRONIDAZOLE","Metronidazole","46708002150","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-021","46708-021-50","46708-021_1e73c48c-80c3-4565-b11e-65e992c3c03a","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED, EXTENDED RELEASE","ORAL","20100507","","ANDA","ANDA090222","Alembic Pharmaceuticals Limited","750","mg/1","","N","20251231"
"2459","METRONIDAZOLE","Metronidazole","46708002171","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-021","46708-021-71","46708-021_1e73c48c-80c3-4565-b11e-65e992c3c03a","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED, EXTENDED RELEASE","ORAL","20100507","","ANDA","ANDA090222","Alembic Pharmaceuticals Limited","750","mg/1","","N","20251231"
"2460","METRONIDAZOLE","Metronidazole","46708002131","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-021","46708-021-31","46708-021_1e73c48c-80c3-4565-b11e-65e992c3c03a","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED, EXTENDED RELEASE","ORAL","20100507","","ANDA","ANDA090222","Alembic Pharmaceuticals Limited","750","mg/1","","N","20251231"
"2461","METRONIDAZOLE","Metronidazole","46708002130","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-021","46708-021-30","46708-021_1e73c48c-80c3-4565-b11e-65e992c3c03a","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED, EXTENDED RELEASE","ORAL","20100507","","ANDA","ANDA090222","Alembic Pharmaceuticals Limited","750","mg/1","","N","20251231"
"2462","AZITHROMYCIN DIHYDRATE","Azithromycin","46708005706","Macrolide Antimicrobial [EPC], Macrolides [CS]","46708-057","46708-057-06","46708-057_bb31fbb2-b157-4333-ac3b-5f3d65039890","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20200129","","ANDA","ANDA211791","Alembic Pharmaceuticals Limited","250","mg/1","","N","20251231"
"2463","AZITHROMYCIN DIHYDRATE","Azithromycin","46708005718","Macrolide Antimicrobial [EPC], Macrolides [CS]","46708-057","46708-057-18","46708-057_bb31fbb2-b157-4333-ac3b-5f3d65039890","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20200129","","ANDA","ANDA211791","Alembic Pharmaceuticals Limited","250","mg/1","","N","20251231"
"2464","AZITHROMYCIN DIHYDRATE","Azithromycin","46708005730","Macrolide Antimicrobial [EPC], Macrolides [CS]","46708-057","46708-057-30","46708-057_bb31fbb2-b157-4333-ac3b-5f3d65039890","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20200129","","ANDA","ANDA211791","Alembic Pharmaceuticals Limited","250","mg/1","","N","20251231"
"2465","AZITHROMYCIN DIHYDRATE","Azithromycin","46708005803","Macrolide Antimicrobial [EPC], Macrolides [CS]","46708-058","46708-058-03","46708-058_ea5ea4f7-a4ce-4644-860a-942898f50a8a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20200129","","ANDA","ANDA211792","Alembic Pharmaceuticals Limited","500","mg/1","","N","20251231"
"2466","AZITHROMYCIN DIHYDRATE","Azithromycin","46708005830","Macrolide Antimicrobial [EPC], Macrolides [CS]","46708-058","46708-058-30","46708-058_ea5ea4f7-a4ce-4644-860a-942898f50a8a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20200129","","ANDA","ANDA211792","Alembic Pharmaceuticals Limited","500","mg/1","","N","20251231"
"2467","LINEZOLID","Linezolid","46708018330","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","46708-183","46708-183-30","46708-183_9ce8d5c0-4471-43ca-a988-f8b741b44178","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151222","","ANDA","ANDA205233","Alembic Pharmaceuticals Limited","600","mg/1","","N","20251231"
"2468","LINEZOLID","Linezolid","46708018391","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","46708-183","46708-183-91","46708-183_9ce8d5c0-4471-43ca-a988-f8b741b44178","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151222","","ANDA","ANDA205233","Alembic Pharmaceuticals Limited","600","mg/1","","N","20251231"
"2469","LINEZOLID","Linezolid","46708018320","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","46708-183","46708-183-20","46708-183_9ce8d5c0-4471-43ca-a988-f8b741b44178","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151222","","ANDA","ANDA205233","Alembic Pharmaceuticals Limited","600","mg/1","","N","20251231"
"2470","LINEZOLID","Linezolid","46708018331","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","46708-183","46708-183-31","46708-183_9ce8d5c0-4471-43ca-a988-f8b741b44178","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151222","","ANDA","ANDA205233","Alembic Pharmaceuticals Limited","600","mg/1","","N","20251231"
"2471","ITRACONAZOLE","itraconazole","46708020404","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","46708-204","46708-204-04","46708-204_13a86518-48bc-421b-ad49-c253bd65b488","HUMAN PRESCRIPTION DRUG","ITRACONAZOLE","","CAPSULE","ORAL","20161216","","ANDA","ANDA206741","Alembic Pharmaceuticals Limited","100","mg/1","","N","20251231"
"2472","ITRACONAZOLE","itraconazole","46708020430","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","46708-204","46708-204-30","46708-204_13a86518-48bc-421b-ad49-c253bd65b488","HUMAN PRESCRIPTION DRUG","ITRACONAZOLE","","CAPSULE","ORAL","20161216","","ANDA","ANDA206741","Alembic Pharmaceuticals Limited","100","mg/1","","N","20251231"
"2473","ITRACONAZOLE","itraconazole","46708020490","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","46708-204","46708-204-90","46708-204_13a86518-48bc-421b-ad49-c253bd65b488","HUMAN PRESCRIPTION DRUG","ITRACONAZOLE","","CAPSULE","ORAL","20161216","","ANDA","ANDA206741","Alembic Pharmaceuticals Limited","100","mg/1","","N","20251231"
"2474","ITRACONAZOLE","itraconazole","46708020410","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","46708-204","46708-204-10","46708-204_13a86518-48bc-421b-ad49-c253bd65b488","HUMAN PRESCRIPTION DRUG","ITRACONAZOLE","","CAPSULE","ORAL","20161216","","ANDA","ANDA206741","Alembic Pharmaceuticals Limited","100","mg/1","","N","20251231"
"2475","ITRACONAZOLE","itraconazole","46708020471","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","46708-204","46708-204-71","46708-204_13a86518-48bc-421b-ad49-c253bd65b488","HUMAN PRESCRIPTION DRUG","ITRACONAZOLE","","CAPSULE","ORAL","20161216","","ANDA","ANDA206741","Alembic Pharmaceuticals Limited","100","mg/1","","N","20251231"
"2476","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","46708025310","Macrolide Antimicrobial [EPC], Macrolides [CS]","46708-253","46708-253-10","46708-253_6a2f7a6c-a45d-448d-8f56-5bd7a5309a2d","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","TABLET, FILM COATED","ORAL","20200128","","ANDA","ANDA211793","Alembic Pharmaceuticals Limited","600","mg/1","","N","20251231"
"2477","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","46708025330","Macrolide Antimicrobial [EPC], Macrolides [CS]","46708-253","46708-253-30","46708-253_6a2f7a6c-a45d-448d-8f56-5bd7a5309a2d","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","TABLET, FILM COATED","ORAL","20200128","","ANDA","ANDA211793","Alembic Pharmaceuticals Limited","600","mg/1","","N","20251231"
"2478","CLARITHROMYCIN","Clarithromycin","46708034430","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","46708-344","46708-344-30","46708-344_17817dba-4183-4a14-a55f-3e1240ea03a1","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20220201","","ANDA","ANDA210459","Alembic Pharmaceuticals Limited","250","mg/1","","N","20251231"
"2479","CLARITHROMYCIN","Clarithromycin","46708034460","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","46708-344","46708-344-60","46708-344_17817dba-4183-4a14-a55f-3e1240ea03a1","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20220201","","ANDA","ANDA210459","Alembic Pharmaceuticals Limited","250","mg/1","","N","20251231"
"2480","CLARITHROMYCIN","Clarithromycin","46708034491","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","46708-344","46708-344-91","46708-344_17817dba-4183-4a14-a55f-3e1240ea03a1","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20220201","","ANDA","ANDA210459","Alembic Pharmaceuticals Limited","250","mg/1","","N","20251231"
"2481","CLARITHROMYCIN","Clarithromycin","46708034560","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","46708-345","46708-345-60","46708-345_17817dba-4183-4a14-a55f-3e1240ea03a1","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20220201","","ANDA","ANDA210459","Alembic Pharmaceuticals Limited","500","mg/1","","N","20251231"
"2482","CLARITHROMYCIN","Clarithromycin","46708034591","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","46708-345","46708-345-91","46708-345_17817dba-4183-4a14-a55f-3e1240ea03a1","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20220201","","ANDA","ANDA210459","Alembic Pharmaceuticals Limited","500","mg/1","","N","20251231"
"2483","CLARITHROMYCIN","Clarithromycin","46708034530","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","46708-345","46708-345-30","46708-345_17817dba-4183-4a14-a55f-3e1240ea03a1","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20220201","","ANDA","ANDA210459","Alembic Pharmaceuticals Limited","500","mg/1","","N","20251231"
"2484","NITROFURANTOIN","NITROFURANTOIN","46708038931","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","46708-389","46708-389-31","46708-389_dacd91fc-bf3f-4ff3-a2ae-c0210796af47","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20210701","","ANDA","ANDA211935","Alembic Pharmaceuticals Limited","25","mg/1","","N","20251231"
"2485","NITROFURANTOIN","NITROFURANTOIN","46708038991","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","46708-389","46708-389-91","46708-389_dacd91fc-bf3f-4ff3-a2ae-c0210796af47","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20210701","","ANDA","ANDA211935","Alembic Pharmaceuticals Limited","25","mg/1","","N","20251231"
"2486","NITROFURANTOIN","NITROFURANTOIN","46708039031","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","46708-390","46708-390-31","46708-390_dacd91fc-bf3f-4ff3-a2ae-c0210796af47","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20210701","","ANDA","ANDA211935","Alembic Pharmaceuticals Limited","50","mg/1","","N","20251231"
"2487","NITROFURANTOIN","NITROFURANTOIN","46708039091","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","46708-390","46708-390-91","46708-390_dacd91fc-bf3f-4ff3-a2ae-c0210796af47","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20210701","","ANDA","ANDA211935","Alembic Pharmaceuticals Limited","50","mg/1","","N","20251231"
"2488","NITROFURANTOIN","NITROFURANTOIN","46708039191","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","46708-391","46708-391-91","46708-391_dacd91fc-bf3f-4ff3-a2ae-c0210796af47","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20210701","","ANDA","ANDA211935","Alembic Pharmaceuticals Limited","100","mg/1","","N","20251231"
"2489","NITROFURANTOIN","NITROFURANTOIN","46708039131","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","46708-391","46708-391-31","46708-391_dacd91fc-bf3f-4ff3-a2ae-c0210796af47","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20210701","","ANDA","ANDA211935","Alembic Pharmaceuticals Limited","100","mg/1","","N","20251231"
"2490","ERYTHROMYCIN","Erythromycin","46708039730","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","46708-397","46708-397-30","46708-397_904b9ab6-9a2a-47f3-8a38-04920ce696e0","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230828","","ANDA","ANDA215661","Alembic Pharmaceuticals Limited","250","mg/1","","N","20251231"
"2491","ERYTHROMYCIN","Erythromycin","46708039731","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","46708-397","46708-397-31","46708-397_904b9ab6-9a2a-47f3-8a38-04920ce696e0","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230828","","ANDA","ANDA215661","Alembic Pharmaceuticals Limited","250","mg/1","","N","20251231"
"2492","ERYTHROMYCIN","Erythromycin","46708039791","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","46708-397","46708-397-91","46708-397_904b9ab6-9a2a-47f3-8a38-04920ce696e0","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230828","","ANDA","ANDA215661","Alembic Pharmaceuticals Limited","250","mg/1","","N","20251231"
"2493","ERYTHROMYCIN","Erythromycin","46708039831","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","46708-398","46708-398-31","46708-398_904b9ab6-9a2a-47f3-8a38-04920ce696e0","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230828","","ANDA","ANDA215661","Alembic Pharmaceuticals Limited","500","mg/1","","N","20251231"
"2494","ERYTHROMYCIN","Erythromycin","46708039891","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","46708-398","46708-398-91","46708-398_904b9ab6-9a2a-47f3-8a38-04920ce696e0","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230828","","ANDA","ANDA215661","Alembic Pharmaceuticals Limited","500","mg/1","","N","20251231"
"2495","ERYTHROMYCIN","Erythromycin","46708039830","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","46708-398","46708-398-30","46708-398_904b9ab6-9a2a-47f3-8a38-04920ce696e0","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230828","","ANDA","ANDA215661","Alembic Pharmaceuticals Limited","500","mg/1","","N","20251231"
"2496","METRONIDAZOLE","Metronidazole","46708042830","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-428","46708-428-30","46708-428_68765ffa-e238-40bb-8235-4ae53fb292e9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Limited","250","mg/1","","N","20251231"
"2497","METRONIDAZOLE","Metronidazole","46708042831","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-428","46708-428-31","46708-428_68765ffa-e238-40bb-8235-4ae53fb292e9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Limited","250","mg/1","","N","20251231"
"2498","METRONIDAZOLE","Metronidazole","46708042850","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-428","46708-428-50","46708-428_68765ffa-e238-40bb-8235-4ae53fb292e9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Limited","250","mg/1","","N","20251231"
"2499","METRONIDAZOLE","Metronidazole","46708042871","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-428","46708-428-71","46708-428_68765ffa-e238-40bb-8235-4ae53fb292e9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Limited","250","mg/1","","N","20251231"
"2500","METRONIDAZOLE","Metronidazole","46708042891","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-428","46708-428-91","46708-428_68765ffa-e238-40bb-8235-4ae53fb292e9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Limited","250","mg/1","","N","20251231"
"2501","METRONIDAZOLE","Metronidazole","46708042861","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-428","46708-428-61","46708-428_68765ffa-e238-40bb-8235-4ae53fb292e9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Limited","250","mg/1","","N","20251231"
"2502","METRONIDAZOLE","Metronidazole","46708042930","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-429","46708-429-30","46708-429_68765ffa-e238-40bb-8235-4ae53fb292e9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Limited","500","mg/1","","N","20251231"
"2503","METRONIDAZOLE","Metronidazole","46708042971","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-429","46708-429-71","46708-429_68765ffa-e238-40bb-8235-4ae53fb292e9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Limited","500","mg/1","","N","20251231"
"2504","METRONIDAZOLE","Metronidazole","46708042991","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-429","46708-429-91","46708-429_68765ffa-e238-40bb-8235-4ae53fb292e9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Limited","500","mg/1","","N","20251231"
"2505","METRONIDAZOLE","Metronidazole","46708042950","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-429","46708-429-50","46708-429_68765ffa-e238-40bb-8235-4ae53fb292e9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Limited","500","mg/1","","N","20251231"
"2506","METRONIDAZOLE","Metronidazole","46708042931","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-429","46708-429-31","46708-429_68765ffa-e238-40bb-8235-4ae53fb292e9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Limited","500","mg/1","","N","20251231"
"2507","METRONIDAZOLE","metronidazole","46708043531","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-435","46708-435-31","46708-435_73035cba-781b-4d60-80bb-8f8ff273a0a1","HUMAN PRESCRIPTION DRUG","Metronidazole","","CAPSULE","ORAL","20161209","","ANDA","ANDA079065","Alembic Pharmaceuticals Limited","375","mg/1","","N","20251231"
"2508","METRONIDAZOLE","metronidazole","46708043550","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-435","46708-435-50","46708-435_73035cba-781b-4d60-80bb-8f8ff273a0a1","HUMAN PRESCRIPTION DRUG","Metronidazole","","CAPSULE","ORAL","20161209","","ANDA","ANDA079065","Alembic Pharmaceuticals Limited","375","mg/1","","N","20251231"
"2509","METRONIDAZOLE","metronidazole","46708043530","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-435","46708-435-30","46708-435_73035cba-781b-4d60-80bb-8f8ff273a0a1","HUMAN PRESCRIPTION DRUG","Metronidazole","","CAPSULE","ORAL","20161209","","ANDA","ANDA079065","Alembic Pharmaceuticals Limited","375","mg/1","","N","20251231"
"2510","METRONIDAZOLE","metronidazole","46708043571","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-435","46708-435-71","46708-435_73035cba-781b-4d60-80bb-8f8ff273a0a1","HUMAN PRESCRIPTION DRUG","Metronidazole","","CAPSULE","ORAL","20161209","","ANDA","ANDA079065","Alembic Pharmaceuticals Limited","375","mg/1","","N","20251231"
"2511","METRONIDAZOLE","metronidazole","46708043591","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-435","46708-435-91","46708-435_73035cba-781b-4d60-80bb-8f8ff273a0a1","HUMAN PRESCRIPTION DRUG","Metronidazole","","CAPSULE","ORAL","20161209","","ANDA","ANDA079065","Alembic Pharmaceuticals Limited","375","mg/1","","N","20251231"
"2512","TAVABOROLE","Tavaborole","46708046704","Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]","46708-467","46708-467-04","46708-467_0bf82467-4605-43ba-a217-cdba1946becd","HUMAN PRESCRIPTION DRUG","Tavaborole","","SOLUTION","TOPICAL","20250218","","ANDA","ANDA212188","Alembic Pharmaceuticals Limited","43.5","mg/mL","","N","20261231"
"2513","TAVABOROLE","Tavaborole","46708046710","Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]","46708-467","46708-467-10","46708-467_0bf82467-4605-43ba-a217-cdba1946becd","HUMAN PRESCRIPTION DRUG","Tavaborole","","SOLUTION","TOPICAL","20250218","","ANDA","ANDA212188","Alembic Pharmaceuticals Limited","43.5","mg/mL","","N","20261231"
"2514","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin ophthalmic solution","46708050503","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","46708-505","46708-505-03","46708-505_09d80c83-4b62-47a1-a3d7-6352bc6a79cd","HUMAN PRESCRIPTION DRUG","Moxifloxacin ophthalmic solution","","SOLUTION/ DROPS","OPHTHALMIC","20190213","","ANDA","ANDA209469","Alembic Pharmaceuticals Limited","5","mg/mL","","N","20251231"
"2515","TOBRAMYCIN","Tobramycin Ophthalmic Solution","46708051805","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","46708-518","46708-518-05","46708-518_14c14f81-6b0a-4176-a5df-d0757cc3260d","HUMAN PRESCRIPTION DRUG","Tobramycin Ophthalmic Solution","","SOLUTION/ DROPS","OPHTHALMIC","20190419","","ANDA","ANDA211847","Alembic Pharmaceuticals Limited","3","mg/mL","","N","20251231"
"2516","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","46708060660","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","46708-606","46708-606-60","46708-606_e15b0fea-44bd-4c3d-a436-c72038dd1792","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20250408","","ANDA","ANDA214090","Alembic Pharmaceuticals Limited","100000; 1","[USP'U]/g; mg/g","","N","20261231"
"2517","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","46708060630","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","46708-606","46708-606-30","46708-606_e15b0fea-44bd-4c3d-a436-c72038dd1792","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20250408","","ANDA","ANDA214090","Alembic Pharmaceuticals Limited","100000; 1","[USP'U]/g; mg/g","","N","20261231"
"2518","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","46708060615","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","46708-606","46708-606-15","46708-606_e15b0fea-44bd-4c3d-a436-c72038dd1792","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20250408","","ANDA","ANDA214090","Alembic Pharmaceuticals Limited","100000; 1","[USP'U]/g; mg/g","","N","20261231"
"2519","CLINDAMYCIN PHOSPHATE","CLINDAMYCIN PHOSPHATE","46708062330","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","46708-623","46708-623-30","46708-623_55359ba6-067b-4e97-8c13-ae3f8dbac818","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PHOSPHATE","","GEL","TOPICAL","20240404","","ANDA","ANDA212466","Alembic Pharmaceuticals Limited","10","mg/g","","N","20261231"
"2520","CLINDAMYCIN PHOSPHATE","CLINDAMYCIN PHOSPHATE","46708062360","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","46708-623","46708-623-60","46708-623_55359ba6-067b-4e97-8c13-ae3f8dbac818","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PHOSPHATE","","GEL","TOPICAL","20240404","","ANDA","ANDA212466","Alembic Pharmaceuticals Limited","10","mg/g","","N","20261231"
"2521","MUPIROCIN CALCIUM","MUPIROCIN","46708062415","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","46708-624","46708-624-15","46708-624_9c983738-f481-4e39-b812-69b45c7e9401","HUMAN PRESCRIPTION DRUG","MUPIROCIN","","CREAM","TOPICAL","20250318","","ANDA","ANDA213053","Alembic Pharmaceuticals Limited","20","mg/g","","N","20261231"
"2522","MUPIROCIN CALCIUM","MUPIROCIN","46708062430","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","46708-624","46708-624-30","46708-624_9c983738-f481-4e39-b812-69b45c7e9401","HUMAN PRESCRIPTION DRUG","MUPIROCIN","","CREAM","TOPICAL","20250318","","ANDA","ANDA213053","Alembic Pharmaceuticals Limited","20","mg/g","","N","20261231"
"2523","METRONIDAZOLE","Metronidazole","46708063060","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-630","46708-630-60","46708-630_ccb6c97f-34f9-4aeb-81ba-824a9b8a0ecd","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20250317","","ANDA","ANDA212646","Alembic Pharmaceuticals Limited","10","mg/g","","N","20261231"
"2524","METRONIDAZOLE","Metronidazole","46708063055","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-630","46708-630-55","46708-630_ccb6c97f-34f9-4aeb-81ba-824a9b8a0ecd","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20250317","","ANDA","ANDA212646","Alembic Pharmaceuticals Limited","10","mg/g","","N","20261231"
"2525","METRONIDAZOLE","Metronidazole","46708063045","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","46708-630","46708-630-45","46708-630_ccb6c97f-34f9-4aeb-81ba-824a9b8a0ecd","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20250317","","ANDA","ANDA212646","Alembic Pharmaceuticals Limited","10","mg/g","","N","20261231"
"2526","TOBRAMYCIN","Tobramycin","47335017149","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","47335-171","47335-171-49","47335-171_fcccf0aa-4457-4836-a74f-594614cbb4a3","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","RESPIRATORY (INHALATION)","20200228","","ANDA","ANDA207136","Sun Pharmaceutical Industries, Inc.","300","mg/5mL","","N","20251231"
"2527","METRONIDAZOLE","metronidazole","47335099301","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","47335-993","47335-993-01","47335-993_9549fa19-5d89-4ad8-82ac-5d023072b126","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","INJECTION, SOLUTION","INTRAVENOUS","20210810","","ANDA","ANDA212435","Sun Pharmaceutical Industries, Inc.","500","mg/100mL","","N","20251231"
"2528","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","47682022335","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-223","47682-223-35","47682-223_0f242fef-1c6b-f78f-e063-6394a90aa5cf","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20130425","","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"2529","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","47682022399","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-223","47682-223-99","47682-223_0f242fef-1c6b-f78f-e063-6394a90aa5cf","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20130425","","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"2530","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","47682022312","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-223","47682-223-12","47682-223_0f242fef-1c6b-f78f-e063-6394a90aa5cf","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20130425","","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"2531","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","47682022373","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-223","47682-223-73","47682-223_0f242fef-1c6b-f78f-e063-6394a90aa5cf","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20130425","","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"2532","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","47682022735","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-227","47682-227-35","47682-227_0f285855-9644-7e1d-e063-6394a90ae46f","HUMAN OTC DRUG","Medi-First Triple Antibiotic","","OINTMENT","TOPICAL","20210601","20280430","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N",""
"2533","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","47682022773","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-227","47682-227-73","47682-227_0f285855-9644-7e1d-e063-6394a90ae46f","HUMAN OTC DRUG","Medi-First Triple Antibiotic","","OINTMENT","TOPICAL","20210601","20280430","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N",""
"2534","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","47682022712","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-227","47682-227-12","47682-227_0f285855-9644-7e1d-e063-6394a90ae46f","HUMAN OTC DRUG","Medi-First Triple Antibiotic","","OINTMENT","TOPICAL","20210601","20280430","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N",""
"2535","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","47682022799","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-227","47682-227-99","47682-227_0f285855-9644-7e1d-e063-6394a90ae46f","HUMAN OTC DRUG","Medi-First Triple Antibiotic","","OINTMENT","TOPICAL","20210601","20280430","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N",""
"2536","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","47682039235","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-392","47682-392-35","47682-392_2d924601-34ee-7b7d-e063-6294a90a7371","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20130412","","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"2537","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","47682039273","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-392","47682-392-73","47682-392_2d924601-34ee-7b7d-e063-6294a90a7371","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20130412","","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"2538","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","47682039299","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-392","47682-392-99","47682-392_2d924601-34ee-7b7d-e063-6294a90a7371","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20130412","","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"2539","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zin, Neomycin Sulfate, Polymyxin B Sulfate","47682039373","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-393","47682-393-73","47682-393_0f27f07f-419a-6097-e063-6394a90a75ed","HUMAN OTC DRUG","Green Guard Triple Antibiotic","","OINTMENT","TOPICAL","20210601","20280430","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N",""
"2540","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zin, Neomycin Sulfate, Polymyxin B Sulfate","47682039399","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-393","47682-393-99","47682-393_0f27f07f-419a-6097-e063-6394a90a75ed","HUMAN OTC DRUG","Green Guard Triple Antibiotic","","OINTMENT","TOPICAL","20210601","20280430","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N",""
"2541","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","47682093473","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-934","47682-934-73","47682-934_0f26e9a6-81a2-e294-e063-6294a90a828a","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20130412","","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"2542","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","47682093873","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-938","47682-938-73","47682-938_0f285855-9644-7e1d-e063-6394a90ae46f","HUMAN OTC DRUG","Medi-First Plus Triple Antibiotic","","OINTMENT","TOPICAL","20210601","20280430","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N",""
"2543","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","47682098235","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-982","47682-982-35","47682-982_2733287e-8940-4a54-e063-6294a90a0614","HUMAN OTC DRUG","Medi-First Triple Antibiotic","","OINTMENT","TOPICAL","20230401","","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"2544","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","47682098273","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-982","47682-982-73","47682-982_2733287e-8940-4a54-e063-6294a90a0614","HUMAN OTC DRUG","Medi-First Triple Antibiotic","","OINTMENT","TOPICAL","20230401","","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"2545","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","47682098373","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","47682-983","47682-983-73","47682-983_2733287e-8940-4a54-e063-6294a90a0614","HUMAN OTC DRUG","Medi-First Plus Triple Antibiotic","","OINTMENT","TOPICAL","20230401","","OTC MONOGRAPH DRUG","M004","Unifirst First Aid Corporation","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"2546","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystalline","47781030301","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","47781-303","47781-303-01","47781-303_c7f2bd99-d26a-a1d6-d844-e3f6be12d0a1","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/ Macrocrystalline","","CAPSULE","ORAL","20110525","","NDA","NDA020064","Alvogen Inc.","25; 75","mg/1; mg/1","","N","20251231"
"2547","NITROFURANTOIN","nitrofurantoin macrocrystals","47781030601","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","47781-306","47781-306-01","47781-306_b63364a4-8ff9-f101-74d4-1459f9f3ce27","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Alvogen Inc.","25","mg/1","","N","20251231"
"2548","NITROFURANTOIN","nitrofurantoin macrocrystals","47781030701","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","47781-307","47781-307-01","47781-307_b63364a4-8ff9-f101-74d4-1459f9f3ce27","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Alvogen Inc.","50","mg/1","","N","20251231"
"2549","NITROFURANTOIN","nitrofurantoin macrocrystals","47781030801","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","47781-308","47781-308-01","47781-308_b63364a4-8ff9-f101-74d4-1459f9f3ce27","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Alvogen Inc.","100","mg/1","","N","20251231"
"2550","CLOTRIMAZOLE","CLOTRIMAZOLE","47832007114","Azole Antifungal [EPC], Azoles [CS]","47832-071","47832-071-14","47832-071_c44f9882-db75-469f-a447-565a8f957645","HUMAN OTC DRUG","JOCK-EZE","","CREAM","TOPICAL","20200121","","OTC MONOGRAPH DRUG","M005","Bentlin Products LLC","10","mg/g","","N","20251231"
"2551","ERYTHROMYCIN","Erythromycin","48102005711","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","48102-057","48102-057-11","48102-057_3365af10-cb24-4961-8511-1ef46c9eebcc","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","20230927","","UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE","","Fera Pharmaceuticals, LLC","5","mg/g","","N","20251231"
"2552","NEOMYCIN SULFATE","NEOMYCIN SULFATE","48201010440","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","48201-104","48201-104-40","48201-104_1d8e2ea5-0d02-1b4d-e063-6294a90aaa59","HUMAN OTC DRUG","POMADA SULFA FIRST AID ANTIBIOTIC","","OINTMENT","TOPICAL","20240718","","OTC MONOGRAPH DRUG","M004","GRANDALL DISTRIBUTING, LLC",".5","g/100g","","N","20251231"
"2553","BACITRACIN ZINC; POLYMYXIN B SULFATE","BACITRACIN ZINC, POLYMYXIN B SULFATE","48201010575","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","48201-105","48201-105-75","48201-105_1d8e4c5c-500c-be32-e063-6294a90a6f87","HUMAN OTC DRUG","POLVO DE SULFA FIRST AID ANTIBIOTIC","","POWDER","TOPICAL","20240718","","OTC MONOGRAPH DRUG","M004","GRANDALL DISTRIBUTING, LLC","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"2554","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","49035001602","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","49035-016","49035-016-02","49035-016_262ee2e3-810d-34ec-e063-6394a90a34e9","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","19951214","","OTC MONOGRAPH DRUG","M004","Wal-Mart Stores, Inc.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"2555","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate","49035006764","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","49035-067","49035-067-64","49035-067_c360fe96-446a-4872-a604-d9a3c813d3ac","HUMAN OTC DRUG","EQUATE Triple Antibiotic","","OINTMENT","TOPICAL","20100831","","OTC MONOGRAPH DRUG","M004","Wal-Mart Stores Inc","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"2556","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate","49035006716","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","49035-067","49035-067-16","49035-067_c360fe96-446a-4872-a604-d9a3c813d3ac","HUMAN OTC DRUG","EQUATE Triple Antibiotic","","OINTMENT","TOPICAL","20100831","","OTC MONOGRAPH DRUG","M004","Wal-Mart Stores Inc","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"2557","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","49035008003","Allylamine Antifungal [EPC], Allylamine [CS]","49035-080","49035-080-03","49035-080_b4d171d1-ad66-494f-9da1-6c692ab72906","HUMAN OTC DRUG","equate","Athletes Foot","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Wal-Mart Stores Inc","1","g/100g","","N","20251231"
"2558","MICONAZOLE NITRATE","Jock Itch Spray","49035013546","Azole Antifungal [EPC], Azoles [CS]","49035-135","49035-135-46","49035-135_296834f9-70c3-ce38-e063-6394a90af538","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, SPRAY","TOPICAL","20190228","","OTC MONOGRAPH DRUG","M005","Wal-Mart Stores, Inc.","1.3","g/130g","","N","20251231"
"2559","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","49035017808","Benzylamine Antifungal [EPC], Benzylamines [CS]","49035-178","49035-178-08","49035-178_db3fd7a4-9c4e-4db3-b5ac-cc75fe1ecc9e","HUMAN OTC DRUG","Butenafine Hydrochloride","Jock Itch","CREAM","TOPICAL","20171116","","ANDA","ANDA205181","Wal-Mart Stores Inc","10","mg/g","","N","20251231"
"2560","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","49035022508","Benzylamine Antifungal [EPC], Benzylamines [CS]","49035-225","49035-225-08","49035-225_02469600-e153-416a-b16a-bde30c4bb2e8","HUMAN OTC DRUG","Athletes Foot Ultra","","CREAM","TOPICAL","20171116","","ANDA","ANDA205181","Wal-Mart Stores Inc","10","mg/g","","N","20251231"
"2561","CLOTRIMAZOLE","CLOTRIMAZOLE","49035025321","Azole Antifungal [EPC], Azoles [CS]","49035-253","49035-253-21","49035-253_b24501ff-35da-4c73-b1e4-79b7978ea22c","HUMAN OTC DRUG","Equate Jock Itch","","CREAM","TOPICAL","20160831","","OTC MONOGRAPH DRUG","M005","WALMART STORES INC","10","mg/g","","N","20251231"
"2562","MICONAZOLE NITRATE","Miconazole Nitrate","49035034707","Azole Antifungal [EPC], Azoles [CS]","49035-347","49035-347-07","49035-347_f69514e9-6424-4254-9aca-4dcfb1ba3eff","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20200501","","ANDA","ANDA074164","EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)","100","mg/g","","N","20251231"
"2563","TIOCONAZOLE","Tioconazole","49035042654","Azole Antifungal [EPC], Azoles [CS]","49035-426","49035-426-54","49035-426_e3bc779e-c779-45e1-b529-69d5848615e8","HUMAN OTC DRUG","Equate tioconazole 1 day","","OINTMENT","VAGINAL","20071101","","ANDA","ANDA075915","Wal-Mart Stores Inc","6.5","g/100g","","N","20251231"
"2564","CLOTRIMAZOLE","Clotrimazole","49035081201","Azole Antifungal [EPC], Azoles [CS]","49035-812","49035-812-01","49035-812_26b9608d-9d01-c817-e063-6394a90a3e86","HUMAN OTC DRUG","Clotrimazole","Athletes Foot","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Wal-Mart Stores, Inc.","10","mg/g","","N","20251231"
"2565","CLOTRIMAZOLE","Clotrimazole","49035081227","Azole Antifungal [EPC], Azoles [CS]","49035-812","49035-812-27","49035-812_26b9608d-9d01-c817-e063-6394a90a3e86","HUMAN OTC DRUG","Clotrimazole","Athletes Foot","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Wal-Mart Stores, Inc.","10","mg/g","","N","20251231"
"2566","CLOTRIMAZOLE","Clotrimazole","49035083705","Azole Antifungal [EPC], Azoles [CS]","49035-837","49035-837-05","49035-837_f5c8213b-f4f7-45bc-87a4-b34aca7cd97b","HUMAN OTC DRUG","Jock Itch","Clotrimazole Antifungal","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Walmart",".01","g/g","","N","20251231"
"2567","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","49035084001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","49035-840","49035-840-01","49035-840_264880b6-7b7d-49d4-80d8-0786382c468d","HUMAN OTC DRUG","Equate First Aid Antibiotic Plus Pain Relief","","CREAM","TOPICAL","20181018","","OTC MONOGRAPH DRUG","M004","Wal-Mart","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"2568","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","49035084705","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","49035-847","49035-847-05","49035-847_929d540d-26c6-4d37-bdc1-831c17376a91","HUMAN OTC DRUG","Equate Antibiotic Plus Pain Relief","","CREAM","TOPICAL","20181018","","OTC MONOGRAPH DRUG","M004","WalMart","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20261231"
"2569","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","49314000601","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","49314-0006","49314-0006-1","49314-0006_12af256b-d49c-6288-e063-6394a90a5d01","HUMAN OTC DRUG","UniShield TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20240302","","OTC MONOGRAPH DRUG","M004","Unishield","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20251231"
"2570","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin zinc and Polymyxin B sulfate","49348027472","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","49348-274","49348-274-72","49348-274_23ad6c3b-e591-46d9-e063-6394a90ae638","HUMAN OTC DRUG","sunmark","double antibiotic","OINTMENT","TOPICAL","19901205","20270930","OTC MONOGRAPH DRUG","M004","Strategic Sourcing Services LLC","500; 10000","[USP'U]/g; [USP'U]/g","","N",""
"2571","CLOTRIMAZOLE","Clotrimazole","49348027972","Azole Antifungal [EPC], Azoles [CS]","49348-279","49348-279-72","49348-279_26be665a-ace5-22fd-e063-6394a90a2a0e","HUMAN OTC DRUG","SUNMARK CLOTRIMAZOLE","","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","Strategic Sourcing Services LLC","10","mg/g","","N","20251231"
"2572","CLOTRIMAZOLE","Clotrimazole","49348037954","Azole Antifungal [EPC], Azoles [CS]","49348-379","49348-379-54","49348-379_28dbde57-a1be-5ad3-e063-6294a90a7998","HUMAN OTC DRUG","sunmark","Clotrimazole 3","CREAM","VAGINAL","20000412","","NDA","NDA021143","Strategic Sourcing Services LLC","2","g/100g","","N","20251231"
"2573","MICONAZOLE NITRATE","Miconazole nitrate","49348053077","Azole Antifungal [EPC], Azoles [CS]","49348-530","49348-530-77","49348-530_26870214-4e9c-4560-87c1-657b0f6c7dcf","HUMAN OTC DRUG","Sunmark Miconazole 7","","CREAM","VAGINAL","20030731","20260301","ANDA","ANDA074760","Strategic Sourcing Services LLC","2","g/100g","","N",""
"2574","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","polymyxin B sulfate, bacitracin zinc, neomycin sulfate, and pramoxine hydrochloride","49348060072","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","49348-600","49348-600-72","49348-600_23ad8112-5f8b-b2a6-e063-6394a90a799a","HUMAN OTC DRUG","sunmark","triple antibiotic plus pain relief","OINTMENT","TOPICAL","20120331","20270831","OTC MONOGRAPH DRUG","M004","Strategic Sourcing Services LLC","500; 3.5; 10000; 10","[iU]/g; mg/g; [iU]/g; mg/g","","N",""
"2575","MICONAZOLE NITRATE","Miconazole Nitrate","49348068972","Azole Antifungal [EPC], Azoles [CS]","49348-689","49348-689-72","49348-689_28dd1b61-76cd-9473-e063-6294a90a07eb","HUMAN OTC DRUG","SUNMARK MICONAZOLE NITRATE","antifungal","CREAM","TOPICAL","19911001","","OTC MONOGRAPH DRUG","M005","Strategic Sourcing Services LLC","20","mg/g","","N","20251231"
"2576","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","49348069069","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","49348-690","49348-690-69","49348-690_23ac9abf-6933-f339-e063-6394a90a7596","HUMAN OTC DRUG","sunmark","antibiotic plus pain relief","CREAM","TOPICAL","20120321","20260331","OTC MONOGRAPH DRUG","M004","Strategic Sourcing Services LLC","3.5; 10000; 10","mg/g; [iU]/g; mg/g","","N",""
"2577","CLOTRIMAZOLE","Clotrimazole","49348079376","Azole Antifungal [EPC], Azoles [CS]","49348-793","49348-793-76","49348-793_a1cb137f-9fd0-4cc9-8e43-11cbca9444aa","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","19930719","","ANDA","ANDA074165","Strategic Sourcing Services LLC","10","mg/g","","N","20251231"
"2578","MICONAZOLE NITRATE","Miconazole Nitrate","49348083361","Azole Antifungal [EPC], Azoles [CS]","49348-833","49348-833-61","49348-833_de25003c-e1bb-41b1-84c2-17f28c5d24bc","HUMAN OTC DRUG","Miconazole 7","","SUPPOSITORY","VAGINAL","20111209","","ANDA","ANDA073507","Strategic Sourcing Services LLC","100","mg/1","","N","20251231"
"2579","MICONAZOLE NITRATE","Miconazole nitrate","49348087277","Azole Antifungal [EPC], Azoles [CS]","49348-872","49348-872-77","49348-872_523629ac-b0d6-4318-affd-ae7732c49ff5","HUMAN OTC DRUG","sunmark miconazole 7","","CREAM","VAGINAL","20031125","20260601","ANDA","ANDA074760","Strategic Sourcing Services LLC","2","g/100g","","N",""
"2580","TOBRAMYCIN","Tobramycin","49502034573","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","49502-345","49502-345-73","49502-345_99c630df-5e03-4944-8225-26940d0ae737","HUMAN PRESCRIPTION DRUG","TOBI","","SOLUTION","ORAL; RESPIRATORY (INHALATION)","20220623","","NDA","NDA050753","Viatris Specialty LLC","300","mg/5mL","","N","20261231"
"2581","TOBRAMYCIN","Tobramycin","49502040124","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","49502-401","49502-401-24","49502-401_1f285be6-ebb6-4127-90b9-da4bd4ae818e","HUMAN PRESCRIPTION DRUG","TOBI Podhaler","","CAPSULE","ORAL; RESPIRATORY (INHALATION)","20210901","20261231","NDA","NDA201688","Viatris Specialty LLC","28","mg/1","","N",""
"2582","TOBRAMYCIN","Tobramycin","49502040109","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","49502-401","49502-401-09","49502-401_1f285be6-ebb6-4127-90b9-da4bd4ae818e","HUMAN PRESCRIPTION DRUG","TOBI Podhaler","","CAPSULE","ORAL; RESPIRATORY (INHALATION)","20210901","20261231","NDA","NDA201688","Viatris Specialty LLC","28","mg/1","","N",""
"2583","TOBRAMYCIN","Tobramycin","49502040157","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","49502-401","49502-401-57","49502-401_1f285be6-ebb6-4127-90b9-da4bd4ae818e","HUMAN PRESCRIPTION DRUG","TOBI Podhaler","","CAPSULE","ORAL; RESPIRATORY (INHALATION)","20210901","20261231","NDA","NDA201688","Viatris Specialty LLC","28","mg/1","","N",""
"2584","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","49687001300","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","49687-0013","49687-0013-0","49687-0013_2b9b528b-164e-a4d3-e063-6294a90a5318","HUMAN OTC DRUG","Antibiotic Application","","OINTMENT","TOPICAL","20160806","","OTC MONOGRAPH DRUG","M003","CMC Group, Inc.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20261231"
"2585","SULFAMETHOXAZOLE; TRIMETHOPRIM","sulfamethoxazole and Trimethoprim","49708014501","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","49708-145","49708-145-01","49708-145_2a76a544-1f84-4b42-e063-6394a90a08d5","HUMAN PRESCRIPTION DRUG","Bactrim","","TABLET","ORAL","20041101","","NDA","NDA017377","Sun Pharmaceutical Industries, Inc","400; 80","mg/1; mg/1","","N","20251231"
"2586","SULFAMETHOXAZOLE; TRIMETHOPRIM","sulfamethoxazole and Trimethoprim","49708014601","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","49708-146","49708-146-01","49708-146_2a76a544-1f84-4b42-e063-6394a90a08d5","HUMAN PRESCRIPTION DRUG","Bactrim DS","","TABLET","ORAL","20041101","","NDA","NDA017377","Sun Pharmaceutical Industries, Inc","800; 160","mg/1; mg/1","","N","20251231"
"2587","BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE","Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride","49884015154","Bismuth [CS], Bismuth [EPC], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","49884-151","49884-151-54","49884-151_11504f8f-0a04-45bc-bcd3-711dbee7f56a","HUMAN PRESCRIPTION DRUG","Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride","","CAPSULE","ORAL","20230307","","ANDA","ANDA205770","Endo USA, Inc.","140; 125; 125","mg/1; mg/1; mg/1","","N","20261231"
"2588","ITRACONAZOLE","Itraconazole","49884023911","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","49884-239","49884-239-11","49884-239_681c75ef-b582-4746-a00c-cc22aaa845fc","HUMAN PRESCRIPTION DRUG","Itraconazole","","CAPSULE","ORAL","20160701","20250731","ANDA","ANDA205724","Par Pharmaceutical, Inc.","100","mg/1","","N",""
"2589","SILVER SULFADIAZINE","Silver Sulfadiazine","49999018550","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","49999-185","49999-185-50","49999-185_72836f60-daab-42a7-a996-19c57426c6e4","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","20120322","20260228","ANDA","ANDA018578","Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC","10","g/1000g","","N",""
"2590","MUPIROCIN","Mupirocin","49999064422","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","49999-644","49999-644-22","49999-644_37cef446-cec1-4b6a-8a11-884c6895e60a","HUMAN PRESCRIPTION DRUG","mupirocin","","OINTMENT","TOPICAL","20091030","20250630","ANDA","ANDA065123","Lake Erie Medical DBA Quality Care Products LLC","20","mg/g","","N",""
"2591","MICONAZOLE NITRATE","Miconazole Nitrate","50066007003","Azole Antifungal [EPC], Azoles [CS]","50066-070","50066-070-03","50066-070_a475c37d-081e-4e6d-a058-7f81ad8c1fdc","HUMAN OTC DRUG","Lagicam","antifungal","CREAM","VAGINAL","20050302","","ANDA","ANDA076773","Genomma Lab USA, Inc.","40","mg/g","","N","20251231"
"2592","MICONAZOLE NITRATE","Miconazole Nitrate","50066007001","Azole Antifungal [EPC], Azoles [CS]","50066-070","50066-070-01","50066-070_a475c37d-081e-4e6d-a058-7f81ad8c1fdc","HUMAN OTC DRUG","Lagicam","antifungal","CREAM","VAGINAL","20050302","","ANDA","ANDA076773","Genomma Lab USA, Inc.","40","mg/g","","N","20251231"
"2593","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","50066008002","Allylamine Antifungal [EPC], Allylamine [CS]","50066-080","50066-080-02","50066-080_15c61d10-5300-8793-e063-6394a90a7d8f","HUMAN OTC DRUG","Silka","Antifungal","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Genomma Lab USA, Inc.","1","g/100g","","N","20251231"
"2594","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","50066008003","Allylamine Antifungal [EPC], Allylamine [CS]","50066-080","50066-080-03","50066-080_15c61d10-5300-8793-e063-6394a90a7d8f","HUMAN OTC DRUG","Silka","Antifungal","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Genomma Lab USA, Inc.","1","g/100g","","N","20251231"
"2595","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","50066008005","Allylamine Antifungal [EPC], Allylamine [CS]","50066-080","50066-080-05","50066-080_15c61d10-5300-8793-e063-6394a90a7d8f","HUMAN OTC DRUG","Silka","Antifungal","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Genomma Lab USA, Inc.","1","g/100g","","N","20251231"
"2596","MICONAZOLE NITRATE","MICONAZOLE NITRATE","50066008446","Azole Antifungal [EPC], Azoles [CS]","50066-084","50066-084-46","50066-084_c55dd887-1f9e-4ffc-a6a7-2ca1fa7d5407","HUMAN OTC DRUG","Silka Athletes Foot","","AEROSOL, SPRAY","TOPICAL","20250203","","OTC MONOGRAPH DRUG","M005","Genomma Lab USA","20","mg/g","","N","20261231"
"2597","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","50066020201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50066-202","50066-202-01","50066-202_1ac8094a-785d-7cdf-e063-6394a90a5326","HUMAN OTC DRUG","TRIPLE ANTIBIOTIC PLUS PAIN RELIEF","","OINTMENT","TOPICAL","20231221","","OTC MONOGRAPH DRUG","M004","GENOMMA LAB USA, INC.","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"2598","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","50066020805","Allylamine Antifungal [EPC], Allylamine [CS]","50066-208","50066-208-05","50066-208_39848469-9f54-4303-a5ea-2c711368b88c","HUMAN OTC DRUG","Silka","Jock Itch","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Genomma Lab USA, Inc.","1","g/100g","","N","20251231"
"2599","CEPHALEXIN","Cephalexin","50090007901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0079","50090-0079-1","50090-0079_4a51af0b-3c86-49da-99b3-5fc4309b2690","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","A-S Medication Solutions","500","mg/1","","N","20251231"
"2600","CEPHALEXIN","Cephalexin","50090007902","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0079","50090-0079-2","50090-0079_4a51af0b-3c86-49da-99b3-5fc4309b2690","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","A-S Medication Solutions","500","mg/1","","N","20251231"
"2601","CEPHALEXIN","Cephalexin","50090007903","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0079","50090-0079-3","50090-0079_4a51af0b-3c86-49da-99b3-5fc4309b2690","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","A-S Medication Solutions","500","mg/1","","N","20251231"
"2602","CEPHALEXIN","Cephalexin","50090007906","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0079","50090-0079-6","50090-0079_4a51af0b-3c86-49da-99b3-5fc4309b2690","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","A-S Medication Solutions","500","mg/1","","N","20251231"
"2603","CEPHALEXIN","Cephalexin","50090007907","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0079","50090-0079-7","50090-0079_4a51af0b-3c86-49da-99b3-5fc4309b2690","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","A-S Medication Solutions","500","mg/1","","N","20251231"
"2604","CEPHALEXIN","Cephalexin","50090007908","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0079","50090-0079-8","50090-0079_4a51af0b-3c86-49da-99b3-5fc4309b2690","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","A-S Medication Solutions","500","mg/1","","N","20251231"
"2605","CEPHALEXIN","Cephalexin","50090007900","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0079","50090-0079-0","50090-0079_4a51af0b-3c86-49da-99b3-5fc4309b2690","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","A-S Medication Solutions","500","mg/1","","N","20251231"
"2606","CEPHALEXIN","Cephalexin","50090007905","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0079","50090-0079-5","50090-0079_4a51af0b-3c86-49da-99b3-5fc4309b2690","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","A-S Medication Solutions","500","mg/1","","N","20251231"
"2607","CEPHALEXIN","Cephalexin","50090008003","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0080","50090-0080-3","50090-0080_98d0a1b2-f6bb-49ff-86b8-d40dd409bba8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","A-S Medication Solutions","500","mg/1","","N","20251231"
"2608","CEPHALEXIN","Cephalexin","50090008001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0080","50090-0080-1","50090-0080_98d0a1b2-f6bb-49ff-86b8-d40dd409bba8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","A-S Medication Solutions","500","mg/1","","N","20251231"
"2609","CEPHALEXIN","Cephalexin","50090008100","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0081","50090-0081-0","50090-0081_fc0f8e56-f656-4ae6-9c83-c7bc4046b42f","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","A-S Medication Solutions","500","mg/1","","N","20261231"
"2610","CEPHALEXIN","Cephalexin","50090008101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0081","50090-0081-1","50090-0081_fc0f8e56-f656-4ae6-9c83-c7bc4046b42f","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","A-S Medication Solutions","500","mg/1","","N","20261231"
"2611","DICLOXACILLIN SODIUM","Dicloxacillin Sodium","50090011601","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0116","50090-0116-1","50090-0116_d57fa00e-29a4-4e5c-bae1-0eb8ad4111f9","HUMAN PRESCRIPTION DRUG","Dicloxacillin Sodium","","CAPSULE","ORAL","19900930","","ANDA","ANDA062286","A-S Medication Solutions","250","mg/1","","N","20251231"
"2612","DICLOXACILLIN SODIUM","Dicloxacillin Sodium","50090011604","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0116","50090-0116-4","50090-0116_d57fa00e-29a4-4e5c-bae1-0eb8ad4111f9","HUMAN PRESCRIPTION DRUG","Dicloxacillin Sodium","","CAPSULE","ORAL","19900930","","ANDA","ANDA062286","A-S Medication Solutions","250","mg/1","","N","20251231"
"2613","DICLOXACILLIN SODIUM","Dicloxacillin Sodium","50090011600","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0116","50090-0116-0","50090-0116_d57fa00e-29a4-4e5c-bae1-0eb8ad4111f9","HUMAN PRESCRIPTION DRUG","Dicloxacillin Sodium","","CAPSULE","ORAL","19900930","","ANDA","ANDA062286","A-S Medication Solutions","250","mg/1","","N","20251231"
"2614","METRONIDAZOLE","Metronidazole","50090020101","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-0201","50090-0201-1","50090-0201_82c2f069-34ee-4c08-89af-e5a486252002","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","A-S Medication Solutions","250","mg/1","","N","20251231"
"2615","METRONIDAZOLE","Metronidazole","50090020102","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-0201","50090-0201-2","50090-0201_82c2f069-34ee-4c08-89af-e5a486252002","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","A-S Medication Solutions","250","mg/1","","N","20251231"
"2616","METRONIDAZOLE","Metronidazole","50090020100","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-0201","50090-0201-0","50090-0201_82c2f069-34ee-4c08-89af-e5a486252002","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","A-S Medication Solutions","250","mg/1","","N","20251231"
"2617","METRONIDAZOLE","Metronidazole","50090021104","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-0211","50090-0211-4","50090-0211_e736d923-a657-43b4-9e91-91cb9c658d73","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","A-S Medication Solutions","500","mg/1","","N","20251231"
"2618","METRONIDAZOLE","Metronidazole","50090021106","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-0211","50090-0211-6","50090-0211_e736d923-a657-43b4-9e91-91cb9c658d73","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","A-S Medication Solutions","500","mg/1","","N","20251231"
"2619","METRONIDAZOLE","Metronidazole","50090021109","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-0211","50090-0211-9","50090-0211_e736d923-a657-43b4-9e91-91cb9c658d73","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","A-S Medication Solutions","500","mg/1","","N","20251231"
"2620","METRONIDAZOLE","Metronidazole","50090021103","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-0211","50090-0211-3","50090-0211_e736d923-a657-43b4-9e91-91cb9c658d73","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","A-S Medication Solutions","500","mg/1","","N","20251231"
"2621","METRONIDAZOLE","Metronidazole","50090021100","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-0211","50090-0211-0","50090-0211_e736d923-a657-43b4-9e91-91cb9c658d73","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","A-S Medication Solutions","500","mg/1","","N","20251231"
"2622","METRONIDAZOLE","Metronidazole","50090021202","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-0212","50090-0212-2","50090-0212_600ef6a3-993b-4319-ba37-f6bad44f53fe","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","A-S Medication Solutions","500","mg/1","","N","20251231"
"2623","METRONIDAZOLE","Metronidazole","50090021201","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-0212","50090-0212-1","50090-0212_600ef6a3-993b-4319-ba37-f6bad44f53fe","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","A-S Medication Solutions","500","mg/1","","N","20251231"
"2624","METRONIDAZOLE","Metronidazole","50090021300","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-0213","50090-0213-0","50090-0213_f8b8b14c-3039-4ba0-8df7-0a50fd016b2d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","A-S Medication Solutions","500","mg/1","","N","20251231"
"2625","CEPHALEXIN","Cephalexin","50090021900","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0219","50090-0219-0","50090-0219_34fade7e-b1ad-4c3b-a290-4819d4223595","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA062703","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"2626","CEPHALEXIN","Cephalexin","50090022000","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0220","50090-0220-0","50090-0220_e03740aa-5184-42e1-a66f-5cd1c297493f","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA062703","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"2627","SILVER SULFADIAZINE","silver sulfadiazine","50090023000","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","50090-0230","50090-0230-0","50090-0230_c49d23c9-9da7-46d4-872a-607b71a2c700","HUMAN PRESCRIPTION DRUG","SILVADENE","","CREAM","TOPICAL","19731126","","NDA","NDA017381","A-S Medication Solutions","10","mg/g","","N","20251231"
"2628","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Polymyxin B Sulfate, Bacitracin Zinc and Neomycin Sulfate","50090023400","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50090-0234","50090-0234-0","50090-0234_970194cb-59e7-49c5-824f-e3fd3f8d4515","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","19950111","","OTC MONOGRAPH DRUG","M004","A-S Medication Solutions","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"2629","SULFACETAMIDE SODIUM","sulfacetamide sodium","50090024600","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","50090-0246","50090-0246-0","50090-0246_e04fb501-e4f0-4e70-8e1d-50ffe50bdaa7","HUMAN PRESCRIPTION DRUG","Sulfacetamide Sodium","","SOLUTION/ DROPS","OPHTHALMIC","19941228","","ANDA","ANDA040066","A-S Medication Solutions","100","mg/mL","","N","20251231"
"2630","GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and gramicidin","50090024700","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50090-0247","50090-0247-0","50090-0247_60de81f3-f08d-46b5-a771-b84312e42721","HUMAN PRESCRIPTION DRUG","NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN","","SOLUTION/ DROPS","OPHTHALMIC","19960131","","ANDA","ANDA064047","A-S Medication Solutions",".025; 1.75; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"2631","AMOXICILLIN","Amoxicillin","50090040400","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0404","50090-0404-0","50090-0404_a0cc68fb-42ca-4ef3-8e6e-a75952096a13","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","A-S Medication Solutions","125","mg/5mL","","N","20251231"
"2632","AMOXICILLIN","Amoxicillin","50090040600","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0406","50090-0406-0","50090-0406_61ee8fbc-3c2b-42ba-880c-d373eee04d51","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","A-S Medication Solutions","125","mg/5mL","","N","20261231"
"2633","AMOXICILLIN","Amoxicillin","50090040700","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0407","50090-0407-0","50090-0407_56178a4a-2449-45f8-8c51-217cc407d077","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"2634","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090040900","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0409","50090-0409-0","50090-0409_acce0bbf-684d-4c34-9d79-ce1514bfd2ab","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","POWDER, FOR SOLUTION","ORAL","19900930","","ANDA","ANDA060456","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"2635","AMOXICILLIN","Amoxicillin","50090041100","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0411","50090-0411-0","50090-0411_44ec7cdd-8503-4c59-8df8-9855651a5997","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"2636","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone","50090043100","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50090-0431","50090-0431-0","50090-0431_08aab101-04b5-4359-bf39-1daecd1faf61","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","19960828","","ANDA","ANDA064065","A-S Medication Solutions","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"2637","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone","50090043300","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50090-0433","50090-0433-0","50090-0433_7dfcddea-2672-4186-90eb-7d3fd1afbdf5","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SOLUTION/ DROPS","AURICULAR (OTIC)","19951229","","ANDA","ANDA064053","A-S Medication Solutions","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"2638","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090044303","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-0443","50090-0443-3","50090-0443_33825777-3310-4c32-9f4b-3e6d12d3315d","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","A-S Medication Solutions","150","mg/1","","N","20251231"
"2639","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090044304","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-0443","50090-0443-4","50090-0443_33825777-3310-4c32-9f4b-3e6d12d3315d","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","A-S Medication Solutions","150","mg/1","","N","20251231"
"2640","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090044306","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-0443","50090-0443-6","50090-0443_33825777-3310-4c32-9f4b-3e6d12d3315d","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","A-S Medication Solutions","150","mg/1","","N","20251231"
"2641","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090044301","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-0443","50090-0443-1","50090-0443_33825777-3310-4c32-9f4b-3e6d12d3315d","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","A-S Medication Solutions","150","mg/1","","N","20251231"
"2642","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090044300","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-0443","50090-0443-0","50090-0443_33825777-3310-4c32-9f4b-3e6d12d3315d","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","A-S Medication Solutions","150","mg/1","","N","20251231"
"2643","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090044307","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-0443","50090-0443-7","50090-0443_33825777-3310-4c32-9f4b-3e6d12d3315d","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","A-S Medication Solutions","150","mg/1","","N","20251231"
"2644","AMOXICILLIN","Amoxicillin","50090045400","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0454","50090-0454-0","50090-0454_f0d75b11-8892-4885-a77d-4a57d0c69246","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","19930101","","ANDA","ANDA064013","A-S Medication Solutions","250","mg/1","","N","20251231"
"2645","AMOXICILLIN","Amoxicillin","50090045405","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0454","50090-0454-5","50090-0454_f0d75b11-8892-4885-a77d-4a57d0c69246","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","19930101","","ANDA","ANDA064013","A-S Medication Solutions","250","mg/1","","N","20251231"
"2646","AMOXICILLIN","Amoxicillin","50090045401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0454","50090-0454-1","50090-0454_f0d75b11-8892-4885-a77d-4a57d0c69246","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","19930101","","ANDA","ANDA064013","A-S Medication Solutions","250","mg/1","","N","20251231"
"2647","AMOXICILLIN","Amoxicillin","50090045500","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0455","50090-0455-0","50090-0455_845fc154-9902-4853-9aac-81a2d9c11799","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","19930101","","ANDA","ANDA064013","A-S Medication Solutions","250","mg/1","","N","20251231"
"2648","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090052500","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-0525","50090-0525-0","50090-0525_17f8da0b-f726-41e9-bd06-237ae59432b4","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20100608","","ANDA","ANDA091348","A-S Medication Solutions","200; 40","mg/5mL; mg/5mL","","N","20251231"
"2649","CLOTRIMAZOLE","Clotrimazole","50090056200","Azole Antifungal [EPC], Azoles [CS]","50090-0562","50090-0562-0","50090-0562_53bae2ad-fb8e-44b5-a92f-744f819b78d4","HUMAN OTC DRUG","clotrimazole","","CREAM","TOPICAL","20110603","20260228","OTC MONOGRAPH DRUG","M005","A-S Medication Solutions","1","g/100g","","N",""
"2650","GENTAMICIN SULFATE","Gentamicin Sulfate","50090056900","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","50090-0569","50090-0569-0","50090-0569_704bbbf7-8b57-4cb3-830c-def5e334618d","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","SOLUTION/ DROPS","OPHTHALMIC","19940511","","ANDA","ANDA064048","A-S Medication Solutions","3","mg/mL","","N","20251231"
"2651","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone","50090057000","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50090-0570","50090-0570-0","50090-0570_25f93496-9b4d-4f8a-bd8c-a5f644bbafff","HUMAN PRESCRIPTION DRUG","Neomycin Polymyxin B Sulfates and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","19950913","","ANDA","ANDA064135","A-S Medication Solutions","1; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"2652","CEFADROXIL","Cefadroxil","50090058000","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0580","50090-0580-0","50090-0580_6b3debc2-ab68-47e0-82d5-6bb8017024c9","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20080423","","ANDA","ANDA065392","A-S Medication Solutions","500","mg/1","","N","20251231"
"2653","CEFADROXIL","Cefadroxil","50090058001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0580","50090-0580-1","50090-0580_6b3debc2-ab68-47e0-82d5-6bb8017024c9","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20080423","","ANDA","ANDA065392","A-S Medication Solutions","500","mg/1","","N","20251231"
"2654","CEFADROXIL","Cefadroxil","50090058002","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0580","50090-0580-2","50090-0580_6b3debc2-ab68-47e0-82d5-6bb8017024c9","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20080423","","ANDA","ANDA065392","A-S Medication Solutions","500","mg/1","","N","20251231"
"2655","SILVER SULFADIAZINE","Silver Sulfadiazine","50090060700","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","50090-0607","50090-0607-0","50090-0607_3bb12787-12de-4aeb-b40e-03c51050f1d2","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","A-S Medication Solutions","10","mg/g","","N","20251231"
"2656","CLOTRIMAZOLE","Clotrimazole","50090061400","Azole Antifungal [EPC], Azoles [CS]","50090-0614","50090-0614-0","50090-0614_838b5967-fc83-4f85-add6-04c09d5a6371","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","19951204","","ANDA","ANDA072641","A-S Medication Solutions","1","g/100g","","N","20251231"
"2657","AMOXICILLIN","Amoxicillin","50090070900","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0709","50090-0709-0","50090-0709_ad315af7-46fa-4b63-a48c-351e3f0c3b18","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","A-S Medication Solutions","500","mg/1","","N","20251231"
"2658","AMOXICILLIN","Amoxicillin","50090071300","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0713","50090-0713-0","50090-0713_ad315af7-46fa-4b63-a48c-351e3f0c3b18","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","A-S Medication Solutions","875","mg/1","","N","20251231"
"2659","AMOXICILLIN","Amoxicillin","50090071301","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0713","50090-0713-1","50090-0713_ad315af7-46fa-4b63-a48c-351e3f0c3b18","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","A-S Medication Solutions","875","mg/1","","N","20251231"
"2660","AMOXICILLIN","Amoxicillin","50090071302","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0713","50090-0713-2","50090-0713_ad315af7-46fa-4b63-a48c-351e3f0c3b18","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","A-S Medication Solutions","875","mg/1","","N","20251231"
"2661","AMOXICILLIN","Amoxicillin","50090071401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0714","50090-0714-1","50090-0714_156fa79e-91a6-460c-8f93-af5115b9588a","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","A-S Medication Solutions","875","mg/1","","N","20251231"
"2662","AMOXICILLIN","Amoxicillin","50090071400","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0714","50090-0714-0","50090-0714_156fa79e-91a6-460c-8f93-af5115b9588a","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","A-S Medication Solutions","875","mg/1","","N","20251231"
"2663","SILVER SULFADIAZINE","Silver Sulfadiazine","50090071700","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","50090-0717","50090-0717-0","50090-0717_8225e8a3-609e-4b82-aaa7-1c6010c07f6e","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","A-S Medication Solutions","10","mg/g","","N","20261231"
"2664","KETOCONAZOLE","ketoconazole","50090072000","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","50090-0720","50090-0720-0","50090-0720_bf765d18-843e-4af4-aab8-e3e1a31c4831","HUMAN PRESCRIPTION DRUG","ketoconazole","","CREAM","TOPICAL","20040428","","ANDA","ANDA076294","A-S Medication Solutions","20","mg/g","","N","20251231"
"2665","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","50090074100","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","50090-0741","50090-0741-0","50090-0741_c81292e5-a450-429d-8909-cf6f039d9430","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20031216","","ANDA","ANDA076002","A-S Medication Solutions",".5; 10","mg/g; mg/g","","N","20251231"
"2666","SILVER SULFADIAZINE","Silver Sulfadiazine","50090076300","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","50090-0763","50090-0763-0","50090-0763_3505508d-ae61-4c63-9ef1-bcd22e3292fb","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","A-S Medication Solutions","10","mg/g","","N","20251231"
"2667","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090082000","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-0820","50090-0820-0","50090-0820_6dff41b3-f2fe-4f50-aef9-0b01bc06d458","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091569","A-S Medication Solutions","500; 125","mg/1; mg/1","","N","20261231"
"2668","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090082003","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-0820","50090-0820-3","50090-0820_6dff41b3-f2fe-4f50-aef9-0b01bc06d458","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091569","A-S Medication Solutions","500; 125","mg/1; mg/1","","N","20261231"
"2669","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090082002","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-0820","50090-0820-2","50090-0820_6dff41b3-f2fe-4f50-aef9-0b01bc06d458","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091569","A-S Medication Solutions","500; 125","mg/1; mg/1","","N","20261231"
"2670","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090082001","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-0820","50090-0820-1","50090-0820_6dff41b3-f2fe-4f50-aef9-0b01bc06d458","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091569","A-S Medication Solutions","500; 125","mg/1; mg/1","","N","20261231"
"2671","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090082200","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-0822","50090-0822-0","50090-0822_6dff41b3-f2fe-4f50-aef9-0b01bc06d458","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20261231"
"2672","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090082201","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-0822","50090-0822-1","50090-0822_6dff41b3-f2fe-4f50-aef9-0b01bc06d458","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20261231"
"2673","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090082203","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-0822","50090-0822-3","50090-0822_6dff41b3-f2fe-4f50-aef9-0b01bc06d458","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20261231"
"2674","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090082202","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-0822","50090-0822-2","50090-0822_6dff41b3-f2fe-4f50-aef9-0b01bc06d458","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20261231"
"2675","AMOXICILLIN","Amoxicillin","50090085800","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-0858","50090-0858-0","50090-0858_332528b5-9d49-4c64-9f7b-d3a27d47e9f1","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065325","A-S Medication Solutions","400","mg/5mL","","N","20251231"
"2676","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystalline","50090086500","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","50090-0865","50090-0865-0","50090-0865_dcdaafda-874e-40b4-8e0f-346570538c61","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/ Macrocrystalline","","CAPSULE","ORAL","20110525","","NDA","NDA020064","A-S Medication Solutions","25; 75","mg/1; mg/1","","N","20251231"
"2677","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystalline","50090086501","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","50090-0865","50090-0865-1","50090-0865_dcdaafda-874e-40b4-8e0f-346570538c61","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/ Macrocrystalline","","CAPSULE","ORAL","20110525","","NDA","NDA020064","A-S Medication Solutions","25; 75","mg/1; mg/1","","N","20251231"
"2678","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystalline","50090086502","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","50090-0865","50090-0865-2","50090-0865_dcdaafda-874e-40b4-8e0f-346570538c61","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/ Macrocrystalline","","CAPSULE","ORAL","20110525","","NDA","NDA020064","A-S Medication Solutions","25; 75","mg/1; mg/1","","N","20251231"
"2679","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystalline","50090086601","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","50090-0866","50090-0866-1","50090-0866_144d42fc-7cc2-4ae4-b050-53d6dfff0b4b","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/ Macrocrystalline","","CAPSULE","ORAL","20110525","","NDA","NDA020064","A-S Medication Solutions","25; 75","mg/1; mg/1","","N","20251231"
"2680","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystalline","50090086600","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","50090-0866","50090-0866-0","50090-0866_144d42fc-7cc2-4ae4-b050-53d6dfff0b4b","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/ Macrocrystalline","","CAPSULE","ORAL","20110525","","NDA","NDA020064","A-S Medication Solutions","25; 75","mg/1; mg/1","","N","20251231"
"2681","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","50090088200","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-0882","50090-0882-0","50090-0882_4f560092-60a1-41f4-85a8-279dc97c81da","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20040507","","NDA AUTHORIZED GENERIC","NDA019992","A-S Medication Solutions","3","mg/mL","","N","20251231"
"2682","TERCONAZOLE","Terconazole","50090091700","Azole Antifungal [EPC], Azoles [CS]","50090-0917","50090-0917-0","50090-0917_36d90915-c768-4dc2-ba7f-6f8fe8764e08","HUMAN PRESCRIPTION DRUG","Terconazole","","CREAM","VAGINAL","20050119","","ANDA","ANDA076043","A-S Medication Solutions","4","mg/g","","N","20251231"
"2683","CLARITHROMYCIN","Clarithromycin","50090092700","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","50090-0927","50090-0927-0","50090-0927_00ba1494-ad88-49d5-bb9f-ce0ab6193853","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","A-S Medication Solutions","250","mg/1","","N","20251231"
"2684","AMOXICILLIN; CLAVULANIC ACID","Amoxicillin and Clavulanate Potassium","50090092800","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-0928","50090-0928-0","50090-0928_77950887-4a8e-4582-bc9c-f23984b05ec8","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20071201","","ANDA","ANDA065191","A-S Medication Solutions","400; 57","mg/5mL; mg/5mL","","N","20251231"
"2685","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","50090094400","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-0944","50090-0944-0","50090-0944_aec67c2e-94ef-4be6-afb1-d5c47bbdfad1","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","A-S Medication Solutions","500","mg/1","","N","20251231"
"2686","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090096700","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-0967","50090-0967-0","50090-0967_c72979ee-21bf-4363-974b-ee51898aeba7","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","A-S Medication Solutions","300","mg/1","","N","20251231"
"2687","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090096701","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-0967","50090-0967-1","50090-0967_c72979ee-21bf-4363-974b-ee51898aeba7","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","A-S Medication Solutions","300","mg/1","","N","20251231"
"2688","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090096702","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-0967","50090-0967-2","50090-0967_c72979ee-21bf-4363-974b-ee51898aeba7","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","A-S Medication Solutions","300","mg/1","","N","20251231"
"2689","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090096704","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-0967","50090-0967-4","50090-0967_c72979ee-21bf-4363-974b-ee51898aeba7","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","A-S Medication Solutions","300","mg/1","","N","20251231"
"2690","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090096703","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-0967","50090-0967-3","50090-0967_c72979ee-21bf-4363-974b-ee51898aeba7","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","A-S Medication Solutions","300","mg/1","","N","20251231"
"2691","CLARITHROMYCIN","Clarithromycin","50090099400","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","50090-0994","50090-0994-0","50090-0994_84ec0223-d179-4a48-a92e-310157d07411","HUMAN PRESCRIPTION DRUG","Clarithromycin","","FOR SUSPENSION","ORAL","20070904","","ANDA","ANDA065283","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"2692","PENICILLIN G BENZATHINE","penicillin G benzathine","50090101600","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1016","50090-1016-0","50090-1016_78cd2843-8c8f-43a1-b511-ba65823588ae","HUMAN PRESCRIPTION DRUG","BICILLIN L-A","","INJECTION, SUSPENSION","INTRAMUSCULAR","19520627","","NDA","NDA050141","A-S Medication Solutions","1200000","[iU]/2mL","","N","20251231"
"2693","PENICILLIN G BENZATHINE","penicillin G benzathine","50090101601","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1016","50090-1016-1","50090-1016_78cd2843-8c8f-43a1-b511-ba65823588ae","HUMAN PRESCRIPTION DRUG","BICILLIN L-A","","INJECTION, SUSPENSION","INTRAMUSCULAR","19520627","","NDA","NDA050141","A-S Medication Solutions","1200000","[iU]/2mL","","N","20251231"
"2694","CEFDINIR","Cefdinir","50090103301","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-1033","50090-1033-1","50090-1033_2b8b8acc-40d9-4992-9c3b-e5f145951211","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20060530","","ANDA","ANDA065264","A-S Medication Solutions","300","mg/1","","N","20261231"
"2695","CEFDINIR","Cefdinir","50090103302","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-1033","50090-1033-2","50090-1033_2b8b8acc-40d9-4992-9c3b-e5f145951211","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20060530","","ANDA","ANDA065264","A-S Medication Solutions","300","mg/1","","N","20261231"
"2696","CEFDINIR","Cefdinir","50090103300","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-1033","50090-1033-0","50090-1033_2b8b8acc-40d9-4992-9c3b-e5f145951211","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20060530","","ANDA","ANDA065264","A-S Medication Solutions","300","mg/1","","N","20261231"
"2697","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","50090104801","Allylamine Antifungal [EPC], Allylamine [CS]","50090-1048","50090-1048-1","50090-1048_1d9dab8d-1e3b-4c35-847d-57dbaa8c2ead","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","A-S Medication Solutions","250","mg/1","","N","20251231"
"2698","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","50090104800","Allylamine Antifungal [EPC], Allylamine [CS]","50090-1048","50090-1048-0","50090-1048_1d9dab8d-1e3b-4c35-847d-57dbaa8c2ead","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","A-S Medication Solutions","250","mg/1","","N","20251231"
"2699","MICONAZOLE NITRATE","Miconazole Nitrate","50090107100","Azole Antifungal [EPC], Azoles [CS]","50090-1071","50090-1071-0","50090-1071_9d2b1e85-ac93-4e13-8da5-554d79bcc38c","HUMAN OTC DRUG","Miconazole Nitrate","","CREAM","TOPICAL","19911001","","OTC MONOGRAPH DRUG","M005","A-S Medication Solutions","20","mg/g","","N","20261231"
"2700","AMOXICILLIN","Amoxicillin","50090108600","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1086","50090-1086-0","50090-1086_6fba8389-62b9-4724-85c4-c1af920a065a","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065325","A-S Medication Solutions","400","mg/5mL","","N","20251231"
"2701","OFLOXACIN","Ofloxacin","50090109000","Quinolone Antimicrobial [EPC], Quinolones [CS]","50090-1090","50090-1090-0","50090-1090_5b341aaa-4e47-4c22-aebb-a5374dd21b83","HUMAN PRESCRIPTION DRUG","Ofloxacin Otic","","SOLUTION","AURICULAR (OTIC)","20040514","","ANDA","ANDA076527","A-S Medication Solutions","3","mg/mL","","N","20251231"
"2702","DEXAMETHASONE; TOBRAMYCIN","Tobramycin and Dexamethasone","50090113500","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","50090-1135","50090-1135-0","50090-1135_3ae18ae8-7fe7-4f51-86d5-25d847181f3f","HUMAN PRESCRIPTION DRUG","Tobramycin and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","20090102","","NDA AUTHORIZED GENERIC","NDA050592","A-S Medication Solutions","1; 3","mg/mL; mg/mL","","N","20251231"
"2703","DEXAMETHASONE; TOBRAMYCIN","Tobramycin and Dexamethasone","50090113600","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","50090-1136","50090-1136-0","50090-1136_97c25fb5-f9a8-470f-83e0-eb6deff071f2","HUMAN PRESCRIPTION DRUG","Tobramycin and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","20090102","","NDA AUTHORIZED GENERIC","NDA050592","A-S Medication Solutions","1; 3","mg/mL; mg/mL","","N","20251231"
"2704","TERCONAZOLE","Terconazole","50090119600","Azole Antifungal [EPC], Azoles [CS]","50090-1196","50090-1196-0","50090-1196_f235c1c5-0e31-43a4-abec-f622945d799e","HUMAN PRESCRIPTION DRUG","Terconazole","","CREAM","VAGINAL","20040406","","ANDA","ANDA075953","A-S Medication Solutions","8","mg/g","","N","20251231"
"2705","BESIFLOXACIN","Besifloxacin","50090124100","Quinolone Antimicrobial [EPC], Quinolones [CS]","50090-1241","50090-1241-0","50090-1241_7acadd2a-73a7-420b-9825-6691b1d60464","HUMAN PRESCRIPTION DRUG","BESIVANCE","","SUSPENSION","OPHTHALMIC","20090528","","NDA","NDA022308","A-S Medication Solutions","6","mg/mL","","N","20251231"
"2706","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","50090127800","Allylamine Antifungal [EPC], Allylamine [CS]","50090-1278","50090-1278-0","50090-1278_d0db1c47-4dfe-443e-a514-09f727fb0b9f","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","A-S Medication Solutions","1","g/100g","","N","20251231"
"2707","AMOXICILLIN","Amoxicillin","50090134700","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1347","50090-1347-0","50090-1347_8ad02473-82e5-42cf-8406-53ef7d6934f8","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065325","A-S Medication Solutions","400","mg/5mL","","N","20251231"
"2708","ERYTHROMYCIN","Erythromycin","50090148400","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","50090-1484","50090-1484-0","50090-1484_ce955047-88f4-44de-a7b1-736baa056fb9","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","19940729","","ANDA","ANDA064067","A-S Medication Solutions","5","mg/g","","N","20251231"
"2709","AMOXICILLIN","Amoxicillin","50090151101","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1511","50090-1511-1","50090-1511_112e3e34-07bd-4b92-abe7-94b08391f30d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20261231"
"2710","AMOXICILLIN","Amoxicillin","50090151102","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1511","50090-1511-2","50090-1511_112e3e34-07bd-4b92-abe7-94b08391f30d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20261231"
"2711","AMOXICILLIN","Amoxicillin","50090151105","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1511","50090-1511-5","50090-1511_112e3e34-07bd-4b92-abe7-94b08391f30d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20261231"
"2712","AMOXICILLIN","Amoxicillin","50090151107","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1511","50090-1511-7","50090-1511_112e3e34-07bd-4b92-abe7-94b08391f30d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20261231"
"2713","AMOXICILLIN","Amoxicillin","50090151100","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1511","50090-1511-0","50090-1511_112e3e34-07bd-4b92-abe7-94b08391f30d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20261231"
"2714","AMOXICILLIN","Amoxicillin","50090151205","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1512","50090-1512-5","50090-1512_b714e6d0-7752-49bc-bcaa-be7ead4939cb","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20261231"
"2715","AMOXICILLIN","Amoxicillin","50090151206","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1512","50090-1512-6","50090-1512_b714e6d0-7752-49bc-bcaa-be7ead4939cb","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20261231"
"2716","AMOXICILLIN","Amoxicillin","50090151204","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1512","50090-1512-4","50090-1512_b714e6d0-7752-49bc-bcaa-be7ead4939cb","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20261231"
"2717","AMOXICILLIN","Amoxicillin","50090151207","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1512","50090-1512-7","50090-1512_b714e6d0-7752-49bc-bcaa-be7ead4939cb","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20261231"
"2718","AMOXICILLIN","Amoxicillin","50090151300","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1513","50090-1513-0","50090-1513_808c999b-4a47-4a79-b02d-091672d68c5e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20261231"
"2719","AMOXICILLIN","Amoxicillin","50090151400","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1514","50090-1514-0","50090-1514_72f678fe-73fe-419f-b25a-ed3f1a767a70","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20261231"
"2720","MUPIROCIN","Mupirocin","50090158700","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","50090-1587","50090-1587-0","50090-1587_84a2980e-170d-4cf5-86bf-8a727921d142","HUMAN PRESCRIPTION DRUG","mupirocin","","OINTMENT","TOPICAL","20091030","","ANDA","ANDA065123","A-S Medication Solutions","20","mg/g","","N","20251231"
"2721","AMOXICILLIN","Amoxicillin","50090159501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1595","50090-1595-1","50090-1595_a76e72f3-cc65-4fd8-93af-5fc5ffd53946","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","A-S Medication Solutions","875","mg/1","","N","20251231"
"2722","AMOXICILLIN","Amoxicillin","50090159500","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1595","50090-1595-0","50090-1595_a76e72f3-cc65-4fd8-93af-5fc5ffd53946","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","A-S Medication Solutions","875","mg/1","","N","20251231"
"2723","AMOXICILLIN","Amoxicillin","50090159502","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1595","50090-1595-2","50090-1595_a76e72f3-cc65-4fd8-93af-5fc5ffd53946","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","A-S Medication Solutions","875","mg/1","","N","20251231"
"2724","AMOXICILLIN","Amoxicillin","50090159600","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1596","50090-1596-0","50090-1596_717f694f-7a56-4ea7-ac1c-fc9db624bf05","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","A-S Medication Solutions","875","mg/1","","N","20261231"
"2725","AMOXICILLIN","Amoxicillin","50090159601","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1596","50090-1596-1","50090-1596_717f694f-7a56-4ea7-ac1c-fc9db624bf05","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","A-S Medication Solutions","875","mg/1","","N","20261231"
"2726","CEFACLOR","Cefaclor","50090160202","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-1602","50090-1602-2","50090-1602_bdfc38c7-4047-429b-a6c1-1100fc4caaaa","HUMAN PRESCRIPTION DRUG","Cefaclor","","CAPSULE","ORAL","20080731","","ANDA","ANDA065146","A-S Medication Solutions","500","mg/1","","N","20251231"
"2727","CEFACLOR","Cefaclor","50090160200","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-1602","50090-1602-0","50090-1602_bdfc38c7-4047-429b-a6c1-1100fc4caaaa","HUMAN PRESCRIPTION DRUG","Cefaclor","","CAPSULE","ORAL","20080731","","ANDA","ANDA065146","A-S Medication Solutions","500","mg/1","","N","20251231"
"2728","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","50090164803","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-1648","50090-1648-3","50090-1648_5f4acec7-3462-49b9-962c-931fedc0f520","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","A-S Medication Solutions","500","mg/1","","N","20261231"
"2729","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","50090164804","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-1648","50090-1648-4","50090-1648_5f4acec7-3462-49b9-962c-931fedc0f520","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","A-S Medication Solutions","500","mg/1","","N","20261231"
"2730","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","50090164800","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-1648","50090-1648-0","50090-1648_5f4acec7-3462-49b9-962c-931fedc0f520","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","A-S Medication Solutions","500","mg/1","","N","20261231"
"2731","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","50090164801","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-1648","50090-1648-1","50090-1648_5f4acec7-3462-49b9-962c-931fedc0f520","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","A-S Medication Solutions","500","mg/1","","N","20261231"
"2732","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","50090164808","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-1648","50090-1648-8","50090-1648_5f4acec7-3462-49b9-962c-931fedc0f520","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","A-S Medication Solutions","500","mg/1","","N","20261231"
"2733","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","50090164807","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-1648","50090-1648-7","50090-1648_5f4acec7-3462-49b9-962c-931fedc0f520","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","A-S Medication Solutions","500","mg/1","","N","20261231"
"2734","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","50090164805","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-1648","50090-1648-5","50090-1648_5f4acec7-3462-49b9-962c-931fedc0f520","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","A-S Medication Solutions","500","mg/1","","N","20261231"
"2735","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","50090164900","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-1649","50090-1649-0","50090-1649_9244d2d7-3da2-46a0-a870-9d1196df1504","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","A-S Medication Solutions","500","mg/1","","N","20251231"
"2736","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","50090164901","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-1649","50090-1649-1","50090-1649_9244d2d7-3da2-46a0-a870-9d1196df1504","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","A-S Medication Solutions","500","mg/1","","N","20251231"
"2737","NYSTATIN","nystatin","50090174000","Polyene Antifungal [EPC], Polyenes [CS]","50090-1740","50090-1740-0","50090-1740_8d9b172d-a817-43b1-9cd9-24243b311f28","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","19950415","","ANDA","ANDA062512","A-S Medication Solutions","100000","[USP'U]/mL","","N","20251231"
"2738","OFLOXACIN","Ofloxacin","50090174400","Quinolone Antimicrobial [EPC], Quinolones [CS]","50090-1744","50090-1744-0","50090-1744_2c2b3d4c-0427-4618-8edd-435118c185bf","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20040514","","ANDA","ANDA076622","A-S Medication Solutions","3","mg/mL","","N","20251231"
"2739","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","50090175400","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-1754","50090-1754-0","50090-1754_1ba814f1-1d24-423b-b0da-3e9c55834970","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20040507","","NDA AUTHORIZED GENERIC","NDA019992","A-S Medication Solutions","3","mg/mL","","N","20251231"
"2740","CLOTRIMAZOLE","Clotrimazole","50090177000","Azole Antifungal [EPC], Azoles [CS]","50090-1770","50090-1770-0","50090-1770_b0ba1ce0-abf7-42a8-a534-b901acbcf823","HUMAN OTC DRUG","clotrimazole","","CREAM","TOPICAL","20110603","","OTC MONOGRAPH DRUG","M005","A-S Medication Solutions","1","g/100g","","N","20251231"
"2741","AMOXICILLIN","Amoxicillin","50090179400","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1794","50090-1794-0","50090-1794_0061b41b-511d-4a65-affb-80988a0602d8","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2742","AMOXICILLIN","Amoxicillin","50090179401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1794","50090-1794-1","50090-1794_0061b41b-511d-4a65-affb-80988a0602d8","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2743","AMOXICILLIN","Amoxicillin","50090179407","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1794","50090-1794-7","50090-1794_0061b41b-511d-4a65-affb-80988a0602d8","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2744","AMOXICILLIN","Amoxicillin","50090179408","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1794","50090-1794-8","50090-1794_0061b41b-511d-4a65-affb-80988a0602d8","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2745","AMOXICILLIN","Amoxicillin","50090179402","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1794","50090-1794-2","50090-1794_0061b41b-511d-4a65-affb-80988a0602d8","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2746","AMOXICILLIN","Amoxicillin","50090179405","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1794","50090-1794-5","50090-1794_0061b41b-511d-4a65-affb-80988a0602d8","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2747","AMOXICILLIN","Amoxicillin","50090179409","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1794","50090-1794-9","50090-1794_0061b41b-511d-4a65-affb-80988a0602d8","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2748","AMOXICILLIN","Amoxicillin","50090179504","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1795","50090-1795-4","50090-1795_4e10c059-531c-4eeb-9b8c-a597f3756c4c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2749","AMOXICILLIN","Amoxicillin","50090179506","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1795","50090-1795-6","50090-1795_4e10c059-531c-4eeb-9b8c-a597f3756c4c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2750","AMOXICILLIN","Amoxicillin","50090179507","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1795","50090-1795-7","50090-1795_4e10c059-531c-4eeb-9b8c-a597f3756c4c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2751","AMOXICILLIN","Amoxicillin","50090179505","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1795","50090-1795-5","50090-1795_4e10c059-531c-4eeb-9b8c-a597f3756c4c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2752","AMOXICILLIN","Amoxicillin","50090179600","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1796","50090-1796-0","50090-1796_54c09f75-0b96-460c-9c9b-ad35e8c1fd15","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2753","AMOXICILLIN","Amoxicillin","50090179601","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1796","50090-1796-1","50090-1796_54c09f75-0b96-460c-9c9b-ad35e8c1fd15","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2754","AMOXICILLIN","Amoxicillin","50090179700","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1797","50090-1797-0","50090-1797_4167cee0-6fab-4412-8c16-a1c9feb78e7d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2755","AMOXICILLIN","Amoxicillin","50090181000","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1810","50090-1810-0","50090-1810_06fe45e9-6194-46f5-9d58-c36b83ff4ea6","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2756","AMOXICILLIN","Amoxicillin","50090181005","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1810","50090-1810-5","50090-1810_06fe45e9-6194-46f5-9d58-c36b83ff4ea6","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2757","AMOXICILLIN","Amoxicillin","50090181007","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1810","50090-1810-7","50090-1810_06fe45e9-6194-46f5-9d58-c36b83ff4ea6","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2758","AMOXICILLIN","Amoxicillin","50090181001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1810","50090-1810-1","50090-1810_06fe45e9-6194-46f5-9d58-c36b83ff4ea6","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2759","AMOXICILLIN","Amoxicillin","50090181002","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1810","50090-1810-2","50090-1810_06fe45e9-6194-46f5-9d58-c36b83ff4ea6","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2760","AMOXICILLIN","Amoxicillin","50090181105","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1811","50090-1811-5","50090-1811_958ce3c7-af3e-4d05-966b-a470e42348cd","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2761","AMOXICILLIN","Amoxicillin","50090181106","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1811","50090-1811-6","50090-1811_958ce3c7-af3e-4d05-966b-a470e42348cd","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2762","AMOXICILLIN","Amoxicillin","50090181107","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1811","50090-1811-7","50090-1811_958ce3c7-af3e-4d05-966b-a470e42348cd","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2763","AMOXICILLIN","Amoxicillin","50090181104","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1811","50090-1811-4","50090-1811_958ce3c7-af3e-4d05-966b-a470e42348cd","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2764","AMOXICILLIN","Amoxicillin","50090181201","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1812","50090-1812-1","50090-1812_af0188fa-4292-46b4-a0e7-4ff27111e8b1","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2765","AMOXICILLIN","Amoxicillin","50090181200","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1812","50090-1812-0","50090-1812_af0188fa-4292-46b4-a0e7-4ff27111e8b1","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2766","AMOXICILLIN","Amoxicillin","50090181300","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1813","50090-1813-0","50090-1813_4febf865-2d45-4945-bde6-5858293b41cc","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","500","mg/1","","N","20251231"
"2767","AMOXICILLIN","Amoxicillin","50090182500","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1825","50090-1825-0","50090-1825_717f694f-7a56-4ea7-ac1c-fc9db624bf05","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","A-S Medication Solutions","500","mg/1","","N","20261231"
"2768","AMOXICILLIN","Amoxicillin","50090182601","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1826","50090-1826-1","50090-1826_4e10c059-531c-4eeb-9b8c-a597f3756c4c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","250","mg/1","","N","20251231"
"2769","AMOXICILLIN","Amoxicillin","50090182600","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-1826","50090-1826-0","50090-1826_4e10c059-531c-4eeb-9b8c-a597f3756c4c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","A-S Medication Solutions","250","mg/1","","N","20251231"
"2770","CLARITHROMYCIN","Clarithromycin","50090183001","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","50090-1830","50090-1830-1","50090-1830_d98ce2fe-31f9-41d1-9dea-6d5cf2d7e218","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","A-S Medication Solutions","500","mg/1","","N","20261231"
"2771","CLARITHROMYCIN","Clarithromycin","50090183002","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","50090-1830","50090-1830-2","50090-1830_d98ce2fe-31f9-41d1-9dea-6d5cf2d7e218","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","A-S Medication Solutions","500","mg/1","","N","20261231"
"2772","CLARITHROMYCIN","Clarithromycin","50090183000","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","50090-1830","50090-1830-0","50090-1830_d98ce2fe-31f9-41d1-9dea-6d5cf2d7e218","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","A-S Medication Solutions","500","mg/1","","N","20261231"
"2773","CLARITHROMYCIN","Clarithromycin","50090183003","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","50090-1830","50090-1830-3","50090-1830_d98ce2fe-31f9-41d1-9dea-6d5cf2d7e218","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","A-S Medication Solutions","500","mg/1","","N","20261231"
"2774","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090185700","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-1857","50090-1857-0","50090-1857_d0027314-c305-448e-ba84-0187f3aba1b0","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201091","A-S Medication Solutions","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"2775","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","50090185900","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50090-1859","50090-1859-0","50090-1859_706f279f-0331-42d8-893f-e367cac94828","HUMAN OTC DRUG","TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20140520","","OTC MONOGRAPH DRUG","M004","A-S Medication Solutions","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"2776","AZITHROMYCIN DIHYDRATE","Azithromycin","50090186800","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-1868","50090-1868-0","50090-1868_4ceb10f9-5c4f-4b5b-be5a-e9e58820558e","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20101228","","ANDA","ANDA065246","A-S Medication Solutions","100","mg/5mL","","N","20251231"
"2777","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","50090187500","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-1875","50090-1875-0","50090-1875_48bba686-fc8a-4b5c-97c8-45e926912fd7","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","A-S Medication Solutions","250","mg/1","","N","20251231"
"2778","DEXAMETHASONE; TOBRAMYCIN","Tobramycin and Dexamethasone","50090189300","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","50090-1893","50090-1893-0","50090-1893_78f8fb83-6956-4d30-877e-51943ea610c1","HUMAN PRESCRIPTION DRUG","Tobramycin and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","19991027","","ANDA","ANDA064134","A-S Medication Solutions","1; 3","mg/mL; mg/mL","","N","20251231"
"2779","DEXAMETHASONE; TOBRAMYCIN","Tobramycin and Dexamethasone","50090191400","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","50090-1914","50090-1914-0","50090-1914_2b4c5f61-608f-4726-82c7-e60a3177e85d","HUMAN PRESCRIPTION DRUG","Tobramycin and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","19991027","","ANDA","ANDA064134","A-S Medication Solutions","1; 3","mg/mL; mg/mL","","N","20251231"
"2780","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","50090193200","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-1932","50090-1932-0","50090-1932_a1fdae88-a72e-482e-8eb6-8d957e9eead3","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20060531","","ANDA","ANDA065049","A-S Medication Solutions","10","mg/mL","","N","20251231"
"2781","ERYTHROMYCIN","erythromycin","50090195800","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","50090-1958","50090-1958-0","50090-1958_c1d481ba-af9a-43d1-80ed-9db6109fe3ad","HUMAN PRESCRIPTION DRUG","erythromycin","","OINTMENT","OPHTHALMIC","20140508","","ANDA","ANDA062447","A-S Medication Solutions","5","mg/g","","N","20251231"
"2782","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090198501","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-1985","50090-1985-1","50090-1985_af021b4e-9b8e-4665-be9f-ae315124d5a4","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","A-S Medication Solutions","150","mg/1","","N","20251231"
"2783","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090198504","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-1985","50090-1985-4","50090-1985_af021b4e-9b8e-4665-be9f-ae315124d5a4","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","A-S Medication Solutions","150","mg/1","","N","20251231"
"2784","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090198500","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-1985","50090-1985-0","50090-1985_af021b4e-9b8e-4665-be9f-ae315124d5a4","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","A-S Medication Solutions","150","mg/1","","N","20251231"
"2785","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090198507","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-1985","50090-1985-7","50090-1985_af021b4e-9b8e-4665-be9f-ae315124d5a4","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","A-S Medication Solutions","150","mg/1","","N","20251231"
"2786","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090198506","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-1985","50090-1985-6","50090-1985_af021b4e-9b8e-4665-be9f-ae315124d5a4","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","A-S Medication Solutions","150","mg/1","","N","20251231"
"2787","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090198503","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-1985","50090-1985-3","50090-1985_af021b4e-9b8e-4665-be9f-ae315124d5a4","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","A-S Medication Solutions","150","mg/1","","N","20251231"
"2788","METRONIDAZOLE","metronidazole","50090212600","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-2126","50090-2126-0","50090-2126_e39bafb7-205b-4ad7-9391-df7c04a88c12","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","VAGINAL","20150401","","NDA AUTHORIZED GENERIC","NDA020208","A-S Medication Solutions","7.5","mg/g","","N","20251231"
"2789","TOBRAMYCIN","Tobramycin","50090212700","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","50090-2127","50090-2127-0","50090-2127_9aee4577-c7ea-43b9-bcfc-94ac6c98608c","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","OPHTHALMIC","19931129","","ANDA","ANDA064052","A-S Medication Solutions","3","mg/mL","","N","20251231"
"2790","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","50090214601","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-2146","50090-2146-1","50090-2146_ef857039-e741-4c82-bb4d-01fb8fd3f15e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","A-S Medication Solutions","250","mg/1","","N","20251231"
"2791","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","50090214603","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-2146","50090-2146-3","50090-2146_ef857039-e741-4c82-bb4d-01fb8fd3f15e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","A-S Medication Solutions","250","mg/1","","N","20251231"
"2792","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","50090214600","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-2146","50090-2146-0","50090-2146_ef857039-e741-4c82-bb4d-01fb8fd3f15e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","A-S Medication Solutions","250","mg/1","","N","20251231"
"2793","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","50090214602","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-2146","50090-2146-2","50090-2146_ef857039-e741-4c82-bb4d-01fb8fd3f15e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","A-S Medication Solutions","250","mg/1","","N","20251231"
"2794","SILVER SULFADIAZINE","Silver Sulfadiazine","50090215200","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","50090-2152","50090-2152-0","50090-2152_eaadd781-8c99-41ba-a7f6-bdf54bb9faf8","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","A-S Medication Solutions","10","mg/g","","N","20251231"
"2795","CEFUROXIME AXETIL","Cefuroxime axetil","50090215700","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-2157","50090-2157-0","50090-2157_4c85dedc-e76f-40fb-bad7-99d7a2146679","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","A-S Medication Solutions","500","mg/1","","N","20251231"
"2796","CEFUROXIME AXETIL","Cefuroxime axetil","50090215800","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-2158","50090-2158-0","50090-2158_4c85dedc-e76f-40fb-bad7-99d7a2146679","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","A-S Medication Solutions","250","mg/1","","N","20251231"
"2797","CEFUROXIME AXETIL","Cefuroxime axetil","50090215803","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-2158","50090-2158-3","50090-2158_4c85dedc-e76f-40fb-bad7-99d7a2146679","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","A-S Medication Solutions","250","mg/1","","N","20251231"
"2798","CEFUROXIME AXETIL","Cefuroxime axetil","50090215901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-2159","50090-2159-1","50090-2159_16361438-6bf9-42ee-93e0-1cda506d9bd3","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","A-S Medication Solutions","250","mg/1","","N","20251231"
"2799","CEFUROXIME AXETIL","Cefuroxime axetil","50090215900","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-2159","50090-2159-0","50090-2159_16361438-6bf9-42ee-93e0-1cda506d9bd3","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","A-S Medication Solutions","250","mg/1","","N","20251231"
"2800","FLUCONAZOLE","Fluconazole","50090219501","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-2195","50090-2195-1","50090-2195_0eaa42bc-0006-47e5-a302-1c369883f0fc","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","A-S Medication Solutions","150","mg/1","","N","20251231"
"2801","FLUCONAZOLE","Fluconazole","50090219503","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-2195","50090-2195-3","50090-2195_0eaa42bc-0006-47e5-a302-1c369883f0fc","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","A-S Medication Solutions","150","mg/1","","N","20251231"
"2802","FLUCONAZOLE","Fluconazole","50090219500","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-2195","50090-2195-0","50090-2195_0eaa42bc-0006-47e5-a302-1c369883f0fc","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","A-S Medication Solutions","150","mg/1","","N","20251231"
"2803","FLUCONAZOLE","Fluconazole","50090219502","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-2195","50090-2195-2","50090-2195_0eaa42bc-0006-47e5-a302-1c369883f0fc","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","A-S Medication Solutions","150","mg/1","","N","20251231"
"2804","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090219800","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-2198","50090-2198-0","50090-2198_94eb5763-343f-4db3-8007-d7ce5c06ee41","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"2805","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090219802","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-2198","50090-2198-2","50090-2198_94eb5763-343f-4db3-8007-d7ce5c06ee41","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"2806","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090219805","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-2198","50090-2198-5","50090-2198_94eb5763-343f-4db3-8007-d7ce5c06ee41","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"2807","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090219801","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-2198","50090-2198-1","50090-2198_94eb5763-343f-4db3-8007-d7ce5c06ee41","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"2808","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090219803","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-2198","50090-2198-3","50090-2198_94eb5763-343f-4db3-8007-d7ce5c06ee41","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"2809","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090219807","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-2198","50090-2198-7","50090-2198_94eb5763-343f-4db3-8007-d7ce5c06ee41","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"2810","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090219900","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-2199","50090-2199-0","50090-2199_e00777f6-c80e-490c-8f6a-ddb3375347c9","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"2811","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090219901","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-2199","50090-2199-1","50090-2199_e00777f6-c80e-490c-8f6a-ddb3375347c9","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"2812","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090220000","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-2200","50090-2200-0","50090-2200_cc82c0de-aee0-43af-ada5-b708b10a653a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"2813","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090220001","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-2200","50090-2200-1","50090-2200_cc82c0de-aee0-43af-ada5-b708b10a653a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"2814","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090220100","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-2201","50090-2201-0","50090-2201_d073e80a-3ed6-4777-a314-a32159c63069","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"2815","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090221900","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-2219","50090-2219-0","50090-2219_e1418e76-31d9-4e56-b9c0-f601bc124baa","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201091","A-S Medication Solutions","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"2816","AMOXICILLIN","Amoxicillin","50090225100","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-2251","50090-2251-0","50090-2251_84350b63-7774-4468-8569-d017580c7d9d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"2817","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and hydrocortisone","50090236500","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50090-2365","50090-2365-0","50090-2365_711c99fe-2737-4c5e-9b16-93d10d2b1115","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SUSPENSION","AURICULAR (OTIC)","20030317","","ANDA","ANDA062488","A-S Medication Solutions","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"2818","MEFLOQUINE HYDROCHLORIDE","Mefloquine Hydrochloride","50090239600","Antimalarial [EPC]","50090-2396","50090-2396-0","50090-2396_4c4467e1-5886-4b66-aaff-8647a8591fce","HUMAN PRESCRIPTION DRUG","Mefloquine Hydrochloride","","TABLET","ORAL","20040106","","ANDA","ANDA076392","A-S Medication Solutions","250","mg/1","","N","20261231"
"2819","POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","Polymyxin B Sulfate and Trimethoprim Sulfate","50090239800","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50090-2398","50090-2398-0","50090-2398_1710b2c7-cef8-409d-85bb-ec640c6c1bd2","HUMAN PRESCRIPTION DRUG","Polymyxin B Sulfate and Trimethoprim","","SOLUTION/ DROPS","OPHTHALMIC","19970214","","ANDA","ANDA064120","A-S Medication Solutions","10000; 1","[USP'U]/mL; mg/mL","","N","20251231"
"2820","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","50090244400","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-2444","50090-2444-0","50090-2444_bcf28f1c-6595-4c9d-914c-3f6fc09a8cf9","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","A-S Medication Solutions","250","mg/1","","N","20251231"
"2821","RIFAXIMIN","rifaximin","50090244500","Rifamycin Antibacterial [EPC], Rifamycins [CS]","50090-2445","50090-2445-0","50090-2445_ea4a4cc3-d11c-46d6-aa97-d65eef8406dd","HUMAN PRESCRIPTION DRUG","XIFAXAN","","TABLET","ORAL","20040725","","NDA","NDA021361","A-S Medication Solutions","200","mg/1","","N","20251231"
"2822","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090247902","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-2479","50090-2479-2","50090-2479_44d27e8f-4c47-4316-83d9-53cce5fe4f1e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"2823","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","50090261100","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-2611","50090-2611-0","50090-2611_c56dde9c-0d73-4667-81df-21302b7313ae","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20130917","","ANDA","ANDA064050","A-S Medication Solutions","10","mg/mL","","N","20251231"
"2824","CEFDINIR","Cefdinir","50090271900","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-2719","50090-2719-0","50090-2719_ea6d412a-1b6c-4291-b13b-38ba666d8bb6","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","A-S Medication Solutions","300","mg/1","","N","20251231"
"2825","CEFDINIR","Cefdinir","50090271902","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-2719","50090-2719-2","50090-2719_ea6d412a-1b6c-4291-b13b-38ba666d8bb6","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","A-S Medication Solutions","300","mg/1","","N","20251231"
"2826","CEFDINIR","Cefdinir","50090271901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-2719","50090-2719-1","50090-2719_ea6d412a-1b6c-4291-b13b-38ba666d8bb6","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","A-S Medication Solutions","300","mg/1","","N","20251231"
"2827","CEFDINIR","Cefdinir","50090271903","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-2719","50090-2719-3","50090-2719_ea6d412a-1b6c-4291-b13b-38ba666d8bb6","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","A-S Medication Solutions","300","mg/1","","N","20251231"
"2828","CEFDINIR","Cefdinir","50090273500","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-2735","50090-2735-0","50090-2735_664df642-b804-4457-b571-d45e9cd547be","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20071214","","ANDA","ANDA065473","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"2829","NYSTATIN","Nystatin","50090276300","Polyene Antifungal [EPC], Polyenes [CS]","50090-2763","50090-2763-0","50090-2763_f2ba1312-720d-4231-ab45-515cc3c67829","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20060921","","ANDA","ANDA062225","A-S Medication Solutions","100000","[USP'U]/g","","N","20251231"
"2830","NYSTATIN","Nystatin","50090285400","Polyene Antifungal [EPC], Polyenes [CS]","50090-2854","50090-2854-0","50090-2854_80810afb-73ae-43f7-ba30-694293ba052f","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20060921","","ANDA","ANDA062225","A-S Medication Solutions","100000","[USP'U]/g","","N","20251231"
"2831","POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","Polymyxin B Sulfate and Trimethoprim","50090292500","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50090-2925","50090-2925-0","50090-2925_024ad216-7433-4c9d-938b-1a8a63316f26","HUMAN PRESCRIPTION DRUG","Polymyxin B Sulfate and Trimethoprim","","SOLUTION","OPHTHALMIC","19980416","","ANDA","ANDA064211","A-S Medication Solutions","10000; 1","[USP'U]/mL; mg/mL","","N","20251231"
"2832","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","50090298000","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","50090-2980","50090-2980-0","50090-2980_db61f577-1818-4643-8712-23db5c162ae6","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil HCl","","TABLET, FILM COATED","ORAL","20120727","","NDA AUTHORIZED GENERIC","NDA021078","A-S Medication Solutions","250; 100","mg/1; mg/1","","N","20251231"
"2833","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","50090298001","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","50090-2980","50090-2980-1","50090-2980_db61f577-1818-4643-8712-23db5c162ae6","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil HCl","","TABLET, FILM COATED","ORAL","20120727","","NDA AUTHORIZED GENERIC","NDA021078","A-S Medication Solutions","250; 100","mg/1; mg/1","","N","20251231"
"2834","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","50090298004","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","50090-2980","50090-2980-4","50090-2980_db61f577-1818-4643-8712-23db5c162ae6","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil HCl","","TABLET, FILM COATED","ORAL","20120727","","NDA AUTHORIZED GENERIC","NDA021078","A-S Medication Solutions","250; 100","mg/1; mg/1","","N","20251231"
"2835","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","50090298005","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","50090-2980","50090-2980-5","50090-2980_db61f577-1818-4643-8712-23db5c162ae6","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil HCl","","TABLET, FILM COATED","ORAL","20120727","","NDA AUTHORIZED GENERIC","NDA021078","A-S Medication Solutions","250; 100","mg/1; mg/1","","N","20251231"
"2836","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","50090298002","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","50090-2980","50090-2980-2","50090-2980_db61f577-1818-4643-8712-23db5c162ae6","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil HCl","","TABLET, FILM COATED","ORAL","20120727","","NDA AUTHORIZED GENERIC","NDA021078","A-S Medication Solutions","250; 100","mg/1; mg/1","","N","20251231"
"2837","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","50090298007","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","50090-2980","50090-2980-7","50090-2980_db61f577-1818-4643-8712-23db5c162ae6","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil HCl","","TABLET, FILM COATED","ORAL","20120727","","NDA AUTHORIZED GENERIC","NDA021078","A-S Medication Solutions","250; 100","mg/1; mg/1","","N","20251231"
"2838","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","50090298008","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","50090-2980","50090-2980-8","50090-2980_db61f577-1818-4643-8712-23db5c162ae6","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil HCl","","TABLET, FILM COATED","ORAL","20120727","","NDA AUTHORIZED GENERIC","NDA021078","A-S Medication Solutions","250; 100","mg/1; mg/1","","N","20251231"
"2839","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","50090298009","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","50090-2980","50090-2980-9","50090-2980_db61f577-1818-4643-8712-23db5c162ae6","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil HCl","","TABLET, FILM COATED","ORAL","20120727","","NDA AUTHORIZED GENERIC","NDA021078","A-S Medication Solutions","250; 100","mg/1; mg/1","","N","20251231"
"2840","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","50090298006","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","50090-2980","50090-2980-6","50090-2980_db61f577-1818-4643-8712-23db5c162ae6","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil HCl","","TABLET, FILM COATED","ORAL","20120727","","NDA AUTHORIZED GENERIC","NDA021078","A-S Medication Solutions","250; 100","mg/1; mg/1","","N","20251231"
"2841","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","50090298003","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","50090-2980","50090-2980-3","50090-2980_db61f577-1818-4643-8712-23db5c162ae6","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil HCl","","TABLET, FILM COATED","ORAL","20120727","","NDA AUTHORIZED GENERIC","NDA021078","A-S Medication Solutions","250; 100","mg/1; mg/1","","N","20251231"
"2842","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","50090312100","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","50090-3121","50090-3121-0","50090-3121_7d710cd6-c236-4be7-90ff-1eb2e5a32a3a","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20010529","","ANDA","ANDA075673","A-S Medication Solutions",".5; 10","mg/g; mg/g","","N","20251231"
"2843","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090317900","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-3179","50090-3179-0","50090-3179_49493aa3-1d9c-4222-bcdf-79a7165fc22e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20261231"
"2844","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090317902","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-3179","50090-3179-2","50090-3179_49493aa3-1d9c-4222-bcdf-79a7165fc22e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20261231"
"2845","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090317901","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-3179","50090-3179-1","50090-3179_49493aa3-1d9c-4222-bcdf-79a7165fc22e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20261231"
"2846","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090317903","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-3179","50090-3179-3","50090-3179_49493aa3-1d9c-4222-bcdf-79a7165fc22e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20261231"
"2847","CEPHALEXIN","Cephalexin","50090319900","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3199","50090-3199-0","50090-3199_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"2848","CEPHALEXIN","Cephalexin","50090319902","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3199","50090-3199-2","50090-3199_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"2849","CEPHALEXIN","Cephalexin","50090319905","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3199","50090-3199-5","50090-3199_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"2850","CEPHALEXIN","Cephalexin","50090319901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3199","50090-3199-1","50090-3199_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"2851","CEPHALEXIN","Cephalexin","50090319907","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3199","50090-3199-7","50090-3199_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"2852","CEPHALEXIN","Cephalexin","50090319903","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3199","50090-3199-3","50090-3199_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"2853","CEPHALEXIN","Cephalexin","50090319906","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3199","50090-3199-6","50090-3199_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"2854","CEPHALEXIN","Cephalexin","50090319908","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3199","50090-3199-8","50090-3199_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"2855","CEPHALEXIN","Cephalexin","50090320201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3202","50090-3202-1","50090-3202_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","A-S Medication Solutions","250","mg/1","","N","20251231"
"2856","CEPHALEXIN","Cephalexin","50090320203","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3202","50090-3202-3","50090-3202_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","A-S Medication Solutions","250","mg/1","","N","20251231"
"2857","CEPHALEXIN","Cephalexin","50090320204","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3202","50090-3202-4","50090-3202_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","A-S Medication Solutions","250","mg/1","","N","20251231"
"2858","CEPHALEXIN","Cephalexin","50090320205","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3202","50090-3202-5","50090-3202_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","A-S Medication Solutions","250","mg/1","","N","20251231"
"2859","CEPHALEXIN","Cephalexin","50090320202","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3202","50090-3202-2","50090-3202_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","A-S Medication Solutions","250","mg/1","","N","20251231"
"2860","CEPHALEXIN","Cephalexin","50090320207","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3202","50090-3202-7","50090-3202_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","A-S Medication Solutions","250","mg/1","","N","20251231"
"2861","CEPHALEXIN","Cephalexin","50090320208","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3202","50090-3202-8","50090-3202_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","A-S Medication Solutions","250","mg/1","","N","20251231"
"2862","CEPHALEXIN","Cephalexin","50090320209","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3202","50090-3202-9","50090-3202_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","A-S Medication Solutions","250","mg/1","","N","20251231"
"2863","CEPHALEXIN","Cephalexin","50090320206","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3202","50090-3202-6","50090-3202_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","A-S Medication Solutions","250","mg/1","","N","20251231"
"2864","CEPHALEXIN","Cephalexin","50090320200","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3202","50090-3202-0","50090-3202_0e469bdd-2787-4583-af53-18ddfff7a079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","A-S Medication Solutions","250","mg/1","","N","20251231"
"2865","CEPHALEXIN","Cephalexin","50090325201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3252","50090-3252-1","50090-3252_dbc11722-8b07-4d5c-8639-38e76d9536a9","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"2866","CEPHALEXIN","Cephalexin","50090325200","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3252","50090-3252-0","50090-3252_dbc11722-8b07-4d5c-8639-38e76d9536a9","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"2867","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc and Polymyxin B Sulfate","50090327400","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50090-3274","50090-3274-0","50090-3274_74cb9c89-7aa7-46cf-a1c0-7f89a9e049f7","HUMAN PRESCRIPTION DRUG","Bacitracin Zinc and Polymyxin B Sulfate","","OINTMENT","OPHTHALMIC","20080425","","ANDA","ANDA064046","A-S Medication Solutions","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"2868","KETOCONAZOLE","Ketoconazole","50090328800","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","50090-3288","50090-3288-0","50090-3288_963fdd93-04a5-4f04-ae86-c96b5c4b9880","HUMAN PRESCRIPTION DRUG","Ketoconazole","","SHAMPOO, SUSPENSION","TOPICAL","20050411","","ANDA","ANDA076942","A-S Medication Solutions","20","mg/mL","","N","20251231"
"2869","CEPHALEXIN","Cephalexin","50090329101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3291","50090-3291-1","50090-3291_dbc11722-8b07-4d5c-8639-38e76d9536a9","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","A-S Medication Solutions","250","mg/1","","N","20251231"
"2870","CEPHALEXIN","Cephalexin","50090329100","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3291","50090-3291-0","50090-3291_dbc11722-8b07-4d5c-8639-38e76d9536a9","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","A-S Medication Solutions","250","mg/1","","N","20251231"
"2871","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090330701","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-3307","50090-3307-1","50090-3307_43a8ced1-f39c-472b-ae6e-2dce4c9f9400","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","A-S Medication Solutions","250","mg/1","","N","20251231"
"2872","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090330700","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-3307","50090-3307-0","50090-3307_43a8ced1-f39c-472b-ae6e-2dce4c9f9400","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","A-S Medication Solutions","250","mg/1","","N","20251231"
"2873","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090330900","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-3309","50090-3309-0","50090-3309_8db70a8b-ed84-424a-9029-709a05d193dc","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","A-S Medication Solutions","400; 57","mg/5mL; mg/5mL","","N","20251231"
"2874","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090337402","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-3374","50090-3374-2","50090-3374_cc9f3ae7-f5ae-4432-9455-e3f9ff5e5c67","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","A-S Medication Solutions","250","mg/1","","N","20251231"
"2875","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090337403","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-3374","50090-3374-3","50090-3374_cc9f3ae7-f5ae-4432-9455-e3f9ff5e5c67","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","A-S Medication Solutions","250","mg/1","","N","20251231"
"2876","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090337400","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-3374","50090-3374-0","50090-3374_cc9f3ae7-f5ae-4432-9455-e3f9ff5e5c67","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","A-S Medication Solutions","250","mg/1","","N","20251231"
"2877","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090337404","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-3374","50090-3374-4","50090-3374_cc9f3ae7-f5ae-4432-9455-e3f9ff5e5c67","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","A-S Medication Solutions","250","mg/1","","N","20251231"
"2878","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090342501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-3425","50090-3425-1","50090-3425_97675890-766d-4b6e-8427-67602c155248","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","250","mg/1","","N","20251231"
"2879","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090342500","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-3425","50090-3425-0","50090-3425_97675890-766d-4b6e-8427-67602c155248","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","250","mg/1","","N","20251231"
"2880","CEPHALEXIN","Cephalexin","50090342701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3427","50090-3427-1","50090-3427_6c865d88-2648-407e-a586-c8ff53bffa36","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"2881","CEPHALEXIN","Cephalexin","50090342703","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3427","50090-3427-3","50090-3427_6c865d88-2648-407e-a586-c8ff53bffa36","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"2882","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090350602","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-3506","50090-3506-2","50090-3506_21100bad-907a-4278-a3fa-d7c1e7275002","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","250","mg/1","","N","20251231"
"2883","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090350603","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-3506","50090-3506-3","50090-3506_21100bad-907a-4278-a3fa-d7c1e7275002","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","250","mg/1","","N","20251231"
"2884","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090350600","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-3506","50090-3506-0","50090-3506_21100bad-907a-4278-a3fa-d7c1e7275002","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","250","mg/1","","N","20251231"
"2885","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090350604","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-3506","50090-3506-4","50090-3506_21100bad-907a-4278-a3fa-d7c1e7275002","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","250","mg/1","","N","20251231"
"2886","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","50090357501","Allylamine Antifungal [EPC], Allylamine [CS]","50090-3575","50090-3575-1","50090-3575_5d6b250e-38e6-4b77-aecf-a2b2f4481970","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","A-S Medication Solutions","250","mg/1","","N","20251231"
"2887","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","50090357500","Allylamine Antifungal [EPC], Allylamine [CS]","50090-3575","50090-3575-0","50090-3575_5d6b250e-38e6-4b77-aecf-a2b2f4481970","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","A-S Medication Solutions","250","mg/1","","N","20251231"
"2888","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","50090365400","Allylamine Antifungal [EPC], Allylamine [CS]","50090-3654","50090-3654-0","50090-3654_96cc504c-9106-48d2-a614-81ad3a4e977c","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","A-S Medication Solutions","250","mg/1","","N","20251231"
"2889","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","50090365401","Allylamine Antifungal [EPC], Allylamine [CS]","50090-3654","50090-3654-1","50090-3654_96cc504c-9106-48d2-a614-81ad3a4e977c","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","A-S Medication Solutions","250","mg/1","","N","20251231"
"2890","CEFDINIR","Cefdinir","50090372300","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3723","50090-3723-0","50090-3723_4817aaa0-92a7-40db-8b54-09478cc73dd2","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070507","","ANDA","ANDA065259","A-S Medication Solutions","250","mg/5mL","","N","20261231"
"2891","NYSTATIN","Nystatin","50090377200","Polyene Antifungal [EPC], Polyenes [CS]","50090-3772","50090-3772-0","50090-3772_0d638967-5c49-4e6f-9f51-2258ff5099a0","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20150401","","ANDA","ANDA061966","A-S Medication Solutions","100000","[USP'U]/g","","N","20261231"
"2892","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","50090379103","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-3791","50090-3791-3","50090-3791_cfb75224-e185-493b-9737-c9cb9c954b9a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","A-S Medication Solutions","500","mg/1","","N","20251231"
"2893","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","50090379104","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-3791","50090-3791-4","50090-3791_cfb75224-e185-493b-9737-c9cb9c954b9a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","A-S Medication Solutions","500","mg/1","","N","20251231"
"2894","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","50090379100","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-3791","50090-3791-0","50090-3791_cfb75224-e185-493b-9737-c9cb9c954b9a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","A-S Medication Solutions","500","mg/1","","N","20251231"
"2895","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","50090379107","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-3791","50090-3791-7","50090-3791_cfb75224-e185-493b-9737-c9cb9c954b9a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","A-S Medication Solutions","500","mg/1","","N","20251231"
"2896","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","50090379108","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-3791","50090-3791-8","50090-3791_cfb75224-e185-493b-9737-c9cb9c954b9a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","A-S Medication Solutions","500","mg/1","","N","20251231"
"2897","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","50090379101","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-3791","50090-3791-1","50090-3791_cfb75224-e185-493b-9737-c9cb9c954b9a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","A-S Medication Solutions","500","mg/1","","N","20251231"
"2898","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","50090379105","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-3791","50090-3791-5","50090-3791_cfb75224-e185-493b-9737-c9cb9c954b9a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","A-S Medication Solutions","500","mg/1","","N","20251231"
"2899","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","50090383800","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-3838","50090-3838-0","50090-3838_f3d65432-050d-4e4f-8cb7-2d20d230a350","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170630","","ANDA","ANDA203702","A-S Medication Solutions","500","mg/1","","N","20251231"
"2900","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","50090385200","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-3852","50090-3852-0","50090-3852_ee3193b9-9650-4cd6-bb66-b1e43c8461ed","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","A-S Medication Solutions","500","mg/1","","N","20251231"
"2901","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090390700","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-3907","50090-3907-0","50090-3907_7cc94978-0e5a-4b5e-b09d-55cc9428e7ef","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","A-S Medication Solutions","300","mg/1","","N","20251231"
"2902","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090390701","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-3907","50090-3907-1","50090-3907_7cc94978-0e5a-4b5e-b09d-55cc9428e7ef","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","A-S Medication Solutions","300","mg/1","","N","20251231"
"2903","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090390703","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-3907","50090-3907-3","50090-3907_7cc94978-0e5a-4b5e-b09d-55cc9428e7ef","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","A-S Medication Solutions","300","mg/1","","N","20251231"
"2904","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090390704","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-3907","50090-3907-4","50090-3907_7cc94978-0e5a-4b5e-b09d-55cc9428e7ef","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","A-S Medication Solutions","300","mg/1","","N","20251231"
"2905","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090390705","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-3907","50090-3907-5","50090-3907_7cc94978-0e5a-4b5e-b09d-55cc9428e7ef","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","A-S Medication Solutions","300","mg/1","","N","20251231"
"2906","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090390702","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-3907","50090-3907-2","50090-3907_7cc94978-0e5a-4b5e-b09d-55cc9428e7ef","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","A-S Medication Solutions","300","mg/1","","N","20251231"
"2907","TOBRAMYCIN","Tobramycin","50090419000","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","50090-4190","50090-4190-0","50090-4190_43826dc7-395b-4848-ae8d-fba8000a0f9e","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION/ DROPS","OPHTHALMIC","20200811","","ANDA","ANDA207444","A-S Medication Solutions","3","mg/mL","","N","20251231"
"2908","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","50090421700","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-4217","50090-4217-0","50090-4217_6241a0e1-3ec2-4a77-bb87-89a75bf2b999","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","SOLUTION","OPHTHALMIC","20181101","","ANDA","ANDA077568","A-S Medication Solutions","3","mg/mL","","N","20251231"
"2909","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","50090422000","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-4220","50090-4220-0","50090-4220_0646e90f-950b-4c44-9931-97ff770e7a48","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","SOLUTION","OPHTHALMIC","20181101","","ANDA","ANDA077568","A-S Medication Solutions","3","mg/mL","","N","20251231"
"2910","CEFAZOLIN SODIUM","Cefazolin","50090425600","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-4256","50090-4256-0","50090-4256_9f453c63-7855-47c4-9ac8-adb3cbe1bb26","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20010918","","ANDA","ANDA065047","A-S Medication Solutions","330","mg/mL","","N","20251231"
"2911","CEFDINIR MONOHYDRATE","Cefdinir","50090425800","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-4258","50090-4258-0","50090-4258_767a4ad4-9fab-4348-9ad4-8054620aaa2d","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070508","","ANDA","ANDA065332","A-S Medication Solutions","125","mg/5mL","","N","20261231"
"2912","MICONAZOLE NITRATE","Miconazole Nitrate","50090435600","Azole Antifungal [EPC], Azoles [CS]","50090-4356","50090-4356-0","50090-4356_54de6aa4-851d-4611-be14-cc689050352f","HUMAN OTC DRUG","Miconazole Nitrate","","CREAM","VAGINAL","19970113","","ANDA","ANDA074444","A-S Medication Solutions","20","mg/g","","N","20251231"
"2913","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090441301","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-4413","50090-4413-1","50090-4413_048fe5ef-29fa-49ac-a63e-00d2b1a7aa1e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20251231"
"2914","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090441300","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-4413","50090-4413-0","50090-4413_048fe5ef-29fa-49ac-a63e-00d2b1a7aa1e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20251231"
"2915","CEPHALEXIN","Cephalexin","50090442201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-4422","50090-4422-1","50090-4422_4c7f0c98-0d84-414e-808a-f2e6f55227d7","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","A-S Medication Solutions","500","mg/1","","N","20251231"
"2916","CEPHALEXIN","Cephalexin","50090442203","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-4422","50090-4422-3","50090-4422_4c7f0c98-0d84-414e-808a-f2e6f55227d7","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","A-S Medication Solutions","500","mg/1","","N","20251231"
"2917","CEPHALEXIN","Cephalexin","50090442205","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-4422","50090-4422-5","50090-4422_4c7f0c98-0d84-414e-808a-f2e6f55227d7","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","A-S Medication Solutions","500","mg/1","","N","20251231"
"2918","CEPHALEXIN","Cephalexin","50090442206","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-4422","50090-4422-6","50090-4422_4c7f0c98-0d84-414e-808a-f2e6f55227d7","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","A-S Medication Solutions","500","mg/1","","N","20251231"
"2919","CEPHALEXIN","Cephalexin","50090442207","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-4422","50090-4422-7","50090-4422_4c7f0c98-0d84-414e-808a-f2e6f55227d7","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","A-S Medication Solutions","500","mg/1","","N","20251231"
"2920","CEPHALEXIN","Cephalexin","50090442208","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-4422","50090-4422-8","50090-4422_4c7f0c98-0d84-414e-808a-f2e6f55227d7","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","A-S Medication Solutions","500","mg/1","","N","20251231"
"2921","CEPHALEXIN","Cephalexin","50090442202","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-4422","50090-4422-2","50090-4422_4c7f0c98-0d84-414e-808a-f2e6f55227d7","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","A-S Medication Solutions","500","mg/1","","N","20251231"
"2922","CEPHALEXIN","Cephalexin","50090442200","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-4422","50090-4422-0","50090-4422_4c7f0c98-0d84-414e-808a-f2e6f55227d7","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","A-S Medication Solutions","500","mg/1","","N","20251231"
"2923","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin and Polymyxin B Sulfates and Dexamethasone","50090443500","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50090-4435","50090-4435-0","50090-4435_721d4725-9333-40ec-9178-7310cf9cebdf","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Dexamethasone","","OINTMENT","OPHTHALMIC","19960221","","NDA AUTHORIZED GENERIC","NDA050065","A-S Medication Solutions","1; 3.5; 10000","mg/g; mg/g; [iU]/g","","N","20251231"
"2924","AZITHROMYCIN DIHYDRATE","Azithromycin","50090445801","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-4458","50090-4458-1","50090-4458_57c5f28a-3308-4eb6-ae6d-9e911f1f6989","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20180806","","ANDA","ANDA211147","A-S Medication Solutions","200","mg/5mL","","N","20251231"
"2925","AZITHROMYCIN DIHYDRATE","Azithromycin","50090445800","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-4458","50090-4458-0","50090-4458_57c5f28a-3308-4eb6-ae6d-9e911f1f6989","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20180806","","ANDA","ANDA211147","A-S Medication Solutions","200","mg/5mL","","N","20251231"
"2926","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","50090452700","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-4527","50090-4527-0","50090-4527_73b54c1b-428f-40d2-b27e-79401310690e","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","","ANDA","ANDA208250","A-S Medication Solutions","250","mg/1","","N","20251231"
"2927","CLOTRIMAZOLE","Clotrimazole","50090457400","Azole Antifungal [EPC], Azoles [CS]","50090-4574","50090-4574-0","50090-4574_fd0b576d-75ef-4ad4-96e2-dd0db37c535f","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","19950601","","OTC MONOGRAPH DRUG","M005","A-S Medication Solutions","1","g/100g","","N","20261231"
"2928","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090457501","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-4575","50090-4575-1","50090-4575_aa5114bb-9acc-4fe5-9bc5-b9205435122f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","A-S Medication Solutions","300","mg/1","","N","20251231"
"2929","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090457502","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-4575","50090-4575-2","50090-4575_aa5114bb-9acc-4fe5-9bc5-b9205435122f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","A-S Medication Solutions","300","mg/1","","N","20251231"
"2930","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090457500","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-4575","50090-4575-0","50090-4575_aa5114bb-9acc-4fe5-9bc5-b9205435122f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","A-S Medication Solutions","300","mg/1","","N","20251231"
"2931","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090457504","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-4575","50090-4575-4","50090-4575_aa5114bb-9acc-4fe5-9bc5-b9205435122f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","A-S Medication Solutions","300","mg/1","","N","20251231"
"2932","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090457503","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-4575","50090-4575-3","50090-4575_aa5114bb-9acc-4fe5-9bc5-b9205435122f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","A-S Medication Solutions","300","mg/1","","N","20251231"
"2933","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090460401","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-4604","50090-4604-1","50090-4604_a7707a1f-8b4e-4ed7-9b8f-42ba1f9c0d34","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","A-S Medication Solutions","500; 125","mg/1; mg/1","","N","20251231"
"2934","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090460403","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-4604","50090-4604-3","50090-4604_a7707a1f-8b4e-4ed7-9b8f-42ba1f9c0d34","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","A-S Medication Solutions","500; 125","mg/1; mg/1","","N","20251231"
"2935","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090460400","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-4604","50090-4604-0","50090-4604_a7707a1f-8b4e-4ed7-9b8f-42ba1f9c0d34","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","A-S Medication Solutions","500; 125","mg/1; mg/1","","N","20251231"
"2936","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090460402","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-4604","50090-4604-2","50090-4604_a7707a1f-8b4e-4ed7-9b8f-42ba1f9c0d34","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","A-S Medication Solutions","500; 125","mg/1; mg/1","","N","20251231"
"2937","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090460404","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-4604","50090-4604-4","50090-4604_a7707a1f-8b4e-4ed7-9b8f-42ba1f9c0d34","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","A-S Medication Solutions","500; 125","mg/1; mg/1","","N","20251231"
"2938","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090465101","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-4651","50090-4651-1","50090-4651_5e478d12-c656-456d-8248-58cb7a1d7f73","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","500","mg/1","","N","20251231"
"2939","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090465100","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-4651","50090-4651-0","50090-4651_5e478d12-c656-456d-8248-58cb7a1d7f73","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","500","mg/1","","N","20251231"
"2940","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090465202","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-4652","50090-4652-2","50090-4652_91634054-22e7-4ac6-9c61-a443a41a390c","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","500","mg/1","","N","20251231"
"2941","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090465205","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-4652","50090-4652-5","50090-4652_91634054-22e7-4ac6-9c61-a443a41a390c","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","500","mg/1","","N","20251231"
"2942","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090465206","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-4652","50090-4652-6","50090-4652_91634054-22e7-4ac6-9c61-a443a41a390c","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","500","mg/1","","N","20251231"
"2943","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090465201","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-4652","50090-4652-1","50090-4652_91634054-22e7-4ac6-9c61-a443a41a390c","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","500","mg/1","","N","20251231"
"2944","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090465204","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-4652","50090-4652-4","50090-4652_91634054-22e7-4ac6-9c61-a443a41a390c","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","500","mg/1","","N","20251231"
"2945","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","50090465902","Antimalarial [EPC], Antirheumatic Agent [EPC]","50090-4659","50090-4659-2","50090-4659_52423747-c25c-4dc5-8cba-b734b7a7692f","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20180517","","ANDA","ANDA210577","A-S Medication Solutions","200","mg/1","","N","20261231"
"2946","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","50090465901","Antimalarial [EPC], Antirheumatic Agent [EPC]","50090-4659","50090-4659-1","50090-4659_52423747-c25c-4dc5-8cba-b734b7a7692f","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20180517","","ANDA","ANDA210577","A-S Medication Solutions","200","mg/1","","N","20261231"
"2947","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090466101","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-4661","50090-4661-1","50090-4661_dc91f2f3-c5e8-4c78-aec4-ad45e327bfa4","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","A-S Medication Solutions","150","mg/1","","N","20251231"
"2948","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090466104","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-4661","50090-4661-4","50090-4661_dc91f2f3-c5e8-4c78-aec4-ad45e327bfa4","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","A-S Medication Solutions","150","mg/1","","N","20251231"
"2949","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090466100","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-4661","50090-4661-0","50090-4661_dc91f2f3-c5e8-4c78-aec4-ad45e327bfa4","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","A-S Medication Solutions","150","mg/1","","N","20251231"
"2950","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090466107","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-4661","50090-4661-7","50090-4661_dc91f2f3-c5e8-4c78-aec4-ad45e327bfa4","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","A-S Medication Solutions","150","mg/1","","N","20251231"
"2951","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090466103","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-4661","50090-4661-3","50090-4661_dc91f2f3-c5e8-4c78-aec4-ad45e327bfa4","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","A-S Medication Solutions","150","mg/1","","N","20251231"
"2952","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090466106","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-4661","50090-4661-6","50090-4661_dc91f2f3-c5e8-4c78-aec4-ad45e327bfa4","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","A-S Medication Solutions","150","mg/1","","N","20251231"
"2953","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","50090470000","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-4700","50090-4700-0","50090-4700_fd1fcc97-fc81-4396-a789-b92409cbf4a7","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","","ANDA","ANDA208249","A-S Medication Solutions","500","mg/1","","N","20251231"
"2954","AZITHROMYCIN DIHYDRATE","Azithromycin","50090472000","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-4720","50090-4720-0","50090-4720_9af8163d-c2dc-4f70-98d5-c1ff0c5a704d","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207370","A-S Medication Solutions","250","mg/1","","N","20261231"
"2955","AZITHROMYCIN DIHYDRATE","Azithromycin","50090472001","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-4720","50090-4720-1","50090-4720_9af8163d-c2dc-4f70-98d5-c1ff0c5a704d","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207370","A-S Medication Solutions","250","mg/1","","N","20261231"
"2956","AZITHROMYCIN DIHYDRATE","Azithromycin","50090472103","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-4721","50090-4721-3","50090-4721_557a7cc9-f9e4-46df-9d45-8be9093edf27","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207370","A-S Medication Solutions","250","mg/1","","N","20251231"
"2957","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin ophthalmic","50090478100","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-4781","50090-4781-0","50090-4781_7bb7b81f-241e-471c-92bd-daf69035980a","HUMAN PRESCRIPTION DRUG","Moxifloxacin ophthalmic solution","","SOLUTION/ DROPS","OPHTHALMIC","20190213","","ANDA","ANDA209469","A-S Medication Solutions","5","mg/mL","","N","20251231"
"2958","CEPHALEXIN","Cephalexin","50090479500","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-4795","50090-4795-0","50090-4795_b0c558df-b03b-4d59-a6a2-d2d3310678ad","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"2959","METRONIDAZOLE","metronidazole","50090480900","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-4809","50090-4809-0","50090-4809_3856b2eb-acbd-4edd-843a-7e2fff034a55","HUMAN PRESCRIPTION DRUG","metronidazole vaginal","","GEL","VAGINAL","20190708","","ANDA","ANDA211786","A-S Medication Solutions","7.5","mg/g","","N","20251231"
"2960","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090484700","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-4847","50090-4847-0","50090-4847_c06c073c-f5f8-41ad-b8e4-7697e3f97fbe","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"2961","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090484701","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-4847","50090-4847-1","50090-4847_c06c073c-f5f8-41ad-b8e4-7697e3f97fbe","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"2962","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090484702","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-4847","50090-4847-2","50090-4847_c06c073c-f5f8-41ad-b8e4-7697e3f97fbe","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"2963","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090484705","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-4847","50090-4847-5","50090-4847_c06c073c-f5f8-41ad-b8e4-7697e3f97fbe","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"2964","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090484707","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-4847","50090-4847-7","50090-4847_c06c073c-f5f8-41ad-b8e4-7697e3f97fbe","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"2965","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090484703","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-4847","50090-4847-3","50090-4847_c06c073c-f5f8-41ad-b8e4-7697e3f97fbe","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"2966","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090484802","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-4848","50090-4848-2","50090-4848_5aaa9a82-c3b8-4ccb-83c4-2ab9cc779d3b","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"2967","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090485000","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-4850","50090-4850-0","50090-4850_16c0bd23-76c4-4294-a819-1ec8b218ca31","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"2968","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090485001","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-4850","50090-4850-1","50090-4850_16c0bd23-76c4-4294-a819-1ec8b218ca31","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"2969","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","50090487600","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","50090-4876","50090-4876-0","50090-4876_5f91163f-04dc-4b91-becb-1c600fc4cad8","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20010529","","ANDA","ANDA075673","A-S Medication Solutions",".64; 10","mg/g; mg/g","","N","20251231"
"2970","CLOTRIMAZOLE","Clotrimazole","50090497100","Azole Antifungal [EPC], Azoles [CS]","50090-4971","50090-4971-0","50090-4971_1542a801-9d52-496b-a62c-7ab76dac5631","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","19950601","","OTC MONOGRAPH DRUG","M005","A-S Medication Solutions","1","g/100g","","N","20251231"
"2971","OFLOXACIN","ofloxacin","50090518600","Quinolone Antimicrobial [EPC], Quinolones [CS]","50090-5186","50090-5186-0","50090-5186_370ae18e-5219-4098-a0d3-4683cf159659","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20190301","","ANDA","ANDA076513","A-S Medication Solutions","3","mg/mL","","N","20251231"
"2972","CEPHALEXIN","Cephalexin","50090519600","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-5196","50090-5196-0","50090-5196_d53accce-79fa-48ff-ba91-88cbe796407d","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"2973","OFLOXACIN","ofloxacin","50090520900","Quinolone Antimicrobial [EPC], Quinolones [CS]","50090-5209","50090-5209-0","50090-5209_0d4fd0ac-d4d7-4178-813d-630a3b89724a","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20190301","","ANDA","ANDA076513","A-S Medication Solutions","3","mg/mL","","N","20251231"
"2974","KETOCONAZOLE","Ketoconazole","50090526500","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","50090-5265","50090-5265-0","50090-5265_feb1a21d-ab6a-4015-99c2-e55a098a10f3","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20190208","","ANDA","ANDA075581","A-S Medication Solutions","20","mg/g","","N","20251231"
"2975","CLARITHROMYCIN","Clarithromycin","50090528201","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","50090-5282","50090-5282-1","50090-5282_81455578-b702-45f6-b99c-22968f4a4f38","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","A-S Medication Solutions","500","mg/1","","N","20251231"
"2976","CLARITHROMYCIN","Clarithromycin","50090528202","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","50090-5282","50090-5282-2","50090-5282_81455578-b702-45f6-b99c-22968f4a4f38","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","A-S Medication Solutions","500","mg/1","","N","20251231"
"2977","CLARITHROMYCIN","Clarithromycin","50090528200","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","50090-5282","50090-5282-0","50090-5282_81455578-b702-45f6-b99c-22968f4a4f38","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","A-S Medication Solutions","500","mg/1","","N","20251231"
"2978","CLARITHROMYCIN","Clarithromycin","50090528203","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","50090-5282","50090-5282-3","50090-5282_81455578-b702-45f6-b99c-22968f4a4f38","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","A-S Medication Solutions","500","mg/1","","N","20251231"
"2979","FLUCONAZOLE","fluconazole","50090529900","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-5299","50090-5299-0","50090-5299_06f4b6eb-beb0-48ae-a320-de15f5740fd7","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","A-S Medication Solutions","100","mg/1","","N","20251231"
"2980","NYSTATIN","NYSTATIN","50090531500","Polyene Antifungal [EPC], Polyenes [CS]","50090-5315","50090-5315-0","50090-5315_7b3059b0-402b-4cea-88c4-5e7e787a34e7","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20200717","","ANDA","ANDA203621","A-S Medication Solutions","100000","[USP'U]/mL","","N","20251231"
"2981","AZITHROMYCIN DIHYDRATE","Azithromycin","50090536600","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-5366","50090-5366-0","50090-5366_eafd3275-4da4-4bc7-95d5-f2d218013280","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207398","A-S Medication Solutions","500","mg/1","","N","20251231"
"2982","AZITHROMYCIN DIHYDRATE","Azithromycin","50090536601","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-5366","50090-5366-1","50090-5366_eafd3275-4da4-4bc7-95d5-f2d218013280","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207398","A-S Medication Solutions","500","mg/1","","N","20251231"
"2983","AZITHROMYCIN DIHYDRATE","Azithromycin","50090537600","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-5376","50090-5376-0","50090-5376_f21ab02c-45c8-4933-8ab6-e676d3062dda","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207398","A-S Medication Solutions","500","mg/1","","N","20251231"
"2984","OFLOXACIN","Ofloxacin","50090542500","Quinolone Antimicrobial [EPC], Quinolones [CS]","50090-5425","50090-5425-0","50090-5425_2a202dde-0c1c-4b95-8692-6079c58564e1","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20141215","","ANDA","ANDA078559","A-S Medication Solutions","3","mg/mL","","N","20251231"
"2985","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090554300","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-5543","50090-5543-0","50090-5543_9a43c172-e359-48f7-813d-1ba3c70a522e","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","500","mg/1","","N","20251231"
"2986","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090554301","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-5543","50090-5543-1","50090-5543_9a43c172-e359-48f7-813d-1ba3c70a522e","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","500","mg/1","","N","20251231"
"2987","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090554302","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-5543","50090-5543-2","50090-5543_9a43c172-e359-48f7-813d-1ba3c70a522e","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","500","mg/1","","N","20251231"
"2988","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090554305","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-5543","50090-5543-5","50090-5543_9a43c172-e359-48f7-813d-1ba3c70a522e","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","500","mg/1","","N","20251231"
"2989","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090554306","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-5543","50090-5543-6","50090-5543_9a43c172-e359-48f7-813d-1ba3c70a522e","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","500","mg/1","","N","20251231"
"2990","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090554304","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-5543","50090-5543-4","50090-5543_9a43c172-e359-48f7-813d-1ba3c70a522e","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","500","mg/1","","N","20251231"
"2991","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","50090557301","Antimalarial [EPC], Antirheumatic Agent [EPC]","50090-5573","50090-5573-1","50090-5573_909ab143-2d20-49be-b4e8-2f4c82bade24","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20191001","","ANDA","ANDA040657","A-S Medication Solutions","200","mg/1","","N","20261231"
"2992","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","50090557302","Antimalarial [EPC], Antirheumatic Agent [EPC]","50090-5573","50090-5573-2","50090-5573_909ab143-2d20-49be-b4e8-2f4c82bade24","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20191001","","ANDA","ANDA040657","A-S Medication Solutions","200","mg/1","","N","20261231"
"2993","MICONAZOLE NITRATE","Miconazole Nitrate","50090560700","Azole Antifungal [EPC], Azoles [CS]","50090-5607","50090-5607-0","50090-5607_5832c1ef-9d62-42ca-a90f-dc6748fb17cf","HUMAN OTC DRUG","Miconazole Nitrate","","CREAM","TOPICAL","20210629","","OTC MONOGRAPH DRUG","M005","A-S Medication Solutions","20","mg/g","","N","20251231"
"2994","OFLOXACIN","Ofloxacin Otic","50090567000","Quinolone Antimicrobial [EPC], Quinolones [CS]","50090-5670","50090-5670-0","50090-5670_8465d7c3-7bb5-409f-9798-b2b55c5a4030","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","AURICULAR (OTIC)","20200317","","ANDA","ANDA211525","A-S Medication Solutions","3","mg/mL","","N","20251231"
"2995","MICONAZOLE NITRATE","Miconazole Nitrate","50090567400","Azole Antifungal [EPC], Azoles [CS]","50090-5674","50090-5674-0","50090-5674_d80e0a1c-83db-44b9-94b6-5e2e83c630d5","HUMAN OTC DRUG","Miconazole Nitrate","","CREAM","TOPICAL","20210629","","OTC MONOGRAPH DRUG","M005","A-S Medication Solutions","20","mg/g","","N","20251231"
"2996","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090567901","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-5679","50090-5679-1","50090-5679_10df7d9e-53c6-429e-9cf2-caa44bfaeb9a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"2997","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090567902","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-5679","50090-5679-2","50090-5679_10df7d9e-53c6-429e-9cf2-caa44bfaeb9a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"2998","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090567900","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-5679","50090-5679-0","50090-5679_10df7d9e-53c6-429e-9cf2-caa44bfaeb9a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"2999","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090567907","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-5679","50090-5679-7","50090-5679_10df7d9e-53c6-429e-9cf2-caa44bfaeb9a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"3000","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090567905","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-5679","50090-5679-5","50090-5679_10df7d9e-53c6-429e-9cf2-caa44bfaeb9a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"3001","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090567903","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-5679","50090-5679-3","50090-5679_10df7d9e-53c6-429e-9cf2-caa44bfaeb9a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"3002","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090568002","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-5680","50090-5680-2","50090-5680_46f58df4-5683-4ecd-805a-9b2c4fc928b3","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"3003","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090568201","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-5682","50090-5682-1","50090-5682_411b5f8e-1ab3-4603-a28c-9fc63e1f8e1e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"3004","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090568200","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-5682","50090-5682-0","50090-5682_411b5f8e-1ab3-4603-a28c-9fc63e1f8e1e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"3005","METRONIDAZOLE","Metronidazole","50090568703","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-5687","50090-5687-3","50090-5687_2e7fc983-d9f5-48ed-befc-fa6d90b32d52","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","A-S Medication Solutions","500","mg/1","","N","20251231"
"3006","METRONIDAZOLE","Metronidazole","50090568704","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-5687","50090-5687-4","50090-5687_2e7fc983-d9f5-48ed-befc-fa6d90b32d52","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","A-S Medication Solutions","500","mg/1","","N","20251231"
"3007","METRONIDAZOLE","Metronidazole","50090568700","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-5687","50090-5687-0","50090-5687_2e7fc983-d9f5-48ed-befc-fa6d90b32d52","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","A-S Medication Solutions","500","mg/1","","N","20251231"
"3008","METRONIDAZOLE","Metronidazole","50090568706","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-5687","50090-5687-6","50090-5687_2e7fc983-d9f5-48ed-befc-fa6d90b32d52","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","A-S Medication Solutions","500","mg/1","","N","20251231"
"3009","METRONIDAZOLE","Metronidazole","50090568709","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-5687","50090-5687-9","50090-5687_2e7fc983-d9f5-48ed-befc-fa6d90b32d52","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","A-S Medication Solutions","500","mg/1","","N","20251231"
"3010","METRONIDAZOLE","Metronidazole","50090568800","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-5688","50090-5688-0","50090-5688_9a6ee7b9-8c85-4e90-beaa-60d38a8b67c8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","A-S Medication Solutions","500","mg/1","","N","20251231"
"3011","METRONIDAZOLE","Metronidazole","50090568801","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-5688","50090-5688-1","50090-5688_9a6ee7b9-8c85-4e90-beaa-60d38a8b67c8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","A-S Medication Solutions","500","mg/1","","N","20251231"
"3012","METRONIDAZOLE","Metronidazole","50090568802","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-5688","50090-5688-2","50090-5688_9a6ee7b9-8c85-4e90-beaa-60d38a8b67c8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","A-S Medication Solutions","500","mg/1","","N","20251231"
"3013","METRONIDAZOLE","Metronidazole","50090569101","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-5691","50090-5691-1","50090-5691_92d7f3e6-cbfc-49e1-937f-1968c988c21d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","A-S Medication Solutions","250","mg/1","","N","20251231"
"3014","METRONIDAZOLE","Metronidazole","50090569102","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-5691","50090-5691-2","50090-5691_92d7f3e6-cbfc-49e1-937f-1968c988c21d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","A-S Medication Solutions","250","mg/1","","N","20251231"
"3015","METRONIDAZOLE","Metronidazole","50090569100","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-5691","50090-5691-0","50090-5691_92d7f3e6-cbfc-49e1-937f-1968c988c21d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","A-S Medication Solutions","250","mg/1","","N","20251231"
"3016","NITROFURANTOIN","Nitrofurantion","50090569300","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","50090-5693","50090-5693-0","50090-5693_e06435c7-1faf-4915-ad61-8b431cf3a53c","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","A-S Medication Solutions","100","mg/1","","N","20251231"
"3017","NITROFURANTOIN","Nitrofurantion","50090569303","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","50090-5693","50090-5693-3","50090-5693_e06435c7-1faf-4915-ad61-8b431cf3a53c","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","A-S Medication Solutions","100","mg/1","","N","20251231"
"3018","NITROFURANTOIN","Nitrofurantion","50090569302","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","50090-5693","50090-5693-2","50090-5693_e06435c7-1faf-4915-ad61-8b431cf3a53c","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","A-S Medication Solutions","100","mg/1","","N","20251231"
"3019","RIFAMPIN","rifampin","50090570900","Rifamycin Antibacterial [EPC], Rifamycins [CS]","50090-5709","50090-5709-0","50090-5709_df7c7de7-f8e3-4351-898d-008666993296","HUMAN PRESCRIPTION DRUG","rifampin","","CAPSULE","ORAL","20140108","","ANDA","ANDA090034","A-S Medication Solutions","300","mg/1","","N","20251231"
"3020","RIFAMPIN","rifampin","50090570903","Rifamycin Antibacterial [EPC], Rifamycins [CS]","50090-5709","50090-5709-3","50090-5709_df7c7de7-f8e3-4351-898d-008666993296","HUMAN PRESCRIPTION DRUG","rifampin","","CAPSULE","ORAL","20140108","","ANDA","ANDA090034","A-S Medication Solutions","300","mg/1","","N","20251231"
"3021","FLUCONAZOLE","Fluconazole","50090576401","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-5764","50090-5764-1","50090-5764_d02789c9-d0d8-4d32-8b97-be24c2b26e44","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20201120","","ANDA","ANDA077253","A-S Medication Solutions","150","mg/1","","N","20251231"
"3022","FLUCONAZOLE","Fluconazole","50090576402","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-5764","50090-5764-2","50090-5764_d02789c9-d0d8-4d32-8b97-be24c2b26e44","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20201120","","ANDA","ANDA077253","A-S Medication Solutions","150","mg/1","","N","20251231"
"3023","FLUCONAZOLE","Fluconazole","50090576400","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-5764","50090-5764-0","50090-5764_d02789c9-d0d8-4d32-8b97-be24c2b26e44","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20201120","","ANDA","ANDA077253","A-S Medication Solutions","150","mg/1","","N","20251231"
"3024","FLUCONAZOLE","Fluconazole","50090576403","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-5764","50090-5764-3","50090-5764_d02789c9-d0d8-4d32-8b97-be24c2b26e44","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20201120","","ANDA","ANDA077253","A-S Medication Solutions","150","mg/1","","N","20251231"
"3025","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","50090577900","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-5779","50090-5779-0","50090-5779_583d05a5-b7e7-4b29-97b0-2d861f80fd55","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20200301","","ANDA","ANDA209846","A-S Medication Solutions","11.9","mg/mL","","N","20251231"
"3026","METRONIDAZOLE","Metronidazole","50090578700","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-5787","50090-5787-0","50090-5787_97b26ff9-6392-4ba3-be9e-f71bbd2921a6","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","A-S Medication Solutions","500","mg/1","","N","20251231"
"3027","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","50090581000","Allylamine Antifungal [EPC], Allylamine [CS]","50090-5810","50090-5810-0","50090-5810_3b41da76-67b3-4921-ae37-d0be4c8ada4c","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","A-S Medication Solutions","1","g/100g","","N","20251231"
"3028","CEFDINIR","cefdinir","50090581100","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-5811","50090-5811-0","50090-5811_af5bca73-a913-4d8f-954d-a6ed48e02d5c","HUMAN PRESCRIPTION DRUG","cefdinir","","POWDER, FOR SUSPENSION","ORAL","20210220","","ANDA","ANDA210534","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"3029","NYSTATIN","Nystatin","50090584500","Polyene Antifungal [EPC], Polyenes [CS]","50090-5845","50090-5845-0","50090-5845_b497547b-3c93-4ea2-bc0e-5f0b1397b831","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20200624","","ANDA","ANDA207767","A-S Medication Solutions","100000","U/g","","N","20251231"
"3030","AMOXICILLIN","Amoxicillin","50090586302","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-5863","50090-5863-2","50090-5863_fa954a9d-1523-4cfe-8a58-d6988cec87fb","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, COATED","ORAL","20060329","","ANDA","ANDA065255","A-S Medication Solutions","875","mg/1","","N","20251231"
"3031","AMOXICILLIN","Amoxicillin","50090586301","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-5863","50090-5863-1","50090-5863_fa954a9d-1523-4cfe-8a58-d6988cec87fb","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, COATED","ORAL","20060329","","ANDA","ANDA065255","A-S Medication Solutions","875","mg/1","","N","20251231"
"3032","AMOXICILLIN","Amoxicillin","50090586300","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-5863","50090-5863-0","50090-5863_fa954a9d-1523-4cfe-8a58-d6988cec87fb","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, COATED","ORAL","20060329","","ANDA","ANDA065255","A-S Medication Solutions","875","mg/1","","N","20251231"
"3033","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090587300","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-5873","50090-5873-0","50090-5873_5ea4c6e7-0fff-4c6c-ae2f-e036637865f3","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","A-S Medication Solutions","400; 57","mg/5mL; mg/5mL","","N","20251231"
"3034","AMOXICILLIN","Amoxicillin","50090588000","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-5880","50090-5880-0","50090-5880_33b6a1ef-8834-4091-9d82-a36696ae7ad6","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, COATED","ORAL","20060329","","ANDA","ANDA065255","A-S Medication Solutions","875","mg/1","","N","20251231"
"3035","AMOXICILLIN","Amoxicillin","50090588001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-5880","50090-5880-1","50090-5880_33b6a1ef-8834-4091-9d82-a36696ae7ad6","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, COATED","ORAL","20060329","","ANDA","ANDA065255","A-S Medication Solutions","875","mg/1","","N","20251231"
"3036","ERYTHROMYCIN","Erythromycin","50090591805","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","50090-5918","50090-5918-5","50090-5918_92c063bb-9f59-40c0-8529-4903e94dfed3","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20210504","","ANDA","ANDA214549","A-S Medication Solutions","250","mg/1","","N","20261231"
"3037","ERYTHROMYCIN","Erythromycin","50090591806","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","50090-5918","50090-5918-6","50090-5918_92c063bb-9f59-40c0-8529-4903e94dfed3","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20210504","","ANDA","ANDA214549","A-S Medication Solutions","250","mg/1","","N","20261231"
"3038","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090593200","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-5932","50090-5932-0","50090-5932_94d504ce-793c-4213-9851-f7e1fece4cd4","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","A-S Medication Solutions","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"3039","CEPHALEXIN","Cephalexin","50090594800","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-5948","50090-5948-0","50090-5948_1e7cbdfc-183a-407e-b3f2-6985ababb93e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20151019","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"3040","CEPHALEXIN","Cephalexin","50090594801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-5948","50090-5948-1","50090-5948_1e7cbdfc-183a-407e-b3f2-6985ababb93e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20151019","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"3041","CEPHALEXIN","Cephalexin","50090594802","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-5948","50090-5948-2","50090-5948_1e7cbdfc-183a-407e-b3f2-6985ababb93e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20151019","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"3042","CEPHALEXIN","Cephalexin","50090594805","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-5948","50090-5948-5","50090-5948_1e7cbdfc-183a-407e-b3f2-6985ababb93e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20151019","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"3043","CEPHALEXIN","Cephalexin","50090594807","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-5948","50090-5948-7","50090-5948_1e7cbdfc-183a-407e-b3f2-6985ababb93e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20151019","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"3044","CEPHALEXIN","Cephalexin","50090594808","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-5948","50090-5948-8","50090-5948_1e7cbdfc-183a-407e-b3f2-6985ababb93e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20151019","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"3045","CEPHALEXIN","Cephalexin","50090594803","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-5948","50090-5948-3","50090-5948_1e7cbdfc-183a-407e-b3f2-6985ababb93e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20151019","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"3046","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate USP, 1%","50090595800","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-5958","50090-5958-0","50090-5958_29660190-d05a-4aef-bbd4-d216b9c419be","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20200113","","ANDA","ANDA212438","A-S Medication Solutions","10","mg/g","","N","20251231"
"3047","CEFDINIR","Cefdinir","50090604100","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-6041","50090-6041-0","50090-6041_71ed5df1-1bf7-43ed-8564-50a121f30c19","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","A-S Medication Solutions","300","mg/1","","N","20251231"
"3048","CEFDINIR","Cefdinir","50090604103","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-6041","50090-6041-3","50090-6041_71ed5df1-1bf7-43ed-8564-50a121f30c19","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","A-S Medication Solutions","300","mg/1","","N","20251231"
"3049","CEFDINIR","Cefdinir","50090604101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-6041","50090-6041-1","50090-6041_71ed5df1-1bf7-43ed-8564-50a121f30c19","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","A-S Medication Solutions","300","mg/1","","N","20251231"
"3050","CEFDINIR","Cefdinir","50090604102","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-6041","50090-6041-2","50090-6041_71ed5df1-1bf7-43ed-8564-50a121f30c19","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","A-S Medication Solutions","300","mg/1","","N","20251231"
"3051","CEFDINIR","Cefdinir","50090604201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-6042","50090-6042-1","50090-6042_9b3bfda0-2a6a-4547-b96d-b1d5f2b9817b","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","A-S Medication Solutions","300","mg/1","","N","20251231"
"3052","CEFDINIR","Cefdinir","50090604200","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-6042","50090-6042-0","50090-6042_9b3bfda0-2a6a-4547-b96d-b1d5f2b9817b","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","A-S Medication Solutions","300","mg/1","","N","20251231"
"3053","CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE","ciprofloxacin hydrochloride and hydrocortisone","50090604300","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-6043","50090-6043-0","50090-6043_cad2cea9-68bf-4e4e-afc6-60bd21846b6c","HUMAN PRESCRIPTION DRUG","CIPRO","HC","SUSPENSION/ DROPS","AURICULAR (OTIC)","19990315","","NDA","NDA020805","A-S Medication Solutions","2; 10","mg/mL; mg/mL","","N","20251231"
"3054","KETOCONAZOLE","Ketoconazole Cream, 2%","50090604600","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","50090-6046","50090-6046-0","50090-6046_9cb63b5f-73e6-404b-8d38-438f82bbdecd","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20210527","","ANDA","ANDA212443","A-S Medication Solutions","20","mg/g","","N","20251231"
"3055","CEFADROXIL","Cefadroxil","50090605001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-6050","50090-6050-1","50090-6050_f7721758-c7eb-4d43-a1bf-59829a432f85","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","A-S Medication Solutions","500","mg/1","","N","20251231"
"3056","CEFADROXIL","Cefadroxil","50090605002","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-6050","50090-6050-2","50090-6050_f7721758-c7eb-4d43-a1bf-59829a432f85","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","A-S Medication Solutions","500","mg/1","","N","20251231"
"3057","CEFADROXIL","Cefadroxil","50090605000","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-6050","50090-6050-0","50090-6050_f7721758-c7eb-4d43-a1bf-59829a432f85","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","A-S Medication Solutions","500","mg/1","","N","20251231"
"3058","AMOXICILLIN","Amoxicillin","50090605600","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-6056","50090-6056-0","50090-6056_eed9bf82-62ca-478b-b20b-12a0449249db","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065387","A-S Medication Solutions","125","mg/5mL","","N","20251231"
"3059","KETOCONAZOLE","Ketoconazole","50090606900","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","50090-6069","50090-6069-0","50090-6069_9fe63a1b-7944-4b27-bd49-288fcb59eccd","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20021218","","ANDA","ANDA075638","A-S Medication Solutions","20","mg/g","","N","20251231"
"3060","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","50090607200","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-6072","50090-6072-0","50090-6072_4cc34840-c7ce-4363-860c-841ab292153f","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20210310","","ANDA","ANDA214251","A-S Medication Solutions","10","mg/g","","N","20251231"
"3061","KETOCONAZOLE","ketoconazole","50090614201","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","50090-6142","50090-6142-1","50090-6142_53e92009-965c-4487-9143-6ca9159893d6","HUMAN PRESCRIPTION DRUG","KETOCONAZOLE","","TABLET","ORAL","20200410","","ANDA","ANDA075912","A-S Medication Solutions","200","mg/1","","N","20251231"
"3062","CEFDINIR","Cefdinir","50090617100","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-6171","50090-6171-0","50090-6171_07cacf06-d973-4928-b449-e3b8d1eee34a","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070507","","ANDA","ANDA065259","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"3063","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","polymyxin B sulfate, bacitracin zinc, neomycin sulfate, and pramoxine hydrochloride","50090617200","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50090-6172","50090-6172-0","50090-6172_8ccae7c4-e443-4cec-a31d-764334293b65","HUMAN OTC DRUG","SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF","","OINTMENT","TOPICAL","20120331","20270831","OTC MONOGRAPH DRUG","M004","A-S Medication Solutions","500; 3.5; 10000; 10","[iU]/g; mg/g; [iU]/g; mg/g","","N",""
"3064","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone","50090618100","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50090-6181","50090-6181-0","50090-6181_0dc2b405-d013-4e99-9a6d-9da394043d20","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Dexamethasone","","OINTMENT","OPHTHALMIC","19940725","","ANDA","ANDA064063","A-S Medication Solutions","1; 3.5; 10000","mg/g; mg/g; [USP'U]/g","","N","20251231"
"3065","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090622200","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-6222","50090-6222-0","50090-6222_2cb8142e-02a7-4914-baaa-9f943a11fccc","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","A-S Medication Solutions","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"3066","AZITHROMYCIN MONOHYDRATE","azithromycin","50090622600","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-6226","50090-6226-0","50090-6226_c0981152-20d0-449e-a639-28342c965a36","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","POWDER, FOR SUSPENSION","ORAL","20180410","","ANDA","ANDA207531","A-S Medication Solutions","200","mg/5mL","","N","20251231"
"3067","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin Ophthalmic","50090624800","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-6248","50090-6248-0","50090-6248_e8f6efeb-45b5-4864-b4b0-880246031cb8","HUMAN PRESCRIPTION DRUG","Moxifloxacin Ophthalmic","","SOLUTION/ DROPS","OPHTHALMIC","20200824","","ANDA","ANDA208778","A-S Medication Solutions","5","mg/mL","","N","20251231"
"3068","TERCONAZOLE","terconazole","50090626600","Azole Antifungal [EPC], Azoles [CS]","50090-6266","50090-6266-0","50090-6266_b7678af0-7092-4103-a9d3-5f76bd03b96b","HUMAN PRESCRIPTION DRUG","Terconazole","","CREAM","VAGINAL","20050218","","ANDA","ANDA076712","A-S Medication Solutions","4","mg/g","","N","20251231"
"3069","AZITHROMYCIN DIHYDRATE","Azithromycin","50090626700","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-6267","50090-6267-0","50090-6267_d90d6b7a-b321-4277-baf4-9fede17b1b3f","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20180806","","ANDA","ANDA211147","A-S Medication Solutions","200","mg/5mL","","N","20251231"
"3070","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","50090628001","Antimalarial [EPC], Antirheumatic Agent [EPC]","50090-6280","50090-6280-1","50090-6280_e3ddf397-4b8f-40cf-adbc-d1f056fc27a6","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET","ORAL","20200512","","ANDA","ANDA213342","A-S Medication Solutions","200","mg/1","","N","20251231"
"3071","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","50090628002","Antimalarial [EPC], Antirheumatic Agent [EPC]","50090-6280","50090-6280-2","50090-6280_e3ddf397-4b8f-40cf-adbc-d1f056fc27a6","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET","ORAL","20200512","","ANDA","ANDA213342","A-S Medication Solutions","200","mg/1","","N","20251231"
"3072","AZITHROMYCIN MONOHYDRATE","azithromycin","50090629600","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-6296","50090-6296-0","50090-6296_5bf7a87e-9897-498b-9797-9d2c8413e86d","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","POWDER, FOR SUSPENSION","ORAL","20180410","","ANDA","ANDA207531","A-S Medication Solutions","200","mg/5mL","","N","20251231"
"3073","TERCONAZOLE","terconazole","50090629900","Azole Antifungal [EPC], Azoles [CS]","50090-6299","50090-6299-0","50090-6299_8878f816-8262-4172-b007-ce8e7ac089bb","HUMAN PRESCRIPTION DRUG","Terconazole","Vaginal Cream 0.8%","CREAM","VAGINAL","20050201","","NDA","NDA021735","A-S Medication Solutions","8","mg/g","","N","20251231"
"3074","AMOXICILLIN","Amoxicillin","50090631900","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-6319","50090-6319-0","50090-6319_41d8987f-fef5-4b91-932a-5fd7f8c3f01a","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20140915","","ANDA","ANDA204030","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"3075","AMOXICILLIN","Amoxicillin","50090632300","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-6323","50090-6323-0","50090-6323_7b8e6d3c-f537-44d3-8c2a-c3dd07ff0f2f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","A-S Medication Solutions","400","mg/5mL","","N","20251231"
"3076","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","50090632400","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-6324","50090-6324-0","50090-6324_a2a30785-599c-4436-a3cc-b4db011b7a87","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, COATED","ORAL","20221121","","NDA AUTHORIZED GENERIC","NDA050720","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20251231"
"3077","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","50090632401","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-6324","50090-6324-1","50090-6324_a2a30785-599c-4436-a3cc-b4db011b7a87","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, COATED","ORAL","20221121","","NDA AUTHORIZED GENERIC","NDA050720","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20251231"
"3078","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","50090632402","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-6324","50090-6324-2","50090-6324_a2a30785-599c-4436-a3cc-b4db011b7a87","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, COATED","ORAL","20221121","","NDA AUTHORIZED GENERIC","NDA050720","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20251231"
"3079","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","50090632403","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-6324","50090-6324-3","50090-6324_a2a30785-599c-4436-a3cc-b4db011b7a87","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, COATED","ORAL","20221121","","NDA AUTHORIZED GENERIC","NDA050720","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20251231"
"3080","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin and polymyxin B sulfates and hydrocortisone otic","50090633600","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50090-6336","50090-6336-0","50090-6336_bf72b106-e8dc-4f1b-bc67-aa6c6f89ed9a","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension","","SUSPENSION","AURICULAR (OTIC)","20190315","","NDA AUTHORIZED GENERIC","NDA060613","A-S Medication Solutions","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"3081","AMOXICILLIN","Amoxicillin","50090634900","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-6349","50090-6349-0","50090-6349_6c7e5e32-ee3c-4368-becf-5681a55e0789","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20140915","","ANDA","ANDA204030","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"3082","AMOXICILLIN","Amoxicillin","50090635100","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-6351","50090-6351-0","50090-6351_a4c80021-7610-435c-bbc3-f285ea3ff088","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20140915","","ANDA","ANDA204030","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"3083","AMOXICILLIN","Amoxicillin","50090635500","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-6355","50090-6355-0","50090-6355_ed1f5615-4881-415d-82c8-003418ade79b","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","A-S Medication Solutions","400","mg/5mL","","N","20251231"
"3084","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin","50090635700","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-6357","50090-6357-0","50090-6357_820f6616-7ce5-4adf-8515-21efd5b02997","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20170701","","ANDA","ANDA202867","A-S Medication Solutions","5","mg/mL","","N","20251231"
"3085","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","50090638100","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-6381","50090-6381-0","50090-6381_63491821-5b94-4a6a-bf52-6a7ba556cabc","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20040813","","ANDA","ANDA065098","A-S Medication Solutions","400; 57","mg/5mL; mg/5mL","","N","20251231"
"3086","CEFDINIR","Cefdinir","50090641700","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-6417","50090-6417-0","50090-6417_1e4f7dd7-60f2-433d-9971-96b9576a4666","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20071214","","ANDA","ANDA065473","A-S Medication Solutions","125","mg/5mL","","N","20251231"
"3087","AZITHROMYCIN DIHYDRATE","Azithromycin","50090643600","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-6436","50090-6436-0","50090-6436_9242208e-0015-49f6-8246-c958618e818f","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210000","A-S Medication Solutions","250","mg/1","","N","20251231"
"3088","CEPHALEXIN","Cephalexin","50090644500","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-6445","50090-6445-0","50090-6445_77c698ed-fa40-46d8-8ea2-b75ab8f1bfad","HUMAN PRESCRIPTION DRUG","cephalexin","","FOR SUSPENSION","ORAL","20170906","","ANDA","ANDA065234","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"3089","AMOXICILLIN","Amoxicillin","50090646900","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-6469","50090-6469-0","50090-6469_94dbe808-3c56-4d9c-9243-0647165bd692","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20140915","","ANDA","ANDA204030","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"3090","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","50090647400","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","50090-6474","50090-6474-0","50090-6474_18a904e4-7b0d-4680-afcf-49260382d113","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20010529","","ANDA","ANDA075673","A-S Medication Solutions",".5; 10","mg/g; mg/g","","N","20251231"
"3091","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090652901","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-6529","50090-6529-1","50090-6529_442f3eaf-3419-4ffb-a1f5-1fa15389b221","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20251231"
"3092","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090652902","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-6529","50090-6529-2","50090-6529_442f3eaf-3419-4ffb-a1f5-1fa15389b221","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20251231"
"3093","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090652900","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-6529","50090-6529-0","50090-6529_442f3eaf-3419-4ffb-a1f5-1fa15389b221","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20251231"
"3094","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090652903","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-6529","50090-6529-3","50090-6529_442f3eaf-3419-4ffb-a1f5-1fa15389b221","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20251231"
"3095","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090653001","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-6530","50090-6530-1","50090-6530_cc11ed72-21ad-4272-948a-85e8b914f598","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20251231"
"3096","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090653000","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-6530","50090-6530-0","50090-6530_cc11ed72-21ad-4272-948a-85e8b914f598","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20251231"
"3097","CLOTRIMAZOLE","Clotrimazole","50090654600","Azole Antifungal [EPC], Azoles [CS]","50090-6546","50090-6546-0","50090-6546_7542ac98-3b2c-4821-966d-0ab40e9a0392","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","19950601","","OTC MONOGRAPH DRUG","M005","A-S Medication Solutions","1","g/100g","","N","20261231"
"3098","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate Topical USP, 1%","50090659200","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-6592","50090-6592-0","50090-6592_a70332eb-6f78-4e96-b489-eb60ad6be2da","HUMAN PRESCRIPTION DRUG","Clindamycin Phoaphate Topical USP, 1%","","SOLUTION","TOPICAL","20190304","","ANDA","ANDA209914","A-S Medication Solutions","10","mg/mL","","N","20251231"
"3099","CLINDAMYCIN PHOSPHATE","Clindamycin phosphate","50090659300","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-6593","50090-6593-0","50090-6593_86b55132-aaea-4c58-b2c9-d2f8fd750089","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20040331","","ANDA","ANDA065184","A-S Medication Solutions","10","mg/mL","","N","20251231"
"3100","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin Hydrochloride","50090660900","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-6609","50090-6609-0","50090-6609_20c49868-6dc2-4951-8729-16b51689c387","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride","","TABLET, FILM COATED","ORAL","20140304","","ANDA","ANDA202632","A-S Medication Solutions","400","mg/1","","N","20251231"
"3101","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin Hydrochloride","50090660901","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-6609","50090-6609-1","50090-6609_20c49868-6dc2-4951-8729-16b51689c387","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride","","TABLET, FILM COATED","ORAL","20140304","","ANDA","ANDA202632","A-S Medication Solutions","400","mg/1","","N","20251231"
"3102","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","50090662900","Antimalarial [EPC], Antirheumatic Agent [EPC]","50090-6629","50090-6629-0","50090-6629_987a57ba-5ae5-48e9-ab97-4c293c2cabc0","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20191001","","ANDA","ANDA040657","A-S Medication Solutions","200","mg/1","","N","20251231"
"3103","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","50090666400","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","50090-6664","50090-6664-0","50090-6664_442cd179-b378-40cc-b7c6-5dbfe2b26401","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","A-S Medication Solutions","25; 75","mg/1; mg/1","","N","20251231"
"3104","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","50090666401","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","50090-6664","50090-6664-1","50090-6664_442cd179-b378-40cc-b7c6-5dbfe2b26401","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","A-S Medication Solutions","25; 75","mg/1; mg/1","","N","20251231"
"3105","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","50090666402","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","50090-6664","50090-6664-2","50090-6664_442cd179-b378-40cc-b7c6-5dbfe2b26401","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","A-S Medication Solutions","25; 75","mg/1; mg/1","","N","20251231"
"3106","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090667501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-6675","50090-6675-1","50090-6675_8a23799c-bf42-492a-8a60-4c89747b72d2","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","500","mg/1","","N","20251231"
"3107","PENICILLIN V POTASSIUM","Penicillin V Potassium","50090667500","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-6675","50090-6675-0","50090-6675_8a23799c-bf42-492a-8a60-4c89747b72d2","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","A-S Medication Solutions","500","mg/1","","N","20251231"
"3108","AMOXICILLIN","Amoxicillin","50090668000","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-6680","50090-6680-0","50090-6680_77936f1d-d70c-4d6d-8aa2-80502c7c7895","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","A-S Medication Solutions","400","mg/5mL","","N","20251231"
"3109","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090669400","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-6694","50090-6694-0","50090-6694_d80d6048-219c-4fbf-ac8c-432993ff9b95","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","A-S Medication Solutions","400; 57","mg/5mL; mg/5mL","","N","20251231"
"3110","FLUCONAZOLE","Fluconazole","50090673300","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-6733","50090-6733-0","50090-6733_5e346534-1159-4c79-9422-1e288b127c62","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","A-S Medication Solutions","100","mg/1","","N","20251231"
"3111","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","50090674800","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","50090-6748","50090-6748-0","50090-6748_ba2e342b-17e2-4dc6-ba23-c7aa41db8090","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20141101","","ANDA","ANDA077066","A-S Medication Solutions","25; 75","mg/1; mg/1","","N","20251231"
"3112","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","50090674801","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","50090-6748","50090-6748-1","50090-6748_ba2e342b-17e2-4dc6-ba23-c7aa41db8090","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20141101","","ANDA","ANDA077066","A-S Medication Solutions","25; 75","mg/1; mg/1","","N","20251231"
"3113","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","50090674802","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","50090-6748","50090-6748-2","50090-6748_ba2e342b-17e2-4dc6-ba23-c7aa41db8090","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20141101","","ANDA","ANDA077066","A-S Medication Solutions","25; 75","mg/1; mg/1","","N","20251231"
"3114","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","50090675001","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","50090-6750","50090-6750-1","50090-6750_c6fe422a-a542-426b-a939-7542ccbd557b","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","A-S Medication Solutions","25; 75","mg/1; mg/1","","N","20251231"
"3115","FLUCONAZOLE","Fluconazole","50090675100","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-6751","50090-6751-0","50090-6751_7a9ab5f3-e4e0-4443-970a-00353257821d","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","A-S Medication Solutions","200","mg/1","","N","20251231"
"3116","FLUCONAZOLE","Fluconazole","50090675101","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-6751","50090-6751-1","50090-6751_7a9ab5f3-e4e0-4443-970a-00353257821d","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","A-S Medication Solutions","200","mg/1","","N","20251231"
"3117","FLUCONAZOLE","Fluconazole","50090675103","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-6751","50090-6751-3","50090-6751_7a9ab5f3-e4e0-4443-970a-00353257821d","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","A-S Medication Solutions","200","mg/1","","N","20251231"
"3118","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","50090676901","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","50090-6769","50090-6769-1","50090-6769_634cd926-12b0-4a21-8648-85b5e672478c","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20141101","","ANDA","ANDA077066","A-S Medication Solutions","25; 75","mg/1; mg/1","","N","20251231"
"3119","AMOXICILLIN","Amoxicillin","50090679100","Penicillin-class Antibacterial [EPC], Penicillins [CS]","50090-6791","50090-6791-0","50090-6791_17b60fa3-c438-49ac-b1bc-72dfbde1848e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20140915","","ANDA","ANDA204030","A-S Medication Solutions","125","mg/5mL","","N","20251231"
"3120","OFLOXACIN","ofloxacin","50090679400","Quinolone Antimicrobial [EPC], Quinolones [CS]","50090-6794","50090-6794-0","50090-6794_911ade83-6dc1-4ef6-9f78-813bfdeba334","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20221207","","ANDA","ANDA215886","A-S Medication Solutions","3","mg/mL","","N","20251231"
"3121","FLUCONAZOLE","Fluconazole","50090684202","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-6842","50090-6842-2","50090-6842_6746cd5d-9b2e-4618-85a6-7a03aa4e18e2","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","A-S Medication Solutions","150","mg/1","","N","20251231"
"3122","FLUCONAZOLE","Fluconazole","50090684203","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-6842","50090-6842-3","50090-6842_6746cd5d-9b2e-4618-85a6-7a03aa4e18e2","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","A-S Medication Solutions","150","mg/1","","N","20251231"
"3123","FLUCONAZOLE","Fluconazole","50090684201","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-6842","50090-6842-1","50090-6842_6746cd5d-9b2e-4618-85a6-7a03aa4e18e2","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","A-S Medication Solutions","150","mg/1","","N","20251231"
"3124","FLUCONAZOLE","Fluconazole","50090684200","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50090-6842","50090-6842-0","50090-6842_6746cd5d-9b2e-4618-85a6-7a03aa4e18e2","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","A-S Medication Solutions","150","mg/1","","N","20251231"
"3125","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090690101","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-6901","50090-6901-1","50090-6901_1ce9fb0c-6acd-4205-8747-528c5339ba19","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"3126","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090690102","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-6901","50090-6901-2","50090-6901_1ce9fb0c-6acd-4205-8747-528c5339ba19","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"3127","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090690103","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-6901","50090-6901-3","50090-6901_1ce9fb0c-6acd-4205-8747-528c5339ba19","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"3128","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090690107","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-6901","50090-6901-7","50090-6901_1ce9fb0c-6acd-4205-8747-528c5339ba19","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"3129","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090690100","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-6901","50090-6901-0","50090-6901_1ce9fb0c-6acd-4205-8747-528c5339ba19","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"3130","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090690105","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-6901","50090-6901-5","50090-6901_1ce9fb0c-6acd-4205-8747-528c5339ba19","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"3131","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090690202","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-6902","50090-6902-2","50090-6902_751ea5bd-2266-48aa-8f5f-184a96aad57a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"3132","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090690400","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-6904","50090-6904-0","50090-6904_bc65fc80-a80b-4f4b-aff0-63f15d1b5e78","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"3133","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090690401","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-6904","50090-6904-1","50090-6904_bc65fc80-a80b-4f4b-aff0-63f15d1b5e78","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20261231"
"3134","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090699700","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-6997","50090-6997-0","50090-6997_7e0dcbd4-5b61-45a7-afaa-7d97da1285f5","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091569","A-S Medication Solutions","500; 125","mg/1; mg/1","","N","20251231"
"3135","CEFUROXIME AXETIL","Cefuroxime Axetil","50090699900","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-6999","50090-6999-0","50090-6999_13ec0bb9-d5aa-4e86-91e2-3be896570a4d","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","A-S Medication Solutions","250","mg/1","","N","20251231"
"3136","CEFUROXIME AXETIL","Cefuroxime Axetil","50090699901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-6999","50090-6999-1","50090-6999_13ec0bb9-d5aa-4e86-91e2-3be896570a4d","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","A-S Medication Solutions","250","mg/1","","N","20251231"
"3137","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090700300","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-7003","50090-7003-0","50090-7003_b4741a82-795f-4aa1-a8d3-7221cba0e766","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20261231"
"3138","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50090700700","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-7007","50090-7007-0","50090-7007_2807f1f8-832c-41f3-b727-50d0e086f471","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","A-S Medication Solutions","150","mg/1","","N","20251231"
"3139","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090700800","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-7008","50090-7008-0","50090-7008_d7937760-72c6-46bb-862b-db3d6b5357c1","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"3140","CEPHALEXIN","Cephalexin","50090702601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-7026","50090-7026-1","50090-7026_86321a24-8210-4279-9a59-1f9a6841605c","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20151019","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"3141","CEPHALEXIN","Cephalexin","50090702603","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-7026","50090-7026-3","50090-7026_86321a24-8210-4279-9a59-1f9a6841605c","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20151019","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"3142","CEPHALEXIN","Cephalexin","50090702700","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-7027","50090-7027-0","50090-7027_86b01cce-7cd7-4aae-9391-9744d05338de","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20151019","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"3143","CEPHALEXIN","Cephalexin","50090709100","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-7091","50090-7091-0","50090-7091_90dcd7f5-e0f8-454d-89b5-2eedeff32e54","HUMAN PRESCRIPTION DRUG","cephalexin","","FOR SUSPENSION","ORAL","20170906","","ANDA","ANDA065234","A-S Medication Solutions","250","mg/5mL","","N","20251231"
"3144","CEFUROXIME AXETIL","Cefuroxime Axetil","50090709500","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-7095","50090-7095-0","50090-7095_89489a3f-de80-46af-b677-cc599a257e56","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","A-S Medication Solutions","250","mg/1","","N","20251231"
"3145","CEFUROXIME AXETIL","Cefuroxime Axetil","50090709503","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-7095","50090-7095-3","50090-7095_89489a3f-de80-46af-b677-cc599a257e56","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","A-S Medication Solutions","250","mg/1","","N","20251231"
"3146","METRONIDAZOLE","Metronidazole","50090716000","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-7160","50090-7160-0","50090-7160_54ce71c2-b878-455c-83b0-70525d10695a","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","VAGINAL","20220624","","ANDA","ANDA215794","A-S Medication Solutions","7.5","mg/g","","N","20251231"
"3147","CEPHALEXIN","Cephalexin","50090716201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-7162","50090-7162-1","50090-7162_4f68a97c-9fb2-4008-a541-e58c38910360","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","A-S Medication Solutions","500","mg/1","","N","20251231"
"3148","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc and Polymyxin B Sulfate","50090718900","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50090-7189","50090-7189-0","50090-7189_69c43b2b-d454-4e99-a846-e976fbebdf12","HUMAN PRESCRIPTION DRUG","Bacitracin Zinc and Polymyxin B Sulfate","","OINTMENT","OPHTHALMIC","20080425","","ANDA","ANDA064046","A-S Medication Solutions","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"3149","OFLOXACIN","ofloxacin otic","50090720700","Quinolone Antimicrobial [EPC], Quinolones [CS]","50090-7207","50090-7207-0","50090-7207_508a2fe4-c2f2-4be2-acca-aadb853708c5","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION","AURICULAR (OTIC)","20220715","","ANDA","ANDA216130","A-S Medication Solutions","3","mg/mL","","N","20251231"
"3150","NITROFURANTOIN","nitrofurantoin macrocrystals","50090721702","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","50090-7217","50090-7217-2","50090-7217_bb60450d-7bb5-434e-b1d5-23d653a1c2fa","HUMAN PRESCRIPTION DRUG","nitrofurantoin","","CAPSULE","ORAL","20231201","","ANDA","ANDA217272","A-S Medication Solutions","100","mg/1","","N","20251231"
"3151","NITROFURANTOIN","nitrofurantoin macrocrystals","50090721703","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","50090-7217","50090-7217-3","50090-7217_bb60450d-7bb5-434e-b1d5-23d653a1c2fa","HUMAN PRESCRIPTION DRUG","nitrofurantoin","","CAPSULE","ORAL","20231201","","ANDA","ANDA217272","A-S Medication Solutions","100","mg/1","","N","20251231"
"3152","NITROFURANTOIN","nitrofurantoin macrocrystals","50090721700","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","50090-7217","50090-7217-0","50090-7217_bb60450d-7bb5-434e-b1d5-23d653a1c2fa","HUMAN PRESCRIPTION DRUG","nitrofurantoin","","CAPSULE","ORAL","20231201","","ANDA","ANDA217272","A-S Medication Solutions","100","mg/1","","N","20251231"
"3153","CEPHALEXIN","Cephalexin","50090722300","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-7223","50090-7223-0","50090-7223_542a71d9-52c6-4240-9f8a-8935b0fc2a41","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","A-S Medication Solutions","500","mg/1","","N","20251231"
"3154","CEPHALEXIN","Cephalexin","50090722400","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50090-7224","50090-7224-0","50090-7224_2438a4d3-3bf6-4666-9494-1e550720c068","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","A-S Medication Solutions","500","mg/1","","N","20251231"
"3155","MOXIFLOXACIN HYDROCHLORIDE","moxifloxacin hydrochloride","50090724401","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-7244","50090-7244-1","50090-7244_54fdd364-609d-4d3a-8f62-8bc20bf3b74e","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN HYDROCHLORIDE","","TABLET, FILM COATED","ORAL","20140304","","ANDA","ANDA202632","A-S Medication Solutions","400","mg/1","","N","20251231"
"3156","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","50090725900","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50090-7259","50090-7259-0","50090-7259_3ffd5291-99b6-4f6b-bc93-236c548f9a1b","HUMAN OTC DRUG","Good Sense First Aid Antibiotic","","OINTMENT","TOPICAL","20140428","","OTC MONOGRAPH DRUG","M004","A-S Medication Solutions","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3157","OFLOXACIN","Ofloxacin","50090726400","Quinolone Antimicrobial [EPC], Quinolones [CS]","50090-7264","50090-7264-0","50090-7264_ff37e0c3-e71b-4cd6-8242-cc71c3374af6","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20040514","","ANDA","ANDA076622","A-S Medication Solutions","3","mg/mL","","N","20251231"
"3158","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","50090726700","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","50090-7267","50090-7267-0","50090-7267_17989953-5ec1-4043-b04f-d237d24afc8e","HUMAN PRESCRIPTION DRUG","TOBRAMYCIN AND DEXAMETHASONE","","SUSPENSION/ DROPS","OPHTHALMIC","20220317","","ANDA","ANDA212715","A-S Medication Solutions","1; 3","mg/mL; mg/mL","","N","20251231"
"3159","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","50090729701","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-7297","50090-7297-1","50090-7297_fa78032d-254d-4305-afe9-f672e95aea29","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","A-S Medication Solutions","250","mg/1","","N","20251231"
"3160","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","50090729702","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-7297","50090-7297-2","50090-7297_fa78032d-254d-4305-afe9-f672e95aea29","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","A-S Medication Solutions","250","mg/1","","N","20251231"
"3161","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","50090729700","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-7297","50090-7297-0","50090-7297_fa78032d-254d-4305-afe9-f672e95aea29","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","A-S Medication Solutions","250","mg/1","","N","20251231"
"3162","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","50090729703","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-7297","50090-7297-3","50090-7297_fa78032d-254d-4305-afe9-f672e95aea29","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","A-S Medication Solutions","250","mg/1","","N","20251231"
"3163","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","50090729801","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-7298","50090-7298-1","50090-7298_7c55988f-8092-42b4-b993-8ffb2fb0d85c","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","A-S Medication Solutions","500","mg/1","","N","20251231"
"3164","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","50090729800","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-7298","50090-7298-0","50090-7298_7c55988f-8092-42b4-b993-8ffb2fb0d85c","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","A-S Medication Solutions","500","mg/1","","N","20251231"
"3165","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","50090729900","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-7299","50090-7299-0","50090-7299_ef8fc905-d91d-4a3e-8959-2d8955936116","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","A-S Medication Solutions","500","mg/1","","N","20251231"
"3166","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","50090730000","Allylamine Antifungal [EPC], Allylamine [CS]","50090-7300","50090-7300-0","50090-7300_89a89899-6387-409a-b941-51a374183b43","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20220128","","ANDA","ANDA078163","A-S Medication Solutions","250","mg/1","","N","20251231"
"3167","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","50090730001","Allylamine Antifungal [EPC], Allylamine [CS]","50090-7300","50090-7300-1","50090-7300_89a89899-6387-409a-b941-51a374183b43","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20220128","","ANDA","ANDA078163","A-S Medication Solutions","250","mg/1","","N","20251231"
"3168","NYSTATIN","Nystatin","50090730300","Polyene Antifungal [EPC], Polyenes [CS]","50090-7303","50090-7303-0","50090-7303_24f18c9a-182a-4233-88bc-852c254a3d8a","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20190724","","ANDA","ANDA212557","A-S Medication Solutions","100000","U/g","","N","20251231"
"3169","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","50090730602","Antimalarial [EPC], Antirheumatic Agent [EPC]","50090-7306","50090-7306-2","50090-7306_b75f9502-33e8-4f7f-9e12-4ca4e673e794","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","A-S Medication Solutions","200","mg/1","","N","20251231"
"3170","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","50090730601","Antimalarial [EPC], Antirheumatic Agent [EPC]","50090-7306","50090-7306-1","50090-7306_b75f9502-33e8-4f7f-9e12-4ca4e673e794","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","A-S Medication Solutions","200","mg/1","","N","20251231"
"3171","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","50090730700","Antimalarial [EPC], Antirheumatic Agent [EPC]","50090-7307","50090-7307-0","50090-7307_e0527cfb-a490-4269-b018-1497eba45d71","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","A-S Medication Solutions","200","mg/1","","N","20251231"
"3172","NITROFURANTOIN","nitrofurantoin (macrocrystals)","50090730800","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","50090-7308","50090-7308-0","50090-7308_b0e07675-526a-4083-a35e-2a93ad10888b","HUMAN PRESCRIPTION DRUG","nitrofurantoin (macrocrystals)","","CAPSULE","ORAL","20230517","","ANDA","ANDA077025","A-S Medication Solutions","100","mg/1","","N","20251231"
"3173","NITROFURANTOIN","nitrofurantoin (macrocrystals)","50090730803","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","50090-7308","50090-7308-3","50090-7308_b0e07675-526a-4083-a35e-2a93ad10888b","HUMAN PRESCRIPTION DRUG","nitrofurantoin (macrocrystals)","","CAPSULE","ORAL","20230517","","ANDA","ANDA077025","A-S Medication Solutions","100","mg/1","","N","20251231"
"3174","NITROFURANTOIN","nitrofurantoin (macrocrystals)","50090730802","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","50090-7308","50090-7308-2","50090-7308_b0e07675-526a-4083-a35e-2a93ad10888b","HUMAN PRESCRIPTION DRUG","nitrofurantoin (macrocrystals)","","CAPSULE","ORAL","20230517","","ANDA","ANDA077025","A-S Medication Solutions","100","mg/1","","N","20251231"
"3175","CLOTRIMAZOLE","Clotrimazole","50090734300","Azole Antifungal [EPC], Azoles [CS]","50090-7343","50090-7343-0","50090-7343_4774f542-49de-4b7e-b301-f8c969e0aca1","HUMAN PRESCRIPTION DRUG","Clotrimazole","","CREAM","TOPICAL","20100804","","ANDA","ANDA090219","A-S Medication Solutions","10","mg/g","","N","20261231"
"3176","METRONIDAZOLE","Metronidazole","50090734500","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50090-7345","50090-7345-0","50090-7345_2a62e93e-8c7d-41c9-92bd-1a9bd2cc631a","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","VAGINAL","20220127","","ANDA","ANDA215794","A-S Medication Solutions","7.5","mg/g","","N","20251231"
"3177","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090735401","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-7354","50090-7354-1","50090-7354_d005db80-b81e-4587-8a6d-8004770e1720","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","A-S Medication Solutions","300","mg/1","","N","20251231"
"3178","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090735403","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-7354","50090-7354-3","50090-7354_d005db80-b81e-4587-8a6d-8004770e1720","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","A-S Medication Solutions","300","mg/1","","N","20251231"
"3179","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090735404","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-7354","50090-7354-4","50090-7354_d005db80-b81e-4587-8a6d-8004770e1720","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","A-S Medication Solutions","300","mg/1","","N","20251231"
"3180","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090735405","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-7354","50090-7354-5","50090-7354_d005db80-b81e-4587-8a6d-8004770e1720","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","A-S Medication Solutions","300","mg/1","","N","20251231"
"3181","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090735402","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-7354","50090-7354-2","50090-7354_d005db80-b81e-4587-8a6d-8004770e1720","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","A-S Medication Solutions","300","mg/1","","N","20251231"
"3182","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090735400","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-7354","50090-7354-0","50090-7354_d005db80-b81e-4587-8a6d-8004770e1720","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","A-S Medication Solutions","300","mg/1","","N","20251231"
"3183","MICONAZOLE NITRATE","Miconazole Nitrate","50090736400","Azole Antifungal [EPC], Azoles [CS]","50090-7364","50090-7364-0","50090-7364_f3a8735f-c2b1-4f30-93de-852163c6899b","HUMAN OTC DRUG","Miconazole Nitrate","","CREAM","TOPICAL","19911001","","OTC MONOGRAPH DRUG","M005","A-S Medication Solutions","20","mg/g","","N","20251231"
"3184","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090737400","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-7374","50090-7374-0","50090-7374_42b67c5c-b01f-4616-a2fc-7db662507228","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","A-S Medication Solutions","150","mg/1","","N","20251231"
"3185","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090737401","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-7374","50090-7374-1","50090-7374_42b67c5c-b01f-4616-a2fc-7db662507228","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","A-S Medication Solutions","150","mg/1","","N","20251231"
"3186","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090737403","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-7374","50090-7374-3","50090-7374_42b67c5c-b01f-4616-a2fc-7db662507228","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","A-S Medication Solutions","150","mg/1","","N","20251231"
"3187","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090737406","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-7374","50090-7374-6","50090-7374_42b67c5c-b01f-4616-a2fc-7db662507228","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","A-S Medication Solutions","150","mg/1","","N","20251231"
"3188","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090737407","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-7374","50090-7374-7","50090-7374_42b67c5c-b01f-4616-a2fc-7db662507228","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","A-S Medication Solutions","150","mg/1","","N","20251231"
"3189","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","50090737404","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50090-7374","50090-7374-4","50090-7374_42b67c5c-b01f-4616-a2fc-7db662507228","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","A-S Medication Solutions","150","mg/1","","N","20251231"
"3190","CLOTRIMAZOLE","Clotrimazole","50090737600","Azole Antifungal [EPC], Azoles [CS]","50090-7376","50090-7376-0","50090-7376_91d92fb9-107b-4c54-93a9-82d636480e89","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","20210629","","ANDA","ANDA074165","A-S Medication Solutions","10","mg/g","","N","20251231"
"3191","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090739301","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-7393","50090-7393-1","50090-7393_d240f96d-e628-4c0f-b7e3-45b1abb03c1b","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"3192","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50090739900","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50090-7399","50090-7399-0","50090-7399_f32958b9-1a7c-4e52-a88d-90273f1dc738","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","A-S Medication Solutions","800; 160","mg/1; mg/1","","N","20251231"
"3193","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","50090741500","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","50090-7415","50090-7415-0","50090-7415_33d6216e-0f37-4df5-bbd9-9506ab9e8e18","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","A-S Medication Solutions","875; 125","mg/1; mg/1","","N","20251231"
"3194","SILVER SULFADIAZINE","Silver Sulfadiazine","50090744700","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","50090-7447","50090-7447-0","50090-7447_121d8f74-205c-48da-bf28-2fc9af22425d","HUMAN PRESCRIPTION DRUG","SSD","","CREAM","TOPICAL","20110504","","NDA","NDA018578","A-S Medication Solutions","10","g/1000g","","N","20251231"
"3195","AZTREONAM","AZTREONAM","50090749400","Monobactam Antibacterial [EPC], Monobactams [CS]","50090-7494","50090-7494-0","50090-7494_60269c3e-8d92-4584-bdfb-4f728c514e98","HUMAN PRESCRIPTION DRUG","AZACTAM","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20100401","","NDA","NDA050580","A-S Medication Solutions","1","g/1","","N","20261231"
"3196","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","50090750600","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-7506","50090-7506-0","50090-7506_a6aa441a-776f-4d0e-bbc8-783a0b2bf9f1","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","A-S Medication Solutions","500","mg/1","","N","20261231"
"3197","KETOCONAZOLE","Ketoconazole","50090753800","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","50090-7538","50090-7538-0","50090-7538_6e43133e-cf9e-454c-aeab-12fba2eff208","HUMAN PRESCRIPTION DRUG","Ketoconazole","","SHAMPOO, SUSPENSION","TOPICAL","20250207","","ANDA","ANDA076942","A-S Medication Solutions","20","mg/mL","","N","20261231"
"3198","AZITHROMYCIN DIHYDRATE","Azithromycin","50090755000","Macrolide Antimicrobial [EPC], Macrolides [CS]","50090-7550","50090-7550-0","50090-7550_8b5cff94-0f6a-4c55-aae8-694eb913eb65","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207370","A-S Medication Solutions","250","mg/1","","N","20261231"
"3199","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","50090758100","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50090-7581","50090-7581-0","50090-7581_5bbb5b8a-c14c-44b2-9bba-3580fa9ef8e6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","A-S Medication Solutions","250","mg/1","","N","20261231"
"3200","METRONIDAZOLE","Metronidazole","50111033306","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50111-333","50111-333-06","50111-333_c6f82723-a668-4dc1-96ea-816620a5b964","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20251231"
"3201","METRONIDAZOLE","Metronidazole","50111033301","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50111-333","50111-333-01","50111-333_c6f82723-a668-4dc1-96ea-816620a5b964","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20251231"
"3202","METRONIDAZOLE","Metronidazole","50111033302","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50111-333","50111-333-02","50111-333_c6f82723-a668-4dc1-96ea-816620a5b964","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20251231"
"3203","METRONIDAZOLE","Metronidazole","50111033401","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50111-334","50111-334-01","50111-334_c6f82723-a668-4dc1-96ea-816620a5b964","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20251231"
"3204","METRONIDAZOLE","Metronidazole","50111033402","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50111-334","50111-334-02","50111-334_c6f82723-a668-4dc1-96ea-816620a5b964","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20251231"
"3205","AZITHROMYCIN MONOHYDRATE","Azithromycin","50111078710","Macrolide Antimicrobial [EPC], Macrolides [CS]","50111-787","50111-787-10","50111-787_96661456-78d1-48f2-bcd9-ceb3a8437387","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065225","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20261231"
"3206","AZITHROMYCIN MONOHYDRATE","Azithromycin","50111078766","Macrolide Antimicrobial [EPC], Macrolides [CS]","50111-787","50111-787-66","50111-787_96661456-78d1-48f2-bcd9-ceb3a8437387","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065225","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20261231"
"3207","AZITHROMYCIN MONOHYDRATE","Azithromycin","50111078751","Macrolide Antimicrobial [EPC], Macrolides [CS]","50111-787","50111-787-51","50111-787_96661456-78d1-48f2-bcd9-ceb3a8437387","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065225","Teva Pharmaceuticals USA, Inc.","250","mg/1","","N","20261231"
"3208","AZITHROMYCIN MONOHYDRATE","Azithromycin","50111078855","Macrolide Antimicrobial [EPC], Macrolides [CS]","50111-788","50111-788-55","50111-788_96661456-78d1-48f2-bcd9-ceb3a8437387","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065223","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20261231"
"3209","AZITHROMYCIN MONOHYDRATE","Azithromycin","50111078867","Macrolide Antimicrobial [EPC], Macrolides [CS]","50111-788","50111-788-67","50111-788_96661456-78d1-48f2-bcd9-ceb3a8437387","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065223","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20261231"
"3210","AZITHROMYCIN MONOHYDRATE","Azithromycin","50111078810","Macrolide Antimicrobial [EPC], Macrolides [CS]","50111-788","50111-788-10","50111-788_96661456-78d1-48f2-bcd9-ceb3a8437387","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065223","Teva Pharmaceuticals USA, Inc.","500","mg/1","","N","20261231"
"3211","AZITHROMYCIN MONOHYDRATE","Azithromycin","50111078910","Macrolide Antimicrobial [EPC], Macrolides [CS]","50111-789","50111-789-10","50111-789_d6a6e6e8-3842-49a7-883b-82aa0916f3c7","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20051201","","ANDA","ANDA065218","Teva Pharmaceuticals USA, Inc.","600","mg/1","","N","20261231"
"3212","CLOTRIMAZOLE","Clotrimazole Topical Solution USP, 1%","50228050231","Azole Antifungal [EPC], Azoles [CS]","50228-502","50228-502-31","50228-502_136855ec-e817-d99c-e063-6394a90a84b1","HUMAN PRESCRIPTION DRUG","Clotrimazole Topical Solution USP, 1%","","SOLUTION","TOPICAL","20231016","","ANDA","ANDA216569","ScieGen Pharmaceuticals, Inc","10","mg/mL","","N","20251231"
"3213","CLOTRIMAZOLE","Clotrimazole Topical Solution USP, 1%","50228050261","Azole Antifungal [EPC], Azoles [CS]","50228-502","50228-502-61","50228-502_136855ec-e817-d99c-e063-6394a90a84b1","HUMAN PRESCRIPTION DRUG","Clotrimazole Topical Solution USP, 1%","","SOLUTION","TOPICAL","20231016","","ANDA","ANDA216569","ScieGen Pharmaceuticals, Inc","10","mg/mL","","N","20251231"
"3214","CLOTRIMAZOLE","Clotrimazole Topical Solution USP, 1%","50228050208","Azole Antifungal [EPC], Azoles [CS]","50228-502","50228-502-08","50228-502_136855ec-e817-d99c-e063-6394a90a84b1","HUMAN PRESCRIPTION DRUG","Clotrimazole Topical Solution USP, 1%","","SOLUTION","TOPICAL","20231016","","ANDA","ANDA216569","ScieGen Pharmaceuticals, Inc","10","mg/mL","","N","20251231"
"3215","CLOTRIMAZOLE","Clotrimazole Topical Solution USP, 1%","50228050230","Azole Antifungal [EPC], Azoles [CS]","50228-502","50228-502-30","50228-502_136855ec-e817-d99c-e063-6394a90a84b1","HUMAN PRESCRIPTION DRUG","Clotrimazole Topical Solution USP, 1%","","SOLUTION","TOPICAL","20231016","","ANDA","ANDA216569","ScieGen Pharmaceuticals, Inc","10","mg/mL","","N","20251231"
"3216","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","50268007415","Macrolide Antimicrobial [EPC], Macrolides [CS]","50268-074","50268-074-15","50268-074_227ed170-0ad6-67a1-e063-6394a90a2be3","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20201211","","ANDA","ANDA208250","AvPAK","250","mg/1","","N","20251231"
"3217","ATOVAQUONE","Atovaquone","50268008612","Antimalarial [EPC], Antiprotozoal [EPC]","50268-086","50268-086-12","50268-086_d5cbb80c-c326-ac08-e053-2995a90a264d","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20200507","","ANDA","ANDA210692","AvPAK","750","mg/5mL","","N","20251231"
"3218","CEPHALEXIN","Cephalexin","50268015115","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50268-151","50268-151-15","50268-151_0e85a5c9-76a7-f621-e063-6394a90a8782","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20140915","","ANDA","ANDA090836","AvPAK","250","mg/1","","N","20251231"
"3219","CEPHALEXIN","Cephalexin","50268015215","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","50268-152","50268-152-15","50268-152_0e85a5c9-76a7-f621-e063-6394a90a8782","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20140915","","ANDA","ANDA090836","AvPAK","500","mg/1","","N","20251231"
"3220","CLARITHROMYCIN","Clarithromycin","50268017815","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","50268-178","50268-178-15","50268-178_0e85fb58-7ccc-8ae3-e063-6294a90a2553","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20161010","","ANDA","ANDA065489","AvPAK","250","mg/1","","N","20251231"
"3221","CLARITHROMYCIN","Clarithromycin","50268017913","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","50268-179","50268-179-13","50268-179_0e85fb58-7ccc-8ae3-e063-6294a90a2553","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20161010","","ANDA","ANDA065489","AvPAK","500","mg/1","","N","20251231"
"3222","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","50268018515","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","50268-185","50268-185-15","50268-185_0e860109-7258-1c28-e063-6394a90a50ef","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20201027","","ANDA","ANDA207402","AvPAK","300","mg/1","","N","20251231"
"3223","FLUCYTOSINE","Flucytosine","50268033112","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","50268-331","50268-331-12","50268-331_0e88b79b-c69b-3c90-e063-6394a90a294f","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20210412","","ANDA","ANDA204652","AvPAK","250","mg/1","","N","20251231"
"3224","FLUCYTOSINE","Flucytosine","50268033212","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","50268-332","50268-332-12","50268-332_0e88b79b-c69b-3c90-e063-6394a90a294f","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20210412","","ANDA","ANDA204652","AvPAK","500","mg/1","","N","20251231"
"3225","FLUCONAZOLE","Fluconazole","50268033715","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50268-337","50268-337-15","50268-337_0e88bd1e-941a-9239-e063-6294a90a846e","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20160909","","ANDA","ANDA077731","AvPAK","100","mg/1","","N","20251231"
"3226","FLUCONAZOLE","Fluconazole","50268033915","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50268-339","50268-339-15","50268-339_0e88bd1e-941a-9239-e063-6294a90a846e","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20160909","","ANDA","ANDA077731","AvPAK","200","mg/1","","N","20251231"
"3227","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","50268041215","Antimalarial [EPC], Antirheumatic Agent [EPC]","50268-412","50268-412-15","50268-412_0e88cfe8-c75b-99cc-e063-6294a90a7959","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20200515","","ANDA","ANDA210441","AvPAK","200","mg/1","","N","20251231"
"3228","ITRACONAZOLE","Itraconazole","50268045012","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","50268-450","50268-450-12","50268-450_0e88cfe8-c75f-99cc-e063-6294a90a7959","HUMAN PRESCRIPTION DRUG","Itraconazole","","CAPSULE","ORAL","20180323","","ANDA","ANDA205080","AvPAK","100","mg/1","","N","20251231"
"3229","MICONAZOLE NITRATE","Miconazole Nitrate","50268050329","Azole Antifungal [EPC], Azoles [CS]","50268-503","50268-503-29","50268-503_130383db-896d-61f7-e063-6394a90a74b1","HUMAN OTC DRUG","miconazole nitrate","","SOLUTION","TOPICAL","20221013","","OTC MONOGRAPH DRUG","M005","AvPAK","20","mg/mL","","N","20251231"
"3230","METRONIDAZOLE","Metronidazole","50268053415","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50268-534","50268-534-15","50268-534_de5b2643-fb04-3d31-e053-2a95a90a28c4","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20191030","","ANDA","ANDA079067","AvPAK","250","mg/1","","N","20251231"
"3231","METRONIDAZOLE","Metronidazole","50268053515","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","50268-535","50268-535-15","50268-535_de5b2643-fb04-3d31-e053-2a95a90a28c4","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20191030","","ANDA","ANDA079067","AvPAK","500","mg/1","","N","20251231"
"3232","MUPIROCIN","Mupirocin","50268056815","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","50268-568","50268-568-15","50268-568_3016064e-3329-e2e8-e063-6294a90aae09","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20190611","","ANDA","ANDA065170","AvPAK","20","mg/g","","N","20261231"
"3233","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin Hydrochloride","50268057613","Quinolone Antimicrobial [EPC], Quinolones [CS]","50268-576","50268-576-13","50268-576_df227112-ca44-427d-e053-2a95a90affb2","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride","","TABLET, FILM COATED","ORAL","20160722","","ANDA","ANDA202632","AvPAK","400","mg/1","","N","20251231"
"3234","NITROFURANTOIN","Nitrofurantoin Macrocrystals","50268062315","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","50268-623","50268-623-15","50268-623_0e77340b-340f-fe13-e063-6294a90a0301","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Macrocrystals","","CAPSULE","ORAL","20171208","","ANDA","ANDA073671","AvPAK","50","mg/1","","N","20251231"
"3235","NITROFURANTOIN","Nitrofurantoin Macrocrystals","50268062415","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","50268-624","50268-624-15","50268-624_0e77340b-340f-fe13-e063-6294a90a0301","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Macrocrystals","","CAPSULE","ORAL","20171208","","ANDA","ANDA073652","AvPAK","100","mg/1","","N","20251231"
"3236","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","50268062515","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","50268-625","50268-625-15","50268-625_0e77340b-340d-fe13-e063-6294a90a0301","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20180815","","ANDA","ANDA207372","AvPAK","25; 75","mg/1; mg/1","","N","20251231"
"3237","POSACONAZOLE","Posaconazole","50268068312","Azole Antifungal [EPC], Azoles [CS]","50268-683","50268-683-12","50268-683_2b4c1730-ff8e-04ea-e063-6394a90a136b","HUMAN PRESCRIPTION DRUG","Posaconazole","","TABLET, DELAYED RELEASE","ORAL","20220509","","ANDA","ANDA212500","AvPAK","100","mg/1","","N","20261231"
"3238","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","50268072815","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","50268-728","50268-728-15","50268-728_d5dfb02c-43e0-2099-e053-2995a90a8afb","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20140923","","ANDA","ANDA090624","AvPAK","400; 80","mg/1; mg/1","","N","20251231"
"3239","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir","50268078712","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","50268-787","50268-787-12","50268-787_0e764061-e7a8-6701-e063-6394a90a489f","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET, FILM COATED","ORAL","20160727","","ANDA","ANDA205166","AvPAK","450","mg/1","","N","20251231"
"3240","VORICONAZOLE","Voriconazole","50268080312","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","50268-803","50268-803-12","50268-803_2b4d4596-5ea1-cb1d-e063-6394a90ab8dd","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, COATED","ORAL","20220819","","ANDA","ANDA206654","AvPAK","200","mg/1","","N","20261231"
"3241","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","50332003202","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50332-0032","50332-0032-2","50332-0032_9bdb3479-2b97-45d5-a82e-a5db1c149595","HUMAN OTC DRUG","TRIBIOTIC","","OINTMENT","TOPICAL","20051003","","OTC MONOGRAPH DRUG","M","HART Health","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3242","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","50332003203","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50332-0032","50332-0032-3","50332-0032_9bdb3479-2b97-45d5-a82e-a5db1c149595","HUMAN OTC DRUG","TRIBIOTIC","","OINTMENT","TOPICAL","20051003","","OTC MONOGRAPH DRUG","M","HART Health","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3243","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","50332003201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50332-0032","50332-0032-1","50332-0032_9bdb3479-2b97-45d5-a82e-a5db1c149595","HUMAN OTC DRUG","TRIBIOTIC","","OINTMENT","TOPICAL","20051003","","OTC MONOGRAPH DRUG","M","HART Health","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3244","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","50332003206","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50332-0032","50332-0032-6","50332-0032_9bdb3479-2b97-45d5-a82e-a5db1c149595","HUMAN OTC DRUG","TRIBIOTIC","","OINTMENT","TOPICAL","20051003","","OTC MONOGRAPH DRUG","M","HART Health","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3245","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","50332003204","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50332-0032","50332-0032-4","50332-0032_9bdb3479-2b97-45d5-a82e-a5db1c149595","HUMAN OTC DRUG","TRIBIOTIC","","OINTMENT","TOPICAL","20051003","","OTC MONOGRAPH DRUG","M","HART Health","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3246","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","50332003205","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50332-0032","50332-0032-5","50332-0032_9bdb3479-2b97-45d5-a82e-a5db1c149595","HUMAN OTC DRUG","TRIBIOTIC","","OINTMENT","TOPICAL","20051003","","OTC MONOGRAPH DRUG","M","HART Health","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3247","SULFACETAMIDE SODIUM; SULFUR","Sodium Sulfacetamide and Sulfur","50405085002","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","50405-850","50405-850-02","50405-850_33c53704-fdee-4209-ac08-24ab0e8ebfd5","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser","","LIQUID","TOPICAL","20230430","","UNAPPROVED DRUG OTHER","","SOHM, Inc","100; 50","mg/g; mg/g","","N","20251231"
"3248","SULFACETAMIDE SODIUM; SULFUR","Sodium Sulfacetamide and Sulfur","50405085001","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","50405-850","50405-850-01","50405-850_33c53704-fdee-4209-ac08-24ab0e8ebfd5","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser","","LIQUID","TOPICAL","20230430","","UNAPPROVED DRUG OTHER","","SOHM, Inc","100; 50","mg/g; mg/g","","N","20251231"
"3249","SULFACETAMIDE SODIUM; SULFUR","Sodium Sulfacetamide and Sulfur","50405085101","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","50405-851","50405-851-01","50405-851_67acba09-6267-4139-ad2b-e6b7849752a9","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10 % and Sulfur 2 % Cleanser","","LOTION","TOPICAL","20230503","","UNAPPROVED DRUG OTHER","","SOHM, Inc","100; 20","mg/g; mg/g","","N","20251231"
"3250","SULFACETAMIDE SODIUM; SULFUR","Sodium Sulfacetamide and Sulfur","50405085201","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","50405-852","50405-852-01","50405-852_03870d74-89a9-4f1d-8852-f3aa9c71daf4","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 9.8 % and Sulfur 4.8 % Cleanser","","LOTION","TOPICAL","20230503","","UNAPPROVED DRUG OTHER","","SOHM, Inc","98; 48","mg/g; mg/g","","N","20251231"
"3251","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin hydrochloride","50419075401","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50419-754","50419-754-01","50419-754_09950353-1b8f-4064-84ce-f844cb085258","HUMAN PRESCRIPTION DRUG","Cipro","","TABLET, FILM COATED","ORAL","19871022","","NDA","NDA019537","Bayer HealthCare Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"3252","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin hydrochloride","50419075801","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","50419-758","50419-758-01","50419-758_09950353-1b8f-4064-84ce-f844cb085258","HUMAN PRESCRIPTION DRUG","Cipro","","TABLET, FILM COATED","ORAL","19871022","","NDA","NDA019537","Bayer HealthCare Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"3253","ITRACONAZOLE","ITRACONAZOLE","50458029001","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","50458-290","50458-290-01","50458-290_2a7f767c-0748-e361-e063-6294a90aa522","HUMAN PRESCRIPTION DRUG","SPORANOX","","CAPSULE","ORAL","19920911","","NDA","NDA020083","Janssen Pharmaceuticals, Inc.","100","mg/1","","N","20251231"
"3254","ITRACONAZOLE","ITRACONAZOLE","50458029004","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","50458-290","50458-290-04","50458-290_2a7f767c-0748-e361-e063-6294a90aa522","HUMAN PRESCRIPTION DRUG","SPORANOX","","CAPSULE","ORAL","19920911","","NDA","NDA020083","Janssen Pharmaceuticals, Inc.","100","mg/1","","N","20251231"
"3255","PRIMAQUINE PHOSPHATE","PRIMAQUINE PHOSPHATE","50742019105","Antimalarial [EPC]","50742-191","50742-191-05","50742-191_aa39ce08-d1dc-463c-95b7-fbd85048767a","HUMAN PRESCRIPTION DRUG","PRIMAQUINE PHOSPHATE","","TABLET, FILM COATED","ORAL","20180123","","ANDA","ANDA206043","Ingenus Pharmaceuticals, LLC","15","mg/1","","N","20251231"
"3256","PRIMAQUINE PHOSPHATE","PRIMAQUINE PHOSPHATE","50742019101","Antimalarial [EPC]","50742-191","50742-191-01","50742-191_aa39ce08-d1dc-463c-95b7-fbd85048767a","HUMAN PRESCRIPTION DRUG","PRIMAQUINE PHOSPHATE","","TABLET, FILM COATED","ORAL","20180123","","ANDA","ANDA206043","Ingenus Pharmaceuticals, LLC","15","mg/1","","N","20251231"
"3257","QUININE SULFATE","QUININE SULFATE","50742023830","Antimalarial [EPC]","50742-238","50742-238-30","50742-238_0a0b38d3-828f-4828-8d8c-92933872aa4f","HUMAN PRESCRIPTION DRUG","QUININE SULFATE","","CAPSULE","ORAL","20171211","","ANDA","ANDA204372","Ingenus Pharmaceuticals, LLC","324","mg/1","","N","20251231"
"3258","BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE","Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride","50742028313","Bismuth [CS], Bismuth [EPC], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","50742-283","50742-283-13","50742-283_b723a88b-c68e-46ef-bac9-4822dcb9c1fe","HUMAN PRESCRIPTION DRUG","Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride","","CAPSULE","ORAL","20230704","","ANDA","ANDA217511","Ingenus Pharmaceuticals, LLC","140; 125; 125","mg/1; mg/1; mg/1","","N","20251231"
"3259","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","50804007601","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50804-076","50804-076-01","50804-076_25dd49e3-8864-e37a-e063-6394a90add11","HUMAN OTC DRUG","GoodSense","Antibiotic plus Pain Relief","CREAM","TOPICAL","20120321","","OTC MONOGRAPH DRUG","M017","Geiss, Destin & Dunn, Inc.","3.5; 10000; 10","mg/g; [iU]/g; mg/g","","N","20251231"
"3260","MICONAZOLE NITRATE","Antifungal Miconazole Liquid Continuous Spray","50804013653","Azole Antifungal [EPC], Azoles [CS]","50804-136","50804-136-53","50804-136_277475fe-f8e5-f20f-e063-6394a90a6e32","HUMAN OTC DRUG","Miconazole nitrate","","AEROSOL, SPRAY","TOPICAL","20210528","","OTC MONOGRAPH DRUG","M005","GEISS, DESTIN AND DUNN, INC.","3","g/150g","","N","20251231"
"3261","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","50814000301","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50814-003","50814-003-01","50814-003_24068fcf-35cb-b705-e063-6394a90a4e7d","HUMAN OTC DRUG","Genuine Triple Antibiotic","","CREAM","TOPICAL","20160323","20251231","OTC MONOGRAPH DRUG","M004","GFA Production (Xiamen) Co., Ltd.","400; 5; 5000","U/g; mg/g; U/g","","N",""
"3262","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","50814000701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50814-007","50814-007-01","50814-007_2c4cfb73-b3b0-daf3-e063-6294a90af289","HUMAN OTC DRUG","First Aid Antibiotic","","OINTMENT","TOPICAL","20160701","20251231","OTC MONOGRAPH DRUG","M003","GFA Production (Xiamen) Co., Ltd.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N",""
"3263","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","50814005801","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50814-058","50814-058-01","50814-058_247ecba5-1967-0179-e063-6394a90a0371","HUMAN OTC DRUG","Genuine First Aid First Aid Antibiotic Bacitracin Zinc","","CREAM","TOPICAL","20200101","","OTC MONOGRAPH DRUG","M004","GFA Production (Xiamen) Co., Ltd.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3264","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","50814007701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","50814-077","50814-077-01","50814-077_0aaeaa08-d664-cb12-e063-6394a90a9163","HUMAN OTC DRUG","Genuine First Aid Antibiotic","","CREAM","TOPICAL","20231101","","OTC MONOGRAPH DRUG","M004","GFA Production(Xiamen) Co.,Ltd","400; 3.5; 5000","U/g; mg/g; U/g","","N","20251231"
"3265","CLOTRIMAZOLE","Clotrimazole","51143000201","Azole Antifungal [EPC], Azoles [CS]","51143-002","51143-002-01","51143-002_25dfbb6a-5aed-1392-e063-6294a90ad636","HUMAN OTC DRUG","Live Better","Antifungal","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","The Great Atlantic & Pacific Tea Company","10","mg/g","","N","20251231"
"3266","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate","51143001602","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51143-016","51143-016-02","51143-016_262ec1b4-8a88-1c1a-e063-6394a90abab3","HUMAN OTC DRUG","Live Better","Triple Antibiotic","OINTMENT","TOPICAL","19951214","","OTC MONOGRAPH DRUG","M004","The Great Atlantic & Pacific Tea Company","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3267","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","51143002702","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51143-027","51143-027-02","51143-027_262f5161-4149-76c3-e063-6394a90ae186","HUMAN OTC DRUG","Live Better","Triple Antibiotic plus Pain Relief","OINTMENT","TOPICAL","20120331","","OTC MONOGRAPH DRUG","M004","The Great Atlantic & Pacific Tea Company","500; 3.5; 10000; 10","[iU]/g; mg/g; [iU]/g; mg/g","","N","20251231"
"3268","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","51224002218","Macrolide Antimicrobial [EPC], Macrolides [CS]","51224-022","51224-022-18","51224-022_a32e11e0-ff6b-486a-a8af-0d029934b24d","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","20261130","ANDA","ANDA208250","TAGI Pharma, Inc.","250","mg/1","","N",""
"3269","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","51224002250","Macrolide Antimicrobial [EPC], Macrolides [CS]","51224-022","51224-022-50","51224-022_a32e11e0-ff6b-486a-a8af-0d029934b24d","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","20261130","ANDA","ANDA208250","TAGI Pharma, Inc.","250","mg/1","","N",""
"3270","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","51224002206","Macrolide Antimicrobial [EPC], Macrolides [CS]","51224-022","51224-022-06","51224-022_a32e11e0-ff6b-486a-a8af-0d029934b24d","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","20261130","ANDA","ANDA208250","TAGI Pharma, Inc.","250","mg/1","","N",""
"3271","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","51224002230","Macrolide Antimicrobial [EPC], Macrolides [CS]","51224-022","51224-022-30","51224-022_a32e11e0-ff6b-486a-a8af-0d029934b24d","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","20261130","ANDA","ANDA208250","TAGI Pharma, Inc.","250","mg/1","","N",""
"3272","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","51224012209","Macrolide Antimicrobial [EPC], Macrolides [CS]","51224-122","51224-122-09","51224-122_4e2d2728-b3ae-4a85-8c2a-5e74c60a0f6b","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","20261031","ANDA","ANDA208249","TAGI Pharma, Inc.","500","mg/1","","N",""
"3273","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","51224012250","Macrolide Antimicrobial [EPC], Macrolides [CS]","51224-122","51224-122-50","51224-122_4e2d2728-b3ae-4a85-8c2a-5e74c60a0f6b","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","20261031","ANDA","ANDA208249","TAGI Pharma, Inc.","500","mg/1","","N",""
"3274","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","51224012203","Macrolide Antimicrobial [EPC], Macrolides [CS]","51224-122","51224-122-03","51224-122_4e2d2728-b3ae-4a85-8c2a-5e74c60a0f6b","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","20261031","ANDA","ANDA208249","TAGI Pharma, Inc.","500","mg/1","","N",""
"3275","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","51224012230","Macrolide Antimicrobial [EPC], Macrolides [CS]","51224-122","51224-122-30","51224-122_4e2d2728-b3ae-4a85-8c2a-5e74c60a0f6b","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","20261031","ANDA","ANDA208249","TAGI Pharma, Inc.","500","mg/1","","N",""
"3276","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","51224022230","Macrolide Antimicrobial [EPC], Macrolides [CS]","51224-222","51224-222-30","51224-222_b392d14a-0c07-47d7-bc25-c2ae3e3d1fbe","HUMAN PRESCRIPTION DRUG","Azithromycin dihydrate","","TABLET, FILM COATED","ORAL","20190701","20250930","ANDA","ANDA207566","TAGI Pharma, Inc.","600","mg/1","","N",""
"3277","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc, Polymyxin B Sulfate","51316004401","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51316-044","51316-044-01","51316-044_50187929-7372-4b3d-939d-d13be4dc4b51","HUMAN OTC DRUG","Antibiotic","","OINTMENT","TOPICAL","20220225","","OTC MONOGRAPH DRUG","M004","CVS PHARMACY, INC","500; 10000","[iU]/g; [iU]/g","","N","20251231"
"3278","MICONAZOLE NITRATE","Miconazole Nitrate","51316098001","Azole Antifungal [EPC], Azoles [CS]","51316-980","51316-980-01","51316-980_2879d468-484b-1348-e063-6394a90aa769","HUMAN OTC DRUG","Anti-Fungal Powder","","POWDER","TOPICAL","20240417","","OTC MONOGRAPH DRUG","M005","CVS Pharmacy","20","mg/g","","N","20251231"
"3279","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","51407008320","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","51407-083","51407-083-20","51407-083_2e72d600-d167-59cf-e063-6394a90a63e5","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20220518","","ANDA","ANDA210568","Golden State Medical Supply, Inc.","100","mg/1","","N","20261231"
"3280","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","51407008420","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","51407-084","51407-084-20","51407-084_2e72d600-d167-59cf-e063-6394a90a63e5","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20220518","","ANDA","ANDA210568","Golden State Medical Supply, Inc.","200","mg/1","","N","20261231"
"3281","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","51407016501","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51407-165","51407-165-01","51407-165_2ee94e9b-43b8-e3d5-e063-6394a90ae89b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076126","Golden State Medical Supply, Inc.","500","mg/1","","N","20261231"
"3282","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","51407016520","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51407-165","51407-165-20","51407-165_2ee94e9b-43b8-e3d5-e063-6394a90ae89b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076126","Golden State Medical Supply, Inc.","500","mg/1","","N","20261231"
"3283","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","51407016528","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51407-165","51407-165-28","51407-165_2ee94e9b-43b8-e3d5-e063-6394a90ae89b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076126","Golden State Medical Supply, Inc.","500","mg/1","","N","20261231"
"3284","KETOCONAZOLE","Ketoconazole","51407027930","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","51407-279","51407-279-30","51407-279_1480e47b-979b-d4ee-e063-6394a90a45cb","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20021218","","ANDA","ANDA075638","Golden State Medical Supply, Inc.","20","mg/g","","N","20251231"
"3285","KETOCONAZOLE","Ketoconazole","51407027960","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","51407-279","51407-279-60","51407-279_1480e47b-979b-d4ee-e063-6394a90a45cb","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20021218","","ANDA","ANDA075638","Golden State Medical Supply, Inc.","20","mg/g","","N","20251231"
"3286","KETOCONAZOLE","Ketoconazole","51407027915","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","51407-279","51407-279-15","51407-279_1480e47b-979b-d4ee-e063-6394a90a45cb","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20021218","","ANDA","ANDA075638","Golden State Medical Supply, Inc.","20","mg/g","","N","20251231"
"3287","MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE","moxifloxacin","51407032103","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51407-321","51407-321-03","51407-321_2760da96-3de1-4bec-e063-6394a90a8af6","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20170630","","ANDA","ANDA090080","Golden State Medical Supply, Inc.","5","mg/mL","","N","20251231"
"3288","CEFUROXIME AXETIL","Cefuroxime axetil","51407033360","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","51407-333","51407-333-60","51407-333_177fc0a6-3f2c-c312-e063-6394a90a2aa0","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20100607","","ANDA","ANDA065496","Golden State Medical Supply, Inc.","250","mg/1","","N","20251231"
"3289","CEFUROXIME AXETIL","Cefuroxime axetil","51407033320","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","51407-333","51407-333-20","51407-333_177fc0a6-3f2c-c312-e063-6394a90a2aa0","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20100607","","ANDA","ANDA065496","Golden State Medical Supply, Inc.","250","mg/1","","N","20251231"
"3290","CEFUROXIME AXETIL","Cefuroxime axetil","51407033420","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","51407-334","51407-334-20","51407-334_177fc0a6-3f2c-c312-e063-6394a90a2aa0","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20100607","","ANDA","ANDA065496","Golden State Medical Supply, Inc.","500","mg/1","","N","20251231"
"3291","CEFUROXIME AXETIL","Cefuroxime axetil","51407033460","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","51407-334","51407-334-60","51407-334_177fc0a6-3f2c-c312-e063-6394a90a2aa0","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20100607","","ANDA","ANDA065496","Golden State Medical Supply, Inc.","500","mg/1","","N","20251231"
"3292","METRONIDAZOLE","metronidazole","51407037201","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51407-372","51407-372-01","51407-372_3662a842-9650-b3e3-e063-6394a90a15a9","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","19860716","","ANDA","ANDA070772","Golden State Medical Supply, Inc.","500","mg/1","","N","20261231"
"3293","METRONIDAZOLE","metronidazole","51407037205","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51407-372","51407-372-05","51407-372_3662a842-9650-b3e3-e063-6394a90a15a9","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","19860716","","ANDA","ANDA070772","Golden State Medical Supply, Inc.","500","mg/1","","N","20261231"
"3294","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","51407037305","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","51407-373","51407-373-05","51407-373_21e07363-d808-a087-e063-6294a90a47c2","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010202","","ANDA","ANDA065061","Golden State Medical Supply, Inc.","150","mg/1","","N","20251231"
"3295","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","51407037301","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","51407-373","51407-373-01","51407-373_21e07363-d808-a087-e063-6294a90a47c2","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010202","","ANDA","ANDA065061","Golden State Medical Supply, Inc.","150","mg/1","","N","20251231"
"3296","METRONIDAZOLE","metronidazole","51407037601","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51407-376","51407-376-01","51407-376_369b223a-92b1-6c76-e063-6394a90ae8ad","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","19860716","","ANDA","ANDA070772","Golden State Medical Supply, Inc.","250","mg/1","","N","20261231"
"3297","METRONIDAZOLE","metronidazole","51407037605","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51407-376","51407-376-05","51407-376_369b223a-92b1-6c76-e063-6394a90ae8ad","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","19860716","","ANDA","ANDA070772","Golden State Medical Supply, Inc.","250","mg/1","","N","20261231"
"3298","FLUCONAZOLE","Fluconazole","51407042430","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51407-424","51407-424-30","51407-424_2788fef7-87d3-5370-e063-6394a90a3b08","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20110307","","ANDA","ANDA078423","Golden State Medical Supply, Inc.","50","mg/1","","N","20251231"
"3299","FLUCONAZOLE","Fluconazole","51407042530","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51407-425","51407-425-30","51407-425_2788fef7-87d3-5370-e063-6394a90a3b08","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20110307","","ANDA","ANDA078423","Golden State Medical Supply, Inc.","100","mg/1","","N","20251231"
"3300","FLUCONAZOLE","Fluconazole","51407042501","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51407-425","51407-425-01","51407-425_2788fef7-87d3-5370-e063-6394a90a3b08","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20110307","","ANDA","ANDA078423","Golden State Medical Supply, Inc.","100","mg/1","","N","20251231"
"3301","FLUCONAZOLE","Fluconazole","51407042612","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51407-426","51407-426-12","51407-426_2788fef7-87d3-5370-e063-6394a90a3b08","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20110307","","ANDA","ANDA078423","Golden State Medical Supply, Inc.","150","mg/1","","N","20251231"
"3302","FLUCONAZOLE","Fluconazole","51407042701","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51407-427","51407-427-01","51407-427_2788fef7-87d3-5370-e063-6394a90a3b08","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20110307","","ANDA","ANDA078423","Golden State Medical Supply, Inc.","200","mg/1","","N","20251231"
"3303","FLUCONAZOLE","Fluconazole","51407042730","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51407-427","51407-427-30","51407-427_2788fef7-87d3-5370-e063-6394a90a3b08","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20110307","","ANDA","ANDA078423","Golden State Medical Supply, Inc.","200","mg/1","","N","20251231"
"3304","ATOVAQUONE","Atovaquone","51407064287","Antimalarial [EPC], Antiprotozoal [EPC]","51407-642","51407-642-87","51407-642_10e84da1-b8e9-6b2e-e063-6394a90aa7c8","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20210330","","ANDA","ANDA212918","Golden State Medical Supply, Inc.","750","mg/5mL","","N","20251231"
"3305","POSACONAZOLE","posaconazole","51407067660","Azole Antifungal [EPC], Azoles [CS]","51407-676","51407-676-60","51407-676_2eebdc24-23e7-4a3c-e063-6394a90a26c1","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","TABLET, DELAYED RELEASE","ORAL","20220510","","ANDA","ANDA212226","Golden State Medical Supply, Inc.","100","mg/1","","N","20261231"
"3306","TRIMETHOPRIM","Trimethoprim","51407073801","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]","51407-738","51407-738-01","51407-738_f756ebc3-07b1-1291-e053-6394a90a313c","HUMAN PRESCRIPTION DRUG","Trimethoprim","","TABLET","ORAL","20221028","","ANDA","ANDA216393","Golden State Medical Supply, Inc.","100","mg/1","","N","20251231"
"3307","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","51407077501","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51407-775","51407-775-01","51407-775_2eed2f37-4778-58f4-e063-6294a90a348e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076126","Golden State Medical Supply, Inc.","250","mg/1","","N","20261231"
"3308","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","51407077650","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51407-776","51407-776-50","51407-776_2eed2f37-4778-58f4-e063-6294a90a348e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076126","Golden State Medical Supply, Inc.","750","mg/1","","N","20261231"
"3309","ERYTHROMYCIN","ERYTHROMYCIN","51407085330","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","51407-853","51407-853-30","51407-853_27c1ce89-9cfb-b5af-e063-6394a90a151b","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, DELAYED RELEASE","ORAL","20210726","","ANDA","ANDA211975","Golden State Medical Supply, Inc.","250","mg/1","","N","20251231"
"3310","ERYTHROMYCIN","ERYTHROMYCIN","51407085430","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","51407-854","51407-854-30","51407-854_27c1ce89-9cfb-b5af-e063-6394a90a151b","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, DELAYED RELEASE","ORAL","20210726","","ANDA","ANDA211975","Golden State Medical Supply, Inc.","500","mg/1","","N","20251231"
"3311","ERYTHROMYCIN","Erythromycin","51407085530","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","51407-855","51407-855-30","51407-855_27c21590-0f41-68a5-e063-6394a90a8a39","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, COATED","ORAL","20200706","","ANDA","ANDA212015","Golden State Medical Supply, Inc.","250","mg/1","","N","20251231"
"3312","ERYTHROMYCIN","Erythromycin","51407085630","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","51407-856","51407-856-30","51407-856_27c21590-0f41-68a5-e063-6394a90a8a39","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, COATED","ORAL","20200706","","ANDA","ANDA212015","Golden State Medical Supply, Inc.","500","mg/1","","N","20251231"
"3313","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","51407086901","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","51407-869","51407-869-01","51407-869_15244130-2905-c8d2-e063-6294a90ae684","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil Hydrochloride","","TABLET, FILM COATED","ORAL","20140527","","ANDA","ANDA202362","Golden State Medical Supply, Inc.","250; 100","mg/1; mg/1","","N","20251231"
"3314","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","51407086924","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","51407-869","51407-869-24","51407-869_15244130-2905-c8d2-e063-6294a90ae684","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil Hydrochloride","","TABLET, FILM COATED","ORAL","20140527","","ANDA","ANDA202362","Golden State Medical Supply, Inc.","250; 100","mg/1; mg/1","","N","20251231"
"3315","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","51655008620","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51655-086","51655-086-20","51655-086_ff0e4e97-8f03-bd36-e053-6394a90a47ae","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20230301","","ANDA","ANDA076558","Northwind Pharmaceuticals, LLC","250","mg/1","","N","20251231"
"3316","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","51655008684","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51655-086","51655-086-84","51655-086_ff0e4e97-8f03-bd36-e053-6394a90a47ae","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20230301","","ANDA","ANDA076558","Northwind Pharmaceuticals, LLC","250","mg/1","","N","20251231"
"3317","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","51655011852","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51655-118","51655-118-52","51655-118_1c6fa2fd-7206-f2ff-e063-6394a90a2a8f","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20230502","","ANDA","ANDA076639","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3318","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","51655011853","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51655-118","51655-118-53","51655-118_1c6fa2fd-7206-f2ff-e063-6394a90a2a8f","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20230502","","ANDA","ANDA076639","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3319","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","51655011884","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51655-118","51655-118-84","51655-118_1c6fa2fd-7206-f2ff-e063-6394a90a2a8f","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20230502","","ANDA","ANDA076639","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3320","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","51655011825","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51655-118","51655-118-25","51655-118_1c6fa2fd-7206-f2ff-e063-6394a90a2a8f","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20230502","","ANDA","ANDA076639","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3321","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","51655011887","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51655-118","51655-118-87","51655-118_1c6fa2fd-7206-f2ff-e063-6394a90a2a8f","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20230502","","ANDA","ANDA076639","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3322","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","51655011820","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51655-118","51655-118-20","51655-118_1c6fa2fd-7206-f2ff-e063-6394a90a2a8f","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20230502","","ANDA","ANDA076639","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3323","AMOXICILLIN","Amoxicillin","51655015621","Penicillin-class Antibacterial [EPC], Penicillins [CS]","51655-156","51655-156-21","51655-156_2abd833e-e8e5-cb77-e063-6294a90ac0ed","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20141106","20261031","ANDA","ANDA065271","Northwind Pharmaceuticals, LLC","500","mg/1","","N",""
"3324","AMOXICILLIN","Amoxicillin","51655015652","Penicillin-class Antibacterial [EPC], Penicillins [CS]","51655-156","51655-156-52","51655-156_2abd833e-e8e5-cb77-e063-6294a90ac0ed","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20141106","20261031","ANDA","ANDA065271","Northwind Pharmaceuticals, LLC","500","mg/1","","N",""
"3325","AMOXICILLIN","Amoxicillin","51655015620","Penicillin-class Antibacterial [EPC], Penicillins [CS]","51655-156","51655-156-20","51655-156_2abd833e-e8e5-cb77-e063-6294a90ac0ed","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20141106","20261031","ANDA","ANDA065271","Northwind Pharmaceuticals, LLC","500","mg/1","","N",""
"3326","AMOXICILLIN","Amoxicillin","51655015651","Penicillin-class Antibacterial [EPC], Penicillins [CS]","51655-156","51655-156-51","51655-156_2abd833e-e8e5-cb77-e063-6294a90ac0ed","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20141106","20261031","ANDA","ANDA065271","Northwind Pharmaceuticals, LLC","500","mg/1","","N",""
"3327","AMOXICILLIN","Amoxicillin","51655015684","Penicillin-class Antibacterial [EPC], Penicillins [CS]","51655-156","51655-156-84","51655-156_2abd833e-e8e5-cb77-e063-6294a90ac0ed","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20141106","20261031","ANDA","ANDA065271","Northwind Pharmaceuticals, LLC","500","mg/1","","N",""
"3328","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","51655018820","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","51655-188","51655-188-20","51655-188_292e095e-21d5-4e8b-e063-6394a90ae06e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20230323","","ANDA","ANDA090624","Northwind Pharmaceuticals, LLC","800; 160","mg/1; mg/1","","N","20251231"
"3329","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","51655018884","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","51655-188","51655-188-84","51655-188_292e095e-21d5-4e8b-e063-6394a90ae06e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20230323","","ANDA","ANDA090624","Northwind Pharmaceuticals, LLC","800; 160","mg/1; mg/1","","N","20251231"
"3330","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","51655018887","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","51655-188","51655-188-87","51655-188_292e095e-21d5-4e8b-e063-6394a90ae06e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20230323","","ANDA","ANDA090624","Northwind Pharmaceuticals, LLC","800; 160","mg/1; mg/1","","N","20251231"
"3331","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","51655018853","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","51655-188","51655-188-53","51655-188_292e095e-21d5-4e8b-e063-6394a90ae06e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20230323","","ANDA","ANDA090624","Northwind Pharmaceuticals, LLC","800; 160","mg/1; mg/1","","N","20251231"
"3332","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","51655021625","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51655-216","51655-216-25","51655-216_03ae508e-57bb-866f-e063-6294a90a67bd","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20230317","","ANDA","ANDA077859","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3333","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","51655021652","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51655-216","51655-216-52","51655-216_03ae508e-57bb-866f-e063-6294a90a67bd","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20230317","","ANDA","ANDA077859","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3334","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","51655021653","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51655-216","51655-216-53","51655-216_03ae508e-57bb-866f-e063-6294a90a67bd","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20230317","","ANDA","ANDA077859","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3335","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","51655021687","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51655-216","51655-216-87","51655-216_03ae508e-57bb-866f-e063-6294a90a67bd","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20230317","","ANDA","ANDA077859","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3336","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","51655021620","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51655-216","51655-216-20","51655-216_03ae508e-57bb-866f-e063-6294a90a67bd","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20230317","","ANDA","ANDA077859","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3337","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","51655021684","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51655-216","51655-216-84","51655-216_03ae508e-57bb-866f-e063-6294a90a67bd","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20230317","","ANDA","ANDA077859","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3338","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","51655030753","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","51655-307","51655-307-53","51655-307_1d154f8c-549d-4ecb-e063-6294a90a05bb","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20221117","","ANDA","ANDA076899","Northwind Pharmaceuticals, LLC","800; 160","mg/1; mg/1","","N","20251231"
"3339","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","51655030784","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","51655-307","51655-307-84","51655-307_1d154f8c-549d-4ecb-e063-6294a90a05bb","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20221117","","ANDA","ANDA076899","Northwind Pharmaceuticals, LLC","800; 160","mg/1; mg/1","","N","20251231"
"3340","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","51655030787","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","51655-307","51655-307-87","51655-307_1d154f8c-549d-4ecb-e063-6294a90a05bb","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20221117","","ANDA","ANDA076899","Northwind Pharmaceuticals, LLC","800; 160","mg/1; mg/1","","N","20251231"
"3341","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","51655030729","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","51655-307","51655-307-29","51655-307_1d154f8c-549d-4ecb-e063-6294a90a05bb","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20221117","","ANDA","ANDA076899","Northwind Pharmaceuticals, LLC","800; 160","mg/1; mg/1","","N","20251231"
"3342","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","51655030720","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","51655-307","51655-307-20","51655-307_1d154f8c-549d-4ecb-e063-6294a90a05bb","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20221117","","ANDA","ANDA076899","Northwind Pharmaceuticals, LLC","800; 160","mg/1; mg/1","","N","20251231"
"3343","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","51655031752","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","51655-317","51655-317-52","51655-317_29797612-62fb-47e4-e063-6394a90a54dd","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20221128","","ANDA","ANDA065442","Northwind Pharmaceuticals, LLC","300","mg/1","","N","20251231"
"3344","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","51655031751","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","51655-317","51655-317-51","51655-317_29797612-62fb-47e4-e063-6394a90a54dd","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20221128","","ANDA","ANDA065442","Northwind Pharmaceuticals, LLC","300","mg/1","","N","20251231"
"3345","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","51655036426","Allylamine Antifungal [EPC], Allylamine [CS]","51655-364","51655-364-26","51655-364_297ac72a-42aa-b41a-e063-6394a90ae70e","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20200528","","ANDA","ANDA077714","Northwind Pharmaceuticals, LLC","250","mg/1","","N","20251231"
"3346","FLUCONAZOLE","Fluconazole","51655043507","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51655-435","51655-435-07","51655-435_1d5e6eab-72e4-e537-e063-6394a90a5762","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20200916","","ANDA","ANDA077731","Northwind Pharmaceuticals, LLC","150","mg/1","","N","20251231"
"3347","FLUCONAZOLE","Fluconazole","51655043586","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51655-435","51655-435-86","51655-435_1d5e6eab-72e4-e537-e063-6394a90a5762","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20200916","","ANDA","ANDA077731","Northwind Pharmaceuticals, LLC","150","mg/1","","N","20251231"
"3348","METRONIDAZOLE","METRONIDAZOLE","51655044120","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51655-441","51655-441-20","51655-441_1d5e99fa-3c4f-2b62-e063-6394a90aac4d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20221130","","ANDA","ANDA205245","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3349","METRONIDAZOLE","METRONIDAZOLE","51655044184","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51655-441","51655-441-84","51655-441_1d5e99fa-3c4f-2b62-e063-6394a90aac4d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20221130","","ANDA","ANDA205245","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3350","METRONIDAZOLE","METRONIDAZOLE","51655044152","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51655-441","51655-441-52","51655-441_1d5e99fa-3c4f-2b62-e063-6394a90aac4d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20221130","","ANDA","ANDA205245","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3351","METRONIDAZOLE","METRONIDAZOLE","51655044121","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51655-441","51655-441-21","51655-441_1d5e99fa-3c4f-2b62-e063-6394a90aac4d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20221130","","ANDA","ANDA205245","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3352","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","51655049020","Quinolone Antimicrobial [EPC], Quinolones [CS]","51655-490","51655-490-20","51655-490_f6debb60-d886-230b-e053-6394a90ad73a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20230105","","ANDA","ANDA208921","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3353","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","51655049052","Quinolone Antimicrobial [EPC], Quinolones [CS]","51655-490","51655-490-52","51655-490_f6debb60-d886-230b-e053-6394a90ad73a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20230105","","ANDA","ANDA208921","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3354","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","51655049053","Quinolone Antimicrobial [EPC], Quinolones [CS]","51655-490","51655-490-53","51655-490_f6debb60-d886-230b-e053-6394a90ad73a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20230105","","ANDA","ANDA208921","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3355","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","51655049087","Quinolone Antimicrobial [EPC], Quinolones [CS]","51655-490","51655-490-87","51655-490_f6debb60-d886-230b-e053-6394a90ad73a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20230105","","ANDA","ANDA208921","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3356","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","51655049084","Quinolone Antimicrobial [EPC], Quinolones [CS]","51655-490","51655-490-84","51655-490_f6debb60-d886-230b-e053-6394a90ad73a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20230105","","ANDA","ANDA208921","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3357","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystals","51655061102","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","51655-611","51655-611-02","51655-611_f32c6784-9b4f-1194-e053-2995a90ac3d6","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/Macrocrystals","","CAPSULE","ORAL","20140718","","NDA","NDA020064","Northwind Pharmaceuticals, LLC","25; 75","mg/1; mg/1","","N","20251231"
"3358","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystals","51655061120","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","51655-611","51655-611-20","51655-611_f32c6784-9b4f-1194-e053-2995a90ac3d6","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/Macrocrystals","","CAPSULE","ORAL","20140718","","NDA","NDA020064","Northwind Pharmaceuticals, LLC","25; 75","mg/1; mg/1","","N","20251231"
"3359","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystals","51655061184","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","51655-611","51655-611-84","51655-611_f32c6784-9b4f-1194-e053-2995a90ac3d6","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/Macrocrystals","","CAPSULE","ORAL","20140718","","NDA","NDA020064","Northwind Pharmaceuticals, LLC","25; 75","mg/1; mg/1","","N","20251231"
"3360","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystals","51655061153","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","51655-611","51655-611-53","51655-611_f32c6784-9b4f-1194-e053-2995a90ac3d6","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/Macrocrystals","","CAPSULE","ORAL","20140718","","NDA","NDA020064","Northwind Pharmaceuticals, LLC","25; 75","mg/1; mg/1","","N","20251231"
"3361","CLARITHROMYCIN","Clarithromycin","51655066852","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","51655-668","51655-668-52","51655-668_1dff4cdb-d5f1-40c4-e063-6294a90a522e","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20230403","","ANDA","ANDA065136","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3362","CLARITHROMYCIN","Clarithromycin","51655066820","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","51655-668","51655-668-20","51655-668_1dff4cdb-d5f1-40c4-e063-6294a90a522e","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20230403","","ANDA","ANDA065136","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3363","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","51655071052","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","51655-710","51655-710-52","51655-710_2a41dbfc-aaa5-e01f-e063-6394a90a512a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20230203","","ANDA","ANDA207402","Northwind Pharmaceuticals, LLC","150","mg/1","","N","20251231"
"3364","FLUCONAZOLE","Fluconazole","51655088907","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51655-889","51655-889-07","51655-889_1ea1e74c-ca14-e737-e063-6294a90a7f83","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20230215","","ANDA","ANDA077253","Northwind Pharmaceuticals, LLC","100","mg/1","","N","20251231"
"3365","AMOXICILLIN","Amoxicillin","51655089452","Penicillin-class Antibacterial [EPC], Penicillins [CS]","51655-894","51655-894-52","51655-894_007a08e3-eee1-4915-e063-6394a90a55de","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20200311","","ANDA","ANDA064076","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3366","NITROFURANTOIN","nitrofurantoin macrocrystals","51655094853","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","51655-948","51655-948-53","51655-948_2a3465ea-2ce6-400f-e063-6394a90a6b35","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230220","","NDA","NDA016620","Northwind Pharmaceuticals, LLC","100","mg/1","","N","20251231"
"3367","NITROFURANTOIN","nitrofurantoin macrocrystals","51655094884","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","51655-948","51655-948-84","51655-948_2a3465ea-2ce6-400f-e063-6394a90a6b35","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230220","","NDA","NDA016620","Northwind Pharmaceuticals, LLC","100","mg/1","","N","20251231"
"3368","NITROFURANTOIN","nitrofurantoin macrocrystals","51655094820","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","51655-948","51655-948-20","51655-948_2a3465ea-2ce6-400f-e063-6394a90a6b35","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230220","","NDA","NDA016620","Northwind Pharmaceuticals, LLC","100","mg/1","","N","20251231"
"3369","NITROFURANTOIN","nitrofurantoin macrocrystals","51655094829","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","51655-948","51655-948-29","51655-948_2a3465ea-2ce6-400f-e063-6394a90a6b35","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230220","","NDA","NDA016620","Northwind Pharmaceuticals, LLC","100","mg/1","","N","20251231"
"3370","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","51655096452","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","51655-964","51655-964-52","51655-964_2a347269-309c-208e-e063-6294a90a5c46","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20140617","","ANDA","ANDA065061","Northwind Pharmaceuticals, LLC","150","mg/1","","N","20251231"
"3371","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","51655096451","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","51655-964","51655-964-51","51655-964_2a347269-309c-208e-e063-6294a90a5c46","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20140617","","ANDA","ANDA065061","Northwind Pharmaceuticals, LLC","150","mg/1","","N","20251231"
"3372","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","51655096421","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","51655-964","51655-964-21","51655-964_2a347269-309c-208e-e063-6294a90a5c46","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20140617","","ANDA","ANDA065061","Northwind Pharmaceuticals, LLC","150","mg/1","","N","20251231"
"3373","METRONIDAZOLE","METRONIDAZOLE","51655097429","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51655-974","51655-974-29","51655-974_1e7b6dfa-2354-7ae5-e063-6394a90aa231","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20230228","","ANDA","ANDA205245","Northwind Pharmaceuticals, LLC","250","mg/1","","N","20251231"
"3374","METRONIDAZOLE","METRONIDAZOLE","51655097452","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51655-974","51655-974-52","51655-974_1e7b6dfa-2354-7ae5-e063-6394a90aa231","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20230228","","ANDA","ANDA205245","Northwind Pharmaceuticals, LLC","250","mg/1","","N","20251231"
"3375","PENICILLIN G POTASSIUM","BUFFERED PENICILLIN G POTASSIUM","51662143601","Penicillin-class Antibacterial [EPC], Penicillins [CS]","51662-1436","51662-1436-1","51662-1436_2b395815-afca-6138-e063-6294a90a91ca","HUMAN PRESCRIPTION DRUG","BUFFERED PENICILLIN G POTASSIUM","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20200129","","ANDA","ANDA065079","HF Acquisition Co LLC, DBA HealthFirst","5000000","[iU]/1","","N","20261231"
"3376","GENTAMICIN SULFATE","GENTAMICIN","51662150803","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","51662-1508","51662-1508-3","51662-1508_1032caaf-e8c2-e3cc-e063-6294a90a47f3","HUMAN PRESCRIPTION DRUG","GENTAMICIN","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20210510","","ANDA","ANDA062366","HF Acquisition Co LLC, DBA HealthFirst","40","mg/mL","","N","20251231"
"3377","AMPICILLIN SODIUM","AMPICILLIN","51662156003","Penicillin-class Antibacterial [EPC], Penicillins [CS]","51662-1560","51662-1560-3","51662-1560_0ef2832c-bb3e-ef66-e063-6294a90ac0d6","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20220731","","ANDA","ANDA065499","HF Acquisition Co LLC, DBA HealthFirst","2","g/1","","N","20251231"
"3378","AMPICILLIN SODIUM","AMPICILLIN","51662159503","Penicillin-class Antibacterial [EPC], Penicillins [CS]","51662-1595","51662-1595-3","51662-1595_100d207d-d9fb-7c75-e063-6394a90a53e8","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220818","","ANDA","ANDA062719","HF Acquisition Co LLC, DBA HealthFirst","250","mg/1","","N","20251231"
"3379","GENTAMICIN SULFATE","GENTAMICIN SULFATE","51662159703","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","51662-1597","51662-1597-3","51662-1597_0ff9b5b7-53ad-15f6-e063-6394a90a82aa","HUMAN PRESCRIPTION DRUG","GENTAMICIN SULFATE","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20221001","","ANDA","ANDA062420","HF Acquisition Co LLC, DBA HealthFirst","40","mg/mL","","N","20251231"
"3380","CLOTRIMAZOLE","Clotrimazole","51672126003","Azole Antifungal [EPC], Azoles [CS]","51672-1260","51672-1260-3","51672-1260_c36fc08c-8853-421c-9b84-96a67c04ea34","HUMAN PRESCRIPTION DRUG","Clotrimazole","","SOLUTION","TOPICAL","19960729","","ANDA","ANDA074580","Taro Pharmaceuticals U.S.A., Inc.","10","mg/mL","","N","20251231"
"3381","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","51672126301","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","51672-1263","51672-1263-1","51672-1263_29a1e8d9-37ca-c648-e063-6294a90a7fb7","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","19871222","","ANDA","ANDA062364","Taro Pharmaceuticals U.S.A., Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"3382","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","51672126303","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","51672-1263","51672-1263-3","51672-1263_29a1e8d9-37ca-c648-e063-6294a90a7fb7","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","19871222","","ANDA","ANDA062364","Taro Pharmaceuticals U.S.A., Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"3383","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","51672127201","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","51672-1272","51672-1272-1","51672-1272_29a1e8d9-37ca-c648-e063-6294a90a7fb7","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","19930329","","ANDA","ANDA063305","Taro Pharmaceuticals U.S.A., Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"3384","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","51672127203","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","51672-1272","51672-1272-3","51672-1272_29a1e8d9-37ca-c648-e063-6294a90a7fb7","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","19930329","","ANDA","ANDA063305","Taro Pharmaceuticals U.S.A., Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"3385","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","51672127202","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","51672-1272","51672-1272-2","51672-1272_29a1e8d9-37ca-c648-e063-6294a90a7fb7","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","19930329","","ANDA","ANDA063305","Taro Pharmaceuticals U.S.A., Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"3386","CLOTRIMAZOLE","Clotrimazole","51672127502","Azole Antifungal [EPC], Azoles [CS]","51672-1275","51672-1275-2","51672-1275_29a18088-fb00-cf86-e063-6394a90ad4b4","HUMAN PRESCRIPTION DRUG","Clotrimazole","","CREAM","TOPICAL","19930831","","ANDA","ANDA072640","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3387","CLOTRIMAZOLE","Clotrimazole","51672127506","Azole Antifungal [EPC], Azoles [CS]","51672-1275","51672-1275-6","51672-1275_29a18088-fb00-cf86-e063-6394a90ad4b4","HUMAN PRESCRIPTION DRUG","Clotrimazole","","CREAM","TOPICAL","19930831","","ANDA","ANDA072640","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3388","CLOTRIMAZOLE","Clotrimazole","51672127501","Azole Antifungal [EPC], Azoles [CS]","51672-1275","51672-1275-1","51672-1275_29a18088-fb00-cf86-e063-6394a90ad4b4","HUMAN PRESCRIPTION DRUG","Clotrimazole","","CREAM","TOPICAL","19930831","","ANDA","ANDA072640","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3389","CLOTRIMAZOLE","Clotrimazole","51672127507","Azole Antifungal [EPC], Azoles [CS]","51672-1275","51672-1275-7","51672-1275_29a18088-fb00-cf86-e063-6394a90ad4b4","HUMAN PRESCRIPTION DRUG","Clotrimazole","","CREAM","TOPICAL","19930831","","ANDA","ANDA072640","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3390","NYSTATIN","Nystatin","51672128902","Polyene Antifungal [EPC], Polyenes [CS]","51672-1289","51672-1289-2","51672-1289_d045b29c-a41d-4c90-8872-5a49ac877a92","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","19930128","","ANDA","ANDA064022","Taro Pharmaceuticals U.S.A., Inc.","100000","[USP'U]/g","","N","20251231"
"3391","NYSTATIN","Nystatin","51672128901","Polyene Antifungal [EPC], Polyenes [CS]","51672-1289","51672-1289-1","51672-1289_d045b29c-a41d-4c90-8872-5a49ac877a92","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","19930128","","ANDA","ANDA064022","Taro Pharmaceuticals U.S.A., Inc.","100000","[USP'U]/g","","N","20251231"
"3392","KETOCONAZOLE","Ketoconazole","51672129803","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","51672-1298","51672-1298-3","51672-1298_10edd94f-c896-6b06-e063-6294a90a38eb","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20021218","","ANDA","ANDA075638","Taro Pharmaceuticals U.S.A., Inc.","20","mg/g","","N","20251231"
"3393","KETOCONAZOLE","Ketoconazole","51672129802","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","51672-1298","51672-1298-2","51672-1298_10edd94f-c896-6b06-e063-6294a90a38eb","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20021218","","ANDA","ANDA075638","Taro Pharmaceuticals U.S.A., Inc.","20","mg/g","","N","20251231"
"3394","KETOCONAZOLE","Ketoconazole","51672129801","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","51672-1298","51672-1298-1","51672-1298_10edd94f-c896-6b06-e063-6294a90a38eb","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20021218","","ANDA","ANDA075638","Taro Pharmaceuticals U.S.A., Inc.","20","mg/g","","N","20251231"
"3395","TERCONAZOLE","Terconazole","51672130200","Azole Antifungal [EPC], Azoles [CS]","51672-1302","51672-1302-0","51672-1302_29a337e5-6e9a-25b9-e063-6394a90ab530","HUMAN PRESCRIPTION DRUG","Terconazole","","CREAM","VAGINAL","20040406","","ANDA","ANDA075953","Taro Pharmaceuticals U.S.A., Inc.","8","mg/g","","N","20251231"
"3396","ECONAZOLE NITRATE","Econazole Nitrate","51672130301","Azole Antifungal [EPC], Azoles [CS]","51672-1303","51672-1303-1","51672-1303_29a359fa-66ee-a7d3-e063-6294a90a6d72","HUMAN PRESCRIPTION DRUG","Econazole Nitrate","","CREAM","TOPICAL","20021126","","ANDA","ANDA076005","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3397","ECONAZOLE NITRATE","Econazole Nitrate","51672130302","Azole Antifungal [EPC], Azoles [CS]","51672-1303","51672-1303-2","51672-1303_29a359fa-66ee-a7d3-e063-6294a90a6d72","HUMAN PRESCRIPTION DRUG","Econazole Nitrate","","CREAM","TOPICAL","20021126","","ANDA","ANDA076005","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3398","ECONAZOLE NITRATE","Econazole Nitrate","51672130308","Azole Antifungal [EPC], Azoles [CS]","51672-1303","51672-1303-8","51672-1303_29a359fa-66ee-a7d3-e063-6294a90a6d72","HUMAN PRESCRIPTION DRUG","Econazole Nitrate","","CREAM","TOPICAL","20021126","","ANDA","ANDA076005","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3399","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","51672130803","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","51672-1308","51672-1308-3","51672-1308_1003cd3d-c3d2-433b-82a1-03844326188d","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","LOTION","TOPICAL","20040728","","ANDA","ANDA076493","Taro Pharmaceuticals U.S.A., Inc.",".5; 10","mg/mL; mg/mL","","N","20251231"
"3400","MUPIROCIN","Mupirocin","51672131200","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","51672-1312","51672-1312-0","51672-1312_49195b56-51d2-4404-96b3-c77a06a295c8","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20050923","","ANDA","ANDA065170","Taro Pharmaceuticals U.S.A., Inc.","20","mg/g","","N","20251231"
"3401","MUPIROCIN","Mupirocin","51672131202","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","51672-1312","51672-1312-2","51672-1312_49195b56-51d2-4404-96b3-c77a06a295c8","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20050923","","ANDA","ANDA065170","Taro Pharmaceuticals U.S.A., Inc.","20","mg/g","","N","20251231"
"3402","MUPIROCIN","Mupirocin","51672131201","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","51672-1312","51672-1312-1","51672-1312_49195b56-51d2-4404-96b3-c77a06a295c8","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20050923","","ANDA","ANDA065170","Taro Pharmaceuticals U.S.A., Inc.","20","mg/g","","N","20251231"
"3403","TERCONAZOLE","Terconazole","51672133003","Azole Antifungal [EPC], Azoles [CS]","51672-1330","51672-1330-3","51672-1330_29a46123-8e28-e2f3-e063-6394a90ad334","HUMAN PRESCRIPTION DRUG","Terconazole","","SUPPOSITORY","VAGINAL","20070309","","ANDA","ANDA077553","Taro Pharmaceuticals U.S.A., Inc.","80","mg/1","","N","20251231"
"3404","OXICONAZOLE NITRATE","Oxiconazole Nitrate","51672135901","Azole Antifungal [EPC], Azoles [CS]","51672-1359","51672-1359-1","51672-1359_29a3f841-725e-fc3c-e063-6294a90a5185","HUMAN PRESCRIPTION DRUG","Oxiconazole Nitrate","","CREAM","TOPICAL","20160307","","ANDA","ANDA205076","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3405","OXICONAZOLE NITRATE","Oxiconazole Nitrate","51672135903","Azole Antifungal [EPC], Azoles [CS]","51672-1359","51672-1359-3","51672-1359_29a3f841-725e-fc3c-e063-6294a90a5185","HUMAN PRESCRIPTION DRUG","Oxiconazole Nitrate","","CREAM","TOPICAL","20160307","","ANDA","ANDA205076","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3406","OXICONAZOLE NITRATE","Oxiconazole Nitrate","51672135902","Azole Antifungal [EPC], Azoles [CS]","51672-1359","51672-1359-2","51672-1359_29a3f841-725e-fc3c-e063-6294a90a5185","HUMAN PRESCRIPTION DRUG","Oxiconazole Nitrate","","CREAM","TOPICAL","20160307","","ANDA","ANDA205076","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3407","OXICONAZOLE NITRATE","Oxiconazole Nitrate","51672135908","Azole Antifungal [EPC], Azoles [CS]","51672-1359","51672-1359-8","51672-1359_29a3f841-725e-fc3c-e063-6294a90a5185","HUMAN PRESCRIPTION DRUG","Oxiconazole Nitrate","","CREAM","TOPICAL","20160307","","ANDA","ANDA205076","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3408","NAFTIFINE HYDROCHLORIDE","Naftifine Hydrochloride","51672136202","Allylamine Antifungal [EPC], Allylamine [CS]","51672-1362","51672-1362-2","51672-1362_067fb7e0-1f18-4e14-8f10-8eca25f5fde4","HUMAN PRESCRIPTION DRUG","Naftifine Hydrochloride","","CREAM","TOPICAL","20160908","","ANDA","ANDA205975","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3409","NAFTIFINE HYDROCHLORIDE","Naftifine Hydrochloride","51672136208","Allylamine Antifungal [EPC], Allylamine [CS]","51672-1362","51672-1362-8","51672-1362_067fb7e0-1f18-4e14-8f10-8eca25f5fde4","HUMAN PRESCRIPTION DRUG","Naftifine Hydrochloride","","CREAM","TOPICAL","20160908","","ANDA","ANDA205975","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3410","NAFTIFINE HYDROCHLORIDE","Naftifine Hydrochloride","51672136203","Allylamine Antifungal [EPC], Allylamine [CS]","51672-1362","51672-1362-3","51672-1362_067fb7e0-1f18-4e14-8f10-8eca25f5fde4","HUMAN PRESCRIPTION DRUG","Naftifine Hydrochloride","","CREAM","TOPICAL","20160908","","ANDA","ANDA205975","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3411","NAFTIFINE HYDROCHLORIDE","Naftifine Hydrochloride","51672136201","Allylamine Antifungal [EPC], Allylamine [CS]","51672-1362","51672-1362-1","51672-1362_067fb7e0-1f18-4e14-8f10-8eca25f5fde4","HUMAN PRESCRIPTION DRUG","Naftifine Hydrochloride","","CREAM","TOPICAL","20160908","","ANDA","ANDA205975","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3412","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate and Benzoyl Peroxide","51672136606","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS]","51672-1366","51672-1366-6","51672-1366_db958941-32f2-47ba-8b8f-a9fcf6560edb","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Benzoyl Peroxide","","GEL","TOPICAL","20171215","","ANDA","ANDA206218","Taro Pharmaceuticals U.S.A., Inc.","50; 10","mg/g; mg/g","","N","20251231"
"3413","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate and Benzoyl Peroxide","51672136703","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS]","51672-1367","51672-1367-3","51672-1367_31e7b626-56fd-4d25-ac69-df91c2603f7c","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Benzoyl Peroxide","","GEL","TOPICAL","20190819","","ANDA","ANDA206575","Taro Pharmaceuticals U.S.A., Inc.","25; 10","mg/g; mg/g","","N","20251231"
"3414","NAFTIFINE HYDROCHLORIDE","Naftifine Hydrochloride","51672136806","Allylamine Antifungal [EPC], Allylamine [CS]","51672-1368","51672-1368-6","51672-1368_3629ccb9-d408-ab33-e063-6394a90a8994","HUMAN PRESCRIPTION DRUG","Naftifine Hydrochloride","","CREAM","TOPICAL","20160106","","ANDA","ANDA206901","Sun Pharmaceutical Industries, Inc.","20","mg/g","","N","20261231"
"3415","NAFTIFINE HYDROCHLORIDE","Naftifine Hydrochloride","51672136803","Allylamine Antifungal [EPC], Allylamine [CS]","51672-1368","51672-1368-3","51672-1368_3629ccb9-d408-ab33-e063-6394a90a8994","HUMAN PRESCRIPTION DRUG","Naftifine Hydrochloride","","CREAM","TOPICAL","20160106","","ANDA","ANDA206901","Sun Pharmaceutical Industries, Inc.","20","mg/g","","N","20261231"
"3416","NAFTIFINE HYDROCHLORIDE","Naftifine Hydrochloride","51672136802","Allylamine Antifungal [EPC], Allylamine [CS]","51672-1368","51672-1368-2","51672-1368_3629ccb9-d408-ab33-e063-6394a90a8994","HUMAN PRESCRIPTION DRUG","Naftifine Hydrochloride","","CREAM","TOPICAL","20160106","","ANDA","ANDA206901","Sun Pharmaceutical Industries, Inc.","20","mg/g","","N","20261231"
"3417","MUPIROCIN CALCIUM","Mupirocin Calcium","51672137002","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","51672-1370","51672-1370-2","51672-1370_2e376ae7-c2e9-44bc-b724-9358d2a28be6","HUMAN PRESCRIPTION DRUG","Mupirocin","","CREAM","TOPICAL","20200427","","ANDA","ANDA207116","Taro Pharmaceuticals U.S.A., Inc.","20","mg/g","","N","20251231"
"3418","MUPIROCIN CALCIUM","Mupirocin Calcium","51672137001","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","51672-1370","51672-1370-1","51672-1370_2e376ae7-c2e9-44bc-b724-9358d2a28be6","HUMAN PRESCRIPTION DRUG","Mupirocin","","CREAM","TOPICAL","20200427","","ANDA","ANDA207116","Taro Pharmaceuticals U.S.A., Inc.","20","mg/g","","N","20251231"
"3419","NAFTIFINE HYDROCHLORIDE","Naftifine Hydrochloride","51672137606","Allylamine Antifungal [EPC], Allylamine [CS]","51672-1376","51672-1376-6","51672-1376_9ffda8a6-78db-4240-a35f-5f63b0526d16","HUMAN PRESCRIPTION DRUG","Naftifine Hydrochloride","","GEL","TOPICAL","20230401","","ANDA","ANDA208201","Taro Pharmaceuticals U.S.A., Inc.","20","mg/g","","N","20251231"
"3420","NAFTIFINE HYDROCHLORIDE","Naftifine Hydrochloride","51672137603","Allylamine Antifungal [EPC], Allylamine [CS]","51672-1376","51672-1376-3","51672-1376_9ffda8a6-78db-4240-a35f-5f63b0526d16","HUMAN PRESCRIPTION DRUG","Naftifine Hydrochloride","","GEL","TOPICAL","20230401","","ANDA","ANDA208201","Taro Pharmaceuticals U.S.A., Inc.","20","mg/g","","N","20251231"
"3421","TAVABOROLE","TAVABOROLE","51672139709","Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]","51672-1397","51672-1397-9","51672-1397_34940f27-ae26-41f3-9544-bd9d500fa85c","HUMAN PRESCRIPTION DRUG","TAVABOROLE","","SOLUTION","TOPICAL","20210507","","ANDA","ANDA212215","Taro Pharmaceuticals U.S.A., Inc.","43.5","mg/mL","","N","20251231"
"3422","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","51672139902","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","51672-1399","51672-1399-2","51672-1399_22cd6e6c-3ad9-9c86-e063-6394a90a6dcc","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20201110","","ANDA","ANDA214052","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3423","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","51672139903","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","51672-1399","51672-1399-3","51672-1399_22cd6e6c-3ad9-9c86-e063-6394a90a6dcc","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20201110","","ANDA","ANDA214052","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3424","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","51672139907","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","51672-1399","51672-1399-7","51672-1399_22cd6e6c-3ad9-9c86-e063-6394a90a6dcc","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20201110","","ANDA","ANDA214052","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3425","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","51672140004","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS]","51672-1400","51672-1400-4","51672-1400_d96b455b-dd02-4c7f-99b9-64723738fd05","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","LOTION","TOPICAL","20210628","","ANDA","ANDA214526","Taro Pharmaceuticals U.S.A., Inc.","10","mg/mL","","N","20251231"
"3426","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate and Benzoyl Peroxide","51672140304","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","51672-1403","51672-1403-4","51672-1403_cd255027-9e43-41a2-b161-8110796e7f5a","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Benzoyl Peroxide","","GEL","TOPICAL","20180605","","ANDA","ANDA208683","Taro Pharmaceuticals U.S.A., Inc.","50; 10","mg/g; mg/g","","N","20251231"
"3427","MICONAZOLE NITRATE","Miconazole Nitrate","51672200101","Azole Antifungal [EPC], Azoles [CS]","51672-2001","51672-2001-1","51672-2001_29a58b98-932e-e119-e063-6294a90a0674","HUMAN OTC DRUG","Miconazole Nitrate","","CREAM","TOPICAL","19911001","","OTC MONOGRAPH DRUG","M005","Taro Pharmaceuticals U.S.A., Inc.","20","mg/g","","N","20251231"
"3428","CLOTRIMAZOLE","Clotrimazole","51672200201","Azole Antifungal [EPC], Azoles [CS]","51672-2002","51672-2002-1","51672-2002_26bed8fc-f3e0-6bbe-e063-6394a90a0472","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","19950601","","OTC MONOGRAPH DRUG","M005","Taro Pharmaceuticals U.S.A., Inc.","1","g/100g","","N","20251231"
"3429","CLOTRIMAZOLE","Clotrimazole","51672200202","Azole Antifungal [EPC], Azoles [CS]","51672-2002","51672-2002-2","51672-2002_26bed8fc-f3e0-6bbe-e063-6394a90a0472","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","19950601","","OTC MONOGRAPH DRUG","M005","Taro Pharmaceuticals U.S.A., Inc.","1","g/100g","","N","20251231"
"3430","CLOTRIMAZOLE","Clotrimazole","51672200306","Azole Antifungal [EPC], Azoles [CS]","51672-2003","51672-2003-6","51672-2003_376636ca-82fd-cf77-e063-6394a90a669d","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","19951204","","ANDA","ANDA072641","Sun Pharmaceutical Industries, Inc.","1","g/100g","","N","20261231"
"3431","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","51672201602","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51672-2016","51672-2016-2","51672-2016_26bf2c8b-3b58-da48-e063-6394a90ac030","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","19951214","","OTC MONOGRAPH DRUG","M004","Taro Pharmaceuticals U.S.A., Inc.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3432","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","51672201601","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51672-2016","51672-2016-1","51672-2016_26bf2c8b-3b58-da48-e063-6394a90ac030","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","19951214","","OTC MONOGRAPH DRUG","M004","Taro Pharmaceuticals U.S.A., Inc.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3433","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","51672202702","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51672-2027","51672-2027-2","51672-2027_103d4ff5-354f-db15-e063-6294a90a30c5","HUMAN OTC DRUG","Triple Antibiotic Plus Pain Relief","","OINTMENT","TOPICAL","20120331","","OTC MONOGRAPH DRUG","M004","Taro Pharmaceuticals U.S.A., Inc.","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"3434","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","51672202701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51672-2027","51672-2027-1","51672-2027_103d4ff5-354f-db15-e063-6294a90a30c5","HUMAN OTC DRUG","Triple Antibiotic Plus Pain Relief","","OINTMENT","TOPICAL","20120331","","OTC MONOGRAPH DRUG","M004","Taro Pharmaceuticals U.S.A., Inc.","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"3435","MICONAZOLE NITRATE","Miconazole Nitrate","51672203507","Azole Antifungal [EPC], Azoles [CS]","51672-2035","51672-2035-7","51672-2035_362a2e22-e1bb-aae7-e063-6394a90a33f0","HUMAN OTC DRUG","Miconazole Nitrate","","CREAM","VAGINAL","19970113","","ANDA","ANDA074444","Sun Pharmaceutical Industries, Inc.","20","mg/g","","N","20261231"
"3436","CLOTRIMAZOLE","Clotrimazole","51672203701","Azole Antifungal [EPC], Azoles [CS]","51672-2037","51672-2037-1","51672-2037_22cc8abd-d3f2-f3bb-e063-6394a90ae7cf","HUMAN OTC DRUG","Clotrimazole","","SOLUTION","TOPICAL","19960501","","OTC MONOGRAPH DRUG","M005","Taro Pharmaceuticals U.S.A., Inc.","1","g/mL","","N","20251231"
"3437","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc and Polymyxin B Sulfate","51672204402","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51672-2044","51672-2044-2","51672-2044_0e4c5189-613d-ebe6-e063-6294a90a58a7","HUMAN OTC DRUG","Double Antibiotic","","OINTMENT","TOPICAL","19901205","","OTC MONOGRAPH DRUG","M004","Taro Pharmaceuticals U.S.A., Inc.","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"3438","CLOTRIMAZOLE","Clotrimazole","51672206200","Azole Antifungal [EPC], Azoles [CS]","51672-2062","51672-2062-0","51672-2062_3376a5d7-fd71-d8ee-e063-6294a90aa509","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","20000412","","NDA","NDA021143","Sun Pharmaceutical Industries, Inc.","2","g/100g","","N","20261231"
"3439","MICONAZOLE NITRATE","Miconazole Nitrate","51672207009","Azole Antifungal [EPC], Azoles [CS]","51672-2070","51672-2070-9","51672-2070_1925fc1c-9d98-44c6-e063-6394a90a9ba6","HUMAN OTC DRUG","Miconazole Nitrate","","CREAM","VAGINAL","20050302","","ANDA","ANDA076773","Taro Pharmaceuticals U.S.A., Inc.","40","mg/g","","N","20251231"
"3440","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","51672208002","Allylamine Antifungal [EPC], Allylamine [CS]","51672-2080","51672-2080-2","51672-2080_37c9904e-d588-a9e6-e063-6294a90a9918","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Sun Pharmaceutical Industries, Inc.","1","g/100g","","N","20261231"
"3441","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","51672208004","Allylamine Antifungal [EPC], Allylamine [CS]","51672-2080","51672-2080-4","51672-2080_37c9904e-d588-a9e6-e063-6294a90a9918","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Sun Pharmaceutical Industries, Inc.","1","g/100g","","N","20261231"
"3442","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","51672208008","Allylamine Antifungal [EPC], Allylamine [CS]","51672-2080","51672-2080-8","51672-2080_37c9904e-d588-a9e6-e063-6294a90a9918","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Sun Pharmaceutical Industries, Inc.","1","g/100g","","N","20261231"
"3443","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","51672208003","Allylamine Antifungal [EPC], Allylamine [CS]","51672-2080","51672-2080-3","51672-2080_37c9904e-d588-a9e6-e063-6294a90a9918","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Sun Pharmaceutical Industries, Inc.","1","g/100g","","N","20261231"
"3444","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","51672208006","Allylamine Antifungal [EPC], Allylamine [CS]","51672-2080","51672-2080-6","51672-2080_37c9904e-d588-a9e6-e063-6294a90a9918","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Sun Pharmaceutical Industries, Inc.","1","g/100g","","N","20261231"
"3445","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","51672208009","Allylamine Antifungal [EPC], Allylamine [CS]","51672-2080","51672-2080-9","51672-2080_37c9904e-d588-a9e6-e063-6294a90a9918","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Sun Pharmaceutical Industries, Inc.","1","g/100g","","N","20261231"
"3446","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","51672210002","Benzylamine Antifungal [EPC], Benzylamines [CS]","51672-2100","51672-2100-2","51672-2100_2c67420b-73a6-4382-bc58-fc031ac3e6af","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","Taro Pharmaceuticals U.S.A., inc.","10","mg/g","","N","20251231"
"3447","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","51672210009","Benzylamine Antifungal [EPC], Benzylamines [CS]","51672-2100","51672-2100-9","51672-2100_2c67420b-73a6-4382-bc58-fc031ac3e6af","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","Taro Pharmaceuticals U.S.A., inc.","10","mg/g","","N","20251231"
"3448","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","51672210001","Benzylamine Antifungal [EPC], Benzylamines [CS]","51672-2100","51672-2100-1","51672-2100_2c67420b-73a6-4382-bc58-fc031ac3e6af","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","Taro Pharmaceuticals U.S.A., inc.","10","mg/g","","N","20251231"
"3449","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","51672210008","Benzylamine Antifungal [EPC], Benzylamines [CS]","51672-2100","51672-2100-8","51672-2100_2c67420b-73a6-4382-bc58-fc031ac3e6af","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","Taro Pharmaceuticals U.S.A., inc.","10","mg/g","","N","20251231"
"3450","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","51672210102","Benzylamine Antifungal [EPC], Benzylamines [CS]","51672-2101","51672-2101-2","51672-2101_a0159f92-c609-486b-a727-bc4d431ed8eb","HUMAN OTC DRUG","Jock Itch","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","Taro Pharmaceuticals U.S.A., inc.","10","mg/g","","N","20251231"
"3451","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","51672210108","Benzylamine Antifungal [EPC], Benzylamines [CS]","51672-2101","51672-2101-8","51672-2101_a0159f92-c609-486b-a727-bc4d431ed8eb","HUMAN OTC DRUG","Jock Itch","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","Taro Pharmaceuticals U.S.A., inc.","10","mg/g","","N","20251231"
"3452","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","51672210101","Benzylamine Antifungal [EPC], Benzylamines [CS]","51672-2101","51672-2101-1","51672-2101_a0159f92-c609-486b-a727-bc4d431ed8eb","HUMAN OTC DRUG","Jock Itch","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","Taro Pharmaceuticals U.S.A., inc.","10","mg/g","","N","20251231"
"3453","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","51672210109","Benzylamine Antifungal [EPC], Benzylamines [CS]","51672-2101","51672-2101-9","51672-2101_a0159f92-c609-486b-a727-bc4d431ed8eb","HUMAN OTC DRUG","Jock Itch","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","Taro Pharmaceuticals U.S.A., inc.","10","mg/g","","N","20251231"
"3454","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","51672212001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51672-2120","51672-2120-1","51672-2120_1701f87e-c8a3-042d-e063-6394a90a88c3","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","","OTC MONOGRAPH DRUG","M004","Taro Pharmaceuticals U.S.A., Inc.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3455","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","51672212003","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51672-2120","51672-2120-3","51672-2120_1701f87e-c8a3-042d-e063-6394a90a88c3","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","","OTC MONOGRAPH DRUG","M004","Taro Pharmaceuticals U.S.A., Inc.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3456","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","51672212008","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51672-2120","51672-2120-8","51672-2120_1701f87e-c8a3-042d-e063-6394a90a88c3","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","","OTC MONOGRAPH DRUG","M004","Taro Pharmaceuticals U.S.A., Inc.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3457","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","51672212002","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51672-2120","51672-2120-2","51672-2120_1701f87e-c8a3-042d-e063-6394a90a88c3","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","","OTC MONOGRAPH DRUG","M004","Taro Pharmaceuticals U.S.A., Inc.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3458","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","51672212009","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51672-2120","51672-2120-9","51672-2120_1701f87e-c8a3-042d-e063-6394a90a88c3","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","","OTC MONOGRAPH DRUG","M004","Taro Pharmaceuticals U.S.A., Inc.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3459","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","51672212006","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51672-2120","51672-2120-6","51672-2120_1701f87e-c8a3-042d-e063-6394a90a88c3","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","","OTC MONOGRAPH DRUG","M004","Taro Pharmaceuticals U.S.A., Inc.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3460","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","51672214001","Allylamine Antifungal [EPC], Allylamine [CS]","51672-2140","51672-2140-1","51672-2140_20219642-1e02-68be-e063-6394a90a6971","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Taro Pharmaceuticals U.S.A., Inc.","1","g/100g","","N","20251231"
"3461","CLOTRIMAZOLE","Clotrimazole","51672215801","Azole Antifungal [EPC], Azoles [CS]","51672-2158","51672-2158-1","51672-2158_22cc8abd-d3f2-f3bb-e063-6394a90ae7cf","HUMAN OTC DRUG","Clotrimazole","","SOLUTION","TOPICAL","20240923","","OTC MONOGRAPH DRUG","M005","Taro Pharmaceuticals U.S.A., Inc.","1","g/mL","","N","20251231"
"3462","KETOCONAZOLE","Ketoconazole","51672402601","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","51672-4026","51672-4026-1","51672-4026_1910e045-f498-db5e-e063-6394a90a77d4","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","19990615","","ANDA","ANDA075319","Taro Pharmaceuticals U.S.A., Inc.","200","mg/1","","N","20251231"
"3463","KETOCONAZOLE","Ketoconazole","51672402602","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","51672-4026","51672-4026-2","51672-4026_1910e045-f498-db5e-e063-6394a90a77d4","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","19990615","","ANDA","ANDA075319","Taro Pharmaceuticals U.S.A., Inc.","200","mg/1","","N","20251231"
"3464","KETOCONAZOLE","Ketoconazole","51672402606","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","51672-4026","51672-4026-6","51672-4026_1910e045-f498-db5e-e063-6394a90a77d4","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","19990615","","ANDA","ANDA075319","Taro Pharmaceuticals U.S.A., Inc.","200","mg/1","","N","20251231"
"3465","KETOCONAZOLE","Ketoconazole","51672402609","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","51672-4026","51672-4026-9","51672-4026_1910e045-f498-db5e-e063-6394a90a77d4","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","19990615","","ANDA","ANDA075319","Taro Pharmaceuticals U.S.A., Inc.","200","mg/1","","N","20251231"
"3466","KETOCONAZOLE","Ketoconazole","51672402600","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","51672-4026","51672-4026-0","51672-4026_1910e045-f498-db5e-e063-6394a90a77d4","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","19990615","","ANDA","ANDA075319","Taro Pharmaceuticals U.S.A., Inc.","200","mg/1","","N","20251231"
"3467","KETOCONAZOLE","Ketoconazole","51672402608","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","51672-4026","51672-4026-8","51672-4026_1910e045-f498-db5e-e063-6394a90a77d4","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","19990615","","ANDA","ANDA075319","Taro Pharmaceuticals U.S.A., Inc.","200","mg/1","","N","20251231"
"3468","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","51672404806","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","51672-4048","51672-4048-6","51672-4048_694c21f7-c6be-4419-96ce-6c2e84178288","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20010529","","ANDA","ANDA075673","Taro Pharmaceuticals U.S.A., Inc.",".5; 10","mg/g; mg/g","","N","20251231"
"3469","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","51672404801","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","51672-4048","51672-4048-1","51672-4048_694c21f7-c6be-4419-96ce-6c2e84178288","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20010529","","ANDA","ANDA075673","Taro Pharmaceuticals U.S.A., Inc.",".5; 10","mg/g; mg/g","","N","20251231"
"3470","FLUCONAZOLE","Fluconazole","51672406400","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51672-4064","51672-4064-0","51672-4064_28eba790-156e-9ec1-e063-6394a90ae3e4","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20040729","","ANDA","ANDA076507","Taro Pharmaceuticals U.S.A., Inc.","50","mg/1","","N","20251231"
"3471","FLUCONAZOLE","Fluconazole","51672406403","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51672-4064","51672-4064-3","51672-4064_28eba790-156e-9ec1-e063-6394a90ae3e4","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20040729","","ANDA","ANDA076507","Taro Pharmaceuticals U.S.A., Inc.","50","mg/1","","N","20251231"
"3472","FLUCONAZOLE","Fluconazole","51672406406","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51672-4064","51672-4064-6","51672-4064_28eba790-156e-9ec1-e063-6394a90ae3e4","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20040729","","ANDA","ANDA076507","Taro Pharmaceuticals U.S.A., Inc.","50","mg/1","","N","20251231"
"3473","FLUCONAZOLE","Fluconazole","51672406503","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51672-4065","51672-4065-3","51672-4065_28eba790-156e-9ec1-e063-6394a90ae3e4","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20040729","","ANDA","ANDA076507","Taro Pharmaceuticals U.S.A., Inc.","100","mg/1","","N","20251231"
"3474","FLUCONAZOLE","Fluconazole","51672406506","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51672-4065","51672-4065-6","51672-4065_28eba790-156e-9ec1-e063-6394a90ae3e4","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20040729","","ANDA","ANDA076507","Taro Pharmaceuticals U.S.A., Inc.","100","mg/1","","N","20251231"
"3475","FLUCONAZOLE","Fluconazole","51672406500","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51672-4065","51672-4065-0","51672-4065_28eba790-156e-9ec1-e063-6394a90ae3e4","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20040729","","ANDA","ANDA076507","Taro Pharmaceuticals U.S.A., Inc.","100","mg/1","","N","20251231"
"3476","FLUCONAZOLE","Fluconazole","51672406607","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51672-4066","51672-4066-7","51672-4066_28eba790-156e-9ec1-e063-6394a90ae3e4","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20040729","","ANDA","ANDA076507","Taro Pharmaceuticals U.S.A., Inc.","150","mg/1","","N","20251231"
"3477","FLUCONAZOLE","Fluconazole","51672406703","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51672-4067","51672-4067-3","51672-4067_28eba790-156e-9ec1-e063-6394a90ae3e4","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20040729","","ANDA","ANDA076507","Taro Pharmaceuticals U.S.A., Inc.","200","mg/1","","N","20251231"
"3478","FLUCONAZOLE","Fluconazole","51672406706","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51672-4067","51672-4067-6","51672-4067_28eba790-156e-9ec1-e063-6394a90ae3e4","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20040729","","ANDA","ANDA076507","Taro Pharmaceuticals U.S.A., Inc.","200","mg/1","","N","20251231"
"3479","FLUCONAZOLE","Fluconazole","51672406700","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","51672-4067","51672-4067-0","51672-4067_28eba790-156e-9ec1-e063-6394a90ae3e4","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20040729","","ANDA","ANDA076507","Taro Pharmaceuticals U.S.A., Inc.","200","mg/1","","N","20251231"
"3480","CLINDAMYCIN PHOSPHATE","Clindamycin phosphate","51672408103","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS]","51672-4081","51672-4081-3","51672-4081_4a44d53f-dbf0-4667-9911-4761be05aa07","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20040331","","ANDA","ANDA065184","Taro Pharmaceuticals U.S.A., Inc.","10","mg/mL","","N","20251231"
"3481","CLINDAMYCIN PHOSPHATE","Clindamycin phosphate","51672408104","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS]","51672-4081","51672-4081-4","51672-4081_4a44d53f-dbf0-4667-9911-4761be05aa07","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20040331","","ANDA","ANDA065184","Taro Pharmaceuticals U.S.A., Inc.","10","mg/mL","","N","20251231"
"3482","METRONIDAZOLE","metronidazole","51672411602","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51672-4116","51672-4116-2","51672-4116_d5b90aeb-7cd5-48b8-97a5-8d6f3307e2a3","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20060718","","ANDA","ANDA077819","Taro Pharmaceuticals U.S.A., Inc.","7.5","mg/g","","N","20251231"
"3483","METRONIDAZOLE","metronidazole","51672411606","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51672-4116","51672-4116-6","51672-4116_d5b90aeb-7cd5-48b8-97a5-8d6f3307e2a3","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20060718","","ANDA","ANDA077819","Taro Pharmaceuticals U.S.A., Inc.","7.5","mg/g","","N","20251231"
"3484","METRONIDAZOLE","metronidazole","51672411605","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51672-4116","51672-4116-5","51672-4116_d5b90aeb-7cd5-48b8-97a5-8d6f3307e2a3","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20060718","","ANDA","ANDA077819","Taro Pharmaceuticals U.S.A., Inc.","7.5","mg/g","","N","20251231"
"3485","NYSTATIN","Nystatin","51672411700","Polyene Antifungal [EPC], Polyenes [CS]","51672-4117","51672-4117-0","51672-4117_29a58f9e-6262-8297-e063-6294a90ad86d","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","19880229","","ANDA","ANDA062876","Taro Pharmaceuticals U.S.A., Inc.","100000","[USP'U]/mL","","N","20251231"
"3486","NYSTATIN","Nystatin","51672411709","Polyene Antifungal [EPC], Polyenes [CS]","51672-4117","51672-4117-9","51672-4117_29a58f9e-6262-8297-e063-6294a90ad86d","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","19880229","","ANDA","ANDA062876","Taro Pharmaceuticals U.S.A., Inc.","100000","[USP'U]/mL","","N","20251231"
"3487","METRONIDAZOLE","Metronidazole","51672416409","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51672-4164","51672-4164-9","51672-4164_6f4c6a7f-eee9-45b2-b0ed-64377aab9d49","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20170314","","ANDA","ANDA204651","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3488","METRONIDAZOLE","Metronidazole","51672416406","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51672-4164","51672-4164-6","51672-4164_6f4c6a7f-eee9-45b2-b0ed-64377aab9d49","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20170314","","ANDA","ANDA204651","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3489","METRONIDAZOLE","Metronidazole","51672416403","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51672-4164","51672-4164-3","51672-4164_6f4c6a7f-eee9-45b2-b0ed-64377aab9d49","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20170314","","ANDA","ANDA204651","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3490","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","51672419403","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","51672-4194","51672-4194-3","51672-4194_357bd300-1ff2-4c79-8310-21c1da2fd8d8","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","AEROSOL, FOAM","TOPICAL","20221001","","ANDA","ANDA210004","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3491","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","51672419407","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","51672-4194","51672-4194-7","51672-4194_357bd300-1ff2-4c79-8310-21c1da2fd8d8","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","AEROSOL, FOAM","TOPICAL","20221001","","ANDA","ANDA210004","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3492","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN MONOHYDRATE","51672420007","Macrolide Antimicrobial [EPC], Macrolides [CS]","51672-4200","51672-4200-7","51672-4200_29a5a45b-90f9-342f-e063-6294a90a785d","HUMAN PRESCRIPTION DRUG","Azithromycin","","SUSPENSION","ORAL","20191211","","ANDA","ANDA211521","Taro Pharmaceuticals U.S.A., Inc.","200","mg/5mL","","N","20251231"
"3493","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN MONOHYDRATE","51672420003","Macrolide Antimicrobial [EPC], Macrolides [CS]","51672-4200","51672-4200-3","51672-4200_29a5a45b-90f9-342f-e063-6294a90a785d","HUMAN PRESCRIPTION DRUG","Azithromycin","","SUSPENSION","ORAL","20191211","","ANDA","ANDA211521","Taro Pharmaceuticals U.S.A., Inc.","200","mg/5mL","","N","20251231"
"3494","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN MONOHYDRATE","51672420005","Macrolide Antimicrobial [EPC], Macrolides [CS]","51672-4200","51672-4200-5","51672-4200_29a5a45b-90f9-342f-e063-6294a90a785d","HUMAN PRESCRIPTION DRUG","Azithromycin","","SUSPENSION","ORAL","20191211","","ANDA","ANDA211521","Taro Pharmaceuticals U.S.A., Inc.","200","mg/5mL","","N","20251231"
"3495","METRONIDAZOLE","Metronidazole","51672421503","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51672-4215","51672-4215-3","51672-4215_a0569c03-e6a4-4bc0-8c9d-f2f84f24cf2a","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20190409","","ANDA","ANDA204651","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3496","METRONIDAZOLE","Metronidazole","51672421506","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51672-4215","51672-4215-6","51672-4215_a0569c03-e6a4-4bc0-8c9d-f2f84f24cf2a","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20190409","","ANDA","ANDA204651","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3497","METRONIDAZOLE","Metronidazole","51672421509","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","51672-4215","51672-4215-9","51672-4215_a0569c03-e6a4-4bc0-8c9d-f2f84f24cf2a","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20190409","","ANDA","ANDA204651","Taro Pharmaceuticals U.S.A., Inc.","10","mg/g","","N","20251231"
"3498","GANCICLOVIR","GANCICLOVIR","51754250003","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","51754-2500","51754-2500-3","51754-2500_238a983f-81bb-4033-b6ca-5fee7d6d291c","HUMAN PRESCRIPTION DRUG","GANCICLOVIR","","INJECTION, SOLUTION","INTRAVENOUS","20170228","","NDA","NDA209347","EXELA PHARMA SCIENCES, LLC","2","mg/mL","","N","20251231"
"3499","GANCICLOVIR","GANCICLOVIR","51754250001","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","51754-2500","51754-2500-1","51754-2500_238a983f-81bb-4033-b6ca-5fee7d6d291c","HUMAN PRESCRIPTION DRUG","GANCICLOVIR","","INJECTION, SOLUTION","INTRAVENOUS","20170228","","NDA","NDA209347","EXELA PHARMA SCIENCES, LLC","2","mg/mL","","N","20251231"
"3500","MEROPENEM","Meropenem","51810050202","Carbapenems [CS], Penem Antibacterial [EPC]","51810-502","51810-502-02","51810-502_716455a3-125c-4510-8639-8889479c1e4d","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20241230","","ANDA","ANDA216424","Qilu Antibiotics Pharmaceutical Co., Ltd.","500","mg/20mL","","N","20261231"
"3501","MEROPENEM","Meropenem","51810050302","Carbapenems [CS], Penem Antibacterial [EPC]","51810-503","51810-503-02","51810-503_716455a3-125c-4510-8639-8889479c1e4d","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20241230","","ANDA","ANDA216424","Qilu Antibiotics Pharmaceutical Co., Ltd.","1","g/30mL","","N","20261231"
"3502","ERTAPENEM SODIUM","ertapenem sodium","51810050402","Carbapenems [CS], Penem Antibacterial [EPC]","51810-504","51810-504-02","51810-504_f098625e-79c1-47cd-ae64-b8f623019356","HUMAN PRESCRIPTION DRUG","Ertapenem","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20241031","","ANDA","ANDA218067","Qilu Antibiotics Pharmaceutical Co., Ltd.","1","g/1","","N","20261231"
"3503","GANCICLOVIR SODIUM","ganciclovir sodium","51817017101","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","51817-171","51817-171-01","51817-171_f05916fd-4785-f545-e053-2995a90aa901","HUMAN PRESCRIPTION DRUG","Ganciclovir","","INJECTION, SOLUTION","INTRAVENOUS","20180424","","ANDA","ANDA207645","Pharmascience Inc.","500","mg/10mL","","N","20251231"
"3504","GANCICLOVIR SODIUM","ganciclovir sodium","51817017102","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","51817-171","51817-171-02","51817-171_f05916fd-4785-f545-e053-2995a90aa901","HUMAN PRESCRIPTION DRUG","Ganciclovir","","INJECTION, SOLUTION","INTRAVENOUS","20180424","","ANDA","ANDA207645","Pharmascience Inc.","500","mg/10mL","","N","20251231"
"3505","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate","51824005201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51824-052","51824-052-01","51824-052_fa69af19-a36d-4de2-9586-b7c257ae552f","HUMAN OTC DRUG","CareALL Triple Antibiotic","","OINTMENT","TOPICAL","20160315","","OTC MONOGRAPH DRUG","M004","New World Imports, Inc","400; 5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3506","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate","51824005214","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51824-052","51824-052-14","51824-052_fa69af19-a36d-4de2-9586-b7c257ae552f","HUMAN OTC DRUG","CareALL Triple Antibiotic","","OINTMENT","TOPICAL","20160315","","OTC MONOGRAPH DRUG","M004","New World Imports, Inc","400; 5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3507","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate","51824005225","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51824-052","51824-052-25","51824-052_fa69af19-a36d-4de2-9586-b7c257ae552f","HUMAN OTC DRUG","CareALL Triple Antibiotic","","OINTMENT","TOPICAL","20160315","","OTC MONOGRAPH DRUG","M004","New World Imports, Inc","400; 5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3508","CLOTRIMAZOLE","Clotrimazole","51824006301","Azole Antifungal [EPC], Azoles [CS]","51824-063","51824-063-01","51824-063_1b131084-a996-4923-9a06-f6f19072ade2","HUMAN OTC DRUG","CAREALL Clotrimazole","","CREAM","TOPICAL","20160321","20270401","OTC MONOGRAPH DRUG","M005","New World Imports, Inc","10","g/g","","N",""
"3509","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine HCl","51824007401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","51824-074","51824-074-01","51824-074_e39e2d7f-8cd0-4d9d-a401-5db982a485cd","HUMAN OTC DRUG","CareALL Triple Antibiotic plus Pain Relief","","OINTMENT","TOPICAL","20190902","","OTC MONOGRAPH DRUG","M004","New World Imports, Inc","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"3510","MICONAZOLE NITRATE","Miconazole Nitrate","51824007801","Azole Antifungal [EPC], Azoles [CS]","51824-078","51824-078-01","51824-078_43eb74b9-a618-4048-9568-456e3a5ebf66","HUMAN OTC DRUG","CAREALL Miconazole Nitrate","","CREAM","TOPICAL","20201201","","OTC MONOGRAPH DRUG","M005","New World Imports, Inc","20","mg/g","","N","20251231"
"3511","CLOTRIMAZOLE","Clotrimazole","51824009301","Azole Antifungal [EPC], Azoles [CS]","51824-093","51824-093-01","51824-093_d24fd08c-0fd6-4d43-ad4e-863172b4ad96","HUMAN OTC DRUG","CAREALL Clotrimazole","","CREAM","TOPICAL","20220701","","OTC MONOGRAPH DRUG","M005","New World Imports, Inc","10","mg/g","","N","20251231"
"3512","ITRACONAZOLE","Itraconazole","51862046260","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","51862-462","51862-462-60","51862-462_2a3303f1-eee7-4c07-9532-e153be149369","HUMAN PRESCRIPTION DRUG","Tolsura","","CAPSULE, GELATIN COATED","ORAL","20181211","","NDA","NDA208901","Mayne Pharma Commercial LLC","65","mg/1","","N","20261231"
"3513","TRIMETHOPRIM","Trimethoprim","51862048601","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]","51862-486","51862-486-01","51862-486_f26c56ff-9afc-47cc-a94a-974bf8f5039f","HUMAN PRESCRIPTION DRUG","Trimethoprim","","TABLET","ORAL","20160718","","NDA","NDA018679","Mayne Pharma","100","mg/1","","N","20251231"
"3514","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","51991052601","Allylamine Antifungal [EPC], Allylamine [CS]","51991-526","51991-526-01","51991-526_1603cd34-5cf4-4130-966f-c156d9237346","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Breckenridge Pharmaceutical, Inc.","250","mg/1","","N","20251231"
"3515","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","51991090601","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","51991-906","51991-906-01","51991-906_cb02d9ed-d0da-4e98-a3e1-7533475ebfcf","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Breckenridge Pharmaceutical, Inc.","250","mg/1","","N","20251231"
"3516","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","51991090605","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","51991-906","51991-906-05","51991-906_cb02d9ed-d0da-4e98-a3e1-7533475ebfcf","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Breckenridge Pharmaceutical, Inc.","250","mg/1","","N","20251231"
"3517","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","51991090633","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","51991-906","51991-906-33","51991-906_cb02d9ed-d0da-4e98-a3e1-7533475ebfcf","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Breckenridge Pharmaceutical, Inc.","250","mg/1","","N","20251231"
"3518","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","51991090705","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","51991-907","51991-907-05","51991-907_cb02d9ed-d0da-4e98-a3e1-7533475ebfcf","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Breckenridge Pharmaceutical, Inc.","500","mg/1","","N","20251231"
"3519","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","51991090733","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","51991-907","51991-907-33","51991-907_cb02d9ed-d0da-4e98-a3e1-7533475ebfcf","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Breckenridge Pharmaceutical, Inc.","500","mg/1","","N","20251231"
"3520","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","51991090701","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","51991-907","51991-907-01","51991-907_cb02d9ed-d0da-4e98-a3e1-7533475ebfcf","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Breckenridge Pharmaceutical, Inc.","500","mg/1","","N","20251231"
"3521","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin Hydrochloride","51991094333","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","51991-943","51991-943-33","51991-943_a6819fae-6e10-4be8-bfcc-3242e2cf6ad7","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride","","TABLET","ORAL","20170502","20250731","ANDA","ANDA205348","Breckenridge Pharmaceutical, Inc.","400","mg/1","","N",""
"3522","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin and Polymyxin B Sulfate","52000001937","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","52000-019","52000-019-37","52000-019_13e174d7-c03d-4a6d-a87d-3dd6da60524f","HUMAN OTC DRUG","Triple Antibiotic First Aid","","OINTMENT","TOPICAL","20150415","","OTC MONOGRAPH DRUG","M004","Universal Distribution Center LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3523","MICONAZOLE NITRATE","Miconazole Nitrate","52000002141","Azole Antifungal [EPC], Azoles [CS]","52000-021","52000-021-41","52000-021_18f39e0a-6734-31b9-e063-6294a90a7204","HUMAN OTC DRUG","Anti-Fungal","","CREAM","TOPICAL","20150415","","OTC MONOGRAPH DRUG","M005","Universal Distribution Center LLC",".02","g/g","","N","20251231"
"3524","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin and Polymyxin B Sulfate","52000005602","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","52000-056","52000-056-02","52000-056_186bb36e-3111-102e-e063-6294a90ae729","HUMAN OTC DRUG","Triple Antibiotic First Aid Antibiotic","","OINTMENT","TOPICAL","20201209","","OTC MONOGRAPH DRUG","M004","Universal Distribution Center LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3525","MICONAZOLE NITRATE","Miconazole Nitrate","52000006101","Azole Antifungal [EPC], Azoles [CS]","52000-061","52000-061-01","52000-061_abef15f7-3144-49c0-8131-138668561d54","HUMAN OTC DRUG","Anti-Fungal","","CREAM","TOPICAL","20201209","","OTC MONOGRAPH DRUG","M005","Universal Distribution Center LLC",".02","g/g","","N","20251231"
"3526","FIDAXOMICIN","fidaxomicin","52015008001","Macrolide Antibacterial [EPC], Macrolides [CS]","52015-080","52015-080-01","52015-080_207669ad-d687-4b94-af2c-6b09470ff2e0","HUMAN PRESCRIPTION DRUG","Dificid","","TABLET, FILM COATED","ORAL","20110527","","NDA","NDA201699","Merck Sharp & Dohme LLC","200","mg/1","","N","20251231"
"3527","FIDAXOMICIN","FIDAXOMICIN","52015070022","Macrolide Antibacterial [EPC], Macrolides [CS]","52015-700","52015-700-22","52015-700_207669ad-d687-4b94-af2c-6b09470ff2e0","HUMAN PRESCRIPTION DRUG","DIFICID","","GRANULE, FOR SUSPENSION","ORAL","20200218","","NDA","NDA213138","Merck Sharp & Dohme LLC","200","mg/5mL","","N","20251231"
"3528","SULFACETAMIDE SODIUM; SULFUR","sodium sulfacetamide, sulfur","52187053016","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","52187-530","52187-530-16","52187-530_b7123c28-8647-1526-e053-2a95a90a6ec3","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE, SULFUR","","LIQUID","TOPICAL","20190130","","UNAPPROVED DRUG OTHER","","KMM Pharmaceuticals, LLC","90; 40","mg/mL; mg/mL","","N","20251231"
"3529","SULFACETAMIDE SODIUM; SULFUR","SODIUM SULFACETAMIDE, SULFUR","52187053116","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","52187-531","52187-531-16","52187-531_a6185774-2622-4f52-e053-2995a90a42c0","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE, SULFUR","","SUSPENSION","TOPICAL","20200520","","UNAPPROVED DRUG OTHER","","KMM Pharmaceuticals, LLC","80; 40","mg/mL; mg/mL","","N","20251231"
"3530","SULFACETAMIDE SODIUM; SULFUR","SODIUM SULFACETAMIDE, SULFUR","52187053612","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","52187-536","52187-536-12","52187-536_ba0fc821-1fc3-20f9-e053-2a95a90ad977","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE, SULFUR","","RINSE","TOPICAL","20210129","","UNAPPROVED DRUG OTHER","","KMM Pharmaceuticals, LLC","100; 50","mg/g; mg/g","","N","20251231"
"3531","SULFACETAMIDE SODIUM; SULFUR","SODIUM SULFACETAMIDE, SULFUR","52187053606","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","52187-536","52187-536-06","52187-536_ba0fc821-1fc3-20f9-e053-2a95a90ad977","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE, SULFUR","","RINSE","TOPICAL","20210129","","UNAPPROVED DRUG OTHER","","KMM Pharmaceuticals, LLC","100; 50","mg/g; mg/g","","N","20251231"
"3532","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","52187054610","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","52187-546","52187-546-10","52187-546_db857027-0176-e452-e053-2995a90a4df5","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser","","LIQUID","TOPICAL","20220331","","UNAPPROVED DRUG OTHER","","KMM Pharmaceuticals, LLC","98; 48","mg/g; mg/g","","N","20251231"
"3533","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","52187054702","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","52187-547","52187-547-02","52187-547_d916e437-366b-c00d-e053-2995a90ace0c","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM, SULFUR","","CREAM","TOPICAL","20220228","","UNAPPROVED DRUG OTHER","","KMM Pharmaceuticals, LLC","98; 48","mg/g; mg/g","","N","20251231"
"3534","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","52187054802","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","52187-548","52187-548-02","52187-548_db841a96-42cc-6ff6-e053-2995a90a7cca","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM, SULFUR","","LOTION","TOPICAL","20220331","","UNAPPROVED DRUG OTHER","","KMM Pharmaceuticals, LLC","98; 48","mg/g; mg/g","","N","20251231"
"3535","SULFACETAMIDE SODIUM","SULFACETAMIDE SODIUM","52187055308","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","52187-553","52187-553-08","52187-553_d7fc8def-53f9-56c1-e053-2995a90a2434","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM","","SHAMPOO","TOPICAL","20211006","","UNAPPROVED DRUG OTHER","","KMM Pharmaceuticals, LLC","98","mg/mL","","N","20251231"
"3536","CLOTRIMAZOLE","Clotrimazole","52389060060","Azole Antifungal [EPC], Azoles [CS]","52389-600","52389-600-60","52389-600_25a4090d-8c5b-b8d8-e063-6294a90a8119","HUMAN OTC DRUG","Fungicure","Intensive","LIQUID","TOPICAL","20080605","","OTC MONOGRAPH DRUG","M005","Kobayashi Healthcare International, Inc.","10","mg/mL","","N","20251231"
"3537","CLOTRIMAZOLE","Clotrimazole","52389064709","Azole Antifungal [EPC], Azoles [CS]","52389-647","52389-647-09","52389-647_188554bd-f678-11ea-e063-6394a90af34e","HUMAN OTC DRUG","Fungicure Manicure Pedicure Liquid Gel","","GEL","TOPICAL","20160705","","OTC MONOGRAPH DRUG","M005","Alva-Amco Pharmacal Companies, Inc.","10","mg/g","","N","20251231"
"3538","CLOTRIMAZOLE","Clotrimazole","52389073309","Azole Antifungal [EPC], Azoles [CS]","52389-733","52389-733-09","52389-733_17f8ab3c-eeb2-fdef-e063-6294a90a4290","HUMAN OTC DRUG","Fungicure Liquid Gel","","GEL","TOPICAL","20151231","","OTC MONOGRAPH DRUG","M005","Alva-Amco Pharmacal Companies, Inc.","10","mg/g","","N","20251231"
"3539","CLOTRIMAZOLE","Clotrimazole","52410302404","Azole Antifungal [EPC], Azoles [CS]","52410-3024","52410-3024-4","52410-3024_228fd50f-b2e4-f63d-e063-6394a90a774b","HUMAN OTC DRUG","Clotrimazole 1%","Athletes Foot","CREAM","TOPICAL","20200304","","OTC MONOGRAPH DRUG","M005","Shield Line LLC","10","mg/g","","N","20251231"
"3540","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate","52410302502","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","52410-3025","52410-3025-2","52410-3025_228f73f8-9c18-87f8-e063-6294a90a0349","HUMAN OTC DRUG","Medpride","First Aid","OINTMENT","TOPICAL","20130517","","OTC MONOGRAPH DRUG","M004","Shield Line LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3541","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate","52410302503","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","52410-3025","52410-3025-3","52410-3025_228f73f8-9c18-87f8-e063-6294a90a0349","HUMAN OTC DRUG","Medpride","First Aid","OINTMENT","TOPICAL","20130517","","OTC MONOGRAPH DRUG","M004","Shield Line LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3542","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate","52410302505","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","52410-3025","52410-3025-5","52410-3025_228f73f8-9c18-87f8-e063-6294a90a0349","HUMAN OTC DRUG","Medpride","First Aid","OINTMENT","TOPICAL","20130517","","OTC MONOGRAPH DRUG","M004","Shield Line LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3543","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate","52410302504","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","52410-3025","52410-3025-4","52410-3025_228f73f8-9c18-87f8-e063-6294a90a0349","HUMAN OTC DRUG","Medpride","First Aid","OINTMENT","TOPICAL","20130517","","OTC MONOGRAPH DRUG","M004","Shield Line LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3544","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystalline","52427028501","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","52427-285","52427-285-01","52427-285_d1c49355-7925-8f7f-1aa4-7ee4a32b6623","HUMAN PRESCRIPTION DRUG","Macrobid","","CAPSULE","ORAL","20110531","","NDA","NDA020064","Almatica Pharma LLC","25; 75","mg/1; mg/1","","N","20251231"
"3545","NITROFURANTOIN","Nitrofurantoin macrocrystals","52427028601","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","52427-286","52427-286-01","52427-286_b5fcd4ec-ceb2-b539-85ad-2247ba54bb6b","HUMAN PRESCRIPTION DRUG","Macrodantin","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Almatica Pharma LLC","25","mg/1","","N","20251231"
"3546","NITROFURANTOIN","Nitrofurantoin macrocrystals","52427028701","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","52427-287","52427-287-01","52427-287_b5fcd4ec-ceb2-b539-85ad-2247ba54bb6b","HUMAN PRESCRIPTION DRUG","Macrodantin","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Almatica Pharma LLC","50","mg/1","","N","20251231"
"3547","NITROFURANTOIN","Nitrofurantoin macrocrystals","52427028801","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","52427-288","52427-288-01","52427-288_b5fcd4ec-ceb2-b539-85ad-2247ba54bb6b","HUMAN PRESCRIPTION DRUG","Macrodantin","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Almatica Pharma LLC","100","mg/1","","N","20251231"
"3548","ERYTHROMYCIN","Erythromycin","52536010303","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","52536-103","52536-103-03","52536-103_f9275e3a-b44f-4839-989c-ee88d44eef46","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20180315","","ANDA","ANDA061621","Wilshire Pharmaceuticals","250","mg/1","","N","20251231"
"3549","ERYTHROMYCIN","Erythromycin","52536010313","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","52536-103","52536-103-13","52536-103_f9275e3a-b44f-4839-989c-ee88d44eef46","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20180315","","ANDA","ANDA061621","Wilshire Pharmaceuticals","250","mg/1","","N","20251231"
"3550","ERYTHROMYCIN","Erythromycin","52536010513","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","52536-105","52536-105-13","52536-105_f9275e3a-b44f-4839-989c-ee88d44eef46","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20180315","","ANDA","ANDA061621","Wilshire Pharmaceuticals","500","mg/1","","N","20251231"
"3551","ERYTHROMYCIN","Erythromycin","52536010503","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","52536-105","52536-105-03","52536-105_f9275e3a-b44f-4839-989c-ee88d44eef46","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20180315","","ANDA","ANDA061621","Wilshire Pharmaceuticals","500","mg/1","","N","20251231"
"3552","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","52536013013","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","52536-130","52536-130-13","52536-130_240e9111-2531-403a-bbd3-161d87185b1e","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN ETHYLSUCCINATE","","SUSPENSION","ORAL","20190325","","NDA","NDA050207","Wilshire Pharmaceuticals","400","mg/5mL","","N","20251231"
"3553","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","52536013213","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","52536-132","52536-132-13","52536-132_240e9111-2531-403a-bbd3-161d87185b1e","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN ETHYLSUCCINATE","","SUSPENSION","ORAL","20200824","","NDA","NDA050207","Wilshire Pharmaceuticals","200","mg/5mL","","N","20251231"
"3554","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","52536013413","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","52536-134","52536-134-13","52536-134_98a85646-cc9b-429f-9b46-4a3ce1b5c129","HUMAN PRESCRIPTION DRUG","Erythromycin Ethylsuccinate","","GRANULE, FOR SUSPENSION","ORAL","20160928","","NDA","NDA050207","Wilshire Pharmaceuticals Inc.","200","mg/5mL","","N","20251231"
"3555","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","52536013613","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","52536-136","52536-136-13","52536-136_98a85646-cc9b-429f-9b46-4a3ce1b5c129","HUMAN PRESCRIPTION DRUG","Erythromycin Ethylsuccinate","","GRANULE, FOR SUSPENSION","ORAL","20160928","","NDA","NDA050207","Wilshire Pharmaceuticals Inc.","200","mg/5mL","","N","20251231"
"3556","ERYTHROMYCIN","Erythromycin","52536018003","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","52536-180","52536-180-03","52536-180_292b4c82-0b72-5283-e063-6394a90ad2ac","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, DELAYED RELEASE","ORAL","20190722","","ANDA","ANDA062298","Wilshire Pharmaceuticals","250","mg/1","","N","20251231"
"3557","ERYTHROMYCIN","Erythromycin","52536018010","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","52536-180","52536-180-10","52536-180_292b4c82-0b72-5283-e063-6394a90ad2ac","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, DELAYED RELEASE","ORAL","20190722","","ANDA","ANDA062298","Wilshire Pharmaceuticals","250","mg/1","","N","20251231"
"3558","ERYTHROMYCIN","Erythromycin","52536018310","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","52536-183","52536-183-10","52536-183_292b4c82-0b72-5283-e063-6394a90ad2ac","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, DELAYED RELEASE","ORAL","20190722","","ANDA","ANDA062298","Wilshire Pharmaceuticals","333","mg/1","","N","20251231"
"3559","ERYTHROMYCIN","Erythromycin","52536018303","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","52536-183","52536-183-03","52536-183_292b4c82-0b72-5283-e063-6394a90ad2ac","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, DELAYED RELEASE","ORAL","20190722","","ANDA","ANDA062298","Wilshire Pharmaceuticals","333","mg/1","","N","20251231"
"3560","ERYTHROMYCIN","Erythromycin","52536018603","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","52536-186","52536-186-03","52536-186_292b4c82-0b72-5283-e063-6394a90ad2ac","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, DELAYED RELEASE","ORAL","20190722","","ANDA","ANDA062298","Wilshire Pharmaceuticals","500","mg/1","","N","20251231"
"3561","ERYTHROMYCIN","Erythromycin","52536018610","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","52536-186","52536-186-10","52536-186_292b4c82-0b72-5283-e063-6394a90ad2ac","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, DELAYED RELEASE","ORAL","20190722","","ANDA","ANDA062298","Wilshire Pharmaceuticals","500","mg/1","","N","20251231"
"3562","CLOTRIMAZOLE","Clotrimazole Topical Solution USP, 1%","52817080030","Azole Antifungal [EPC], Azoles [CS]","52817-800","52817-800-30","52817-800_ed514fee-9f8f-4262-86c5-d632dca0d9b8","HUMAN PRESCRIPTION DRUG","Clotrimazole Topical Solution USP, 1%","","SOLUTION","TOPICAL","20190725","","ANDA","ANDA212281","TruPharma LLC","10","mg/mL","","N","20251231"
"3563","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc, Polymyxin B Sulfate","53145030404","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","53145-304","53145-304-04","53145-304_2b362c67-d115-fb81-e063-6394a90aeb65","HUMAN OTC DRUG","Polvos de Sulpha","First Aid Antibiotic","POWDER","TOPICAL","20061211","","OTC MONOGRAPH DRUG","M004","Menper Distributors Inc.","500; 10000","[USP'U]/g; [USP'U]/g","","N","20261231"
"3564","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin, neomycin, polymyxin B, pramoxine hydrochloride","53329003101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","53329-031","53329-031-01","53329-031_27d45d53-49b5-6478-e063-6394a90acc72","HUMAN OTC DRUG","Curad Maximum Strength Triple Antibiotic","","OINTMENT","TOPICAL","20191201","","OTC MONOGRAPH DRUG","M004","Medline Industries, LP","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"3565","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin B sulfate","53329008796","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","53329-087","53329-087-96","53329-087_2850a74e-12a3-88d3-e063-6394a90a831b","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20180101","","OTC MONOGRAPH DRUG","M004","Medline Industries, LP","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3566","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin B sulfate","53329008701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","53329-087","53329-087-01","53329-087_2850a74e-12a3-88d3-e063-6394a90a831b","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20180101","","OTC MONOGRAPH DRUG","M004","Medline Industries, LP","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3567","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin B sulfate","53329008787","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","53329-087","53329-087-87","53329-087_2850a74e-12a3-88d3-e063-6394a90a831b","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20180101","","OTC MONOGRAPH DRUG","M004","Medline Industries, LP","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3568","MICONAZOLE NITRATE","miconazole nitrate","53329014744","Azole Antifungal [EPC], Azoles [CS]","53329-147","53329-147-44","53329-147_0d997d1d-8664-201f-e063-6394a90a285e","HUMAN OTC DRUG","Medline","","CREAM","TOPICAL","20230801","","OTC MONOGRAPH DRUG","M005","Medline Industries, LP","20","mg/mL","","N","20251231"
"3569","MICONAZOLE NITRATE","Miconazole Nitrate","53329016204","Azole Antifungal [EPC], Azoles [CS]","53329-162","53329-162-04","53329-162_21612597-34b4-7f04-e063-6294a90aac2d","HUMAN OTC DRUG","Remedy Antifungal","With Olivamine","CREAM","TOPICAL","20070101","","OTC MONOGRAPH DRUG","M005","Medline Industries, LP","2","g/100g","","N","20251231"
"3570","MICONAZOLE NITRATE","Miconazole Nitrate","53329016979","Azole Antifungal [EPC], Azoles [CS]","53329-169","53329-169-79","53329-169_240d63a6-5b9d-ceb3-e063-6394a90aff4d","HUMAN OTC DRUG","Remedy Antifungal","","POWDER","TOPICAL","20121119","","OTC MONOGRAPH DRUG","M005","Medline Industries, LP","2","g/100g","","N","20251231"
"3571","MICONAZOLE NITRATE","Miconazole Nitrate","53329017110","Azole Antifungal [EPC], Azoles [CS]","53329-171","53329-171-10","53329-171_10198f85-ea69-f655-e063-6294a90a3ce3","HUMAN OTC DRUG","Remedy with Phytoplex","","OINTMENT","TOPICAL","20160411","20251130","OTC MONOGRAPH DRUG","M005","Medline Industries, LP","2","g/100g","","N",""
"3572","MICONAZOLE NITRATE","miconazol nitrate","53329017210","Azole Antifungal [EPC], Azoles [CS]","53329-172","53329-172-10","53329-172_1019b6bd-5a4a-1999-e063-6294a90a8929","HUMAN OTC DRUG","Medline","","OINTMENT","TOPICAL","20240101","","OTC MONOGRAPH DRUG","M005","Medline Industries, LP","2","g/100g","","N","20251231"
"3573","MICONAZOLE NITRATE","Miconazole nitrate","53329021844","Azole Antifungal [EPC], Azoles [CS]","53329-218","53329-218-44","53329-218_23fc754d-37f6-aaea-e063-6294a90a1f7d","HUMAN OTC DRUG","Medline","","CREAM","TOPICAL","20241001","","OTC MONOGRAPH DRUG","M005","Medline Industries, LP","20","mg/100g","","N","20251231"
"3574","MICONAZOLE NITRATE","miconazole nitrate","53329077414","Azole Antifungal [EPC], Azoles [CS]","53329-774","53329-774-14","53329-774_1c481f65-6f87-e7a8-e063-6294a90a8c30","HUMAN OTC DRUG","Aloe Vesta","","OINTMENT","TOPICAL","20200930","20251130","OTC MONOGRAPH DRUG","M005","Medline Industries, LP","2","g/100g","","N",""
"3575","MICONAZOLE NITRATE","miconazole nitrate","53329077464","Azole Antifungal [EPC], Azoles [CS]","53329-774","53329-774-64","53329-774_1c481f65-6f87-e7a8-e063-6294a90a8c30","HUMAN OTC DRUG","Aloe Vesta","","OINTMENT","TOPICAL","20200930","20251130","OTC MONOGRAPH DRUG","M005","Medline Industries, LP","2","g/100g","","N",""
"3576","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","53489014501","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","53489-145","53489-145-01","53489-145_31dd7abe-e7f2-10df-e063-6394a90a93e2","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","19860825","","ANDA","ANDA071017","Sun Pharmaceutical Industries, Inc.","400; 80","mg/1; mg/1","","N","20261231"
"3577","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","53489014505","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","53489-145","53489-145-05","53489-145_31dd7abe-e7f2-10df-e063-6394a90a93e2","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","19860825","","ANDA","ANDA071017","Sun Pharmaceutical Industries, Inc.","400; 80","mg/1; mg/1","","N","20261231"
"3578","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","53489014601","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","53489-146","53489-146-01","53489-146_31dd7abe-e7f2-10df-e063-6394a90a93e2","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","19860825","","ANDA","ANDA071017","Sun Pharmaceutical Industries, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"3579","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","53489014605","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","53489-146","53489-146-05","53489-146_31dd7abe-e7f2-10df-e063-6394a90a93e2","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","19860825","","ANDA","ANDA071017","Sun Pharmaceutical Industries, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"3580","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","53746027101","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","53746-271","53746-271-01","53746-271_bc5fe496-071b-4c25-95da-14c6c561e79e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100225","","ANDA","ANDA076899","Amneal Pharmaceuticals of New York LLC","400; 80","mg/1; mg/1","","N","20261231"
"3581","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","53746027105","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","53746-271","53746-271-05","53746-271_bc5fe496-071b-4c25-95da-14c6c561e79e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100225","","ANDA","ANDA076899","Amneal Pharmaceuticals of New York LLC","400; 80","mg/1; mg/1","","N","20261231"
"3582","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","53746027150","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","53746-271","53746-271-50","53746-271_bc5fe496-071b-4c25-95da-14c6c561e79e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100225","","ANDA","ANDA076899","Amneal Pharmaceuticals of New York LLC","400; 80","mg/1; mg/1","","N","20261231"
"3583","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","53746027110","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","53746-271","53746-271-10","53746-271_bc5fe496-071b-4c25-95da-14c6c561e79e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100225","","ANDA","ANDA076899","Amneal Pharmaceuticals of New York LLC","400; 80","mg/1; mg/1","","N","20261231"
"3584","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","53746027201","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","53746-272","53746-272-01","53746-272_bc5fe496-071b-4c25-95da-14c6c561e79e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Amneal Pharmaceuticals of New York LLC","800; 160","mg/1; mg/1","","N","20261231"
"3585","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","53746027202","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","53746-272","53746-272-02","53746-272_bc5fe496-071b-4c25-95da-14c6c561e79e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Amneal Pharmaceuticals of New York LLC","800; 160","mg/1; mg/1","","N","20261231"
"3586","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","53746027205","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","53746-272","53746-272-05","53746-272_bc5fe496-071b-4c25-95da-14c6c561e79e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Amneal Pharmaceuticals of New York LLC","800; 160","mg/1; mg/1","","N","20261231"
"3587","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","53746027224","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","53746-272","53746-272-24","53746-272_bc5fe496-071b-4c25-95da-14c6c561e79e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Amneal Pharmaceuticals of New York LLC","800; 160","mg/1; mg/1","","N","20261231"
"3588","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","53746027211","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","53746-272","53746-272-11","53746-272_bc5fe496-071b-4c25-95da-14c6c561e79e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Amneal Pharmaceuticals of New York LLC","800; 160","mg/1; mg/1","","N","20261231"
"3589","CLINDAMYCIN PALMITATE HYDROCHLORIDE","Clindamycin Palmitate Hydrochloride","53746046819","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","53746-468","53746-468-19","53746-468_b9016023-7843-48e3-8ff6-2e5a70aa5daf","HUMAN PRESCRIPTION DRUG","Clindamycin Palmitate Hydrochloride","(Pediatric)","POWDER, FOR SOLUTION","ORAL","20240401","","ANDA","ANDA203513","Amneal Pharmaceuticals of New York LLC","75","mg/5mL","","N","20251231"
"3590","DEMECLOCYCLINE HYDROCHLORIDE","Demeclocycline","53746055401","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","53746-554","53746-554-01","53746-554_bd37276e-8e9f-48ec-9565-a83a5a4f9aea","HUMAN PRESCRIPTION DRUG","Demeclocycline Hydrochloride","","TABLET","ORAL","20220525","","ANDA","ANDA065425","Amneal Pharmaceuticals of New York LLC","150","mg/1","","N","20251231"
"3591","DEMECLOCYCLINE HYDROCHLORIDE","Demeclocycline","53746055548","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","53746-555","53746-555-48","53746-555_bd37276e-8e9f-48ec-9565-a83a5a4f9aea","HUMAN PRESCRIPTION DRUG","Demeclocycline Hydrochloride","","TABLET","ORAL","20220525","","ANDA","ANDA065425","Amneal Pharmaceuticals of New York LLC","300","mg/1","","N","20251231"
"3592","CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE","Ciprofloxacin and Dexamethasone","53746083153","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","53746-831","53746-831-53","53746-831_718cd533-d887-4ef1-a7d0-fca696242bb2","HUMAN PRESCRIPTION DRUG","Ciprofloxacin and Dexamethasone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","20240326","","ANDA","ANDA216501","Amneal Pharmaceuticals of New York LLC","3; 1","mg/mL; mg/mL","","N","20251231"
"3593","MICONAZOLE NITRATE","Anti-fungal Powder Miconazole Nitrate Talc Free","53943012025","Azole Antifungal [EPC], Azoles [CS]","53943-120","53943-120-25","53943-120_289f7173-f079-0d23-e063-6394a90a4559","HUMAN OTC DRUG","Miconazole Nitrate","","POWDER","TOPICAL","20180212","20260228","OTC MONOGRAPH DRUG","M005","Discount Drug Mart","1.42","g/71g","","N",""
"3594","MICONAZOLE NITRATE","Anti-fungal Powder Miconazole Nitrate Talc Free","53943097601","Azole Antifungal [EPC], Azoles [CS]","53943-976","53943-976-01","53943-976_37790c01-bbb0-8aa8-e063-6394a90af230","HUMAN OTC DRUG","Miconazole Nitrate","","POWDER","TOPICAL","20250603","","OTC MONOGRAPH DRUG","M005","Discount Drug Mart, Inc","20","mg/g","","N","20261231"
"3595","NEOMYCIN SULFATE","NEOMYCIN SULFATE","54312001935","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","54312-019","54312-019-35","54312-019_374ee359-e33b-31d5-e063-6394a90a3ee6","HUMAN OTC DRUG","VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC","","OINTMENT","TOPICAL","20160730","","OTC MONOGRAPH DRUG","M004","Compania Internacional de Comercio, S.A.P.I de C.V.","3.5","mg/g","","N","20261231"
"3596","NEOMYCIN SULFATE","NEOMYCIN SULFATE","54312001931","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","54312-019","54312-019-31","54312-019_374ee359-e33b-31d5-e063-6394a90a3ee6","HUMAN OTC DRUG","VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC","","OINTMENT","TOPICAL","20160730","","OTC MONOGRAPH DRUG","M004","Compania Internacional de Comercio, S.A.P.I de C.V.","3.5","mg/g","","N","20261231"
"3597","SULFAMETHOXAZOLE; TRIMETHOPRIM","SULFAMETHOXAZOLE, TRIMETHOPRIM","54348062506","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","54348-625","54348-625-06","54348-625_ea935f93-6c2d-2e8a-e053-2995a90a2ce0","HUMAN PRESCRIPTION DRUG","Sulfamethox-TMP DS","","TABLET","ORAL","20190711","","ANDA","ANDA076899","PharmPak, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"3598","SULFAMETHOXAZOLE; TRIMETHOPRIM","SULFAMETHOXAZOLE, TRIMETHOPRIM","54348062510","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","54348-625","54348-625-10","54348-625_ea935f93-6c2d-2e8a-e053-2995a90a2ce0","HUMAN PRESCRIPTION DRUG","Sulfamethox-TMP DS","","TABLET","ORAL","20190711","","ANDA","ANDA076899","PharmPak, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"3599","SULFAMETHOXAZOLE; TRIMETHOPRIM","SULFAMETHOXAZOLE, TRIMETHOPRIM","54348062514","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","54348-625","54348-625-14","54348-625_ea935f93-6c2d-2e8a-e053-2995a90a2ce0","HUMAN PRESCRIPTION DRUG","Sulfamethox-TMP DS","","TABLET","ORAL","20190711","","ANDA","ANDA076899","PharmPak, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"3600","SULFAMETHOXAZOLE; TRIMETHOPRIM","SULFAMETHOXAZOLE, TRIMETHOPRIM","54348062520","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","54348-625","54348-625-20","54348-625_ea935f93-6c2d-2e8a-e053-2995a90a2ce0","HUMAN PRESCRIPTION DRUG","Sulfamethox-TMP DS","","TABLET","ORAL","20190711","","ANDA","ANDA076899","PharmPak, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"3601","CIPROFLOXACIN HYDROCHLORIDE","CIPROFLOXACIN","54348066206","Quinolone Antimicrobial [EPC], Quinolones [CS]","54348-662","54348-662-06","54348-662_ea938405-8d24-fa08-e053-2995a90af8dc","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20190710","","ANDA","ANDA076639","PharmPak, Inc.","250","mg/1","","N","20251231"
"3602","CIPROFLOXACIN HYDROCHLORIDE","CIPROFLOXACIN","54348066214","Quinolone Antimicrobial [EPC], Quinolones [CS]","54348-662","54348-662-14","54348-662_ea938405-8d24-fa08-e053-2995a90af8dc","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20190710","","ANDA","ANDA076639","PharmPak, Inc.","250","mg/1","","N","20251231"
"3603","CIPROFLOXACIN HYDROCHLORIDE","CIPROFLOXACIN","54348066301","Quinolone Antimicrobial [EPC], Quinolones [CS]","54348-663","54348-663-01","54348-663_ea938ef9-a316-2003-e053-2a95a90aa829","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20190710","","ANDA","ANDA076639","PharmPak, Inc.","500","mg/1","","N","20251231"
"3604","CIPROFLOXACIN HYDROCHLORIDE","CIPROFLOXACIN","54348066314","Quinolone Antimicrobial [EPC], Quinolones [CS]","54348-663","54348-663-14","54348-663_ea938ef9-a316-2003-e053-2a95a90aa829","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20190710","","ANDA","ANDA076639","PharmPak, Inc.","500","mg/1","","N","20251231"
"3605","CIPROFLOXACIN HYDROCHLORIDE","CIPROFLOXACIN","54348066306","Quinolone Antimicrobial [EPC], Quinolones [CS]","54348-663","54348-663-06","54348-663_ea938ef9-a316-2003-e053-2a95a90aa829","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20190710","","ANDA","ANDA076639","PharmPak, Inc.","500","mg/1","","N","20251231"
"3606","METRONIDAZOLE","METRONIDAZOLE","54348074004","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","54348-740","54348-740-04","54348-740_ea93abaf-cd17-a842-e053-2995a90a8fb3","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20190710","","ANDA","ANDA203458","PharmPak, Inc.","500","mg/1","","N","20251231"
"3607","METRONIDAZOLE","METRONIDAZOLE","54348074009","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","54348-740","54348-740-09","54348-740_ea93abaf-cd17-a842-e053-2995a90a8fb3","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20190710","","ANDA","ANDA203458","PharmPak, Inc.","500","mg/1","","N","20251231"
"3608","METRONIDAZOLE","METRONIDAZOLE","54348074014","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","54348-740","54348-740-14","54348-740_ea93abaf-cd17-a842-e053-2995a90a8fb3","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20190710","","ANDA","ANDA203458","PharmPak, Inc.","500","mg/1","","N","20251231"
"3609","METRONIDAZOLE","METRONIDAZOLE","54348074000","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","54348-740","54348-740-00","54348-740_ea93abaf-cd17-a842-e053-2995a90a8fb3","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20190710","","ANDA","ANDA203458","PharmPak, Inc.","500","mg/1","","N","20251231"
"3610","METRONIDAZOLE","METRONIDAZOLE","54348074028","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","54348-740","54348-740-28","54348-740_ea93abaf-cd17-a842-e053-2995a90a8fb3","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20190710","","ANDA","ANDA203458","PharmPak, Inc.","500","mg/1","","N","20251231"
"3611","METRONIDAZOLE","METRONIDAZOLE","54348074508","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","54348-745","54348-745-08","54348-745_eaa5779b-424d-01ba-e053-2a95a90ae500","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20190712","","ANDA","ANDA203458","PharmPak, Inc.","250","mg/1","","N","20251231"
"3612","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","NITROFURANTOIN MONOHYDRATE","54348084910","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","54348-849","54348-849-10","54348-849_eaa5e1eb-d68d-a3f7-e053-2995a90aa735","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Mono","","CAPSULE","ORAL","20190710","","NDA","NDA020064","PharmPak, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"3613","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","NITROFURANTOIN MONOHYDRATE","54348084914","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","54348-849","54348-849-14","54348-849_eaa5e1eb-d68d-a3f7-e053-2995a90aa735","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Mono","","CAPSULE","ORAL","20190710","","NDA","NDA020064","PharmPak, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"3614","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","NITROFURANTOIN MONOHYDRATE","54348084906","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","54348-849","54348-849-06","54348-849_eaa5e1eb-d68d-a3f7-e053-2995a90aa735","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Mono","","CAPSULE","ORAL","20190710","","NDA","NDA020064","PharmPak, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"3615","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN MONOHYDRATE","54348085700","Macrolide Antimicrobial [EPC], Macrolides [CS]","54348-857","54348-857-00","54348-857_eb018961-75d1-2d69-e053-2995a90a38be","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190710","","ANDA","ANDA065225","PharmPak, Inc.","500","mg/1","","N","20251231"
"3616","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN MONOHYDRATE","54348085702","Macrolide Antimicrobial [EPC], Macrolides [CS]","54348-857","54348-857-02","54348-857_eb018961-75d1-2d69-e053-2995a90a38be","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190710","","ANDA","ANDA065225","PharmPak, Inc.","500","mg/1","","N","20251231"
"3617","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN MONOHYDRATE","54348085701","Macrolide Antimicrobial [EPC], Macrolides [CS]","54348-857","54348-857-01","54348-857_eb018961-75d1-2d69-e053-2995a90a38be","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190710","","ANDA","ANDA065225","PharmPak, Inc.","500","mg/1","","N","20251231"
"3618","CLOTRIMAZOLE","Clotrimazole","54473009601","Azole Antifungal [EPC], Azoles [CS]","54473-096","54473-096-01","54473-096_30cde80e-e74e-d8f5-e063-6394a90abd48","HUMAN OTC DRUG","Dermatin","Antifungal","CREAM","TOPICAL","20120101","","OTC MONOGRAPH DRUG","M005","Melaleuca, Inc.",".01","g/g","","N","20261231"
"3619","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc and Neomycin and Polymyxin B sulfate","54473029101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","54473-291","54473-291-01","54473-291_225405da-0aaa-6848-e063-6394a90a7f33","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","19950701","","OTC MONOGRAPH DRUG","M004","Melaleuca, Inc.","500; 3.5; 10000","U/g; mg/g; U/g","","N","20251231"
"3620","CLOTRIMAZOLE","clotrimazole 1%","54633001701","Azole Antifungal [EPC], Azoles [CS]","54633-017","54633-017-01","54633-017_60cb962b-0e2d-105a-e053-2a91aa0a040e","HUMAN OTC DRUG","Fortinia OF","","SOLUTION","TOPICAL","20170705","","OTC MONOGRAPH FINAL","part333C","The Podiatree Company","1","g/100mL","","N","20251231"
"3621","CLOTRIMAZOLE","Clotrimazole","54633001830","Azole Antifungal [EPC], Azoles [CS]","54633-018","54633-018-30","54633-018_68a4ed34-f491-67a6-e053-2a91aa0a0428","HUMAN OTC DRUG","Clotrimazole","","SOLUTION","TOPICAL","20180330","","OTC MONOGRAPH FINAL","part333C","The Podiatree Company","1","g/mL","","N","20251231"
"3622","CLOTRIMAZOLE","Clotrimazole","54633001810","Azole Antifungal [EPC], Azoles [CS]","54633-018","54633-018-10","54633-018_68a4ed34-f491-67a6-e053-2a91aa0a0428","HUMAN OTC DRUG","Clotrimazole","","SOLUTION","TOPICAL","20180330","","OTC MONOGRAPH FINAL","part333C","The Podiatree Company","1","g/mL","","N","20251231"
"3623","CLOTRIMAZOLE","clotrimazole 1%","54633021401","Azole Antifungal [EPC], Azoles [CS]","54633-214","54633-214-01","54633-214_60dcd391-7bf3-9ec2-e053-2991aa0a4a17","HUMAN OTC DRUG","Fortinia","","SOLUTION","TOPICAL","20141001","","OTC MONOGRAPH FINAL","part333C","The Podiatree Company","1","g/100mL","","N","20251231"
"3624","CLOTRIMAZOLE","Clotrimazole","54633031480","Azole Antifungal [EPC], Azoles [CS]","54633-314","54633-314-80","54633-314_60ba7ee8-7134-c6bb-e053-2a91aa0ac466","HUMAN OTC DRUG","Fortinia","","CREAM","TOPICAL","20150202","","OTC MONOGRAPH FINAL","part333C","The Podiatree Company","10","mg/g","","N","20251231"
"3625","NAFTIFINE HYDROCHLORIDE","Naftifine Hydrochloride","54766077245","Allylamine Antifungal [EPC], Allylamine [CS]","54766-772","54766-772-45","54766-772_0c509c9b-c156-802c-e063-6394a90a5b3b","HUMAN PRESCRIPTION DRUG","Naftin","","GEL","TOPICAL","20180301","","NDA","NDA204286","Sebela Pharmaceuticals Inc.","2","g/100g","","N","20251231"
"3626","NAFTIFINE HYDROCHLORIDE","Naftifine Hydrochloride","54766077260","Allylamine Antifungal [EPC], Allylamine [CS]","54766-772","54766-772-60","54766-772_0c509c9b-c156-802c-e063-6394a90a5b3b","HUMAN PRESCRIPTION DRUG","Naftin","","GEL","TOPICAL","20180301","","NDA","NDA204286","Sebela Pharmaceuticals Inc.","2","g/100g","","N","20251231"
"3627","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin","55111011230","Quinolone Antimicrobial [EPC], Quinolones [CS]","55111-112","55111-112-30","55111-112_b7966736-4865-d3ad-d218-886c8a286492","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","TABLET, FILM COATED","ORAL","20140305","","ANDA","ANDA076938","Dr. Reddy's Laboratories Limited","400","mg/1","","N","20251231"
"3628","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin","55111011266","Quinolone Antimicrobial [EPC], Quinolones [CS]","55111-112","55111-112-66","55111-112_b7966736-4865-d3ad-d218-886c8a286492","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","TABLET, FILM COATED","ORAL","20140305","","ANDA","ANDA076938","Dr. Reddy's Laboratories Limited","400","mg/1","","N","20251231"
"3629","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin","55111011201","Quinolone Antimicrobial [EPC], Quinolones [CS]","55111-112","55111-112-01","55111-112_b7966736-4865-d3ad-d218-886c8a286492","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","TABLET, FILM COATED","ORAL","20140305","","ANDA","ANDA076938","Dr. Reddy's Laboratories Limited","400","mg/1","","N","20251231"
"3630","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin","55111011205","Quinolone Antimicrobial [EPC], Quinolones [CS]","55111-112","55111-112-05","55111-112_b7966736-4865-d3ad-d218-886c8a286492","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","TABLET, FILM COATED","ORAL","20140305","","ANDA","ANDA076938","Dr. Reddy's Laboratories Limited","400","mg/1","","N","20251231"
"3631","FLUCONAZOLE","Fluconazole","55111014330","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55111-143","55111-143-30","55111-143_703af55b-63c6-e305-82a9-d3486e42c2b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140620","","ANDA","ANDA076658","Dr. Reddy's Laboratories Limited","50","mg/1","","N","20251231"
"3632","FLUCONAZOLE","Fluconazole","55111014378","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55111-143","55111-143-78","55111-143_703af55b-63c6-e305-82a9-d3486e42c2b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140620","","ANDA","ANDA076658","Dr. Reddy's Laboratories Limited","50","mg/1","","N","20251231"
"3633","FLUCONAZOLE","Fluconazole","55111014301","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55111-143","55111-143-01","55111-143_703af55b-63c6-e305-82a9-d3486e42c2b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140620","","ANDA","ANDA076658","Dr. Reddy's Laboratories Limited","50","mg/1","","N","20251231"
"3634","FLUCONAZOLE","Fluconazole","55111014305","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55111-143","55111-143-05","55111-143_703af55b-63c6-e305-82a9-d3486e42c2b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140620","","ANDA","ANDA076658","Dr. Reddy's Laboratories Limited","50","mg/1","","N","20251231"
"3635","FLUCONAZOLE","Fluconazole","55111014430","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55111-144","55111-144-30","55111-144_703af55b-63c6-e305-82a9-d3486e42c2b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140620","","ANDA","ANDA076658","Dr. Reddy's Laboratories Limited","100","mg/1","","N","20251231"
"3636","FLUCONAZOLE","Fluconazole","55111014478","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55111-144","55111-144-78","55111-144_703af55b-63c6-e305-82a9-d3486e42c2b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140620","","ANDA","ANDA076658","Dr. Reddy's Laboratories Limited","100","mg/1","","N","20251231"
"3637","FLUCONAZOLE","Fluconazole","55111014401","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55111-144","55111-144-01","55111-144_703af55b-63c6-e305-82a9-d3486e42c2b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140620","","ANDA","ANDA076658","Dr. Reddy's Laboratories Limited","100","mg/1","","N","20251231"
"3638","FLUCONAZOLE","Fluconazole","55111014405","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55111-144","55111-144-05","55111-144_703af55b-63c6-e305-82a9-d3486e42c2b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140620","","ANDA","ANDA076658","Dr. Reddy's Laboratories Limited","100","mg/1","","N","20251231"
"3639","FLUCONAZOLE","Fluconazole","55111014512","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55111-145","55111-145-12","55111-145_703af55b-63c6-e305-82a9-d3486e42c2b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140620","","ANDA","ANDA076658","Dr. Reddy's Laboratories Limited","150","mg/1","","N","20251231"
"3640","FLUCONAZOLE","Fluconazole","55111014605","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55111-146","55111-146-05","55111-146_703af55b-63c6-e305-82a9-d3486e42c2b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140620","","ANDA","ANDA076658","Dr. Reddy's Laboratories Limited","200","mg/1","","N","20251231"
"3641","FLUCONAZOLE","Fluconazole","55111014630","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55111-146","55111-146-30","55111-146_703af55b-63c6-e305-82a9-d3486e42c2b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140620","","ANDA","ANDA076658","Dr. Reddy's Laboratories Limited","200","mg/1","","N","20251231"
"3642","FLUCONAZOLE","Fluconazole","55111014678","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55111-146","55111-146-78","55111-146_703af55b-63c6-e305-82a9-d3486e42c2b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140620","","ANDA","ANDA076658","Dr. Reddy's Laboratories Limited","200","mg/1","","N","20251231"
"3643","FLUCONAZOLE","Fluconazole","55111014601","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55111-146","55111-146-01","55111-146_703af55b-63c6-e305-82a9-d3486e42c2b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140620","","ANDA","ANDA076658","Dr. Reddy's Laboratories Limited","200","mg/1","","N","20251231"
"3644","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","55111025030","Allylamine Antifungal [EPC], Allylamine [CS]","55111-250","55111-250-30","55111-250_9c427fa5-f0ef-593a-376a-0de7943c4057","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20070702","","ANDA","ANDA076390","Dr.Reddys Laboratories Limited","250","mg/1","","N","20251231"
"3645","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","55111025079","Allylamine Antifungal [EPC], Allylamine [CS]","55111-250","55111-250-79","55111-250_9c427fa5-f0ef-593a-376a-0de7943c4057","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20070702","","ANDA","ANDA076390","Dr.Reddys Laboratories Limited","250","mg/1","","N","20251231"
"3646","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","55111025090","Allylamine Antifungal [EPC], Allylamine [CS]","55111-250","55111-250-90","55111-250_9c427fa5-f0ef-593a-376a-0de7943c4057","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20070702","","ANDA","ANDA076390","Dr.Reddys Laboratories Limited","250","mg/1","","N","20251231"
"3647","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","55111025005","Allylamine Antifungal [EPC], Allylamine [CS]","55111-250","55111-250-05","55111-250_9c427fa5-f0ef-593a-376a-0de7943c4057","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20070702","","ANDA","ANDA076390","Dr.Reddys Laboratories Limited","250","mg/1","","N","20251231"
"3648","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","55111025001","Allylamine Antifungal [EPC], Allylamine [CS]","55111-250","55111-250-01","55111-250_9c427fa5-f0ef-593a-376a-0de7943c4057","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20070702","","ANDA","ANDA076390","Dr.Reddys Laboratories Limited","250","mg/1","","N","20251231"
"3649","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir","55111076278","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","55111-762","55111-762-78","55111-762_01a187d9-f0b8-d068-0be0-98654e8de135","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET, FILM COATED","ORAL","20141215","","ANDA","ANDA203511","Dr. Reddy's Laboratories Limited","450","mg/1","","N","20251231"
"3650","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir","55111076260","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","55111-762","55111-762-60","55111-762_01a187d9-f0b8-d068-0be0-98654e8de135","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET, FILM COATED","ORAL","20141215","","ANDA","ANDA203511","Dr. Reddy's Laboratories Limited","450","mg/1","","N","20251231"
"3651","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir","55111076205","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","55111-762","55111-762-05","55111-762_01a187d9-f0b8-d068-0be0-98654e8de135","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET, FILM COATED","ORAL","20141215","","ANDA","ANDA203511","Dr. Reddy's Laboratories Limited","450","mg/1","","N","20251231"
"3652","APIS MELLIFERA; BARIUM CHLORIDE DIHYDRATE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS BILE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; IODINE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; MILK THISTLE; PHOSPHORUS; QUININE SULFATE; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED","Berberis Vulgaris, Carduus Marianus, Chelidonium Majus, Collinsonia Canadensis, Solidago Virgaurea, Hydrastis Canadensis, Fel Tauri, Apis Mellifica, Baryta Muriatica, Ceanothus Americanus, Chininum Sulphuricum, Conium Maculatum, Iodium, Lachesis Mutus, Mercurius Solubilis, Nux Vomica, Phosphorus, Silicea","55146000201","Allergens [CS], Allergens [CS], Antimalarial [EPC], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]","55146-002","55146-002-01","55146-002_be798e0d-d9b8-46be-98f0-91753533fe14","HUMAN OTC DRUG","2 Lymphatic Drainage","","LIQUID","ORAL","20190611","20250821","UNAPPROVED HOMEOPATHIC","","Biotics Research Corporation","30; 30; 3; 6; 30; 3; 3; 30; 5; 30; 30; 30; 3; 30; 30; 30; 3; 30","[hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL","","N",""
"3653","AMPICILLIN SODIUM","Ampicillin Sodium","55150011110","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55150-111","55150-111-10","55150-111_40727d21-0d6f-4699-b7d9-d135a05d1efa","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120201","","ANDA","ANDA065499","Eugia US LLC","250","mg/1","","N","20251231"
"3654","AMPICILLIN SODIUM","Ampicillin Sodium","55150011210","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55150-112","55150-112-10","55150-112_40727d21-0d6f-4699-b7d9-d135a05d1efa","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120201","","ANDA","ANDA065499","Eugia US LLC","500","mg/1","","N","20251231"
"3655","AMPICILLIN SODIUM","Ampicillin Sodium","55150011310","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55150-113","55150-113-10","55150-113_40727d21-0d6f-4699-b7d9-d135a05d1efa","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120201","","ANDA","ANDA065499","Eugia US LLC","1","g/1","","N","20251231"
"3656","AMPICILLIN SODIUM","Ampicillin Sodium","55150011420","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55150-114","55150-114-20","55150-114_40727d21-0d6f-4699-b7d9-d135a05d1efa","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20120201","","ANDA","ANDA065499","Eugia US LLC","2","g/1","","N","20251231"
"3657","AMPICILLIN SODIUM","Ampicillin Sodium","55150011599","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55150-115","55150-115-99","55150-115_9877b042-21b9-479a-b176-4e65403760e2","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20120201","","ANDA","ANDA065493","Eugia US LLC","10","g/100mL","","N","20251231"
"3658","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin Sodium and Sulbactam Sodium","55150011610","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55150-116","55150-116-10","55150-116_4fcea57e-e6b9-46fb-b16a-ddce41773e0f","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120210","","ANDA","ANDA090349","Eugia US LLC","1; .5","g/1; g/1","","N","20251231"
"3659","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin Sodium and Sulbactam Sodium","55150011620","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55150-116","55150-116-20","55150-116_4fcea57e-e6b9-46fb-b16a-ddce41773e0f","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120210","","ANDA","ANDA090349","Eugia US LLC","1; .5","g/1; g/1","","N","20251231"
"3660","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin Sodium and Sulbactam Sodium","55150011720","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55150-117","55150-117-20","55150-117_4fcea57e-e6b9-46fb-b16a-ddce41773e0f","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120210","","ANDA","ANDA090349","Eugia US LLC","2; 1","g/1; g/1","","N","20251231"
"3661","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin Sodium and Sulbactam Sodium","55150011710","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55150-117","55150-117-10","55150-117_4fcea57e-e6b9-46fb-b16a-ddce41773e0f","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120210","","ANDA","ANDA090349","Eugia US LLC","2; 1","g/1; g/1","","N","20251231"
"3662","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin Sodium and Sulbactam Sodium","55150011801","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55150-118","55150-118-01","55150-118_437a26f4-776b-4f74-99b2-09ad79831b0c","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20120210","","ANDA","ANDA090339","Eugia US LLC","100; 50","mg/mL; mg/mL","","N","20251231"
"3663","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin Sodium and Sulbactam Sodium","55150011899","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55150-118","55150-118-99","55150-118_437a26f4-776b-4f74-99b2-09ad79831b0c","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20120210","","ANDA","ANDA090339","Eugia US LLC","100; 50","mg/mL; mg/mL","","N","20251231"
"3664","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin Sodium and Tazobactam Sodium","55150011909","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55150-119","55150-119-09","55150-119_a5d8625e-e630-4076-bc55-46ebe861c6a5","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20120123","","ANDA","ANDA065498","Eugia US LLC","2; .25","g/1; g/1","","N","20251231"
"3665","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin Sodium and Tazobactam Sodium","55150011930","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55150-119","55150-119-30","55150-119_a5d8625e-e630-4076-bc55-46ebe861c6a5","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20120123","","ANDA","ANDA065498","Eugia US LLC","2; .25","g/1; g/1","","N","20251231"
"3666","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin Sodium and Tazobactam Sodium","55150012030","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55150-120","55150-120-30","55150-120_bb7a6ade-2050-4538-97d8-cbfe970deac5","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20120123","","ANDA","ANDA065498","Eugia US LLC","3; .375","g/1; g/1","","N","20251231"
"3667","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin Sodium and Tazobactam Sodium","55150012009","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55150-120","55150-120-09","55150-120_bb7a6ade-2050-4538-97d8-cbfe970deac5","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20120123","","ANDA","ANDA065498","Eugia US LLC","3; .375","g/1; g/1","","N","20251231"
"3668","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin Sodium and Tazobactam Sodium","55150012109","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55150-121","55150-121-09","55150-121_a5d8625e-e630-4076-bc55-46ebe861c6a5","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20120123","","ANDA","ANDA065498","Eugia US LLC","4; .5","g/1; g/1","","N","20251231"
"3669","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin Sodium and Tazobactam Sodium","55150012150","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55150-121","55150-121-50","55150-121_a5d8625e-e630-4076-bc55-46ebe861c6a5","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20120123","","ANDA","ANDA065498","Eugia US LLC","4; .5","g/1; g/1","","N","20251231"
"3670","NAFCILLIN SODIUM","Nafcillin Sodium","55150012215","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55150-122","55150-122-15","55150-122_28e98899-0ddc-4a5c-90de-ca7650f00ed9","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20121226","","ANDA","ANDA091613","Eugia US LLC","1","g/4mL","","N","20251231"
"3671","NAFCILLIN SODIUM","Nafcillin Sodium","55150012315","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55150-123","55150-123-15","55150-123_d905fe2c-b3b6-450b-b27c-cb0c7159bf8f","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20121226","","ANDA","ANDA091613","Eugia US LLC","2","g/8mL","","N","20251231"
"3672","NAFCILLIN SODIUM","Nafcillin Sodium","55150012316","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55150-123","55150-123-16","55150-123_d905fe2c-b3b6-450b-b27c-cb0c7159bf8f","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20121226","","ANDA","ANDA091613","Eugia US LLC","2","g/8mL","","N","20251231"
"3673","NAFCILLIN SODIUM","Nafcillin Sodium","55150012499","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55150-124","55150-124-99","55150-124_75a0071e-380b-40c6-86ad-78eaae0e4922","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20121226","","ANDA","ANDA091614","Eugia US LLC","10","g/100mL","","N","20251231"
"3674","NAFCILLIN SODIUM","Nafcillin Sodium","55150012409","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55150-124","55150-124-09","55150-124_75a0071e-380b-40c6-86ad-78eaae0e4922","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20121226","","ANDA","ANDA091614","Eugia US LLC","10","g/100mL","","N","20251231"
"3675","OXACILLIN SODIUM","Oxacillin Sodium","55150012715","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55150-127","55150-127-15","55150-127_c46c59f4-6728-464b-a25c-00cf4b515fe1","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20130118","","ANDA","ANDA201539","Eugia US LLC","1","g/1","","N","20251231"
"3676","OXACILLIN SODIUM","Oxacillin Sodium","55150012824","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55150-128","55150-128-24","55150-128_c46c59f4-6728-464b-a25c-00cf4b515fe1","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20130118","","ANDA","ANDA201539","Eugia US LLC","2","g/1","","N","20251231"
"3677","OXACILLIN SODIUM","Oxacillin Sodium","55150012999","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55150-129","55150-129-99","55150-129_8483535d-845a-4c9b-9c6a-36841e5b1747","HUMAN PRESCRIPTION DRUG","Oxacillin","","POWDER, FOR SOLUTION","INTRAVENOUS","20130118","","ANDA","ANDA201538","Eugia US LLC","10","g/100mL","","N","20251231"
"3678","AZITHROMYCIN MONOHYDRATE","Azithromycin","55150017410","Macrolide Antimicrobial [EPC], Macrolides [CS]","55150-174","55150-174-10","55150-174_6760771b-9c61-458d-9778-81a3da96cb9f","HUMAN PRESCRIPTION DRUG","Azithromycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20150619","","ANDA","ANDA203294","Eugia US LLC","500","mg/1","","N","20251231"
"3679","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin Sodium and Sulbactam Sodium","55150017899","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55150-178","55150-178-99","55150-178_7f843346-d0ed-4449-bd2a-683732a32bcf","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20120913","","ANDA","ANDA090340","Eugia US LLC","1; .5","g/1; g/1","","N","20251231"
"3680","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin Sodium and Sulbactam Sodium","55150017999","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55150-179","55150-179-99","55150-179_7f843346-d0ed-4449-bd2a-683732a32bcf","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20120913","","ANDA","ANDA090340","Eugia US LLC","2; 1","g/1; g/1","","N","20251231"
"3681","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","55150020310","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","55150-203","55150-203-10","55150-203_e18e1eed-339d-429d-b1ee-b7d6ffde85eb","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20160331","","ANDA","ANDA205780","Eugia US LLC","500","mg/10mL","","N","20251231"
"3682","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","55150020420","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","55150-204","55150-204-20","55150-204_e18e1eed-339d-429d-b1ee-b7d6ffde85eb","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20160331","","ANDA","ANDA205780","Eugia US LLC","1","g/20mL","","N","20251231"
"3683","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","55150020599","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","55150-205","55150-205-99","55150-205_a5a491c0-5875-4031-b547-c33e02413357","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20160329","","ANDA","ANDA205779","Eugia US LLC","5","g/1","","N","20251231"
"3684","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","55150020699","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","55150-206","55150-206-99","55150-206_a5a491c0-5875-4031-b547-c33e02413357","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20160329","","ANDA","ANDA205779","Eugia US LLC","10","g/1","","N","20251231"
"3685","MEROPENEM","Meropenem","55150020720","Carbapenems [CS], Penem Antibacterial [EPC]","55150-207","55150-207-20","55150-207_d6c1dfdb-0ec9-4a26-a529-bbc4d3a5af9a","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20170327","","ANDA","ANDA205835","Eugia US LLC","500","mg/1","","N","20251231"
"3686","MEROPENEM","Meropenem","55150020830","Carbapenems [CS], Penem Antibacterial [EPC]","55150-208","55150-208-30","55150-208_d6c1dfdb-0ec9-4a26-a529-bbc4d3a5af9a","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20170327","","ANDA","ANDA205835","Eugia US LLC","1","g/1","","N","20251231"
"3687","TIGECYCLINE","Tigecycline","55150022810","Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]","55150-228","55150-228-10","55150-228_a5262444-a326-478c-a6d6-b515ef3d1219","HUMAN PRESCRIPTION DRUG","Tigecycline","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190611","","ANDA","ANDA206335","Eugia US LLC","50","mg/1","","N","20261231"
"3688","POLYMYXIN B SULFATE","Polymyxin B","55150023410","Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55150-234","55150-234-10","55150-234_097fa44b-506b-4ee0-9f64-4b560c3ed41c","HUMAN PRESCRIPTION DRUG","Polymyxin B","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC","20160404","","ANDA","ANDA206589","Eugia US LLC","500000","[USP'U]/1","","N","20261231"
"3689","LINEZOLID","Linezolid","55150024251","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","55150-242","55150-242-51","55150-242_dd9cd434-03f1-4f0d-ad84-c5611f6e5abf","HUMAN PRESCRIPTION DRUG","Linezolid","","INJECTION, SOLUTION","INTRAVENOUS","20160804","","ANDA","ANDA206917","Eugia US LLC","600","mg/300mL","","N","20251231"
"3690","ERTAPENEM SODIUM","Ertapenem","55150028209","Carbapenems [CS], Penem Antibacterial [EPC]","55150-282","55150-282-09","55150-282_250abb8f-6547-4f69-94c3-87917dc34240","HUMAN PRESCRIPTION DRUG","Ertapenem","","INJECTION","INTRAMUSCULAR; INTRAVENOUS","20180625","","ANDA","ANDA209133","Eugia US LLC","1","g/1","","N","20251231"
"3691","ERTAPENEM SODIUM","Ertapenem","55150028220","Carbapenems [CS], Penem Antibacterial [EPC]","55150-282","55150-282-20","55150-282_250abb8f-6547-4f69-94c3-87917dc34240","HUMAN PRESCRIPTION DRUG","Ertapenem","","INJECTION","INTRAMUSCULAR; INTRAVENOUS","20180625","","ANDA","ANDA209133","Eugia US LLC","1","g/1","","N","20251231"
"3692","VORICONAZOLE","Voriconazole","55150032101","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55150-321","55150-321-01","55150-321_13107b7f-40e5-4e02-99e7-74469a806b3d","HUMAN PRESCRIPTION DRUG","Voriconazole","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230202","","ANDA","ANDA212162","Eugia US LLC","10","mg/mL","","N","20251231"
"3693","DAPTOMYCIN","DAPTOMYCIN","55150034401","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","55150-344","55150-344-01","55150-344_2106b93b-565c-43f9-9432-c5787c3aab5e","HUMAN PRESCRIPTION DRUG","DAPTOMYCIN","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210902","","ANDA","ANDA213171","Eugia US LLC","500","mg/10mL","","N","20251231"
"3694","AMPHOTERICIN B","Amphotericin B","55150036501","Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]","55150-365","55150-365-01","55150-365_6f24975c-5191-4fc2-a8da-e57358f8e154","HUMAN PRESCRIPTION DRUG","Amphotericin B","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20221117","","ANDA","ANDA214010","Eugia US LLC","50","mg/12.5mL","","N","20251231"
"3695","POSACONAZOLE","POSACONAZOLE","55150038801","Azole Antifungal [EPC], Azoles [CS]","55150-388","55150-388-01","55150-388_6d1e5905-71b9-480b-82ae-5c92a2374e1d","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","INJECTION","INTRAVENOUS","20231226","","ANDA","ANDA214842","Eugia US LLC","18","mg/mL","","N","20261231"
"3696","GENTAMICIN SULFATE","Gentamicin","55150040125","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","55150-401","55150-401-25","55150-401_f8c608b3-50b8-4d5d-9e8a-e92c0d2e3cdc","HUMAN PRESCRIPTION DRUG","Gentamicin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240108","","ANDA","ANDA215236","Eugia US LLC","10","mg/mL","","N","20251231"
"3697","GENTAMICIN SULFATE","Gentamicin","55150040225","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","55150-402","55150-402-25","55150-402_60ca1487-392d-4721-aa45-3de38722896c","HUMAN PRESCRIPTION DRUG","Gentamicin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240108","","ANDA","ANDA215237","Eugia US LLC","40","mg/mL","","N","20251231"
"3698","GENTAMICIN SULFATE","Gentamicin","55150040325","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","55150-403","55150-403-25","55150-403_60ca1487-392d-4721-aa45-3de38722896c","HUMAN PRESCRIPTION DRUG","Gentamicin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240108","","ANDA","ANDA215237","Eugia US LLC","40","mg/mL","","N","20251231"
"3699","TOBRAMYCIN SULFATE","TOBRAMYCIN","55150047006","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","55150-470","55150-470-06","55150-470_a4205ba6-2eba-4e4e-a2d4-b54447ed85f1","HUMAN PRESCRIPTION DRUG","TOBRAMYCIN","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230621","","ANDA","ANDA217519","Eugia US LLC","1.2","g/30mL","","N","20251231"
"3700","VANCOMYCIN HYDROCHLORIDE","Vancomycin hydrochloride","55150047110","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","55150-471","55150-471-10","55150-471_9aa42538-c84e-4886-8d3d-a7dfded5120f","HUMAN PRESCRIPTION DRUG","Vancomycin hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230804","","ANDA","ANDA217401","Eugia US LLC","1.25","g/25mL","","N","20251231"
"3701","VANCOMYCIN HYDROCHLORIDE","Vancomycin hydrochloride","55150047210","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","55150-472","55150-472-10","55150-472_9aa42538-c84e-4886-8d3d-a7dfded5120f","HUMAN PRESCRIPTION DRUG","Vancomycin hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230804","","ANDA","ANDA217401","Eugia US LLC","1.5","g/30mL","","N","20251231"
"3702","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin Sodium and Tazobactam Sodium","55150047301","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55150-473","55150-473-01","55150-473_d55bf2c9-ae5b-4a09-8151-9ba0046a7d3e","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20231012","","ANDA","ANDA217409","Eugia US LLC","36; 4.5","g/250mL; g/250mL","","N","20251231"
"3703","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin Sodium and Tazobactam Sodium","55150047401","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55150-474","55150-474-01","55150-474_d55bf2c9-ae5b-4a09-8151-9ba0046a7d3e","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20231012","","ANDA","ANDA217409","Eugia US LLC","12; 1.5","g/100mL; g/100mL","","N","20251231"
"3704","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","55154207400","Antimalarial [EPC], Antirheumatic Agent [EPC]","55154-2074","55154-2074-0","55154-2074_8cad48ab-2436-4cca-855e-db78d5f85176","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080805","","ANDA","ANDA040657","Cardinal Health 107, LLC","200","mg/1","","N","20251231"
"3705","METRONIDAZOLE","METRONIDAZOLE","55154234300","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","55154-2343","55154-2343-0","55154-2343_4e1ac737-c353-4764-bd35-dc844e75b562","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20250305","","ANDA","ANDA205245","Cardinal Health 107, LLC","250","mg/1","","N","20261231"
"3706","GENTAMICIN SULFATE","Gentamicin Sulfate","55154239205","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","55154-2392","55154-2392-5","55154-2392_5f7d3639-e80e-47cb-9d1a-0a73fbe79ffc","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19830815","","ANDA","ANDA062420","Cardinal Health 107, LLC","40","mg/mL","","N","20251231"
"3707","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","55154336800","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","55154-3368","55154-3368-0","55154-3368_6ad9a13c-ed4e-4124-90ae-f42c19c34dd1","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","20251031","ANDA","ANDA076558","Cardinal Health 107, LLC","500","mg/1","","N",""
"3708","AZITHROMYCIN DIHYDRATE","azithromycin","55154337400","Macrolide Antimicrobial [EPC], Macrolides [CS]","55154-3374","55154-3374-0","55154-3374_e6490132-6f7a-479f-8b30-ea2c7d6737ea","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20240702","","ANDA","ANDA065398","Cardinal Health 107, LLC","250","mg/1","","N","20261231"
"3709","FLUCONAZOLE","Fluconazole","55154340000","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55154-3400","55154-3400-0","55154-3400_525c35d1-6a57-4a09-9589-7ed633451445","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20150625","","ANDA","ANDA076658","Cardinal Health 107, LLC","100","mg/1","","N","20261231"
"3710","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","55154356700","Antimalarial [EPC], Antirheumatic Agent [EPC]","55154-3567","55154-3567-0","55154-3567_aefe1ab9-8684-4589-a465-9571a68bb36e","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20180501","","ANDA","ANDA210441","Cardinal Health 107, LLC","200","mg/1","","N","20251231"
"3711","NYSTATIN","NYSTATIN","55154431405","Polyene Antifungal [EPC], Polyenes [CS]","55154-4314","55154-4314-5","55154-4314_236f95a1-7117-49f7-933c-fb4061db46ba","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20200717","","ANDA","ANDA203621","Cardinal Health 107, LLC","100000","[USP'U]/mL","","N","20251231"
"3712","NYSTATIN","NYSTATIN","55154578805","Polyene Antifungal [EPC], Polyenes [CS]","55154-5788","55154-5788-5","55154-5788_0351dbf0-f3b1-42f7-a2a2-6097216043d6","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20200717","","ANDA","ANDA203621","Cardinal Health 107, LLC","100000","[USP'U]/mL","","N","20251231"
"3713","RIFAXIMIN","rifaximin","55154677708","Rifamycin Antibacterial [EPC], Rifamycins [CS]","55154-6777","55154-6777-8","55154-6777_aec372d7-7d45-4db2-a948-7dc40431b0a0","HUMAN PRESCRIPTION DRUG","XIFAXAN","","TABLET","ORAL","20100501","","NDA","NDA021361","Cardinal Health 107, LLC","550","mg/1","","N","20251231"
"3714","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","55154727600","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","55154-7276","55154-7276-0","55154-7276_eab154cd-630f-45ff-b1c7-126bf04e5bc6","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20090410","","ANDA","ANDA065061","Cardinal Health 107, LLC","150","mg/1","","N","20251231"
"3715","ERYTHROMYCIN","Erythromycin","55154785000","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","55154-7850","55154-7850-0","55154-7850_1d46b877-1df6-46f8-86c6-0eb975dca22d","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","19940729","","ANDA","ANDA064067","Cardinal Health 107, LLC","5","mg/g","","N","20261231"
"3716","FLUCONAZOLE","Fluconazole","55154787500","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55154-7875","55154-7875-0","55154-7875_525c35d1-6a57-4a09-9589-7ed633451445","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20150625","","ANDA","ANDA076658","Cardinal Health 107, LLC","200","mg/1","","N","20261231"
"3717","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","55154789500","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","55154-7895","55154-7895-0","55154-7895_573678d7-3b95-42ac-ad89-adeef6eec887","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Cardinal Health 107, LLC","800; 160","mg/1; mg/1","","N","20261231"
"3718","METRONIDAZOLE","Metronidazole","55154819000","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","55154-8190","55154-8190-0","55154-8190_ef717c92-9474-46d7-9555-4226732bed42","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20200220","","ANDA","ANDA070772","Cardinal Health 107, LLC","500","mg/1","","N","20261231"
"3719","AMOXICILLIN","Amoxicillin","55289001906","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-019","55289-019-06","55289-019_2abb7167-1ba1-cf06-e063-6294a90a3a74","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"3720","AMOXICILLIN","Amoxicillin","55289001924","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-019","55289-019-24","55289-019_2abb7167-1ba1-cf06-e063-6294a90a3a74","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"3721","AMOXICILLIN","Amoxicillin","55289001930","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-019","55289-019-30","55289-019_2abb7167-1ba1-cf06-e063-6294a90a3a74","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"3722","AMOXICILLIN","Amoxicillin","55289001940","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-019","55289-019-40","55289-019_2abb7167-1ba1-cf06-e063-6294a90a3a74","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"3723","AMOXICILLIN","Amoxicillin","55289001921","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-019","55289-019-21","55289-019_2abb7167-1ba1-cf06-e063-6294a90a3a74","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"3724","AMOXICILLIN","Amoxicillin","55289001960","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-019","55289-019-60","55289-019_2abb7167-1ba1-cf06-e063-6294a90a3a74","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"3725","AMOXICILLIN","Amoxicillin","55289001915","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-019","55289-019-15","55289-019_2abb7167-1ba1-cf06-e063-6294a90a3a74","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"3726","AMOXICILLIN","Amoxicillin","55289002004","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-020","55289-020-04","55289-020_2abbae2e-2b8d-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3727","AMOXICILLIN","Amoxicillin","55289002006","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-020","55289-020-06","55289-020_2abbae2e-2b8d-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3728","AMOXICILLIN","Amoxicillin","55289002009","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-020","55289-020-09","55289-020_2abbae2e-2b8d-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3729","AMOXICILLIN","Amoxicillin","55289002015","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-020","55289-020-15","55289-020_2abbae2e-2b8d-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3730","AMOXICILLIN","Amoxicillin","55289002021","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-020","55289-020-21","55289-020_2abbae2e-2b8d-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3731","AMOXICILLIN","Amoxicillin","55289002024","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-020","55289-020-24","55289-020_2abbae2e-2b8d-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3732","AMOXICILLIN","Amoxicillin","55289002030","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-020","55289-020-30","55289-020_2abbae2e-2b8d-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3733","AMOXICILLIN","Amoxicillin","55289002040","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-020","55289-020-40","55289-020_2abbae2e-2b8d-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3734","AMOXICILLIN","Amoxicillin","55289002042","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-020","55289-020-42","55289-020_2abbae2e-2b8d-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3735","AMOXICILLIN","Amoxicillin","55289002050","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-020","55289-020-50","55289-020_2abbae2e-2b8d-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3736","AMOXICILLIN","Amoxicillin","55289002056","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-020","55289-020-56","55289-020_2abbae2e-2b8d-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3737","AMOXICILLIN","Amoxicillin","55289002060","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-020","55289-020-60","55289-020_2abbae2e-2b8d-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3738","AMOXICILLIN","Amoxicillin","55289002063","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-020","55289-020-63","55289-020_2abbae2e-2b8d-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3739","AMOXICILLIN","Amoxicillin","55289002014","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-020","55289-020-14","55289-020_2abbae2e-2b8d-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3740","AMOXICILLIN","Amoxicillin","55289002028","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-020","55289-020-28","55289-020_2abbae2e-2b8d-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3741","ERYTHROMYCIN","Erythromycin","55289002504","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","55289-025","55289-025-04","55289-025_2411e48d-3703-4283-e063-6294a90a3de3","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20110906","","ANDA","ANDA061621","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3742","ERYTHROMYCIN","Erythromycin","55289002530","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","55289-025","55289-025-30","55289-025_2411e48d-3703-4283-e063-6294a90a3de3","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20110906","","ANDA","ANDA061621","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3743","ERYTHROMYCIN","Erythromycin","55289002540","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","55289-025","55289-025-40","55289-025_2411e48d-3703-4283-e063-6294a90a3de3","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20110906","","ANDA","ANDA061621","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3744","ERYTHROMYCIN","Erythromycin","55289002528","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","55289-025","55289-025-28","55289-025_2411e48d-3703-4283-e063-6294a90a3de3","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20110906","","ANDA","ANDA061621","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3745","ERYTHROMYCIN","Erythromycin","55289002520","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","55289-025","55289-025-20","55289-025_2411e48d-3703-4283-e063-6294a90a3de3","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20110906","","ANDA","ANDA061621","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3746","CEPHALEXIN","Cephalexin","55289005706","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-057","55289-057-06","55289-057_2411e47c-c945-6db3-e063-6294a90a2ede","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"3747","CEPHALEXIN","Cephalexin","55289005710","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-057","55289-057-10","55289-057_2411e47c-c945-6db3-e063-6294a90a2ede","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"3748","CEPHALEXIN","Cephalexin","55289005720","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-057","55289-057-20","55289-057_2411e47c-c945-6db3-e063-6294a90a2ede","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"3749","CEPHALEXIN","Cephalexin","55289005724","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-057","55289-057-24","55289-057_2411e47c-c945-6db3-e063-6294a90a2ede","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"3750","CEPHALEXIN","Cephalexin","55289005728","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-057","55289-057-28","55289-057_2411e47c-c945-6db3-e063-6294a90a2ede","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"3751","CEPHALEXIN","Cephalexin","55289005740","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-057","55289-057-40","55289-057_2411e47c-c945-6db3-e063-6294a90a2ede","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"3752","CEPHALEXIN","Cephalexin","55289005715","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-057","55289-057-15","55289-057_2411e47c-c945-6db3-e063-6294a90a2ede","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"3753","CEPHALEXIN","Cephalexin","55289005730","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-057","55289-057-30","55289-057_2411e47c-c945-6db3-e063-6294a90a2ede","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"3754","CEPHALEXIN","Cephalexin","55289005804","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-058","55289-058-04","55289-058_2411fb7c-1d66-492a-e063-6394a90a7ac1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3755","CEPHALEXIN","Cephalexin","55289005808","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-058","55289-058-08","55289-058_2411fb7c-1d66-492a-e063-6394a90a7ac1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3756","CEPHALEXIN","Cephalexin","55289005820","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-058","55289-058-20","55289-058_2411fb7c-1d66-492a-e063-6394a90a7ac1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3757","CEPHALEXIN","Cephalexin","55289005821","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-058","55289-058-21","55289-058_2411fb7c-1d66-492a-e063-6394a90a7ac1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3758","CEPHALEXIN","Cephalexin","55289005824","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-058","55289-058-24","55289-058_2411fb7c-1d66-492a-e063-6394a90a7ac1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3759","CEPHALEXIN","Cephalexin","55289005814","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-058","55289-058-14","55289-058_2411fb7c-1d66-492a-e063-6394a90a7ac1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3760","CEPHALEXIN","Cephalexin","55289005830","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-058","55289-058-30","55289-058_2411fb7c-1d66-492a-e063-6394a90a7ac1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3761","CEPHALEXIN","Cephalexin","55289005840","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-058","55289-058-40","55289-058_2411fb7c-1d66-492a-e063-6394a90a7ac1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3762","CEPHALEXIN","Cephalexin","55289005828","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-058","55289-058-28","55289-058_2411fb7c-1d66-492a-e063-6394a90a7ac1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3763","CEPHALEXIN","Cephalexin","55289005810","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-058","55289-058-10","55289-058_2411fb7c-1d66-492a-e063-6394a90a7ac1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3764","ERYTHROMYCIN","Erythromycin","55289007540","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","55289-075","55289-075-40","55289-075_24122abc-7658-f3d0-e063-6394a90a2a52","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20110906","","ANDA","ANDA061621","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"3765","ERYTHROMYCIN","Erythromycin","55289007556","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","55289-075","55289-075-56","55289-075_24122abc-7658-f3d0-e063-6394a90a2a52","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20110906","","ANDA","ANDA061621","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"3766","ERYTHROMYCIN","Erythromycin","55289007503","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","55289-075","55289-075-03","55289-075_24122abc-7658-f3d0-e063-6394a90a2a52","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20110906","","ANDA","ANDA061621","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"3767","AMOXICILLIN","Amoxicillin","55289018206","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-182","55289-182-06","55289-182_2c4e99fe-a404-98b5-e063-6294a90aecab","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","19930101","","ANDA","ANDA064013","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"3768","AMOXICILLIN","Amoxicillin","55289018230","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-182","55289-182-30","55289-182_2c4e99fe-a404-98b5-e063-6294a90aecab","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","19930101","","ANDA","ANDA064013","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"3769","AMOXICILLIN","Amoxicillin","55289018240","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-182","55289-182-40","55289-182_2c4e99fe-a404-98b5-e063-6294a90aecab","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","19930101","","ANDA","ANDA064013","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"3770","AMOXICILLIN","Amoxicillin","55289018290","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-182","55289-182-90","55289-182_2c4e99fe-a404-98b5-e063-6294a90aecab","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","19930101","","ANDA","ANDA064013","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"3771","AMOXICILLIN","Amoxicillin","55289018214","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-182","55289-182-14","55289-182_2c4e99fe-a404-98b5-e063-6294a90aecab","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","19930101","","ANDA","ANDA064013","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"3772","AMOXICILLIN","Amoxicillin","55289018209","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-182","55289-182-09","55289-182_2c4e99fe-a404-98b5-e063-6294a90aecab","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","19930101","","ANDA","ANDA064013","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"3773","ERYTHROMYCIN","Erythromycin","55289021740","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","55289-217","55289-217-40","55289-217_24124330-2e81-2ee8-e063-6394a90a5301","HUMAN PRESCRIPTION DRUG","ERY-TAB","","TABLET, DELAYED RELEASE","ORAL","20110418","","ANDA","ANDA062298","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3774","ERYTHROMYCIN","Erythromycin","55289021728","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","55289-217","55289-217-28","55289-217_24124330-2e81-2ee8-e063-6394a90a5301","HUMAN PRESCRIPTION DRUG","ERY-TAB","","TABLET, DELAYED RELEASE","ORAL","20110418","","ANDA","ANDA062298","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"3775","CEFPODOXIME PROXETIL","CEFPODOXIME PROXETIL","55289039302","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-393","55289-393-02","55289-393_242103c2-b148-9ebc-e063-6294a90af2e0","HUMAN PRESCRIPTION DRUG","CEFPODOXIME PROXETIL","","TABLET, FILM COATED","ORAL","20070611","","ANDA","ANDA065370","PD-Rx Pharmaceuticals, Inc.","200","mg/1","","N","20251231"
"3776","ERYTHROMYCIN","Erythromycin","55289052530","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","55289-525","55289-525-30","55289-525_24234da5-48b9-b80c-e063-6294a90a9390","HUMAN PRESCRIPTION DRUG","ERY-TAB","","TABLET, DELAYED RELEASE","ORAL","20110418","","ANDA","ANDA062298","PD-Rx Pharmaceuticals, Inc.","333","mg/1","","N","20251231"
"3777","ERYTHROMYCIN","Erythromycin","55289052540","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","55289-525","55289-525-40","55289-525_24234da5-48b9-b80c-e063-6294a90a9390","HUMAN PRESCRIPTION DRUG","ERY-TAB","","TABLET, DELAYED RELEASE","ORAL","20110418","","ANDA","ANDA062298","PD-Rx Pharmaceuticals, Inc.","333","mg/1","","N","20251231"
"3778","ERYTHROMYCIN","Erythromycin","55289052521","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","55289-525","55289-525-21","55289-525_24234da5-48b9-b80c-e063-6294a90a9390","HUMAN PRESCRIPTION DRUG","ERY-TAB","","TABLET, DELAYED RELEASE","ORAL","20110418","","ANDA","ANDA062298","PD-Rx Pharmaceuticals, Inc.","333","mg/1","","N","20251231"
"3779","ERYTHROMYCIN","Erythromycin","55289052542","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","55289-525","55289-525-42","55289-525_24234da5-48b9-b80c-e063-6294a90a9390","HUMAN PRESCRIPTION DRUG","ERY-TAB","","TABLET, DELAYED RELEASE","ORAL","20110418","","ANDA","ANDA062298","PD-Rx Pharmaceuticals, Inc.","333","mg/1","","N","20251231"
"3780","ERYTHROMYCIN","Erythromycin","55289052563","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","55289-525","55289-525-63","55289-525_24234da5-48b9-b80c-e063-6294a90a9390","HUMAN PRESCRIPTION DRUG","ERY-TAB","","TABLET, DELAYED RELEASE","ORAL","20110418","","ANDA","ANDA062298","PD-Rx Pharmaceuticals, Inc.","333","mg/1","","N","20251231"
"3781","CEFADROXIL","Cefadroxil","55289058914","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-589","55289-589-14","55289-589_30c9166e-2f2c-211a-e063-6294a90a05c7","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070131","","ANDA","ANDA065282","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3782","CEFADROXIL","Cefadroxil","55289058920","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-589","55289-589-20","55289-589_30c9166e-2f2c-211a-e063-6294a90a05c7","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070131","","ANDA","ANDA065282","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3783","CEFADROXIL","Cefadroxil","55289058910","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-589","55289-589-10","55289-589_30c9166e-2f2c-211a-e063-6294a90a05c7","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070131","","ANDA","ANDA065282","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3784","CEFADROXIL","Cefadroxil","55289058928","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","55289-589","55289-589-28","55289-589_30c9166e-2f2c-211a-e063-6294a90a05c7","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070131","","ANDA","ANDA065282","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"3785","DICLOXACILLIN SODIUM","Dicloxacillin Sodium","55289059220","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-592","55289-592-20","55289-592_24237654-eb25-9773-e063-6294a90a41f6","HUMAN PRESCRIPTION DRUG","Dicloxacillin Sodium","","CAPSULE","ORAL","19900930","","ANDA","ANDA062286","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"3786","DICLOXACILLIN SODIUM","Dicloxacillin Sodium","55289059228","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-592","55289-592-28","55289-592_24237654-eb25-9773-e063-6294a90a41f6","HUMAN PRESCRIPTION DRUG","Dicloxacillin Sodium","","CAPSULE","ORAL","19900930","","ANDA","ANDA062286","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"3787","DICLOXACILLIN SODIUM","Dicloxacillin Sodium","55289059240","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-592","55289-592-40","55289-592_24237654-eb25-9773-e063-6294a90a41f6","HUMAN PRESCRIPTION DRUG","Dicloxacillin Sodium","","CAPSULE","ORAL","19900930","","ANDA","ANDA062286","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"3788","DICLOXACILLIN SODIUM","Dicloxacillin Sodium","55289059210","Penicillin-class Antibacterial [EPC], Penicillins [CS]","55289-592","55289-592-10","55289-592_24237654-eb25-9773-e063-6294a90a41f6","HUMAN PRESCRIPTION DRUG","Dicloxacillin Sodium","","CAPSULE","ORAL","19900930","","ANDA","ANDA062286","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"3789","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","55289076710","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55289-767","55289-767-10","55289-767_23a7cf9e-f224-06c2-e063-6394a90aa623","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065096","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"3790","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","55289076721","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55289-767","55289-767-21","55289-767_23a7cf9e-f224-06c2-e063-6394a90aa623","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065096","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"3791","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","55289076728","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55289-767","55289-767-28","55289-767_23a7cf9e-f224-06c2-e063-6394a90aa623","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065096","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"3792","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","55289076730","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55289-767","55289-767-30","55289-767_23a7cf9e-f224-06c2-e063-6394a90aa623","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065096","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"3793","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","55289076720","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55289-767","55289-767-20","55289-767_23a7cf9e-f224-06c2-e063-6394a90aa623","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065096","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"3794","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","55289076714","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55289-767","55289-767-14","55289-767_23a7cf9e-f224-06c2-e063-6394a90aa623","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065096","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"3795","FLUCONAZOLE","Fluconazole","55289082420","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55289-824","55289-824-20","55289-824_2ac0449d-f1fd-33f4-e063-6394a90a9402","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20060125","","ANDA","ANDA077253","PD-Rx Pharmaceuticals, Inc.","200","mg/1","","N","20261231"
"3796","FLUCONAZOLE","Fluconazole","55289082430","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55289-824","55289-824-30","55289-824_2ac0449d-f1fd-33f4-e063-6394a90a9402","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20060125","","ANDA","ANDA077253","PD-Rx Pharmaceuticals, Inc.","200","mg/1","","N","20261231"
"3797","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","55289084520","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55289-845","55289-845-20","55289-845_23a7e042-da20-3754-e063-6394a90a333b","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065101","PD-Rx Pharmaceuticals, Inc.","500; 125","mg/1; mg/1","","N","20251231"
"3798","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","55289084521","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55289-845","55289-845-21","55289-845_23a7e042-da20-3754-e063-6394a90a333b","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065101","PD-Rx Pharmaceuticals, Inc.","500; 125","mg/1; mg/1","","N","20251231"
"3799","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","55289084506","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55289-845","55289-845-06","55289-845_23a7e042-da20-3754-e063-6394a90a333b","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065101","PD-Rx Pharmaceuticals, Inc.","500; 125","mg/1; mg/1","","N","20251231"
"3800","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","55289084528","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55289-845","55289-845-28","55289-845_23a7e042-da20-3754-e063-6394a90a333b","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065101","PD-Rx Pharmaceuticals, Inc.","500; 125","mg/1; mg/1","","N","20251231"
"3801","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","55289084530","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","55289-845","55289-845-30","55289-845_23a7e042-da20-3754-e063-6394a90a333b","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065101","PD-Rx Pharmaceuticals, Inc.","500; 125","mg/1; mg/1","","N","20251231"
"3802","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","55301006764","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55301-067","55301-067-64","55301-067_873258e7-0455-4fa5-8009-2115731eb2e2","HUMAN OTC DRUG","Exchange Select triple antibiotic","","OINTMENT","TOPICAL","20160226","","OTC MONOGRAPH DRUG","M004","Army & Air Force Exchange Service","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3803","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl","55301012364","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55301-123","55301-123-64","55301-123_2b8b5d3a-ddcc-4213-a71e-f47a140f917f","HUMAN OTC DRUG","Exchange Select First Aid Triple Anitbiotic Pain Relieving","","OINTMENT","TOPICAL","20160303","","OTC MONOGRAPH DRUG","M004","Army & Air Force Exchange Service","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"3804","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Triple Antibiotic Ointment","55305012302","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55305-123","55305-123-02","55305-123_2f17a165-59de-9519-e063-6394a90a7a19","HUMAN OTC DRUG","Aerosoothe","","OINTMENT","TOPICAL","20151020","","OTC MONOGRAPH DRUG","M004","Aero Healthcare US LLC","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20261231"
"3805","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Triple Antibiotic Ointment","55305012303","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55305-123","55305-123-03","55305-123_2f17a165-59de-9519-e063-6394a90a7a19","HUMAN OTC DRUG","Aerosoothe","","OINTMENT","TOPICAL","20151020","","OTC MONOGRAPH DRUG","M004","Aero Healthcare US LLC","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20261231"
"3806","CLOTRIMAZOLE","Clotrimazole","55315000856","Azole Antifungal [EPC], Azoles [CS]","55315-008","55315-008-56","55315-008_26b9cd50-063e-1b5a-e063-6394a90afd2e","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20181115","","OTC MONOGRAPH DRUG","M005","FRED'S, INC.","10","mg/g","","N","20251231"
"3807","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and POLYMYXIN B SULFATE","55315018056","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55315-180","55315-180-56","55315-180_262eb18a-a71b-2a8d-e063-6394a90a4951","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20181115","","OTC MONOGRAPH DRUG","M004","Fred's, Inc.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3808","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and pramoxine hydrochloride","55315019234","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55315-192","55315-192-34","55315-192_262f6744-cc2c-8528-e063-6394a90afd88","HUMAN OTC DRUG","Triple Antibiotic","Plus Pain Relief","OINTMENT","TOPICAL","20120331","","OTC MONOGRAPH DRUG","M004","FRED'S, INC.","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"3809","MICONAZOLE NITRATE","Miconazole Nitrate","55315073743","Azole Antifungal [EPC], Azoles [CS]","55315-737","55315-737-43","55315-737_4c5dc483-ffb4-4a86-bdd1-dbfef0d41a26","HUMAN OTC DRUG","Freds","Miconazole 3","CREAM","VAGINAL","20050302","","ANDA","ANDA076773","FRED'S, INC.","40","mg/g","","N","20251231"
"3810","MICONAZOLE NITRATE","Miconazole Nitrate","55315081563","Azole Antifungal [EPC], Azoles [CS]","55315-815","55315-815-63","55315-815_a97a84b3-99ed-4470-91f0-dc519360d24f","HUMAN OTC DRUG","Miconazole Nitrate","","CREAM","VAGINAL","19970113","","ANDA","ANDA074444","FRED'S, INC.","20","mg/g","","N","20251231"
"3811","MICONAZOLE NITRATE","Miconazole Nitrate","55319053901","Azole Antifungal [EPC], Azoles [CS]","55319-539","55319-539-01","55319-539_277416fa-2dcf-259d-e063-6394a90a76fc","HUMAN OTC DRUG","Antifungal Liquid Continuous","","AEROSOL, SPRAY","TOPICAL","20240506","","OTC MONOGRAPH DRUG","M005","Family Dollar Services, Inc","20","mg/g","","N","20251231"
"3812","MICONAZOLE NITRATE","Miconazole Nitrate","55319057315","Azole Antifungal [EPC], Azoles [CS]","55319-573","55319-573-15","55319-573_a56993bb-45a8-4d07-b330-fdccd1c2e137","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20230701","","ANDA","ANDA074164","Family Dollar (FAMILY WELLNESS)","20","mg/g","","N","20261231"
"3813","MICONAZOLE NITRATE","Miconazole Nitrate","55319073045","Azole Antifungal [EPC], Azoles [CS]","55319-730","55319-730-45","55319-730_cf56ebd6-1cd9-49e2-94cc-fc8010b65f81","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20060606","","ANDA","ANDA074164","Family Dollar (FAMILY WELLNESS)","20","mg/g","","N","20251231"
"3814","CLOTRIMAZOLE","CLOTRIMAZOLE","55319098000","Azole Antifungal [EPC], Azoles [CS]","55319-980","55319-980-00","55319-980_2ef25a3a-88ac-a05e-e063-6294a90ae1ac","HUMAN OTC DRUG","Family Wellness Clotrimazole 1 Anti Fungal Cream","","CREAM","TOPICAL","20240101","","OTC MONOGRAPH DRUG","M005","Family Dollar Stores, Inc","10","mg/g","","N","20261231"
"3815","KETOCONAZOLE","Ketoconazole","55505019257","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","55505-192","55505-192-57","55505-192_eb3335cc-c12d-4a90-a926-c5b426d5b7b1","HUMAN OTC DRUG","Nizoral","","SHAMPOO","TOPICAL","20190107","","NDA","NDA020310","Kramer Laboratories","10","mg/mL","","N","20251231"
"3816","KETOCONAZOLE","Ketoconazole","55505019259","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","55505-192","55505-192-59","55505-192_eb3335cc-c12d-4a90-a926-c5b426d5b7b1","HUMAN OTC DRUG","Nizoral","","SHAMPOO","TOPICAL","20190107","","NDA","NDA020310","Kramer Laboratories","10","mg/mL","","N","20251231"
"3817","KETOCONAZOLE","Ketoconazole","55505019233","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","55505-192","55505-192-33","55505-192_eb3335cc-c12d-4a90-a926-c5b426d5b7b1","HUMAN OTC DRUG","Nizoral","","SHAMPOO","TOPICAL","20190107","","NDA","NDA020310","Kramer Laboratories","10","mg/mL","","N","20251231"
"3818","KETOCONAZOLE","Ketoconazole","55505019240","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","55505-192","55505-192-40","55505-192_eb3335cc-c12d-4a90-a926-c5b426d5b7b1","HUMAN OTC DRUG","Nizoral","","SHAMPOO","TOPICAL","20190107","","NDA","NDA020310","Kramer Laboratories","10","mg/mL","","N","20251231"
"3819","KETOCONAZOLE","Ketoconazole","55505019640","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","55505-196","55505-196-40","55505-196_e16aea23-df78-4668-8da0-c47cfa8f7187","HUMAN OTC DRUG","Nizoral","","SHAMPOO","TOPICAL","20220616","","NDA","NDA020310","Kramer Laboratories","10","mg/mL","","N","20251231"
"3820","KETOCONAZOLE","Ketoconazole","55505019664","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","55505-196","55505-196-64","55505-196_e16aea23-df78-4668-8da0-c47cfa8f7187","HUMAN OTC DRUG","Nizoral","","SHAMPOO","TOPICAL","20220616","","NDA","NDA020310","Kramer Laboratories","10","mg/mL","","N","20251231"
"3821","KETOCONAZOLE","Ketoconazole","55505019633","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","55505-196","55505-196-33","55505-196_e16aea23-df78-4668-8da0-c47cfa8f7187","HUMAN OTC DRUG","Nizoral","","SHAMPOO","TOPICAL","20220616","","NDA","NDA020310","Kramer Laboratories","10","mg/mL","","N","20251231"
"3822","KETOCONAZOLE","Ketoconazole","55505019672","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","55505-196","55505-196-72","55505-196_e16aea23-df78-4668-8da0-c47cfa8f7187","HUMAN OTC DRUG","Nizoral","","SHAMPOO","TOPICAL","20220616","","NDA","NDA020310","Kramer Laboratories","10","mg/mL","","N","20251231"
"3823","KETOCONAZOLE","Ketoconazole","55505019647","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","55505-196","55505-196-47","55505-196_e16aea23-df78-4668-8da0-c47cfa8f7187","HUMAN OTC DRUG","Nizoral","","SHAMPOO","TOPICAL","20220616","","NDA","NDA020310","Kramer Laboratories","10","mg/mL","","N","20251231"
"3824","KETOCONAZOLE","Ketoconazole","55505019665","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","55505-196","55505-196-65","55505-196_e16aea23-df78-4668-8da0-c47cfa8f7187","HUMAN OTC DRUG","Nizoral","","SHAMPOO","TOPICAL","20220616","","NDA","NDA020310","Kramer Laboratories","10","mg/mL","","N","20251231"
"3825","KETOCONAZOLE","Ketoconazole","55505023365","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","55505-233","55505-233-65","55505-233_b3f35e51-c03f-4ad2-9891-23a10eb02783","HUMAN OTC DRUG","Nizoral","","SHAMPOO","TOPICAL","20241101","","NDA","NDA020310","Kramer Laboratories","10","mg/mL","","N","20251231"
"3826","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","55550045101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55550-451","55550-451-01","55550-451_700a2d8c-d404-4d15-8f0b-a9fb1f540888","HUMAN OTC DRUG","Be Smart Get Prepared Triple Antibiotic","","OINTMENT","TOPICAL","20240816","","OTC MONOGRAPH DRUG","M004","Total Resources International, Inc","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20251231"
"3827","NEOMYCIN SULFATE","neomycin sulfate","55550073021","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","55550-730","55550-730-21","55550-730_e387e3e5-d08d-4b37-840b-cb49168001a8","HUMAN OTC DRUG","Antibiotic","","OINTMENT","TOPICAL","20191007","","OTC MONOGRAPH DRUG","M004","Total Resources International","3.5","mg/g","","N","20251231"
"3828","CLOTRIMAZOLE","Clotrimazole","55614065001","Azole Antifungal [EPC], Azoles [CS]","55614-650","55614-650-01","55614-650_5c56fc44-d398-4fbc-aa91-2acc3714965e","HUMAN OTC DRUG","HUA TUO XIAN GAO ANTIFUNGAL","","OINTMENT","TOPICAL","20200401","","OTC MONOGRAPH DRUG","part333C","MADISON ONE ACME INC","1","g/100g","","N","20251231"
"3829","CLOTRIMAZOLE","CLOTRIMAZOLE","55621000301","Azole Antifungal [EPC], Azoles [CS]","55621-003","55621-003-01","55621-003_08ad180e-e87c-ba6f-e063-6394a90a2bc7","HUMAN OTC DRUG","TheraPlus","Plus","CREAM","TOPICAL","20130301","","OTC MONOGRAPH DRUG","M005","Zhejiang Jingwei Pharmaceutical Co., Ltd.","1","g/100g","","N","20251231"
"3830","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate","55681002014","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55681-020","55681-020-14","55681-020_37a3916f-cc1b-41a0-e063-6394a90a35ed","HUMAN OTC DRUG","ProCure Triple Antibiotic","","OINTMENT","TOPICAL","20250616","","OTC MONOGRAPH DRUG","M004","Twin Med LLC","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20261231"
"3831","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate","55681002001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55681-020","55681-020-01","55681-020_37a3916f-cc1b-41a0-e063-6394a90a35ed","HUMAN OTC DRUG","ProCure Triple Antibiotic","","OINTMENT","TOPICAL","20250616","","OTC MONOGRAPH DRUG","M004","Twin Med LLC","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20261231"
"3832","MICONAZOLE NITRATE","Antifungal","55681016503","Azole Antifungal [EPC], Azoles [CS]","55681-165","55681-165-03","55681-165_37fecb31-8cd4-d37f-e063-6394a90a63a3","HUMAN OTC DRUG","Miconazole nitrate","","POWDER","TOPICAL","20220819","","OTC MONOGRAPH DRUG","M005","TWIN MED, LLC","2","g/100g","","N","20261231"
"3833","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B","55681021602","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55681-216","55681-216-02","55681-216_37feb566-9772-cf1c-e063-6394a90abfba","HUMAN OTC DRUG","ProcureTriple Antibiotic","Triple Antibiotic","OINTMENT","TOPICAL","20130205","","OTC MONOGRAPH DRUG","M004","TWIN MED, LLC","400; 3.5; 5000","U/g; mg/g; U/g","","N","20261231"
"3834","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B","55681021601","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55681-216","55681-216-01","55681-216_37feb566-9772-cf1c-e063-6394a90abfba","HUMAN OTC DRUG","ProcureTriple Antibiotic","Triple Antibiotic","OINTMENT","TOPICAL","20130205","","OTC MONOGRAPH DRUG","M004","TWIN MED, LLC","400; 3.5; 5000","U/g; mg/g; U/g","","N","20261231"
"3835","AZITHROMYCIN MONOHYDRATE","Azithromycin","55695000200","Macrolide Antimicrobial [EPC], Macrolides [CS]","55695-002","55695-002-00","55695-002_1287e725-48d5-e23e-e063-6394a90a96ac","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20101228","","ANDA","ANDA065246","STATE HEALTH SERVICES, TEXAS DEPARTMENT OF","100","mg/5mL","","N","20251231"
"3836","AZITHROMYCIN MONOHYDRATE","Azithromycin","55695000300","Macrolide Antimicrobial [EPC], Macrolides [CS]","55695-003","55695-003-00","55695-003_1287e725-48d5-e23e-e063-6394a90a96ac","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20101217","","ANDA","ANDA065246","STATE HEALTH SERVICES, TEXAS DEPARTMENT OF","200","mg/5mL","","N","20251231"
"3837","AZITHROMYCIN MONOHYDRATE","Azithromycin","55695000301","Macrolide Antimicrobial [EPC], Macrolides [CS]","55695-003","55695-003-01","55695-003_1287e725-48d5-e23e-e063-6394a90a96ac","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20101217","","ANDA","ANDA065246","STATE HEALTH SERVICES, TEXAS DEPARTMENT OF","200","mg/5mL","","N","20251231"
"3838","METRONIDAZOLE","Metronidazole","55700029814","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","55700-298","55700-298-14","55700-298_3a93841b-bd44-407f-a18d-6bee13438b7f","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","20270331","ANDA","ANDA203458","Quality Care Products LLC","500","mg/1","","N",""
"3839","METRONIDAZOLE","Metronidazole","55700029821","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","55700-298","55700-298-21","55700-298_3a93841b-bd44-407f-a18d-6bee13438b7f","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","20270331","ANDA","ANDA203458","Quality Care Products LLC","500","mg/1","","N",""
"3840","METRONIDAZOLE","Metronidazole","55700029804","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","55700-298","55700-298-04","55700-298_3a93841b-bd44-407f-a18d-6bee13438b7f","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","20270331","ANDA","ANDA203458","Quality Care Products LLC","500","mg/1","","N",""
"3841","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","55700061114","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","55700-611","55700-611-14","55700-611_b44a332e-98a1-4f1b-b06b-3a9b044cb926","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20180504","20281130","ANDA","ANDA090624","Quality Care Products LLC","800; 160","mg/1; mg/1","","N",""
"3842","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","55700061128","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","55700-611","55700-611-28","55700-611_b44a332e-98a1-4f1b-b06b-3a9b044cb926","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20180504","20281130","ANDA","ANDA090624","Quality Care Products LLC","800; 160","mg/1; mg/1","","N",""
"3843","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","55700061106","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","55700-611","55700-611-06","55700-611_b44a332e-98a1-4f1b-b06b-3a9b044cb926","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20180504","20281130","ANDA","ANDA090624","Quality Care Products LLC","800; 160","mg/1; mg/1","","N",""
"3844","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","55700061120","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","55700-611","55700-611-20","55700-611_b44a332e-98a1-4f1b-b06b-3a9b044cb926","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20180504","20281130","ANDA","ANDA090624","Quality Care Products LLC","800; 160","mg/1; mg/1","","N",""
"3845","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","55700073705","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","55700-737","55700-737-05","55700-737_33813b09-7ba5-460b-8c3e-be20781ed105","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","SOLUTION","OPHTHALMIC","20190329","20250930","ANDA","ANDA077568","Quality Care Products, LLC","3","mg/mL","","N",""
"3846","TOBRAMYCIN","Tobramycin","55700074705","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","55700-747","55700-747-05","55700-747_48a025a5-9b40-4a5b-a5a9-b39da7b91592","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION/ DROPS","OPHTHALMIC","20190426","20250930","ANDA","ANDA207444","Quality Care Products, LLC","3","mg/mL","","N",""
"3847","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","55700076130","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","55700-761","55700-761-30","55700-761_5fd32756-e7e4-4d84-bc33-bf64234d4300","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190607","20271130","ANDA","ANDA207402","Quality Care Products, LLC","300","mg/1","","N",""
"3848","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","55700076121","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","55700-761","55700-761-21","55700-761_5fd32756-e7e4-4d84-bc33-bf64234d4300","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190607","20271130","ANDA","ANDA207402","Quality Care Products, LLC","300","mg/1","","N",""
"3849","FLUCONAZOLE","Fluconazole","55700091601","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","55700-916","55700-916-01","55700-916_500be20b-3c04-4037-b4d4-e3e0ec28143c","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210713","20260331","ANDA","ANDA076658","Quality Care Products, LLC","150","mg/1","","N",""
"3850","ACONITUM NAPELLUS; ALLYLTHIOUREA; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; DYSPHANIA AMBROSIOIDES; GOLDENSEAL; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; QUININE SULFATE; SALICYLIC ACID; TOBACCO LEAF; VIOLA ODORATA","Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac., Tabacum, Thiosinaminum, Viola odorata","55714242601","Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vasodilation [PE], Vegetable Proteins [CS]","55714-2426","55714-2426-1","55714-2426_2d819b58-7e70-172a-e063-6294a90ad34a","HUMAN OTC DRUG","Ear Ringing","","LIQUID","ORAL","20190131","","UNAPPROVED HOMEOPATHIC","","Newton Laboratories, Inc.","10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20261231"
"3851","ACONITUM NAPELLUS; ALLYLTHIOUREA; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; DYSPHANIA AMBROSIOIDES; GOLDENSEAL; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; QUININE SULFATE; SALICYLIC ACID; TOBACCO LEAF; VIOLA ODORATA","Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac., Tabacum, Thiosinaminum, Viola odorata","55714242701","Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vasodilation [PE], Vegetable Proteins [CS]","55714-2427","55714-2427-1","55714-2427_b4f49f06-d9f7-0d09-e053-2a95a90ac5f0","HUMAN OTC DRUG","Ear Ringing","","PELLET","ORAL","20190131","","UNAPPROVED HOMEOPATHIC","","Newton Laboratories, Inc.","10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10","[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g","","N","20261231"
"3852","ACONITUM NAPELLUS; ALLYLTHIOUREA; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; DYSPHANIA AMBROSIOIDES; GOLDENSEAL; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; QUININE SULFATE; SALICYLIC ACID; TOBACCO LEAF; VIOLA ODORATA","Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac., Tabacum, Thiosinaminum, Viola odorata","55714258801","Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vasodilation [PE], Vegetable Proteins [CS]","55714-2588","55714-2588-1","55714-2588_10437086-0291-3a3b-e063-6294a90af4e4","HUMAN OTC DRUG","Ear Ringing","","LIQUID","ORAL","20240131","","UNAPPROVED HOMEOPATHIC","","Newton Laboratories, Inc.","15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"3853","ACONITUM NAPELLUS; ALLYLTHIOUREA; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; DYSPHANIA AMBROSIOIDES; GOLDENSEAL; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; QUININE SULFATE; SALICYLIC ACID; TOBACCO LEAF; VIOLA ODORATA","Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac., Tabacum, Thiosinaminum, Viola odorata","55714258901","Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vasodilation [PE], Vegetable Proteins [CS]","55714-2589","55714-2589-1","55714-2589_1045ca15-6ed3-a700-e063-6394a90ad96e","HUMAN OTC DRUG","Ear Ringing","","PELLET","ORAL","20240131","","UNAPPROVED HOMEOPATHIC","","Newton Laboratories, Inc.","15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15","[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g","","N","20251231"
"3854","ACONITUM NAPELLUS; ALLYLTHIOUREA; ANEMONE PULSATILLA; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; DYSPHANIA AMBROSIOIDES; GOLDENSEAL; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; QUININE SULFATE; SALICYLIC ACID; TOBACCO LEAF; VIOLA ODORATA","Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac., Tabacum, Thiosinaminum, Viola odorata","55714485701","Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vasodilation [PE], Vegetable Proteins [CS]","55714-4857","55714-4857-1","55714-4857_10462abf-9261-c0fe-e063-6394a90a7a71","HUMAN OTC DRUG","Tinnitus","","LIQUID","ORAL","20240131","","UNAPPROVED HOMEOPATHIC","","Newton Laboratories, Inc.","20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"3855","CLOTRIMAZOLE","Clotrimazole","55758010202","Azole Antifungal [EPC], Azoles [CS]","55758-102","55758-102-02","55758-102_28d8d548-1c4e-c68c-e063-6394a90a0a2a","HUMAN OTC DRUG","Cura Hongo","Antifungal","CREAM","TOPICAL","20220531","","OTC MONOGRAPH DRUG","M005","Pharmadel LLC","1","g/100g","","N","20251231"
"3856","CLOTRIMAZOLE","Clotrimazole","55758043401","Azole Antifungal [EPC], Azoles [CS]","55758-434","55758-434-01","55758-434_2746335f-345b-0c54-e063-6294a90a98dd","HUMAN OTC DRUG","Cura Hongos","Antifungal","LOTION","TOPICAL","20241104","","OTC MONOGRAPH DRUG","M005","Pharmadel LLC","1","g/100mL","","N","20251231"
"3857","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate","55758044002","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55758-440","55758-440-02","55758-440_25a394ea-7ad8-78af-e063-6394a90a1947","HUMAN OTC DRUG","Rapidol","Triple Antibiotic","OINTMENT","TOPICAL","20241104","","OTC MONOGRAPH DRUG","M004","Pharmadel LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3858","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin, Polymyxin B, Pramoxine HCl","55910006164","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55910-061","55910-061-64","55910-061_2947f5c9-f1df-420e-aca6-bff2d13abd92","HUMAN OTC DRUG","DG Health Antibiotic","","CREAM","TOPICAL","20110114","","OTC MONOGRAPH DRUG","M004","Dolgencorp Inc","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"3859","CLOTRIMAZOLE","CLOTRIMAZOLE","55910011800","Azole Antifungal [EPC], Azoles [CS]","55910-118","55910-118-00","55910-118_2f347ed2-93c9-02dd-e063-6294a90ab4d2","HUMAN OTC DRUG","DG Health Athletes Foot","","CREAM","TOPICAL","20250225","","OTC MONOGRAPH DRUG","M005","Dolgencorp, Inc.","10","mg/g","","N","20261231"
"3860","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","55910020916","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55910-209","55910-209-16","55910-209_ca0e7599-0ddf-49b6-a919-a43afbeab74a","HUMAN OTC DRUG","DG Health Triple Antibiotic","","OINTMENT","TOPICAL","20150623","","OTC MONOGRAPH DRUG","M004","Dolgencorp, LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3861","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","55910020964","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55910-209","55910-209-64","55910-209_ca0e7599-0ddf-49b6-a919-a43afbeab74a","HUMAN OTC DRUG","DG Health Triple Antibiotic","","OINTMENT","TOPICAL","20150623","","OTC MONOGRAPH DRUG","M004","Dolgencorp, LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3862","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl","55910044664","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55910-446","55910-446-64","55910-446_57b0362e-26fe-4c1d-b63a-abd11679c31d","HUMAN OTC DRUG","dg health triple antibiotic","","OINTMENT","TOPICAL","20200106","","OTC MONOGRAPH DRUG","M004","Dolgencorp, LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"3863","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl","55910067964","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","55910-679","55910-679-64","55910-679_eddbaf7c-a7ff-43d2-84da-b1c3f080fc26","HUMAN OTC DRUG","DG Health Antibiotic","","OINTMENT","TOPICAL","20150926","","OTC MONOGRAPH DRUG","M004","Dolgencorp, LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"3864","MICONAZOLE NITRATE","Miconazole nitrate","55910069829","Azole Antifungal [EPC], Azoles [CS]","55910-698","55910-698-29","55910-698_8c3aedbe-c817-4088-85ea-79a3128c056d","HUMAN OTC DRUG","DG Health Miconazole","","CREAM","VAGINAL","20200318","","ANDA","ANDA074760","Dolgencorp, LLC","2","g/100g","","N","20251231"
"3865","TIOCONAZOLE","Tioconazole","55910073154","Azole Antifungal [EPC], Azoles [CS]","55910-731","55910-731-54","55910-731_76043021-1ced-40da-8b62-fa2de5c2839d","HUMAN OTC DRUG","dg health tioconazole 1","","OINTMENT","VAGINAL","20190301","","ANDA","ANDA075915","Dolgencorp, LLC","6.5","g/100g","","N","20251231"
"3866","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","56062008002","Allylamine Antifungal [EPC], Allylamine [CS]","56062-080","56062-080-02","56062-080_ee5222be-8caa-4797-bcc5-b81f0d2af9bc","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Publix Super Markets Inc.","1","g/100g","","N","20251231"
"3867","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin, Neomycin, Polymyxin B, Pramoxine Hydrochloride","56062067964","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","56062-679","56062-679-64","56062-679_83350012-0110-4b7d-98b9-aba92dc8fee1","HUMAN OTC DRUG","triple antibiotic","","OINTMENT","TOPICAL","20241122","","OTC MONOGRAPH DRUG","M004","Publix Super Markets Inc","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"3868","CLOTRIMAZOLE","Clotrimazole 1%","56062081428","Azole Antifungal [EPC], Azoles [CS]","56062-814","56062-814-28","56062-814_9c2ec1aa-6907-46ed-8e06-ef6ff8cf7441","HUMAN OTC DRUG","Publix Athletic Foot","","CREAM","TOPICAL","20240715","","OTC MONOGRAPH DRUG","M005","PUBLIX SUPER MARKETS, INC.","10","mg/g","","N","20251231"
"3869","CLOTRIMAZOLE","Clotrimazole 1%","56062081728","Azole Antifungal [EPC], Azoles [CS]","56062-817","56062-817-28","56062-817_78c33045-bd41-489a-98ec-9afd8461bbea","HUMAN OTC DRUG","Publix Athletic Foot","","CREAM","TOPICAL","20240810","","OTC MONOGRAPH DRUG","M005","PUBLIX SUPER MARKETS, INC.","10","mg/g","","N","20251231"
"3870","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc 400 U, Polymxyin B Sulfate 5,000 U, Neomycin Sulfate 3.5mg/g","56062083028","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","56062-830","56062-830-28","56062-830_97093e84-1aef-46f4-aa65-d08cecc21e68","HUMAN OTC DRUG","Publix Triple Antibiotic","","OINTMENT","TOPICAL","20240715","","OTC MONOGRAPH DRUG","M004","PUBLIX SUPER MARKETS, INC.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3871","MICONAZOLE NITRATE","Antifungal Miconazole Powder Spray","56104012101","Azole Antifungal [EPC], Azoles [CS]","56104-121","56104-121-01","56104-121_29b6fb49-f5fd-d406-e063-6294a90ace19","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, SPRAY","TOPICAL","20220412","","OTC MONOGRAPH DRUG","M005","Premier Brands of America Inc.","2.6","g/130g","","N","20261231"
"3872","MICONAZOLE NITRATE","Athletes Foot Powder Spray Talc Free","56104013146","Azole Antifungal [EPC], Azoles [CS]","56104-131","56104-131-46","56104-131_380ec2cf-7b21-1ba3-e063-6394a90a2fdb","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, POWDER","TOPICAL","20181203","","OTC MONOGRAPH DRUG","M005","Premier Brands of America Inc.","2.6","g/130g","","N","20261231"
"3873","MICONAZOLE NITRATE","Miconazole Nitrate","56104025301","Azole Antifungal [EPC], Azoles [CS]","56104-253","56104-253-01","56104-253_247610b3-d569-b653-e063-6294a90a9cca","HUMAN OTC DRUG","Anti- Fungal Miconazole Nitrate","","POWDER","TOPICAL","20220411","","OTC MONOGRAPH DRUG","M005","Premier Brands of America Inc.","1.42","g/71g","","N","20251231"
"3874","MICONAZOLE NITRATE","Miconazole Nitrate","56104025601","Azole Antifungal [EPC], Azoles [CS]","56104-256","56104-256-01","56104-256_24763776-e3c2-0ca6-e063-6294a90a1da1","HUMAN OTC DRUG","Antifungal Miconazole","","AEROSOL, SPRAY","TOPICAL","20210929","","OTC MONOGRAPH DRUG","M005","Premier Brands of America Inc.","2.6","g/130g","","N","20251231"
"3875","MICONAZOLE NITRATE","Miconazole Nitrate","56104035001","Azole Antifungal [EPC], Azoles [CS]","56104-350","56104-350-01","56104-350_137e0adf-cd43-6c74-e063-6294a90a4fb5","HUMAN OTC DRUG","Foot Powder","","POWDER","TOPICAL","20231003","","OTC MONOGRAPH DRUG","M005","Premier Brands of America Inc.","20","mg/g","","N","20251231"
"3876","MICONAZOLE NITRATE","Miconazole Nitrate","56104050000","Azole Antifungal [EPC], Azoles [CS]","56104-500","56104-500-00","56104-500_24772a63-2e4a-9c2c-e063-6394a90af49b","HUMAN OTC DRUG","Anti-fungal Powder Miconazole Nitrate","","POWDER","TOPICAL","20230912","","OTC MONOGRAPH DRUG","M005","Premier Brands of America Inc.","20","mg/g","","N","20251231"
"3877","MICONAZOLE NITRATE","Antifungal Miconazole Liquid Continuous Spray","56104090301","Azole Antifungal [EPC], Azoles [CS]","56104-903","56104-903-01","56104-903_38045f75-42be-7abb-e063-6294a90a8db6","HUMAN OTC DRUG","Miconazole nitrate","","AEROSOL, SPRAY","TOPICAL","20250618","","OTC MONOGRAPH DRUG","M005","Premier Brands of America Inc.","20","mg/g","","N","20261231"
"3878","FLUCONAZOLE","Fluconazole","57237000330","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","57237-003","57237-003-30","57237-003_1018b9ad-7145-49b4-903a-b483797d7c86","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Rising Pharma Holdings, Inc.","50","mg/1","","N","20251231"
"3879","FLUCONAZOLE","Fluconazole","57237000430","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","57237-004","57237-004-30","57237-004_1018b9ad-7145-49b4-903a-b483797d7c86","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Rising Pharma Holdings, Inc.","100","mg/1","","N","20251231"
"3880","FLUCONAZOLE","Fluconazole","57237000511","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","57237-005","57237-005-11","57237-005_1018b9ad-7145-49b4-903a-b483797d7c86","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Rising Pharma Holdings, Inc.","150","mg/1","","N","20251231"
"3881","FLUCONAZOLE","Fluconazole","57237000630","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","57237-006","57237-006-30","57237-006_1018b9ad-7145-49b4-903a-b483797d7c86","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Rising Pharma Holdings, Inc.","200","mg/1","","N","20251231"
"3882","FLUCONAZOLE","Fluconazole","57237000601","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","57237-006","57237-006-01","57237-006_1018b9ad-7145-49b4-903a-b483797d7c86","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Rising Pharma Holdings, Inc.","200","mg/1","","N","20251231"
"3883","AMOXICILLIN","Amoxicillin","57237002801","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-028","57237-028-01","57237-028_679691e2-bbbf-4ed0-a31b-e538b3df75c0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Rising Pharma Holdings, Inc.","500","mg/1","","N","20251231"
"3884","AMOXICILLIN","Amoxicillin","57237002820","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-028","57237-028-20","57237-028_679691e2-bbbf-4ed0-a31b-e538b3df75c0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Rising Pharma Holdings, Inc.","500","mg/1","","N","20251231"
"3885","AMOXICILLIN","Amoxicillin","57237002920","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-029","57237-029-20","57237-029_679691e2-bbbf-4ed0-a31b-e538b3df75c0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Rising Pharma Holdings, Inc.","875","mg/1","","N","20251231"
"3886","AMOXICILLIN","Amoxicillin","57237002901","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-029","57237-029-01","57237-029_679691e2-bbbf-4ed0-a31b-e538b3df75c0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Rising Pharma Holdings, Inc.","875","mg/1","","N","20251231"
"3887","AMOXICILLIN","Amoxicillin","57237003001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-030","57237-030-01","57237-030_4e6f21c7-0e2a-4361-9549-ab42efd08d5b","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Rising Pharma Holdings, Inc.","250","mg/1","","N","20251231"
"3888","AMOXICILLIN","Amoxicillin","57237003005","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-030","57237-030-05","57237-030_4e6f21c7-0e2a-4361-9549-ab42efd08d5b","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Rising Pharma Holdings, Inc.","250","mg/1","","N","20251231"
"3889","AMOXICILLIN","Amoxicillin","57237003101","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-031","57237-031-01","57237-031_4e6f21c7-0e2a-4361-9549-ab42efd08d5b","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Rising Pharma Holdings, Inc.","500","mg/1","","N","20251231"
"3890","AMOXICILLIN","Amoxicillin","57237003105","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-031","57237-031-05","57237-031_4e6f21c7-0e2a-4361-9549-ab42efd08d5b","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Rising Pharma Holdings, Inc.","500","mg/1","","N","20251231"
"3891","AMOXICILLIN","Amoxicillin","57237003201","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-032","57237-032-01","57237-032_62bfc65c-04fe-43b5-b659-d37067b280c0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","Rising Pharma Holdings, Inc.","200","mg/5mL","","N","20251231"
"3892","AMOXICILLIN","Amoxicillin","57237003250","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-032","57237-032-50","57237-032_62bfc65c-04fe-43b5-b659-d37067b280c0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","Rising Pharma Holdings, Inc.","200","mg/5mL","","N","20251231"
"3893","AMOXICILLIN","Amoxicillin","57237003275","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-032","57237-032-75","57237-032_62bfc65c-04fe-43b5-b659-d37067b280c0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","Rising Pharma Holdings, Inc.","200","mg/5mL","","N","20251231"
"3894","AMOXICILLIN","Amoxicillin","57237003350","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-033","57237-033-50","57237-033_62bfc65c-04fe-43b5-b659-d37067b280c0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","Rising Pharma Holdings, Inc.","400","mg/5mL","","N","20251231"
"3895","AMOXICILLIN","Amoxicillin","57237003375","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-033","57237-033-75","57237-033_62bfc65c-04fe-43b5-b659-d37067b280c0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","Rising Pharma Holdings, Inc.","400","mg/5mL","","N","20251231"
"3896","AMOXICILLIN","Amoxicillin","57237003301","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-033","57237-033-01","57237-033_62bfc65c-04fe-43b5-b659-d37067b280c0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","Rising Pharma Holdings, Inc.","400","mg/5mL","","N","20251231"
"3897","PENICILLIN V POTASSIUM","Penicillin V Potassium","57237004001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-040","57237-040-01","57237-040_2334dad4-7145-499c-959b-bdd69a400ffb","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Rising Health, LLC","250","mg/1","","N","20251231"
"3898","PENICILLIN V POTASSIUM","Penicillin V Potassium","57237004099","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-040","57237-040-99","57237-040_2334dad4-7145-499c-959b-bdd69a400ffb","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Rising Health, LLC","250","mg/1","","N","20251231"
"3899","PENICILLIN V POTASSIUM","Penicillin V Potassium","57237004105","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-041","57237-041-05","57237-041_2334dad4-7145-499c-959b-bdd69a400ffb","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Rising Health, LLC","500","mg/1","","N","20251231"
"3900","PENICILLIN V POTASSIUM","Penicillin V Potassium","57237004199","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-041","57237-041-99","57237-041_2334dad4-7145-499c-959b-bdd69a400ffb","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Rising Health, LLC","500","mg/1","","N","20251231"
"3901","PENICILLIN V POTASSIUM","Penicillin V Potassium","57237004101","Penicillin-class Antibacterial [EPC], Penicillins [CS]","57237-041","57237-041-01","57237-041_2334dad4-7145-499c-959b-bdd69a400ffb","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Rising Health, LLC","500","mg/1","","N","20251231"
"3902","CLARITHROMYCIN","Clarithromycin","57237004460","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","57237-044","57237-044-60","57237-044_ce30a7ce-c4f2-41b3-966d-c79fab80f76b","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Rising Pharma Holdings, Inc.","250","mg/1","","N","20251231"
"3903","CLARITHROMYCIN","Clarithromycin","57237004560","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","57237-045","57237-045-60","57237-045_ce30a7ce-c4f2-41b3-966d-c79fab80f76b","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Rising Pharma Holdings, Inc.","500","mg/1","","N","20251231"
"3904","CEFUROXIME AXETIL","Cefuroxime Axetil","57237005860","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","57237-058","57237-058-60","57237-058_d7e9c50b-74c7-4c0b-9c73-8802fa288cd8","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET, FILM COATED","ORAL","20060329","","ANDA","ANDA065308","Rising Pharma Holdings, Inc.","250","mg/1","","N","20251231"
"3905","CEFUROXIME AXETIL","Cefuroxime Axetil","57237005820","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","57237-058","57237-058-20","57237-058_d7e9c50b-74c7-4c0b-9c73-8802fa288cd8","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET, FILM COATED","ORAL","20060329","","ANDA","ANDA065308","Rising Pharma Holdings, Inc.","250","mg/1","","N","20251231"
"3906","CEFUROXIME AXETIL","Cefuroxime Axetil","57237005920","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","57237-059","57237-059-20","57237-059_d7e9c50b-74c7-4c0b-9c73-8802fa288cd8","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET, FILM COATED","ORAL","20060329","","ANDA","ANDA065308","Rising Pharma Holdings, Inc.","500","mg/1","","N","20251231"
"3907","CEFUROXIME AXETIL","Cefuroxime Axetil","57237005960","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","57237-059","57237-059-60","57237-059_d7e9c50b-74c7-4c0b-9c73-8802fa288cd8","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET, FILM COATED","ORAL","20060329","","ANDA","ANDA065308","Rising Pharma Holdings, Inc.","500","mg/1","","N","20251231"
"3908","CEFADROXIL","Cefadroxil","57237009601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","57237-096","57237-096-01","57237-096_15dc4c1d-6a9a-4c87-a037-e6fc34d84ad9","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","Rising Pharma Holdings, Inc.","500","mg/1","","N","20251231"
"3909","CEFADROXIL","Cefadroxil","57237009650","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","57237-096","57237-096-50","57237-096_15dc4c1d-6a9a-4c87-a037-e6fc34d84ad9","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","Rising Pharma Holdings, Inc.","500","mg/1","","N","20251231"
"3910","CEFADROXIL","Cefadroxil","57237009750","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","57237-097","57237-097-50","57237-097_59b4c983-458c-4363-b2e6-4253a2bc7992","HUMAN PRESCRIPTION DRUG","Cefadroxil","","POWDER, FOR SUSPENSION","ORAL","20130425","","ANDA","ANDA065349","Rising Pharma Holdings, Inc.","250","mg/5mL","","N","20251231"
"3911","CEFADROXIL","Cefadroxil","57237009701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","57237-097","57237-097-01","57237-097_59b4c983-458c-4363-b2e6-4253a2bc7992","HUMAN PRESCRIPTION DRUG","Cefadroxil","","POWDER, FOR SUSPENSION","ORAL","20130425","","ANDA","ANDA065349","Rising Pharma Holdings, Inc.","250","mg/5mL","","N","20251231"
"3912","CEFADROXIL","Cefadroxil","57237009801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","57237-098","57237-098-01","57237-098_59b4c983-458c-4363-b2e6-4253a2bc7992","HUMAN PRESCRIPTION DRUG","Cefadroxil","","POWDER, FOR SUSPENSION","ORAL","20130425","","ANDA","ANDA065349","Rising Pharma Holdings, Inc.","500","mg/5mL","","N","20251231"
"3913","CEFADROXIL","Cefadroxil","57237009875","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","57237-098","57237-098-75","57237-098_59b4c983-458c-4363-b2e6-4253a2bc7992","HUMAN PRESCRIPTION DRUG","Cefadroxil","","POWDER, FOR SUSPENSION","ORAL","20130425","","ANDA","ANDA065349","Rising Pharma Holdings, Inc.","500","mg/5mL","","N","20251231"
"3914","CEFDINIR","Cefdinir","57237009960","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","57237-099","57237-099-60","57237-099_084623a7-ebe0-4468-9a4b-9fd016e96c3c","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","Rising Pharma Holdings, Inc.","300","mg/1","","N","20251231"
"3915","FLUCONAZOLE","Fluconazole","57237014935","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","57237-149","57237-149-35","57237-149_8c4429e6-5542-4bec-9d50-1021ea548c01","HUMAN PRESCRIPTION DRUG","Fluconazole","","POWDER, FOR SUSPENSION","ORAL","20090918","","ANDA","ANDA079150","Rising Pharma Holdings, Inc.","10","mg/mL","","N","20251231"
"3916","FLUCONAZOLE","Fluconazole","57237015035","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","57237-150","57237-150-35","57237-150_8c4429e6-5542-4bec-9d50-1021ea548c01","HUMAN PRESCRIPTION DRUG","Fluconazole","","POWDER, FOR SUSPENSION","ORAL","20090918","","ANDA","ANDA079150","Rising Pharma Holdings, Inc.","40","mg/mL","","N","20251231"
"3917","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin Hydrochloride","57237015630","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","57237-156","57237-156-30","57237-156_6c9f3f5a-1e8f-4d13-9452-61fbb4807410","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride","","TABLET, FILM COATED","ORAL","20140304","","ANDA","ANDA202632","Rising Pharma Holdings, Inc.","400","mg/1","","N","20251231"
"3918","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","57237023205","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","57237-232","57237-232-05","57237-232_a7ba2917-7474-437f-8c18-a2f06c2c8bd2","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Rising Pharma Holdings, Inc.","400; 80","mg/1; mg/1","","N","20261231"
"3919","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","57237023201","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","57237-232","57237-232-01","57237-232_a7ba2917-7474-437f-8c18-a2f06c2c8bd2","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Rising Pharma Holdings, Inc.","400; 80","mg/1; mg/1","","N","20261231"
"3920","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","57237023305","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","57237-233","57237-233-05","57237-233_a7ba2917-7474-437f-8c18-a2f06c2c8bd2","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Rising Pharma Holdings, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"3921","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","57237023301","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","57237-233","57237-233-01","57237-233_a7ba2917-7474-437f-8c18-a2f06c2c8bd2","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Rising Pharma Holdings, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"3922","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","57243012001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","57243-120","57243-120-01","57243-120_4a9f8454-d28e-49e3-b179-5fe244770ffb","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","","OTC MONOGRAPH FINAL","part333B","Salado Sales, Inc","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3923","NITROFURANTOIN","Nitrofurantion","57664023188","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","57664-231","57664-231-88","57664-231_163dd253-35bc-4eb8-8bfc-a3ec65c9da14","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Sun Pharmaceutical Industries, Inc.","25","mg/1","","N","20251231"
"3924","NITROFURANTOIN","Nitrofurantion","57664023118","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","57664-231","57664-231-18","57664-231_163dd253-35bc-4eb8-8bfc-a3ec65c9da14","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Sun Pharmaceutical Industries, Inc.","25","mg/1","","N","20251231"
"3925","NITROFURANTOIN","Nitrofurantion","57664023218","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","57664-232","57664-232-18","57664-232_163dd253-35bc-4eb8-8bfc-a3ec65c9da14","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Sun Pharmaceutical Industries, Inc.","50","mg/1","","N","20251231"
"3926","NITROFURANTOIN","Nitrofurantion","57664023288","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","57664-232","57664-232-88","57664-232_163dd253-35bc-4eb8-8bfc-a3ec65c9da14","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Sun Pharmaceutical Industries, Inc.","50","mg/1","","N","20251231"
"3927","NITROFURANTOIN","Nitrofurantion","57664023388","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","57664-233","57664-233-88","57664-233_163dd253-35bc-4eb8-8bfc-a3ec65c9da14","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Sun Pharmaceutical Industries, Inc.","100","mg/1","","N","20251231"
"3928","NITROFURANTOIN","Nitrofurantion","57664023318","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","57664-233","57664-233-18","57664-233_163dd253-35bc-4eb8-8bfc-a3ec65c9da14","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Sun Pharmaceutical Industries, Inc.","100","mg/1","","N","20251231"
"3929","LINEZOLID","linezolid","57664068230","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","57664-682","57664-682-30","57664-682_2e599906-ac35-54ab-e063-6394a90ac605","HUMAN PRESCRIPTION DRUG","Linezolid","","INJECTION, SOLUTION","INTRAVENOUS","20170201","","ANDA","ANDA207354","Sun Pharmaceutical Industries, Inc.","200","mg/100mL","","N","20261231"
"3930","LINEZOLID","linezolid","57664068357","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","57664-683","57664-683-57","57664-683_2e599906-ac35-54ab-e063-6394a90ac605","HUMAN PRESCRIPTION DRUG","Linezolid","","INJECTION, SOLUTION","INTRAVENOUS","20170201","","ANDA","ANDA207354","Sun Pharmaceutical Industries, Inc.","600","mg/300mL","","N","20261231"
"3931","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","57664076113","Antimalarial [EPC], Antirheumatic Agent [EPC]","57664-761","57664-761-13","57664-761_cb7adb60-886b-4415-9b04-b6d37712bbe0","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET","ORAL","20180618","","ANDA","ANDA201691","Sun Pharmaceutical Industries, Inc.","200","mg/1","","N","20251231"
"3932","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","57664076188","Antimalarial [EPC], Antirheumatic Agent [EPC]","57664-761","57664-761-88","57664-761_cb7adb60-886b-4415-9b04-b6d37712bbe0","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET","ORAL","20180618","","ANDA","ANDA201691","Sun Pharmaceutical Industries, Inc.","200","mg/1","","N","20251231"
"3933","AMPHOTERICIN B; DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-; DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-","amphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-","57665010141","Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]","57665-101","57665-101-41","57665-101_0aab355d-bbe3-5a46-e063-6294a90a971f","HUMAN PRESCRIPTION DRUG","ABELCET","","INJECTION","INTRAVENOUS","20101018","","NDA","NDA050724","Leadiant Biosciences, Inc.","5; 3.4; 1.5","mg/mL; mg/mL; mg/mL","","N","20251231"
"3934","AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN","omeprazole magnesium, amoxicillin and rifabutin","57841115002","Cytochrome P450 2C19 Inhibitors [MoA], Penicillin-class Antibacterial [EPC], Penicillins [CS], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA], Rifamycin Antimycobacterial [EPC], Rifamycins [CS]","57841-1150","57841-1150-2","57841-1150_e510947e-c830-4542-ab34-5a4c442bced6","HUMAN PRESCRIPTION DRUG","Talicia","","CAPSULE, DELAYED RELEASE","ORAL","20200309","","NDA","NDA213004","RedHill Biopharma Ltd","250; 10; 12.5","mg/1; mg/1; mg/1","","N","20251231"
"3935","AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN","omeprazole magnesium, amoxicillin and rifabutin","57841115004","Cytochrome P450 2C19 Inhibitors [MoA], Penicillin-class Antibacterial [EPC], Penicillins [CS], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA], Rifamycin Antimycobacterial [EPC], Rifamycins [CS]","57841-1150","57841-1150-4","57841-1150_e510947e-c830-4542-ab34-5a4c442bced6","HUMAN PRESCRIPTION DRUG","Talicia","","CAPSULE, DELAYED RELEASE","ORAL","20200309","","NDA","NDA213004","RedHill Biopharma Ltd","250; 10; 12.5","mg/1; mg/1; mg/1","","N","20251231"
"3936","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","57883040410","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","57883-404","57883-404-10","57883-404_290515fd-224a-21ae-e063-6294a90a9047","HUMAN PRESCRIPTION DRUG","Plexion","","CLOTH","TOPICAL","20050901","","UNAPPROVED DRUG OTHER","","Brava Pharmaceuticals, LLC","98; 48","mg/g; mg/g","","N","20251231"
"3937","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","57883040460","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","57883-404","57883-404-60","57883-404_290515fd-224a-21ae-e063-6294a90a9047","HUMAN PRESCRIPTION DRUG","Plexion","","CLOTH","TOPICAL","20050901","","UNAPPROVED DRUG OTHER","","Brava Pharmaceuticals, LLC","98; 48","mg/g; mg/g","","N","20251231"
"3938","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.","57896014314","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","57896-143","57896-143-14","57896-143_0df8f032-44e7-2544-e063-6394a90a0413","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20220401","","OTC MONOGRAPH DRUG","M004","Geri-Care Pharmaceuticals, Corp","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"3939","ARABICA COFFEE BEAN; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAPSICUM; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; POTASSIUM DICHROMATE; QUININE ARSENITE; SANGUINARIA CANADENSIS ROOT; SODIUM CHLORIDE; SPIGELIA ANTHELMIA WHOLE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR","Belladonna, Bryonia, Capsicum annuum, Chininum arsenicosum, Coffea cruda, Gelsemium sempervirens, Glonoinum, Ignatia amara, Kali bichromicum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Sanguinaria canadensis, Spigelia anthelmia, Sulphur","57955283002","Allergens [CS], Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS], Vasodilation [PE], Vegetable Proteins [CS]","57955-2830","57955-2830-2","57955-2830_2ea77949-04c8-45bc-9ce5-f322424771b6","HUMAN OTC DRUG","Headache Relief","","LIQUID","ORAL","20220722","20250701","UNAPPROVED HOMEOPATHIC","","King Bio Inc.","10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10","[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL","","N",""
"3940","DALBAVANCIN HYDROCHLORIDE","Dalbavancin","57970010001","Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]","57970-100","57970-100-01","57970-100_9840e7c6-777e-4c3b-96bb-fb4cc4576894","HUMAN PRESCRIPTION DRUG","DALVANCE","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20140523","","NDA","NDA021883","Allergan, Inc.","500","mg/25mL","","N","20261231"
"3941","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Triple Antibiotic","58228200902","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","58228-2009","58228-2009-2","58228-2009_27d72809-cedb-6510-e063-6394a90abd63","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20230410","","OTC MONOGRAPH DRUG","M004","ProStat First Aid","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3942","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","PS-2261 Triple Antibiotic, 0.5g","58228226101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","58228-2261","58228-2261-1","58228-2261_27d720a1-bb9e-654a-e063-6394a90aba37","HUMAN OTC DRUG","PS-2261 Triple Antibiotic, 0.5g","","OINTMENT","TOPICAL","20230731","","OTC MONOGRAPH DRUG","M004","ProStat First Aid LLC","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3943","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","PS - 2895 Triple Antibiotic , 0.5g","58228289501","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","58228-2895","58228-2895-1","58228-2895_27d71c35-fa29-f96c-e063-6394a90acd56","HUMAN OTC DRUG","PS - 2895 Triple Antibiotic , 0.5g","","OINTMENT","TOPICAL","20230731","","OTC MONOGRAPH DRUG","M004","Prostat First Aid LLC","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3944","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Triple Antibiotic","58228620901","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","58228-6209","58228-6209-1","58228-6209_27d6a644-e540-58e8-e063-6394a90a24c0","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20240126","","OTC MONOGRAPH DRUG","M004","Front Line Safety","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"3945","BAPTISIA TINCTORIA; CITRULLUS COLOCYNTHIS FRUIT PULP; FERROSOFERRIC PHOSPHATE; MATRICARIA CHAMOMILLA; MERCURIC CHLORIDE; NERIUM OLEANDER LEAF; PHOSPHORIC ACID; QUININE ARSENITE; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT","QUININE ARSENITE, PHOSPHORIC ACID, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, MERCURIC CHLORIDE, VERATRUM ALBUM ROOT, BAPTISIA TINCTORIA, FERROSOFERRIC PHOSPHATE, NERIUM OLEANDER LEAF, and TOXICODENDRON PUBESCENS LEAF","58264000401","Antimalarial [EPC]","58264-0004","58264-0004-1","58264-0004_2b9ea1fc-59a3-8189-e063-6394a90a9ae6","HUMAN OTC DRUG","D-4","","SOLUTION","SUBLINGUAL","19900101","","UNAPPROVED HOMEOPATHIC","","DNA Labs, Inc.","4; 6; 8; 4; 5; 6; 3; 12; 4; 6","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20261231"
"3946","MICONAZOLE NITRATE","Tolnaftate","58593062553","Azole Antifungal [EPC], Azoles [CS]","58593-625","58593-625-53","58593-625_23fec4f5-badc-34b6-e063-6294a90a260e","HUMAN OTC DRUG","Hongo Killer","","AEROSOL, SPRAY","TOPICAL","20041001","","OTC MONOGRAPH DRUG","M005","Efficient Laboratories Inc",".2","g/10g","","N","20251231"
"3947","SULFACETAMIDE SODIUM; SULFUR","SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream","58657046801","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","58657-468","58657-468-01","58657-468_27b31ba7-c0e2-2280-e063-6394a90a887e","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream","","CREAM","TOPICAL","20220515","","UNAPPROVED DRUG OTHER","","Method Pharmaceuticals, LLC","100; 50","mg/g; mg/g","","N","20251231"
"3948","SULFACETAMIDE SODIUM; SULFUR","SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream","58657046802","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","58657-468","58657-468-02","58657-468_27b31ba7-c0e2-2280-e063-6394a90a887e","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream","","CREAM","TOPICAL","20220515","","UNAPPROVED DRUG OTHER","","Method Pharmaceuticals, LLC","100; 50","mg/g; mg/g","","N","20251231"
"3949","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","58657046916","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","58657-469","58657-469-16","58657-469_2759fc77-6d52-7cac-e063-6394a90a55e7","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 8% and Sulfur 4% Cleanser","","LIQUID","TOPICAL","20220201","","UNAPPROVED DRUG OTHER","","Method Pharmaceuticals","80; 40","mg/mL; mg/mL","","N","20251231"
"3950","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","58657047108","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","58657-471","58657-471-08","58657-471_2759f74e-cf67-8bbc-e063-6394a90ace21","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10% and Sulfur 2% Cleanser","","LIQUID","TOPICAL","20220201","","UNAPPROVED DRUG OTHER","","Method Pharmaceuticals","100; 20","mg/g; mg/g","","N","20251231"
"3951","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","58657047206","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","58657-472","58657-472-06","58657-472_275a112d-6ec3-c3d9-e063-6294a90af5a4","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide and Sulfur","","LIQUID","TOPICAL","20211115","","UNAPPROVED DRUG OTHER","","Method Pharmaceuticals, LLC","100; 50","mg/g; mg/g","","N","20251231"
"3952","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","58657047207","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","58657-472","58657-472-07","58657-472_275a112d-6ec3-c3d9-e063-6294a90af5a4","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide and Sulfur","","LIQUID","TOPICAL","20211115","","UNAPPROVED DRUG OTHER","","Method Pharmaceuticals, LLC","100; 50","mg/g; mg/g","","N","20251231"
"3953","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","58657047208","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","58657-472","58657-472-08","58657-472_275a112d-6ec3-c3d9-e063-6294a90af5a4","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide and Sulfur","","LIQUID","TOPICAL","20211115","","UNAPPROVED DRUG OTHER","","Method Pharmaceuticals, LLC","100; 50","mg/g; mg/g","","N","20251231"
"3954","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","58657047213","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","58657-472","58657-472-13","58657-472_275a112d-6ec3-c3d9-e063-6294a90af5a4","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide and Sulfur","","LIQUID","TOPICAL","20211115","","UNAPPROVED DRUG OTHER","","Method Pharmaceuticals, LLC","100; 50","mg/g; mg/g","","N","20251231"
"3955","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","58657047212","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","58657-472","58657-472-12","58657-472_275a112d-6ec3-c3d9-e063-6294a90af5a4","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide and Sulfur","","LIQUID","TOPICAL","20211115","","UNAPPROVED DRUG OTHER","","Method Pharmaceuticals, LLC","100; 50","mg/g; mg/g","","N","20251231"
"3956","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","58657047316","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","58657-473","58657-473-16","58657-473_275a333c-1c0a-e9f5-e063-6394a90ae3f5","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 9% and Sulfur 4% Cleanser","","LIQUID","TOPICAL","20220201","","UNAPPROVED DRUG OTHER","","Method Pharmaceuticals","90; 40","mg/mL; mg/mL","","N","20251231"
"3957","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","58657047416","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","58657-474","58657-474-16","58657-474_275a4953-bd5a-ce58-e063-6394a90aa4a6","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 9% and Sulfur 4.5% Cleanser","","LIQUID","TOPICAL","20220201","","UNAPPROVED DRUG OTHER","","Method Pharmaceuticals","90; 45","mg/g; mg/g","","N","20251231"
"3958","SULFACETAMIDE SODIUM","Sodium Sulfacetamide","58657047712","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","58657-477","58657-477-12","58657-477_275a4642-c1aa-e937-e063-6394a90adaa2","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide","","LIQUID","TOPICAL","20220115","","UNAPPROVED DRUG OTHER","","Method Pharmaceuticals, LLC","100","mg/g","","N","20251231"
"3959","SULFACETAMIDE SODIUM","Sodium Sulfacetamide","58657047716","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","58657-477","58657-477-16","58657-477_275a4642-c1aa-e937-e063-6394a90adaa2","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide","","LIQUID","TOPICAL","20220115","","UNAPPROVED DRUG OTHER","","Method Pharmaceuticals, LLC","100","mg/g","","N","20251231"
"3960","SULFACETAMIDE SODIUM","Sodium Sulfacetamide","58657047706","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","58657-477","58657-477-06","58657-477_275a4642-c1aa-e937-e063-6394a90adaa2","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide","","LIQUID","TOPICAL","20220115","","UNAPPROVED DRUG OTHER","","Method Pharmaceuticals, LLC","100","mg/g","","N","20251231"
"3961","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","58657067501","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","58657-675","58657-675-01","58657-675_281065d7-ab7e-202a-e063-6394a90a8ed0","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Method Pharmaceuticals, LLC","250","mg/1","","N","20251231"
"3962","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","58657067601","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","58657-676","58657-676-01","58657-676_281065d7-ab7e-202a-e063-6394a90a8ed0","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Method Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"3963","METRONIDAZOLE","metronidazole","58657073956","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","58657-739","58657-739-56","58657-739_2c610b34-5c40-3c3d-e063-6294a90ac26d","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20250104","","ANDA","ANDA070772","Method Pharmaceuticals LLC","125","mg/1","","N","20261231"
"3964","METRONIDAZOLE","metronidazole","58657073901","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","58657-739","58657-739-01","58657-739_2c610b34-5c40-3c3d-e063-6294a90ac26d","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20250104","","ANDA","ANDA070772","Method Pharmaceuticals LLC","125","mg/1","","N","20261231"
"3965","BACITRACIN ZINC; POLYMYXIN B SULFATE","BACITRACIN ZINC and POLYMYXIN B SULFATE","58980001205","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","58980-012","58980-012-05","58980-012_35044adf-06bd-4875-bf03-38d8e2960271","HUMAN OTC DRUG","BACITRACIN ZINC","","OINTMENT","TOPICAL","20170915","","OTC MONOGRAPH DRUG","M004","STRATUS PHARMACEUTICALS INC","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"3966","BACITRACIN ZINC; POLYMYXIN B SULFATE","BACITRACIN ZINC and POLYMYXIN B SULFATE","58980001201","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","58980-012","58980-012-01","58980-012_35044adf-06bd-4875-bf03-38d8e2960271","HUMAN OTC DRUG","BACITRACIN ZINC","","OINTMENT","TOPICAL","20170915","","OTC MONOGRAPH DRUG","M004","STRATUS PHARMACEUTICALS INC","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"3967","MICONAZOLE NITRATE","Miconazole Nitrate","58980081810","Azole Antifungal [EPC], Azoles [CS]","58980-818","58980-818-10","58980-818_fa7abfcb-49d5-412f-88ab-68af39fd0f5d","HUMAN OTC DRUG","Azolen","","TINCTURE","TOPICAL","20170915","","OTC MONOGRAPH FINAL","part333C","Stratus Pharmaceuticals, Inc.","20","mg/mL","","N","20251231"
"3968","MICONAZOLE NITRATE","MICONAZOLE NITRATE","58980081960","Azole Antifungal [EPC], Azoles [CS]","58980-819","58980-819-60","58980-819_85b974c1-bef2-4320-93a4-0fcf7774c55c","HUMAN OTC DRUG","AZOLEN","","LIQUID","TOPICAL","20230914","","OTC MONOGRAPH DRUG","M005","STRATUS PHARMACEUTICALS INC","2","mg/g","","N","20251231"
"3969","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate, and PRAMOXINE HYDROCHLORIDE","58988117001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","58988-1170","58988-1170-1","58988-1170_ea8f2105-b483-4ecb-b1a9-babd58f2e44a","HUMAN OTC DRUG","Cuadriderma","","OINTMENT","TOPICAL","20130531","","OTC MONOGRAPH DRUG","M004","ProMex LLC","500; 3.5; 10000; 10","[iU]/g; mg/g; [iU]/g; mg/g","","N","20251231"
"3970","CLOTRIMAZOLE","Clotrimazole","59088044107","Azole Antifungal [EPC], Azoles [CS]","59088-441","59088-441-07","59088-441_23740ac5-b214-253d-e063-6394a90a1951","HUMAN OTC DRUG","Mycozyl AC","","CREAM","TOPICAL","20210406","","OTC MONOGRAPH DRUG","M005","PureTek Corporation","10","mg/g","","N","20251231"
"3971","MICONAZOLE NITRATE","Miconazole Nitrate","59088044207","Azole Antifungal [EPC], Azoles [CS]","59088-442","59088-442-07","59088-442_237410ce-a7e8-47ec-e063-6394a90a89a2","HUMAN OTC DRUG","Mycozyl AP","","POWDER","TOPICAL","20201208","","OTC MONOGRAPH DRUG","M005","PureTek Corporation","2","g/85g","","N","20251231"
"3972","CLOTRIMAZOLE","Clotrimazole","59088047607","Azole Antifungal [EPC], Azoles [CS]","59088-476","59088-476-07","59088-476_23737455-6b67-0f15-e063-6394a90a215a","HUMAN OTC DRUG","Micotrin AC","","CREAM","TOPICAL","20211025","","OTC MONOGRAPH DRUG","M005","PureTek Corporation","10","mg/g","","N","20251231"
"3973","MICONAZOLE NITRATE","Miconazole Nitrate","59088047807","Azole Antifungal [EPC], Azoles [CS]","59088-478","59088-478-07","59088-478_23737640-ab36-eddf-e063-6394a90a3bef","HUMAN OTC DRUG","Micotrin AP","","POWDER","TOPICAL","20211025","","OTC MONOGRAPH DRUG","M005","PureTek Corporation","2","g/85g","","N","20251231"
"3974","CLOTRIMAZOLE","Clotrimazole","59088064207","Azole Antifungal [EPC], Azoles [CS]","59088-642","59088-642-07","59088-642_dd05f5f9-2413-1295-e053-2995a90acb96","HUMAN OTC DRUG","Micomitin Antifungal","","CREAM","TOPICAL","20220419","","OTC MONOGRAPH DRUG","M005","PureTek Corporation","10","mg/g","","N","20251231"
"3975","AMOXICILLIN","Amoxicillin","59115004101","Penicillin-class Antibacterial [EPC], Penicillins [CS]","59115-041","59115-041-01","59115-041_cb87b82e-ef92-4f64-a6c2-204e6aa3c7c8","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20070205","","ANDA","ANDA065291","Hikma Pharmaceutical","500","mg/1","","N","20251231"
"3976","AMOXICILLIN","Amoxicillin","59115004122","Penicillin-class Antibacterial [EPC], Penicillins [CS]","59115-041","59115-041-22","59115-041_cb87b82e-ef92-4f64-a6c2-204e6aa3c7c8","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20070205","","ANDA","ANDA065291","Hikma Pharmaceutical","500","mg/1","","N","20251231"
"3977","AMOXICILLIN","Amoxicillin","59115004155","Penicillin-class Antibacterial [EPC], Penicillins [CS]","59115-041","59115-041-55","59115-041_cb87b82e-ef92-4f64-a6c2-204e6aa3c7c8","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20070205","","ANDA","ANDA065291","Hikma Pharmaceutical","500","mg/1","","N","20251231"
"3978","MICONAZOLE NITRATE","Miconazole Nitrate","59208000103","Azole Antifungal [EPC], Azoles [CS]","59208-001","59208-001-03","59208-001_2d927507-5752-c247-e063-6294a90afa27","HUMAN OTC DRUG","Conazol","","CREAM","TOPICAL","20190301","","OTC MONOGRAPH DRUG","M005","Laboratorios Liomont, S.A. de C.V.","20","mg/g","","N","20261231"
"3979","MICONAZOLE NITRATE","Miconazole Nitrate","59208000130","Azole Antifungal [EPC], Azoles [CS]","59208-001","59208-001-30","59208-001_2d927507-5752-c247-e063-6294a90afa27","HUMAN OTC DRUG","Conazol","","CREAM","TOPICAL","20190301","","OTC MONOGRAPH DRUG","M005","Laboratorios Liomont, S.A. de C.V.","20","mg/g","","N","20261231"
"3980","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","59212056210","Antimalarial [EPC], Antirheumatic Agent [EPC]","59212-562","59212-562-10","59212-562_87a25f49-2516-4dcc-a305-650393c756b3","HUMAN PRESCRIPTION DRUG","Plaquenil","","TABLET","ORAL","20130628","","NDA","NDA009768","Advanz Pharma (US) Corp.","200","mg/1","","N","20261231"
"3981","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","59212056260","Antimalarial [EPC], Antirheumatic Agent [EPC]","59212-562","59212-562-60","59212-562_87a25f49-2516-4dcc-a305-650393c756b3","HUMAN PRESCRIPTION DRUG","Plaquenil","","TABLET","ORAL","20130628","","NDA","NDA009768","Advanz Pharma (US) Corp.","200","mg/1","","N","20261231"
"3982","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","59212056211","Antimalarial [EPC], Antirheumatic Agent [EPC]","59212-562","59212-562-11","59212-562_87a25f49-2516-4dcc-a305-650393c756b3","HUMAN PRESCRIPTION DRUG","Plaquenil","","TABLET","ORAL","20130628","","NDA","NDA009768","Advanz Pharma (US) Corp.","200","mg/1","","N","20261231"
"3983","OFLOXACIN","Ofloxacin","59390014005","Quinolone Antimicrobial [EPC], Quinolones [CS]","59390-140","59390-140-05","59390-140_28125c1a-d1b0-4763-9b5e-07b4cfc2d889","HUMAN PRESCRIPTION DRUG","Ofloxacin ophthalmic","","SOLUTION","OPHTHALMIC","20130531","","ANDA","ANDA202692","Altaire Pharmaceuticals Inc.","3","mg/mL","","N","20251231"
"3984","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59390021710","Quinolone Antimicrobial [EPC], Quinolones [CS]","59390-217","59390-217-10","59390-217_f31149b7-60fc-4cef-8270-5eb8ff2b42bb","HUMAN PRESCRIPTION DRUG","Ciprofloxacin HCl Ophthalmic","","SOLUTION","OPHTHALMIC","20180504","","ANDA","ANDA204613","Altaire Pharmaceuticals Inc.","3","mg/mL","","N","20251231"
"3985","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59390021702","Quinolone Antimicrobial [EPC], Quinolones [CS]","59390-217","59390-217-02","59390-217_f31149b7-60fc-4cef-8270-5eb8ff2b42bb","HUMAN PRESCRIPTION DRUG","Ciprofloxacin HCl Ophthalmic","","SOLUTION","OPHTHALMIC","20180504","","ANDA","ANDA204613","Altaire Pharmaceuticals Inc.","3","mg/mL","","N","20251231"
"3986","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59390021705","Quinolone Antimicrobial [EPC], Quinolones [CS]","59390-217","59390-217-05","59390-217_f31149b7-60fc-4cef-8270-5eb8ff2b42bb","HUMAN PRESCRIPTION DRUG","Ciprofloxacin HCl Ophthalmic","","SOLUTION","OPHTHALMIC","20180504","","ANDA","ANDA204613","Altaire Pharmaceuticals Inc.","3","mg/mL","","N","20251231"
"3987","CEFIDEROCOL SULFATE TOSYLATE","Cefiderocol sulfate tosylate","59630026610","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","59630-266","59630-266-10","59630-266_364befdd-44a1-4e90-e063-6294a90a0293","HUMAN PRESCRIPTION DRUG","Fetroja","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20200131","","NDA","NDA209445","Shionogi Inc.","1","g/10mL","","N","20261231"
"3988","MICONAZOLE NITRATE","Miconazole Nitrate","59640010101","Azole Antifungal [EPC], Azoles [CS]","59640-101","59640-101-01","59640-101_2e204120-4d0d-07e9-e063-6294a90a997e","HUMAN OTC DRUG","HEB Athlete Foot Antifungal","","AEROSOL, POWDER","TOPICAL","20250214","","OTC MONOGRAPH DRUG","M005","HEB","20","mg/g","","N","20261231"
"3989","AZITHROMYCIN DIHYDRATE","Azithromycin","59651000715","Macrolide Antimicrobial [EPC], Macrolides [CS]","59651-007","59651-007-15","59651-007_c2e840f6-e3a8-4524-a36e-2ce70d67cf2a","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20181009","","ANDA","ANDA209201","Aurobindo Pharma Limited","100","mg/5mL","","N","20251231"
"3990","AZITHROMYCIN DIHYDRATE","Azithromycin","59651000823","Macrolide Antimicrobial [EPC], Macrolides [CS]","59651-008","59651-008-23","59651-008_c2e840f6-e3a8-4524-a36e-2ce70d67cf2a","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20181009","","ANDA","ANDA209201","Aurobindo Pharma Limited","200","mg/5mL","","N","20251231"
"3991","AZITHROMYCIN DIHYDRATE","Azithromycin","59651000830","Macrolide Antimicrobial [EPC], Macrolides [CS]","59651-008","59651-008-30","59651-008_c2e840f6-e3a8-4524-a36e-2ce70d67cf2a","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20181009","","ANDA","ANDA209201","Aurobindo Pharma Limited","200","mg/5mL","","N","20251231"
"3992","AZITHROMYCIN DIHYDRATE","Azithromycin","59651000815","Macrolide Antimicrobial [EPC], Macrolides [CS]","59651-008","59651-008-15","59651-008_c2e840f6-e3a8-4524-a36e-2ce70d67cf2a","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20181009","","ANDA","ANDA209201","Aurobindo Pharma Limited","200","mg/5mL","","N","20251231"
"3993","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","59651002555","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","59651-025","59651-025-55","59651-025_8c4f5611-f65b-42c2-8412-e616f149ee90","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20190419","","ANDA","ANDA209371","Aurobindo Pharma Limited","125; 31.25","mg/5mL; mg/5mL","","N","20251231"
"3994","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","59651002575","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","59651-025","59651-025-75","59651-025_8c4f5611-f65b-42c2-8412-e616f149ee90","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20190419","","ANDA","ANDA209371","Aurobindo Pharma Limited","125; 31.25","mg/5mL; mg/5mL","","N","20251231"
"3995","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","59651002501","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","59651-025","59651-025-01","59651-025_8c4f5611-f65b-42c2-8412-e616f149ee90","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20190419","","ANDA","ANDA209371","Aurobindo Pharma Limited","125; 31.25","mg/5mL; mg/5mL","","N","20251231"
"3996","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","59651002601","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","59651-026","59651-026-01","59651-026_8c4f5611-f65b-42c2-8412-e616f149ee90","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20190419","","ANDA","ANDA209371","Aurobindo Pharma Limited","250; 62.5","mg/5mL; mg/5mL","","N","20251231"
"3997","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","59651002675","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","59651-026","59651-026-75","59651-026_8c4f5611-f65b-42c2-8412-e616f149ee90","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20190419","","ANDA","ANDA209371","Aurobindo Pharma Limited","250; 62.5","mg/5mL; mg/5mL","","N","20251231"
"3998","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","59651002655","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","59651-026","59651-026-55","59651-026_8c4f5611-f65b-42c2-8412-e616f149ee90","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20190419","","ANDA","ANDA209371","Aurobindo Pharma Limited","250; 62.5","mg/5mL; mg/5mL","","N","20251231"
"3999","TOBRAMYCIN","TOBRAMYCIN","59651012956","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","59651-129","59651-129-56","59651-129_faec0c96-e264-6fee-e053-6394a90a23ca","HUMAN PRESCRIPTION DRUG","TOBRAMYCIN","","SOLUTION","RESPIRATORY (INHALATION)","20210122","","ANDA","ANDA210871","Aurobindo Pharma Limited","300","mg/5mL","","N","20251231"
"4000","NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","59651020623","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","59651-206","59651-206-23","59651-206_30c5502b-09bd-4fd7-bec8-aba74d302e09","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","SUSPENSION","ORAL","20230511","","ANDA","ANDA212607","Aurobindo Pharma Limited","25","mg/5mL","","N","20251231"
"4001","FLUCYTOSINE","FLUCYTOSINE","59651033101","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","59651-331","59651-331-01","59651-331_bf0234fe-1b94-44fb-a06d-86af5c5c07ea","HUMAN PRESCRIPTION DRUG","FLUCYTOSINE","","CAPSULE","ORAL","20200501","","ANDA","ANDA213665","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"4002","FLUCYTOSINE","FLUCYTOSINE","59651033201","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","59651-332","59651-332-01","59651-332_bf0234fe-1b94-44fb-a06d-86af5c5c07ea","HUMAN PRESCRIPTION DRUG","FLUCYTOSINE","","CAPSULE","ORAL","20200501","","ANDA","ANDA213665","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"4003","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir hydrochloride powder,","59651044401","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","59651-444","59651-444-01","59651-444_35206f58-c331-40c6-9849-8a0cee6b2084","HUMAN PRESCRIPTION DRUG","Valganciclovir","","FOR SOLUTION","ORAL","20221117","","ANDA","ANDA215124","Aurobindo Pharma Limited","50","mg/mL","","N","20251231"
"4004","AMPICILLIN TRIHYDRATE","Ampicillin","59651055005","Penicillin-class Antibacterial [EPC], Penicillins [CS]","59651-550","59651-550-05","59651-550_12bdd485-f4e9-4300-a935-bc4537487736","HUMAN PRESCRIPTION DRUG","Ampicillin","","CAPSULE","ORAL","20231031","","ANDA","ANDA216554","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"4005","AMPICILLIN TRIHYDRATE","Ampicillin","59651055001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","59651-550","59651-550-01","59651-550_12bdd485-f4e9-4300-a935-bc4537487736","HUMAN PRESCRIPTION DRUG","Ampicillin","","CAPSULE","ORAL","20231031","","ANDA","ANDA216554","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"4006","AMPICILLIN TRIHYDRATE","Ampicillin","59651055101","Penicillin-class Antibacterial [EPC], Penicillins [CS]","59651-551","59651-551-01","59651-551_12bdd485-f4e9-4300-a935-bc4537487736","HUMAN PRESCRIPTION DRUG","Ampicillin","","CAPSULE","ORAL","20231031","","ANDA","ANDA216554","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"4007","AMPICILLIN TRIHYDRATE","Ampicillin","59651055105","Penicillin-class Antibacterial [EPC], Penicillins [CS]","59651-551","59651-551-05","59651-551_12bdd485-f4e9-4300-a935-bc4537487736","HUMAN PRESCRIPTION DRUG","Ampicillin","","CAPSULE","ORAL","20231031","","ANDA","ANDA216554","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"4008","DICLOXACILLIN SODIUM","DICLOXACILLIN SODIUM","59651056501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","59651-565","59651-565-01","59651-565_faee6e2d-1b9c-4121-bc22-41313539b366","HUMAN PRESCRIPTION DRUG","DICLOXACILLIN SODIUM","","CAPSULE","ORAL","20220923","","ANDA","ANDA216845","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"4009","DICLOXACILLIN SODIUM","DICLOXACILLIN SODIUM","59651056601","Penicillin-class Antibacterial [EPC], Penicillins [CS]","59651-566","59651-566-01","59651-566_faee6e2d-1b9c-4121-bc22-41313539b366","HUMAN PRESCRIPTION DRUG","DICLOXACILLIN SODIUM","","CAPSULE","ORAL","20220923","","ANDA","ANDA216845","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"4010","PYRIMETHAMINE","Pyrimethamine","59651059001","Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]","59651-590","59651-590-01","59651-590_3214e53b-6abb-4a20-b849-0558e79dac05","HUMAN PRESCRIPTION DRUG","Pyrimethamine","","TABLET","ORAL","20221025","","ANDA","ANDA216983","Aurobindo Pharma Limited","25","mg/1","","N","20251231"
"4011","PYRIMETHAMINE","Pyrimethamine","59651059030","Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]","59651-590","59651-590-30","59651-590_3214e53b-6abb-4a20-b849-0558e79dac05","HUMAN PRESCRIPTION DRUG","Pyrimethamine","","TABLET","ORAL","20221025","","ANDA","ANDA216983","Aurobindo Pharma Limited","25","mg/1","","N","20251231"
"4012","POSACONAZOLE","POSACONAZOLE","59651059660","Azole Antifungal [EPC], Azoles [CS]","59651-596","59651-596-60","59651-596_8c734106-02cb-47c6-89fd-e4fe1cdff758","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","TABLET, DELAYED RELEASE","ORAL","20240718","","ANDA","ANDA217119","Aurobindo Pharma Limited","100","mg/1","","N","20251231"
"4013","CEPHALEXIN","Cephalexin","59651072850","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","59651-728","59651-728-50","59651-728_e52db116-14f2-437d-8097-0150193d4655","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20231206","","ANDA","ANDA065253","Aurobindo Pharma Limited","750","mg/1","","N","20251231"
"4014","CEPHALEXIN","Cephalexin","59651072820","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","59651-728","59651-728-20","59651-728_e52db116-14f2-437d-8097-0150193d4655","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20231206","","ANDA","ANDA065253","Aurobindo Pharma Limited","750","mg/1","","N","20251231"
"4015","NITROFURANTOIN","nitrofurantoin (macrocrystals)","59651075301","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","59651-753","59651-753-01","59651-753_bac7a3bd-df62-4b82-853c-f4d6ea650c62","HUMAN PRESCRIPTION DRUG","nitrofurantoin (macrocrystals)","","CAPSULE","ORAL","20230512","","ANDA","ANDA074967","Aurobindo Pharma Limited","50","mg/1","","N","20251231"
"4016","CEPHALEXIN","Cephalexin","59651078301","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","59651-783","59651-783-01","59651-783_e46059e1-3ce9-4a3c-80ce-464b140600ce","HUMAN PRESCRIPTION DRUG","Cephalexin","","TABLET, FILM COATED","ORAL","20240927","","ANDA","ANDA218817","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"4017","CEPHALEXIN","Cephalexin","59651078401","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","59651-784","59651-784-01","59651-784_e46059e1-3ce9-4a3c-80ce-464b140600ce","HUMAN PRESCRIPTION DRUG","Cephalexin","","TABLET, FILM COATED","ORAL","20240927","","ANDA","ANDA218817","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"4018","NITROFURANTOIN","nitrofurantoin (macrocrystals)","59651079501","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","59651-795","59651-795-01","59651-795_04053ba5-ceb5-4f34-9878-8abf1e552da2","HUMAN PRESCRIPTION DRUG","nitrofurantoin (macrocrystals)","","CAPSULE","ORAL","20230517","","ANDA","ANDA077025","Aurobindo Pharma Limited","100","mg/1","","N","20251231"
"4019","METRONIDAZOLE","METRONIDAZOLE","59651081360","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","59651-813","59651-813-60","59651-813_d9d4caed-2fa9-4b46-9b7c-d60ec3b879b2","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","GEL","TOPICAL","20241015","","ANDA","ANDA218941","Aurobindo Pharma Limited","10","mg/g","","N","20251231"
"4020","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651086601","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-866","59651-866-01","59651-866_6509ff3b-0698-43e4-b6e5-3aa572ed4350","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","Aurobindo Pharma Limited","250","mg/1","","N","20261231"
"4021","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651086620","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-866","59651-866-20","59651-866_6509ff3b-0698-43e4-b6e5-3aa572ed4350","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","Aurobindo Pharma Limited","250","mg/1","","N","20261231"
"4022","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651086699","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-866","59651-866-99","59651-866_6509ff3b-0698-43e4-b6e5-3aa572ed4350","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","Aurobindo Pharma Limited","250","mg/1","","N","20261231"
"4023","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651086630","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-866","59651-866-30","59651-866_6509ff3b-0698-43e4-b6e5-3aa572ed4350","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","Aurobindo Pharma Limited","250","mg/1","","N","20261231"
"4024","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651086701","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-867","59651-867-01","59651-867_6509ff3b-0698-43e4-b6e5-3aa572ed4350","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","Aurobindo Pharma Limited","500","mg/1","","N","20261231"
"4025","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651086705","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-867","59651-867-05","59651-867_6509ff3b-0698-43e4-b6e5-3aa572ed4350","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","Aurobindo Pharma Limited","500","mg/1","","N","20261231"
"4026","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651086720","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-867","59651-867-20","59651-867_6509ff3b-0698-43e4-b6e5-3aa572ed4350","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","Aurobindo Pharma Limited","500","mg/1","","N","20261231"
"4027","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651086799","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-867","59651-867-99","59651-867_6509ff3b-0698-43e4-b6e5-3aa572ed4350","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","Aurobindo Pharma Limited","500","mg/1","","N","20261231"
"4028","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651086730","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-867","59651-867-30","59651-867_6509ff3b-0698-43e4-b6e5-3aa572ed4350","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","Aurobindo Pharma Limited","500","mg/1","","N","20261231"
"4029","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651087301","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-873","59651-873-01","59651-873_6509ff3b-0698-43e4-b6e5-3aa572ed4350","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","Aurobindo Pharma Limited","750","mg/1","","N","20261231"
"4030","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651087305","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-873","59651-873-05","59651-873_6509ff3b-0698-43e4-b6e5-3aa572ed4350","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","Aurobindo Pharma Limited","750","mg/1","","N","20261231"
"4031","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651087398","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-873","59651-873-98","59651-873_6509ff3b-0698-43e4-b6e5-3aa572ed4350","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","Aurobindo Pharma Limited","750","mg/1","","N","20261231"
"4032","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651087320","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-873","59651-873-20","59651-873_6509ff3b-0698-43e4-b6e5-3aa572ed4350","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","Aurobindo Pharma Limited","750","mg/1","","N","20261231"
"4033","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651087350","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-873","59651-873-50","59651-873_6509ff3b-0698-43e4-b6e5-3aa572ed4350","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","Aurobindo Pharma Limited","750","mg/1","","N","20261231"
"4034","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","59651088905","Antimalarial [EPC], Antirheumatic Agent [EPC]","59651-889","59651-889-05","59651-889_e6f889ff-c5ba-4324-b87c-ec3ac942be2f","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET, FILM COATED","ORAL","20250307","","ANDA","ANDA040274","Aurobindo Pharma Limited","200","mg/1","","N","20261231"
"4035","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","59651088901","Antimalarial [EPC], Antirheumatic Agent [EPC]","59651-889","59651-889-01","59651-889_e6f889ff-c5ba-4324-b87c-ec3ac942be2f","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET, FILM COATED","ORAL","20250307","","ANDA","ANDA040274","Aurobindo Pharma Limited","200","mg/1","","N","20261231"
"4036","NYSTATIN","NYSTATIN","59651090730","Polyene Antifungal [EPC], Polyenes [CS]","59651-907","59651-907-30","59651-907_1a24e1d4-b691-4849-822a-9a9a4aed4b27","HUMAN PRESCRIPTION DRUG","NYSTATIN","","CREAM","TOPICAL","20250321","","ANDA","ANDA219527","Aurobindo Pharma Limited","100000","[USP'U]/g","","N","20261231"
"4037","NYSTATIN","NYSTATIN","59651090714","Polyene Antifungal [EPC], Polyenes [CS]","59651-907","59651-907-14","59651-907_1a24e1d4-b691-4849-822a-9a9a4aed4b27","HUMAN PRESCRIPTION DRUG","NYSTATIN","","CREAM","TOPICAL","20250321","","ANDA","ANDA219527","Aurobindo Pharma Limited","100000","[USP'U]/g","","N","20261231"
"4038","NITROFURANTOIN","nitrofurantoin (macrocrystals)","59651094201","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","59651-942","59651-942-01","59651-942_04053ba5-ceb5-4f34-9878-8abf1e552da2","HUMAN PRESCRIPTION DRUG","nitrofurantoin (macrocrystals)","","CAPSULE","ORAL","20241002","","ANDA","ANDA077025","Aurobindo Pharma Limited","25","mg/1","","N","20251231"
"4039","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651097601","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-976","59651-976-01","59651-976_1b0919a9-bcfc-4e58-b084-0454bf244665","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20250327","","ANDA","ANDA077859","Aurobindo Pharma Limited","250","mg/1","","N","20261231"
"4040","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651097699","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-976","59651-976-99","59651-976_1b0919a9-bcfc-4e58-b084-0454bf244665","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20250327","","ANDA","ANDA077859","Aurobindo Pharma Limited","250","mg/1","","N","20261231"
"4041","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651097620","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-976","59651-976-20","59651-976_1b0919a9-bcfc-4e58-b084-0454bf244665","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20250327","","ANDA","ANDA077859","Aurobindo Pharma Limited","250","mg/1","","N","20261231"
"4042","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651097630","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-976","59651-976-30","59651-976_1b0919a9-bcfc-4e58-b084-0454bf244665","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20250327","","ANDA","ANDA077859","Aurobindo Pharma Limited","250","mg/1","","N","20261231"
"4043","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651097701","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-977","59651-977-01","59651-977_1b0919a9-bcfc-4e58-b084-0454bf244665","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20250327","","ANDA","ANDA077859","Aurobindo Pharma Limited","500","mg/1","","N","20261231"
"4044","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651097730","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-977","59651-977-30","59651-977_1b0919a9-bcfc-4e58-b084-0454bf244665","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20250327","","ANDA","ANDA077859","Aurobindo Pharma Limited","500","mg/1","","N","20261231"
"4045","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651097799","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-977","59651-977-99","59651-977_1b0919a9-bcfc-4e58-b084-0454bf244665","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20250327","","ANDA","ANDA077859","Aurobindo Pharma Limited","500","mg/1","","N","20261231"
"4046","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651097720","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-977","59651-977-20","59651-977_1b0919a9-bcfc-4e58-b084-0454bf244665","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20250327","","ANDA","ANDA077859","Aurobindo Pharma Limited","500","mg/1","","N","20261231"
"4047","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651097705","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-977","59651-977-05","59651-977_1b0919a9-bcfc-4e58-b084-0454bf244665","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20250327","","ANDA","ANDA077859","Aurobindo Pharma Limited","500","mg/1","","N","20261231"
"4048","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651097801","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-978","59651-978-01","59651-978_1b0919a9-bcfc-4e58-b084-0454bf244665","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20250327","","ANDA","ANDA077859","Aurobindo Pharma Limited","750","mg/1","","N","20261231"
"4049","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651097820","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-978","59651-978-20","59651-978_1b0919a9-bcfc-4e58-b084-0454bf244665","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20250327","","ANDA","ANDA077859","Aurobindo Pharma Limited","750","mg/1","","N","20261231"
"4050","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651097850","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-978","59651-978-50","59651-978_1b0919a9-bcfc-4e58-b084-0454bf244665","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20250327","","ANDA","ANDA077859","Aurobindo Pharma Limited","750","mg/1","","N","20261231"
"4051","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651097898","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-978","59651-978-98","59651-978_1b0919a9-bcfc-4e58-b084-0454bf244665","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20250327","","ANDA","ANDA077859","Aurobindo Pharma Limited","750","mg/1","","N","20261231"
"4052","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","59651097805","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","59651-978","59651-978-05","59651-978_1b0919a9-bcfc-4e58-b084-0454bf244665","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20250327","","ANDA","ANDA077859","Aurobindo Pharma Limited","750","mg/1","","N","20261231"
"4053","MICONAZOLE NITRATE","Miconazole Nitrate","59726098801","Azole Antifungal [EPC], Azoles [CS]","59726-988","59726-988-01","59726-988_e318656a-0f0d-4a15-bc63-23ebd8f58ea1","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20210528","","ANDA","ANDA074164","P & L Development, LLC","20","mg/g","","N","20251231"
"4054","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","59746076206","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","59746-762","59746-762-06","59746-762_1f7aa03c-8f2f-f6f2-e063-6394a90ae072","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","Jubilant Cadista Pharmaceuticals Inc.","25; 75","mg/1; mg/1","","N","20251231"
"4055","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","59746076236","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","59746-762","59746-762-36","59746-762_1f7aa03c-8f2f-f6f2-e063-6394a90ae072","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","Jubilant Cadista Pharmaceuticals Inc.","25; 75","mg/1; mg/1","","N","20251231"
"4056","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","59746076201","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","59746-762","59746-762-01","59746-762_1f7aa03c-8f2f-f6f2-e063-6394a90ae072","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","Jubilant Cadista Pharmaceuticals Inc.","25; 75","mg/1; mg/1","","N","20251231"
"4057","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","59746076215","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","59746-762","59746-762-15","59746-762_1f7aa03c-8f2f-f6f2-e063-6394a90ae072","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","Jubilant Cadista Pharmaceuticals Inc.","25; 75","mg/1; mg/1","","N","20251231"
"4058","SILVER SULFADIAZINE","silver sulfadiazine","59762013100","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","59762-0131","59762-0131-0","59762-0131_975b1cec-6ff7-4da9-bc6e-2a90ab13b000","HUMAN PRESCRIPTION DRUG","SILVER SULFADIAZINE","","CREAM","TOPICAL","20180115","","NDA AUTHORIZED GENERIC","NDA017381","Mylan Pharmaceuticals Inc.","10","mg/g","","N","20261231"
"4059","SILVER SULFADIAZINE","silver sulfadiazine","59762013102","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","59762-0131","59762-0131-2","59762-0131_975b1cec-6ff7-4da9-bc6e-2a90ab13b000","HUMAN PRESCRIPTION DRUG","SILVER SULFADIAZINE","","CREAM","TOPICAL","20180115","","NDA AUTHORIZED GENERIC","NDA017381","Mylan Pharmaceuticals Inc.","10","mg/g","","N","20261231"
"4060","SILVER SULFADIAZINE","silver sulfadiazine","59762013106","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","59762-0131","59762-0131-6","59762-0131_975b1cec-6ff7-4da9-bc6e-2a90ab13b000","HUMAN PRESCRIPTION DRUG","SILVER SULFADIAZINE","","CREAM","TOPICAL","20180115","","NDA AUTHORIZED GENERIC","NDA017381","Mylan Pharmaceuticals Inc.","10","mg/g","","N","20261231"
"4061","SILVER SULFADIAZINE","silver sulfadiazine","59762013108","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","59762-0131","59762-0131-8","59762-0131_975b1cec-6ff7-4da9-bc6e-2a90ab13b000","HUMAN PRESCRIPTION DRUG","SILVER SULFADIAZINE","","CREAM","TOPICAL","20180115","","NDA AUTHORIZED GENERIC","NDA017381","Mylan Pharmaceuticals Inc.","10","mg/g","","N","20261231"
"4062","SILVER SULFADIAZINE","silver sulfadiazine","59762013104","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","59762-0131","59762-0131-4","59762-0131_975b1cec-6ff7-4da9-bc6e-2a90ab13b000","HUMAN PRESCRIPTION DRUG","SILVER SULFADIAZINE","","CREAM","TOPICAL","20180115","","NDA AUTHORIZED GENERIC","NDA017381","Mylan Pharmaceuticals Inc.","10","mg/g","","N","20261231"
"4063","SILVER SULFADIAZINE","silver sulfadiazine","59762013105","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","59762-0131","59762-0131-5","59762-0131_975b1cec-6ff7-4da9-bc6e-2a90ab13b000","HUMAN PRESCRIPTION DRUG","SILVER SULFADIAZINE","","CREAM","TOPICAL","20180115","","NDA AUTHORIZED GENERIC","NDA017381","Mylan Pharmaceuticals Inc.","10","mg/g","","N","20261231"
"4064","VORICONAZOLE","Voriconazole","59762093503","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","59762-0935","59762-0935-3","59762-0935_4b88fe78-3f1a-4bc2-b3c4-63b15d3aff01","HUMAN PRESCRIPTION DRUG","Voriconazole","","POWDER, FOR SUSPENSION","ORAL","20131216","","NDA AUTHORIZED GENERIC","NDA021630","Mylan Pharmaceuticals Inc.","40","mg/mL","","N","20261231"
"4065","LINEZOLID","linezolid","59762130701","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","59762-1307","59762-1307-1","59762-1307_4de67c3c-cad0-4da2-8eab-da7a184135bc","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151012","20260831","NDA AUTHORIZED GENERIC","NDA021130","Mylan Pharmaceuticals Inc.","600","mg/1","","N",""
"4066","LINEZOLID","linezolid","59762130702","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","59762-1307","59762-1307-2","59762-1307_4de67c3c-cad0-4da2-8eab-da7a184135bc","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151012","20260831","NDA AUTHORIZED GENERIC","NDA021130","Mylan Pharmaceuticals Inc.","600","mg/1","","N",""
"4067","LINEZOLID","linezolid","59762130804","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","59762-1308","59762-1308-4","59762-1308_2da839d4-4cba-4ca2-8149-0488263af184","HUMAN PRESCRIPTION DRUG","Linezolid","","SUSPENSION","ORAL","20150518","","NDA AUTHORIZED GENERIC","NDA021132","Mylan Pharmaceuticals Inc.","100","mg/5mL","","N","20261231"
"4068","LINEZOLID","linezolid","59762130801","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","59762-1308","59762-1308-1","59762-1308_2da839d4-4cba-4ca2-8149-0488263af184","HUMAN PRESCRIPTION DRUG","Linezolid","","SUSPENSION","ORAL","20150518","","NDA AUTHORIZED GENERIC","NDA021132","Mylan Pharmaceuticals Inc.","100","mg/5mL","","N","20261231"
"4069","AZITHROMYCIN DIHYDRATE","azithromycin","59762219803","Macrolide Antimicrobial [EPC], Macrolides [CS]","59762-2198","59762-2198-3","59762-2198_e9a1b4cb-03dd-4867-9460-c3917673d108","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20190513","20250630","NDA AUTHORIZED GENERIC","NDA050711","Mylan Pharmaceuticals Inc.","250","mg/1","","N",""
"4070","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","59762305102","Macrolide Antimicrobial [EPC], Macrolides [CS]","59762-3051","59762-3051-2","59762-3051_84a47d17-3a7d-4d2c-8dbe-3c2b6a9aefba","HUMAN PRESCRIPTION DRUG","azithromycin","","POWDER, FOR SUSPENSION","ORAL","19990212","20260429","NDA AUTHORIZED GENERIC","NDA050693","Mylan Pharmaceuticals Inc.","1","g/1","","N",""
"4071","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","59762305101","Macrolide Antimicrobial [EPC], Macrolides [CS]","59762-3051","59762-3051-1","59762-3051_84a47d17-3a7d-4d2c-8dbe-3c2b6a9aefba","HUMAN PRESCRIPTION DRUG","azithromycin","","POWDER, FOR SUSPENSION","ORAL","19990212","20260429","NDA AUTHORIZED GENERIC","NDA050693","Mylan Pharmaceuticals Inc.","1","g/1","","N",""
"4072","AZITHROMYCIN DIHYDRATE","azithromycin","59762312001","Macrolide Antimicrobial [EPC], Macrolides [CS]","59762-3120","59762-3120-1","59762-3120_e9a1b4cb-03dd-4867-9460-c3917673d108","HUMAN PRESCRIPTION DRUG","azithromycin","","POWDER, FOR SUSPENSION","ORAL","19951019","20251130","NDA AUTHORIZED GENERIC","NDA050710","Mylan Pharmaceuticals Inc.","200","mg/5mL","","N",""
"4073","AZITHROMYCIN DIHYDRATE","azithromycin","59762313001","Macrolide Antimicrobial [EPC], Macrolides [CS]","59762-3130","59762-3130-1","59762-3130_e9a1b4cb-03dd-4867-9460-c3917673d108","HUMAN PRESCRIPTION DRUG","azithromycin","","POWDER, FOR SUSPENSION","ORAL","19951019","20250930","NDA AUTHORIZED GENERIC","NDA050710","Mylan Pharmaceuticals Inc.","900","mg/22.5mL","","N",""
"4074","AZITHROMYCIN DIHYDRATE","azithromycin","59762314001","Macrolide Antimicrobial [EPC], Macrolides [CS]","59762-3140","59762-3140-1","59762-3140_e9a1b4cb-03dd-4867-9460-c3917673d108","HUMAN PRESCRIPTION DRUG","azithromycin","","POWDER, FOR SUSPENSION","ORAL","19951019","20250831","NDA AUTHORIZED GENERIC","NDA050710","Mylan Pharmaceuticals Inc.","1200","mg/30mL","","N",""
"4075","CLINDAMYCIN HYDROCHLORIDE","clindamycin hydrochloride","59762332801","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","59762-3328","59762-3328-1","59762-3328_22f6efe7-086e-46c6-a8cb-597327980009","HUMAN PRESCRIPTION DRUG","clindamycin hydrochloride","","CAPSULE","ORAL","19700522","","NDA AUTHORIZED GENERIC","NDA050162","Mylan Pharmaceuticals Inc.","150","mg/1","","N","20261231"
"4076","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","59762374302","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","59762-3743","59762-3743-2","59762-3743_e361f22b-095a-4949-96fd-85ccfcad66c5","HUMAN PRESCRIPTION DRUG","clindamycin phosphate","","GEL","TOPICAL","19870107","","NDA AUTHORIZED GENERIC","NDA050615","Mylan Pharmaceuticals Inc.","10","mg/g","","N","20261231"
"4077","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","59762374301","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","59762-3743","59762-3743-1","59762-3743_e361f22b-095a-4949-96fd-85ccfcad66c5","HUMAN PRESCRIPTION DRUG","clindamycin phosphate","","GEL","TOPICAL","19870107","","NDA AUTHORIZED GENERIC","NDA050615","Mylan Pharmaceuticals Inc.","10","mg/g","","N","20261231"
"4078","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","59762374401","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","59762-3744","59762-3744-1","59762-3744_e361f22b-095a-4949-96fd-85ccfcad66c5","HUMAN PRESCRIPTION DRUG","clindamycin phosphate","","LOTION","TOPICAL","19890531","","NDA AUTHORIZED GENERIC","NDA050600","Mylan Pharmaceuticals Inc.","10","mg/mL","","N","20261231"
"4079","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","59762500901","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","59762-5009","59762-5009-1","59762-5009_e0f094fb-01dc-409e-a111-9a2bcc847fd7","HUMAN PRESCRIPTION DRUG","clindamycin phosphate","","CREAM","VAGINAL","19920811","","NDA AUTHORIZED GENERIC","NDA050680","Mylan Pharmaceuticals Inc.","20","mg/g","","N","20261231"
"4080","CLINDAMYCIN HYDROCHLORIDE","clindamycin hydrochloride","59762501002","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","59762-5010","59762-5010-2","59762-5010_22f6efe7-086e-46c6-a8cb-597327980009","HUMAN PRESCRIPTION DRUG","clindamycin hydrochloride","","CAPSULE","ORAL","19700522","","NDA AUTHORIZED GENERIC","NDA050162","Mylan Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"4081","CLINDAMYCIN HYDROCHLORIDE","clindamycin hydrochloride","59762501001","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","59762-5010","59762-5010-1","59762-5010_22f6efe7-086e-46c6-a8cb-597327980009","HUMAN PRESCRIPTION DRUG","clindamycin hydrochloride","","CAPSULE","ORAL","19700522","","NDA AUTHORIZED GENERIC","NDA050162","Mylan Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"4082","FLUCONAZOLE","fluconazole","59762502901","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","59762-5029","59762-5029-1","59762-5029_b7f9a6ca-c916-42af-9b23-5676c873f60f","HUMAN PRESCRIPTION DRUG","Fluconazole","","POWDER, FOR SUSPENSION","ORAL","19931223","","NDA AUTHORIZED GENERIC","NDA020090","Mylan Pharmaceuticals Inc.","10","mg/mL","","N","20261231"
"4083","FLUCONAZOLE","fluconazole","59762503001","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","59762-5030","59762-5030-1","59762-5030_b7f9a6ca-c916-42af-9b23-5676c873f60f","HUMAN PRESCRIPTION DRUG","Fluconazole","","POWDER, FOR SUSPENSION","ORAL","19931223","","NDA AUTHORIZED GENERIC","NDA020090","Mylan Pharmaceuticals Inc.","40","mg/mL","","N","20261231"
"4084","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","59779008002","Allylamine Antifungal [EPC], Allylamine [CS]","59779-080","59779-080-02","59779-080_3091053e-f70c-fadd-e063-6394a90a6b4d","HUMAN OTC DRUG","CVS Pharmacy","Athletes Foot","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","CVS Pharmacy","1","g/100g","","N","20261231"
"4085","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","59779008001","Allylamine Antifungal [EPC], Allylamine [CS]","59779-080","59779-080-01","59779-080_3091053e-f70c-fadd-e063-6394a90a6b4d","HUMAN OTC DRUG","CVS Pharmacy","Athletes Foot","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","CVS Pharmacy","1","g/100g","","N","20261231"
"4086","MICONAZOLE NITRATE","Athletes Foot Spray","59779009753","Azole Antifungal [EPC], Azoles [CS]","59779-097","59779-097-53","59779-097_266b5a17-54dc-ae3b-e063-6394a90a4ce7","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, SPRAY","TOPICAL","20140101","","OTC MONOGRAPH DRUG","M005","CVS Pharmacy","3","g/150g","","N","20251231"
"4087","CLOTRIMAZOLE","Clotrimazole","59779030501","Azole Antifungal [EPC], Azoles [CS]","59779-305","59779-305-01","59779-305_25dfb38f-88e6-ebd5-e063-6394a90af927","HUMAN OTC DRUG","Clotrimazole 1%","Athletes Foot","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","CVS Pharmacy","10","mg/g","","N","20251231"
"4088","CLOTRIMAZOLE","Clotrimazole","59779030502","Azole Antifungal [EPC], Azoles [CS]","59779-305","59779-305-02","59779-305_25dfb38f-88e6-ebd5-e063-6394a90af927","HUMAN OTC DRUG","Clotrimazole 1%","Athletes Foot","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","CVS Pharmacy","10","mg/g","","N","20251231"
"4089","CLOTRIMAZOLE","Clotrimazole","59779030503","Azole Antifungal [EPC], Azoles [CS]","59779-305","59779-305-03","59779-305_25dfb38f-88e6-ebd5-e063-6394a90af927","HUMAN OTC DRUG","Clotrimazole 1%","Athletes Foot","CREAM","TOPICAL","19930831","","OTC MONOGRAPH DRUG","M005","CVS Pharmacy","10","mg/g","","N","20251231"
"4090","CLOTRIMAZOLE","Clotrimazole","59779051001","Azole Antifungal [EPC], Azoles [CS]","59779-510","59779-510-01","59779-510_b886e679-57c8-4725-bc47-8e005cddc1ce","HUMAN OTC DRUG","CVS Pharmacy","ITCH RELIEF ANTIFUNGAL","CREAM","TOPICAL","20130110","","OTC MONOGRAPH DRUG","M005","CVS Pharmacy","10","mg/g","","N","20251231"
"4091","CLOTRIMAZOLE","Clotrimazole","59779051401","Azole Antifungal [EPC], Azoles [CS]","59779-514","59779-514-01","59779-514_1aa45b8f-bfb3-db6a-e063-6294a90ae4c9","HUMAN OTC DRUG","CVS","Antifungal Ringworm","CREAM","TOPICAL","19950601","","OTC MONOGRAPH DRUG","M005","CVS Pharmacy","1","g/100g","","N","20251231"
"4092","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","59779052301","Allylamine Antifungal [EPC], Allylamine [CS]","59779-523","59779-523-01","59779-523_17581a5d-e6f1-7972-e063-6294a90aef36","HUMAN OTC DRUG","CVS","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","CVS Pharmacy","1","g/100g","","N","20251231"
"4093","TIOCONAZOLE","Tioconazole","59779071826","Azole Antifungal [EPC], Azoles [CS]","59779-718","59779-718-26","59779-718_dced1baf-2eaf-4201-96ca-44beb1155af4","HUMAN OTC DRUG","tioconazole 1","","OINTMENT","VAGINAL","20151112","","ANDA","ANDA075915","CVS Pharmacy","6.5","g/100g","","N","20251231"
"4094","NEOMYCIN SULFATE","First Aid Ointment","59898073003","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","59898-730","59898-730-03","59898-730_114a2220-0e1c-1b8e-e063-6294a90a5f95","HUMAN OTC DRUG","Water-Jel Neomycin Antibiotic","","OINTMENT","TOPICAL","20100331","","OTC MONOGRAPH DRUG","M004","Water-Jel Technologies","3.5","mg/g","","N","20251231"
"4095","NEOMYCIN SULFATE","First Aid Ointment","59898073004","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","59898-730","59898-730-04","59898-730_114a2220-0e1c-1b8e-e063-6294a90a5f95","HUMAN OTC DRUG","Water-Jel Neomycin Antibiotic","","OINTMENT","TOPICAL","20100331","","OTC MONOGRAPH DRUG","M004","Water-Jel Technologies","3.5","mg/g","","N","20251231"
"4096","NEOMYCIN SULFATE","First Aid Ointment","59898073036","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","59898-730","59898-730-36","59898-730_114a2220-0e1c-1b8e-e063-6294a90a5f95","HUMAN OTC DRUG","Water-Jel Neomycin Antibiotic","","OINTMENT","TOPICAL","20100331","","OTC MONOGRAPH DRUG","M004","Water-Jel Technologies","3.5","mg/g","","N","20251231"
"4097","NEOMYCIN SULFATE","First Aid Ointment","59898073002","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","59898-730","59898-730-02","59898-730_114a2220-0e1c-1b8e-e063-6294a90a5f95","HUMAN OTC DRUG","Water-Jel Neomycin Antibiotic","","OINTMENT","TOPICAL","20100331","","OTC MONOGRAPH DRUG","M004","Water-Jel Technologies","3.5","mg/g","","N","20251231"
"4098","NEOMYCIN SULFATE","First Aid Ointment","59898073001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","59898-730","59898-730-01","59898-730_114a2220-0e1c-1b8e-e063-6294a90a5f95","HUMAN OTC DRUG","Water-Jel Neomycin Antibiotic","","OINTMENT","TOPICAL","20100331","","OTC MONOGRAPH DRUG","M004","Water-Jel Technologies","3.5","mg/g","","N","20251231"
"4099","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Polymyxin B Sulfate, Neomycin Sulfate","59898074003","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","59898-740","59898-740-03","59898-740_5e332a38-e153-d2c4-e053-2a91aa0abb49","HUMAN OTC DRUG","Water-Jel 3-in-1 Antibiotic","","OINTMENT","TOPICAL","20100330","","OTC MONOGRAPH FINAL","part333B","Water-Jel Technologies","417.8; 3.5; 5322.8","[iU]/g; mg/g; [iU]/g","","N","20251231"
"4100","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Polymyxin B Sulfate, Neomycin Sulfate","59898074034","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","59898-740","59898-740-34","59898-740_5e332a38-e153-d2c4-e053-2a91aa0abb49","HUMAN OTC DRUG","Water-Jel 3-in-1 Antibiotic","","OINTMENT","TOPICAL","20100330","","OTC MONOGRAPH FINAL","part333B","Water-Jel Technologies","417.8; 3.5; 5322.8","[iU]/g; mg/g; [iU]/g","","N","20251231"
"4101","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Polymyxin B Sulfate, Neomycin Sulfate","59898074036","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","59898-740","59898-740-36","59898-740_5e332a38-e153-d2c4-e053-2a91aa0abb49","HUMAN OTC DRUG","Water-Jel 3-in-1 Antibiotic","","OINTMENT","TOPICAL","20100330","","OTC MONOGRAPH FINAL","part333B","Water-Jel Technologies","417.8; 3.5; 5322.8","[iU]/g; mg/g; [iU]/g","","N","20251231"
"4102","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Polymyxin B Sulfate, Neomycin Sulfate","59898074002","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","59898-740","59898-740-02","59898-740_5e332a38-e153-d2c4-e053-2a91aa0abb49","HUMAN OTC DRUG","Water-Jel 3-in-1 Antibiotic","","OINTMENT","TOPICAL","20100330","","OTC MONOGRAPH FINAL","part333B","Water-Jel Technologies","417.8; 3.5; 5322.8","[iU]/g; mg/g; [iU]/g","","N","20251231"
"4103","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Polymyxin B Sulfate, Neomycin Sulfate","59898074038","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","59898-740","59898-740-38","59898-740_5e332a38-e153-d2c4-e053-2a91aa0abb49","HUMAN OTC DRUG","Water-Jel 3-in-1 Antibiotic","","OINTMENT","TOPICAL","20100330","","OTC MONOGRAPH FINAL","part333B","Water-Jel Technologies","417.8; 3.5; 5322.8","[iU]/g; mg/g; [iU]/g","","N","20251231"
"4104","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Polymyxin B Sulfate, Neomycin Sulfate","59898074001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","59898-740","59898-740-01","59898-740_5e332a38-e153-d2c4-e053-2a91aa0abb49","HUMAN OTC DRUG","Water-Jel 3-in-1 Antibiotic","","OINTMENT","TOPICAL","20100330","","OTC MONOGRAPH FINAL","part333B","Water-Jel Technologies","417.8; 3.5; 5322.8","[iU]/g; mg/g; [iU]/g","","N","20251231"
"4105","CASPOFUNGIN ACETATE","CASPOFUNGIN ACETATE","59923061370","Echinocandin Antifungal [EPC], Lipopeptides [CS]","59923-613","59923-613-70","59923-613_2851bc69-ff37-4e0f-9d9b-d3ea05a79ccb","HUMAN PRESCRIPTION DRUG","CASPOFUNGIN ACETATE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20211001","","ANDA","ANDA211263","Areva Pharmaceuticals","7","mg/mL","","N","20251231"
"4106","CASPOFUNGIN ACETATE","CASPOFUNGIN ACETATE","59923061450","Echinocandin Antifungal [EPC], Lipopeptides [CS]","59923-614","59923-614-50","59923-614_2851bc69-ff37-4e0f-9d9b-d3ea05a79ccb","HUMAN PRESCRIPTION DRUG","CASPOFUNGIN ACETATE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20211001","","ANDA","ANDA211263","Areva Pharmaceuticals","5","mg/mL","","N","20251231"
"4107","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","59961014345","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","59961-143","59961-143-45","59961-143_0f161d30-f187-f4f9-e063-6294a90acfa9","HUMAN OTC DRUG","Travel Savvy First Aid Triple Antibiotic","","OINTMENT","TOPICAL","20131125","","OTC MONOGRAPH DRUG","M004","Bellegrove Medical Supply, Inc.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"4108","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin","60219150301","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","60219-1503","60219-1503-1","60219-1503_0488543c-588b-4b75-acb3-4999aa84ebfc","HUMAN PRESCRIPTION DRUG","Erythromycin Ethylsuccinate","","SUSPENSION","ORAL","20231202","","ANDA","ANDA211204","Amneal Pharmaceuticals NY LLC","200","mg/5mL","","N","20261231"
"4109","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin","60219150402","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","60219-1504","60219-1504-2","60219-1504_0488543c-588b-4b75-acb3-4999aa84ebfc","HUMAN PRESCRIPTION DRUG","Erythromycin Ethylsuccinate","","SUSPENSION","ORAL","20231202","","ANDA","ANDA211204","Amneal Pharmaceuticals NY LLC","400","mg/5mL","","N","20261231"
"4110","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","60219152201","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","60219-1522","60219-1522-1","60219-1522_e39a0066-7e93-4bae-9042-05f1052d1867","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20220810","","ANDA","ANDA210674","Amneal Pharmaceuticals NY LLC","250","mg/1","","N","20261231"
"4111","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","60219152301","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","60219-1523","60219-1523-1","60219-1523_e39a0066-7e93-4bae-9042-05f1052d1867","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20220810","","ANDA","ANDA210674","Amneal Pharmaceuticals NY LLC","500","mg/1","","N","20261231"
"4112","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","60219154401","Antimalarial [EPC], Antirheumatic Agent [EPC]","60219-1544","60219-1544-1","60219-1544_9ed00eb1-8c8a-4ef0-af47-ab11bc98a9d1","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20180517","","ANDA","ANDA210577","Amneal Pharmaceuticals NY LLC","200","mg/1","","N","20251231"
"4113","MICONAZOLE NITRATE","2% Miconazole Nitrate Cream","60232000902","Azole Antifungal [EPC], Azoles [CS]","60232-0009","60232-0009-2","60232-0009_6f337fb6-6e77-4f2d-8c68-b54dbb366947","HUMAN OTC DRUG","Private Label Antifungal Barrier Cream","","CREAM","TOPICAL","20101122","","OTC MONOGRAPH DRUG","M017","Swiss-American CDMO, LLC","20","g/1000g","","N","20251231"
"4114","MICONAZOLE NITRATE","2% Miconazole Nitrate Cream","60232000905","Azole Antifungal [EPC], Azoles [CS]","60232-0009","60232-0009-5","60232-0009_6f337fb6-6e77-4f2d-8c68-b54dbb366947","HUMAN OTC DRUG","Private Label Antifungal Barrier Cream","","CREAM","TOPICAL","20101122","","OTC MONOGRAPH DRUG","M017","Swiss-American CDMO, LLC","20","g/1000g","","N","20251231"
"4115","MICONAZOLE NITRATE","2% Miconazole Nitrate Cream","60232000904","Azole Antifungal [EPC], Azoles [CS]","60232-0009","60232-0009-4","60232-0009_6f337fb6-6e77-4f2d-8c68-b54dbb366947","HUMAN OTC DRUG","Private Label Antifungal Barrier Cream","","CREAM","TOPICAL","20101122","","OTC MONOGRAPH DRUG","M017","Swiss-American CDMO, LLC","20","g/1000g","","N","20251231"
"4116","MICONAZOLE NITRATE","miconazole nitrate antifungal cream","60232004601","Azole Antifungal [EPC], Azoles [CS]","60232-0046","60232-0046-1","60232-0046_05322d7d-55e0-47ae-aa76-58f346e44c4e","HUMAN OTC DRUG","Private Label Antifungal Barrier Cream","","CREAM","TOPICAL","20250509","","OTC MONOGRAPH DRUG","M005","Swiss-American CDMO, LLC","200","g/1000g","","N","20261231"
"4117","KETOCONAZOLE","Ketoconazole","60429002001","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","60429-020","60429-020-01","60429-020_1bd1d2cb-61ba-02f5-e063-6394a90a42c0","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","19990615","","ANDA","ANDA075319","Golden State Medical Supply, Inc.","200","mg/1","","N","20251231"
"4118","PRIMAQUINE PHOSPHATE","Primaquine Phosphate","60429003514","Antimalarial [EPC]","60429-035","60429-035-14","60429-035_28f38923-9f3e-b41e-e063-6394a90afe65","HUMAN PRESCRIPTION DRUG","Primaquine Phosphate","","TABLET","ORAL","20140225","","ANDA","ANDA204476","Golden State Medical Supply, Inc.","15","mg/1","","N","20251231"
"4119","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","60429004220","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","60429-042","60429-042-20","60429-042_2bc37c4b-f0da-5e5f-e063-6294a90a0760","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Golden State Medical Supply, Inc.","500","mg/1","","N","20261231"
"4120","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","60429022230","Allylamine Antifungal [EPC], Allylamine [CS]","60429-222","60429-222-30","60429-222_1fd3299e-fb05-430a-e063-6394a90a6ff1","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20100604","","ANDA","ANDA077714","Golden State Medical Supply, Inc.","250","mg/1","","N","20251231"
"4121","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","60429025901","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","60429-259","60429-259-01","60429-259_36efef59-2b05-db1b-e063-6394a90af8ea","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","19860825","","ANDA","ANDA071017","Golden State Medical Supply, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"4122","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir","60429084660","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","60429-846","60429-846-60","60429-846_1274f28f-fd5b-f5f1-e063-6394a90ac7d2","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET, FILM COATED","ORAL","20141104","","ANDA","ANDA203511","Golden State Medical Supply, Inc.","450","mg/1","","N","20251231"
"4123","OFLOXACIN","Ofloxacin","60505036301","Quinolone Antimicrobial [EPC], Quinolones [CS]","60505-0363","60505-0363-1","60505-0363_3e9adf52-6167-eeb7-1344-11eecb51d01d","HUMAN PRESCRIPTION DRUG","Ofloxacin Otic","","SOLUTION","AURICULAR (OTIC)","20040514","","ANDA","ANDA076527","Apotex Corp.","3","mg/mL","","N","20251231"
"4124","OFLOXACIN","Ofloxacin","60505036302","Quinolone Antimicrobial [EPC], Quinolones [CS]","60505-0363","60505-0363-2","60505-0363_3e9adf52-6167-eeb7-1344-11eecb51d01d","HUMAN PRESCRIPTION DRUG","Ofloxacin Otic","","SOLUTION","AURICULAR (OTIC)","20040514","","ANDA","ANDA076527","Apotex Corp.","3","mg/mL","","N","20251231"
"4125","OFLOXACIN","ofloxacin","60505056001","Quinolone Antimicrobial [EPC], Quinolones [CS]","60505-0560","60505-0560-1","60505-0560_ff0c502f-8592-1305-347e-a507a74c036b","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20190301","","ANDA","ANDA076513","Apotex Corp.","3","mg/mL","","N","20251231"
"4126","OFLOXACIN","ofloxacin","60505056000","Quinolone Antimicrobial [EPC], Quinolones [CS]","60505-0560","60505-0560-0","60505-0560_ff0c502f-8592-1305-347e-a507a74c036b","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20190301","","ANDA","ANDA076513","Apotex Corp.","3","mg/mL","","N","20251231"
"4127","MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE","moxifloxacin","60505058204","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","60505-0582","60505-0582-4","60505-0582_1aa41701-bece-6547-3c9b-8fa0825722fd","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20170701","","ANDA","ANDA090080","Apotex Corp.","5","mg/mL","","N","20251231"
"4128","TIGECYCLINE","TIGECYCLINE","60505609801","Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]","60505-6098","60505-6098-1","60505-6098_0297a568-6dca-efb2-e5cb-2cd21891ef3e","HUMAN PRESCRIPTION DRUG","Tigecycline","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190409","","ANDA","ANDA204439","Apotex Corp","50","mg/5mL","","N","20261231"
"4129","CEFAZOLIN SODIUM","Cefazolin","60505614205","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6142","60505-6142-5","60505-6142_7d0963ca-83fa-4041-a753-bfccbab3e8db","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170630","","ANDA","ANDA203661","Apotex Corp.","1","g/1","","N","20251231"
"4130","CEFAZOLIN SODIUM","Cefazolin","60505614304","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6143","60505-6143-4","60505-6143_0c85a6e9-ce7a-2903-e063-6294a90ad28b","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20190328","","ANDA","ANDA209217","Apotex Corp.","10","g/1","","N","20251231"
"4131","CEFEPIME HYDROCHLORIDE","Cefepime","60505614404","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6144","60505-6144-4","60505-6144_12c44be3-e077-4579-ad2e-868b503eadb5","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20171114","","ANDA","ANDA203704","Apotex Corp.","1","g/1","","N","20251231"
"4132","CEFEPIME HYDROCHLORIDE","Cefepime","60505614504","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6145","60505-6145-4","60505-6145_12c44be3-e077-4579-ad2e-868b503eadb5","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20171114","","ANDA","ANDA203704","Apotex Corp.","2","g/1","","N","20251231"
"4133","CEFEPIME HYDROCHLORIDE","Cefepime","60505614604","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6146","60505-6146-4","60505-6146_e1dbb0ac-a9df-41c4-acb2-3e3f5732f7ef","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170330","","ANDA","ANDA203704","Apotex Corp.","1","g/1","","N","20251231"
"4134","CEFEPIME HYDROCHLORIDE","Cefepime","60505614600","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6146","60505-6146-0","60505-6146_e1dbb0ac-a9df-41c4-acb2-3e3f5732f7ef","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170330","","ANDA","ANDA203704","Apotex Corp.","1","g/1","","N","20251231"
"4135","CEFEPIME HYDROCHLORIDE","Cefepime","60505614700","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6147","60505-6147-0","60505-6147_e1dbb0ac-a9df-41c4-acb2-3e3f5732f7ef","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20170330","","ANDA","ANDA203704","Apotex Corp.","2","g/1","","N","20251231"
"4136","CEFEPIME HYDROCHLORIDE","Cefepime","60505614704","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6147","60505-6147-4","60505-6147_e1dbb0ac-a9df-41c4-acb2-3e3f5732f7ef","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20170330","","ANDA","ANDA203704","Apotex Corp.","2","g/1","","N","20251231"
"4137","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","60505614804","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6148","60505-6148-4","60505-6148_0432e6c3-ad77-726c-e063-6294a90a798c","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170630","","ANDA","ANDA203702","Apotex Corp.","1","g/1","","N","20251231"
"4138","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","60505614800","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6148","60505-6148-0","60505-6148_0432e6c3-ad77-726c-e063-6294a90a798c","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170630","","ANDA","ANDA203702","Apotex Corp.","1","g/1","","N","20251231"
"4139","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","60505614904","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6149","60505-6149-4","60505-6149_0432e6c3-ad77-726c-e063-6294a90a798c","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170630","","ANDA","ANDA203702","Apotex Corp.","2","g/1","","N","20251231"
"4140","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","60505615005","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6150","60505-6150-5","60505-6150_7e33cb12-f475-450f-9df3-9158dea19877","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20190121","","ANDA","ANDA209218","Apotex Corp.","10","g/1","","N","20251231"
"4141","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","60505615104","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6151","60505-6151-4","60505-6151_0432e6c3-ad77-726c-e063-6294a90a798c","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170630","","ANDA","ANDA203702","Apotex Corp.","250","mg/1","","N","20251231"
"4142","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","60505615101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6151","60505-6151-1","60505-6151_0432e6c3-ad77-726c-e063-6294a90a798c","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170630","","ANDA","ANDA203702","Apotex Corp.","250","mg/1","","N","20251231"
"4143","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","60505615204","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6152","60505-6152-4","60505-6152_0432e6c3-ad77-726c-e063-6294a90a798c","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170630","","ANDA","ANDA203702","Apotex Corp.","500","mg/1","","N","20251231"
"4144","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","60505615201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6152","60505-6152-1","60505-6152_0432e6c3-ad77-726c-e063-6294a90a798c","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170630","","ANDA","ANDA203702","Apotex Corp.","500","mg/1","","N","20251231"
"4145","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN and TAZOBACTAM","60505615604","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","60505-6156","60505-6156-4","60505-6156_0702bfe3-61ba-4c3e-a9e4-ceafca2a8821","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20190315","","ANDA","ANDA204959","Apotex Corp.","2; .25","g/10mL; g/10mL","","N","20261231"
"4146","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN and TAZOBACTAM","60505615704","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","60505-6157","60505-6157-4","60505-6157_0702bfe3-61ba-4c3e-a9e4-ceafca2a8821","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20190315","","ANDA","ANDA204959","Apotex Corp.","3; .375","g/15mL; g/15mL","","N","20261231"
"4147","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN and TAZOBACTAM","60505615904","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","60505-6159","60505-6159-4","60505-6159_0702bfe3-61ba-4c3e-a9e4-ceafca2a8821","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20190315","","ANDA","ANDA204959","Apotex Corp.","4; .5","g/20mL; g/20mL","","N","20261231"
"4148","ERTAPENEM SODIUM","Ertapenem Sodium","60505619604","Carbapenems [CS], Penem Antibacterial [EPC]","60505-6196","60505-6196-4","60505-6196_0c5d06ec-0530-f60c-e063-6394a90a79b9","HUMAN PRESCRIPTION DRUG","Ertapenem","","INJECTION","INTRAMUSCULAR; INTRAVENOUS","20190402","","ANDA","ANDA207647","Apotex Corp","1","g/20mL","","N","20251231"
"4149","DAPTOMYCIN","Daptomycin","60505622904","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","60505-6229","60505-6229-4","60505-6229_bd835d4b-9824-4797-9df1-8237d3b6fca1","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220223","","ANDA","ANDA215316","APOTEX CORP.","500","mg/10mL","","N","20251231"
"4150","CEFAZOLIN SODIUM","Cefazolin","60505623105","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6231","60505-6231-5","60505-6231_7d0963ca-83fa-4041-a753-bfccbab3e8db","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220318","","ANDA","ANDA203661","Apotex Corp.","2","g/1","","N","20251231"
"4151","CEFAZOLIN SODIUM","Cefazolin","60505624304","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6243","60505-6243-4","60505-6243_90d68812-6ff8-4372-a838-b415162dd40e","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220901","","ANDA","ANDA203661","Apotex Corp.","1","g/1","","N","20251231"
"4152","CEFAZOLIN SODIUM","Cefazolin","60505624404","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6244","60505-6244-4","60505-6244_0c841753-3bec-fb8a-e063-6294a90a0d2b","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20220901","","ANDA","ANDA209217","Apotex Corp.","10","g/1","","N","20251231"
"4153","CEFEPIME HYDROCHLORIDE","Cefepime","60505624504","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6245","60505-6245-4","60505-6245_dcfcbe55-750e-4f29-9ebe-fbf25d4083cd","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220901","","ANDA","ANDA203704","Apotex Corp.","1","g/1","","N","20251231"
"4154","CEFEPIME HYDROCHLORIDE","Cefepime","60505624604","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6246","60505-6246-4","60505-6246_dcfcbe55-750e-4f29-9ebe-fbf25d4083cd","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20220901","","ANDA","ANDA203704","Apotex Corp.","2","g/1","","N","20251231"
"4155","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","60505626200","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","60505-6262","60505-6262-0","60505-6262_36e76c91-4d5f-402d-addd-eef8d5cef887","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230926","","ANDA","ANDA217243","Apotex Corp.","36; 4.5","g/180mL; g/180mL","","N","20251231"
"4156","CEFAZOLIN SODIUM","Cefazolin","60505626605","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60505-6266","60505-6266-5","60505-6266_7d0963ca-83fa-4041-a753-bfccbab3e8db","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240213","","ANDA","ANDA203661","Apotex Corp.","3","g/1","","N","20251231"
"4157","CEPHALEXIN","Cephalexin","60687015201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60687-152","60687-152-01","60687-152_297a2904-b417-5ef6-e063-6394a90a35cf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20151019","","ANDA","ANDA090836","American Health Packaging","250","mg/1","","N","20251231"
"4158","CEPHALEXIN","Cephalexin","60687016301","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60687-163","60687-163-01","60687-163_297a2904-b417-5ef6-e063-6394a90a35cf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20151019","","ANDA","ANDA090836","American Health Packaging","500","mg/1","","N","20251231"
"4159","CEFUROXIME AXETIL","Cefuroxime axetil","60687027294","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60687-272","60687-272-94","60687-272_1e13a1b8-d8b6-b5b1-e063-6394a90acd5a","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20180523","","ANDA","ANDA065496","American Health Packaging","250","mg/1","","N","20251231"
"4160","VORICONAZOLE","Voriconazole","60687027321","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","60687-273","60687-273-21","60687-273_21c9dfbd-fcc6-2369-e063-6394a90a27eb","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, FILM COATED","ORAL","20170811","","ANDA","ANDA203503","American Health Packaging","200","mg/1","","N","20251231"
"4161","CEFUROXIME AXETIL","Cefuroxime axetil","60687028394","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60687-283","60687-283-94","60687-283_1e13a1b8-d8b6-b5b1-e063-6394a90acd5a","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20230626","","ANDA","ANDA065496","American Health Packaging","500","mg/1","","N","20251231"
"4162","VORICONAZOLE","Voriconazole","60687029421","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","60687-294","60687-294-21","60687-294_21c9dfbd-fcc6-2369-e063-6394a90a27eb","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, FILM COATED","ORAL","20180307","","ANDA","ANDA203503","American Health Packaging","50","mg/1","","N","20251231"
"4163","ITRACONAZOLE","Itraconazole","60687029925","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","60687-299","60687-299-25","60687-299_31555f81-410c-9a69-e063-6394a90ab705","HUMAN PRESCRIPTION DRUG","Itraconazole","","CAPSULE","ORAL","20170502","","ANDA","ANDA205080","American Health Packaging","100","mg/1","","N","20261231"
"4164","LINEZOLID","Linezolid","60687030921","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","60687-309","60687-309-21","60687-309_278685f1-7b24-ea7e-e063-6394a90a9713","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20180215","","ANDA","ANDA204239","American Health Packaging","600","mg/1","","N","20251231"
"4165","CLARITHROMYCIN","Clarithromycin","60687043521","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","60687-435","60687-435-21","60687-435_2a812d71-5647-6ab6-e063-6294a90af21d","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20200129","","ANDA","ANDA203584","American Health Packaging","500","mg/1","","N","20261231"
"4166","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","60687044275","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","60687-442","60687-442-75","60687-442_3546bee9-e4fa-333e-e063-6394a90a4200","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20241107","","ANDA","ANDA091348","American Health Packaging","200; 40","mg/5mL; mg/5mL","","N","20261231"
"4167","POSACONAZOLE","Posaconazole","60687052321","Azole Antifungal [EPC], Azoles [CS]","60687-523","60687-523-21","60687-523_2669999c-7aac-8076-e063-6394a90a9665","HUMAN PRESCRIPTION DRUG","Posaconazole","","TABLET, DELAYED RELEASE","ORAL","20200611","","ANDA","ANDA212411","American Health Packaging","100","mg/1","","N","20251231"
"4168","POSACONAZOLE","Posaconazole","60687052394","Azole Antifungal [EPC], Azoles [CS]","60687-523","60687-523-94","60687-523_2669999c-7aac-8076-e063-6394a90a9665","HUMAN PRESCRIPTION DRUG","Posaconazole","","TABLET, DELAYED RELEASE","ORAL","20200611","","ANDA","ANDA212411","American Health Packaging","100","mg/1","","N","20251231"
"4169","METRONIDAZOLE","Metronidazole","60687052601","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","60687-526","60687-526-01","60687-526_2be7b41c-f9be-c1ef-e063-6294a90a1d4e","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20200409","","ANDA","ANDA070772","American Health Packaging","250","mg/1","","N","20261231"
"4170","ATOVAQUONE","Atovaquone","60687053478","Antimalarial [EPC], Antiprotozoal [EPC]","60687-534","60687-534-78","60687-534_0293429b-79ec-fa1a-e063-6394a90a21cb","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20201021","","ANDA","ANDA210692","American Health Packaging","750","mg/5mL","","N","20251231"
"4171","ATOVAQUONE","Atovaquone","60687053436","Antimalarial [EPC], Antiprotozoal [EPC]","60687-534","60687-534-36","60687-534_0293429b-79ec-fa1a-e063-6394a90a21cb","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20201021","","ANDA","ANDA210692","American Health Packaging","750","mg/5mL","","N","20251231"
"4172","METRONIDAZOLE","Metronidazole","60687055001","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","60687-550","60687-550-01","60687-550_2be7b41c-f9be-c1ef-e063-6294a90a1d4e","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20200320","","ANDA","ANDA070772","American Health Packaging","500","mg/1","","N","20261231"
"4173","RIFAMPIN","Rifampin","60687057521","Rifamycin Antibacterial [EPC], Rifamycins [CS]","60687-575","60687-575-21","60687-575_2251fcf7-6c7d-322f-e063-6394a90a178c","HUMAN PRESCRIPTION DRUG","Rifampin","","CAPSULE","ORAL","20210305","","ANDA","ANDA090034","American Health Packaging","150","mg/1","","N","20251231"
"4174","RIFAMPIN","Rifampin","60687058601","Rifamycin Antibacterial [EPC], Rifamycins [CS]","60687-586","60687-586-01","60687-586_2251fcf7-6c7d-322f-e063-6394a90a178c","HUMAN PRESCRIPTION DRUG","Rifampin","","CAPSULE","ORAL","20210309","","ANDA","ANDA090034","American Health Packaging","300","mg/1","","N","20251231"
"4175","FLUCYTOSINE","Flucytosine","60687059921","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","60687-599","60687-599-21","60687-599_284ff75e-657f-cfe0-e063-6394a90a8cab","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20211217","","ANDA","ANDA213665","American Health Packaging","250","mg/1","","N","20251231"
"4176","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","60687060365","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","60687-603","60687-603-65","60687-603_26f6d11f-ea94-4c81-e063-6294a90a2aa5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20220202","20260331","ANDA","ANDA090624","American Health Packaging","400; 80","mg/1; mg/1","","N",""
"4177","FLUCYTOSINE","Flucytosine","60687061021","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","60687-610","60687-610-21","60687-610_284ff75e-657f-cfe0-e063-6394a90a8cab","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20211203","","ANDA","ANDA213665","American Health Packaging","500","mg/1","","N","20251231"
"4178","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","60687061401","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","60687-614","60687-614-01","60687-614_26f6d11f-ea94-4c81-e063-6294a90a2aa5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20220103","","ANDA","ANDA090624","American Health Packaging","800; 160","mg/1; mg/1","","N","20251231"
"4179","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","60687063301","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","60687-633","60687-633-01","60687-633_313fe40d-0be7-a91a-e063-6294a90ae6ec","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20220901","20260228","ANDA","ANDA207372","American Health Packaging","25; 75","mg/1; mg/1","","N",""
"4180","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","60687063365","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","60687-633","60687-633-65","60687-633_313fe40d-0be7-a91a-e063-6294a90ae6ec","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20220901","20260228","ANDA","ANDA207372","American Health Packaging","25; 75","mg/1; mg/1","","N",""
"4181","DEMECLOCYCLINE HYDROCHLORIDE","Demeclocycline","60687069101","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","60687-691","60687-691-01","60687-691_230a18ee-ef80-61c6-e063-6394a90acb5d","HUMAN PRESCRIPTION DRUG","Demeclocycline Hydrochloride","","TABLET","ORAL","20220906","","ANDA","ANDA065425","American Health Packaging","150","mg/1","","N","20251231"
"4182","CEFDINIR","Cefdinir","60687069921","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","60687-699","60687-699-21","60687-699_1a4d74b5-b0f7-ccd0-e063-6394a90ab754","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20230626","","ANDA","ANDA210220","American Health Packaging","300","mg/1","","N","20251231"
"4183","DEMECLOCYCLINE HYDROCHLORIDE","Demeclocycline","60687070565","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","60687-705","60687-705-65","60687-705_230a18ee-ef80-61c6-e063-6394a90acb5d","HUMAN PRESCRIPTION DRUG","Demeclocycline Hydrochloride","","TABLET","ORAL","20230119","","ANDA","ANDA065425","American Health Packaging","300","mg/1","","N","20251231"
"4184","TOBRAMYCIN","Tobramycin","60687073183","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","60687-731","60687-731-83","60687-731_04b21517-df48-d524-e063-6294a90aae3f","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","RESPIRATORY (INHALATION)","20240519","","ANDA","ANDA207136","American Health Packaging","300","mg/5mL","","N","20251231"
"4185","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","60687074201","Macrolide Antimicrobial [EPC], Macrolides [CS]","60687-742","60687-742-01","60687-742_18e60c6f-78b0-176f-e063-6294a90af494","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET","ORAL","20230420","","ANDA","ANDA065398","American Health Packaging","250","mg/1","","N","20251231"
"4186","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","60687074265","Macrolide Antimicrobial [EPC], Macrolides [CS]","60687-742","60687-742-65","60687-742_18e60c6f-78b0-176f-e063-6294a90af494","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET","ORAL","20230420","","ANDA","ANDA065398","American Health Packaging","250","mg/1","","N","20251231"
"4187","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","60687075321","Macrolide Antimicrobial [EPC], Macrolides [CS]","60687-753","60687-753-21","60687-753_18e60c6f-78b0-176f-e063-6294a90af494","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET","ORAL","20230801","","ANDA","ANDA065399","American Health Packaging","500","mg/1","","N","20251231"
"4188","LINEZOLID","Linezolid","60687075405","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","60687-754","60687-754-05","60687-754_03380d95-6c5f-1701-e063-6294a90abb95","HUMAN PRESCRIPTION DRUG","Linezolid","","GRANULE, FOR SUSPENSION","ORAL","20230820","","ANDA","ANDA211813","American Health Packaging","100","mg/5mL","","N","20251231"
"4189","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir Hydrochloride","60687076513","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","60687-765","60687-765-13","60687-765_038956dc-dd87-2583-e063-6294a90aa282","HUMAN PRESCRIPTION DRUG","Valganciclovir","","POWDER, FOR SOLUTION","ORAL","20230820","","ANDA","ANDA211475","American Health Packaging","50","mg/mL","","N","20251231"
"4190","AMOXICILLIN","Amoxicillin","60687077601","Penicillin-class Antibacterial [EPC], Penicillins [CS]","60687-776","60687-776-01","60687-776_2f75b1e8-87b4-bd7d-e063-6294a90a0587","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20250227","","ANDA","ANDA065271","American Health Packaging","250","mg/1","","N","20261231"
"4191","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","60687078194","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","60687-781","60687-781-94","60687-781_2913cd51-933f-3392-e063-6394a90a26a8","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20240726","","ANDA","ANDA091569","American Health Packaging","250; 125","mg/1; mg/1","","N","20251231"
"4192","AMOXICILLIN","Amoxicillin","60687078701","Penicillin-class Antibacterial [EPC], Penicillins [CS]","60687-787","60687-787-01","60687-787_2f75b1e8-87b4-bd7d-e063-6294a90a0587","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20250303","","ANDA","ANDA065271","American Health Packaging","500","mg/1","","N","20261231"
"4193","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","60687079201","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","60687-792","60687-792-01","60687-792_2913cd51-933f-3392-e063-6394a90a26a8","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20240726","","ANDA","ANDA091569","American Health Packaging","500; 125","mg/1; mg/1","","N","20251231"
"4194","AMOXICILLIN","Amoxicillin","60687079825","Penicillin-class Antibacterial [EPC], Penicillins [CS]","60687-798","60687-798-25","60687-798_2e6b8e92-7283-db33-e063-6394a90a77d5","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20250216","","ANDA","ANDA065256","American Health Packaging","500","mg/1","","N","20261231"
"4195","NYSTATIN","Nystatin","60687080017","Polyene Antifungal [EPC], Polyenes [CS]","60687-800","60687-800-17","60687-800_11ff6ced-6e23-9aa1-e063-6294a90a7c04","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20240226","","ANDA","ANDA203621","American Health Packaging","100000","[USP'U]/mL","","N","20251231"
"4196","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","60687080301","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","60687-803","60687-803-01","60687-803_2913cd51-933f-3392-e063-6394a90a26a8","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20240726","","ANDA","ANDA091568","American Health Packaging","875; 125","mg/1; mg/1","","N","20251231"
"4197","AMOXICILLIN","Amoxicillin","60687080928","Penicillin-class Antibacterial [EPC], Penicillins [CS]","60687-809","60687-809-28","60687-809_2e6b8e92-7283-db33-e063-6394a90a77d5","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20250216","","ANDA","ANDA065256","American Health Packaging","875","mg/1","","N","20261231"
"4198","NITROFURANTOIN","Nitrofurantoin Macrocrystals","60687083901","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","60687-839","60687-839-01","60687-839_1702f6a9-7bc3-2221-e063-6294a90a96e9","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Macrocrystals","","CAPSULE","ORAL","20240428","","ANDA","ANDA217272","American Health Packaging","50","mg/1","","N","20251231"
"4199","NITROFURANTOIN","Nitrofurantoin Macrocrystals","60687085001","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","60687-850","60687-850-01","60687-850_1702f6a9-7bc3-2221-e063-6294a90a96e9","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Macrocrystals","","CAPSULE","ORAL","20240428","","ANDA","ANDA217272","American Health Packaging","100","mg/1","","N","20251231"
"4200","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","60687086001","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","60687-860","60687-860-01","60687-860_1e1459c8-0c3b-0e40-e063-6294a90a5374","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240825","","ANDA","ANDA077859","American Health Packaging","500","mg/1","","N","20251231"
"4201","GENTAMICIN SULFATE","gentamicin sulfate","60758018805","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","60758-188","60758-188-05","60758-188_0b295ef8-52d7-4199-91f4-53838936257a","HUMAN PRESCRIPTION DRUG","GENTAMICIN SULFATE","","SOLUTION/ DROPS","OPHTHALMIC","19980105","","ANDA","ANDA062452","Pacific Pharma, Inc.","3","mg/mL","","N","20251231"
"4202","GATIFLOXACIN","gatifloxacin","60758061525","Quinolone Antimicrobial [EPC], Quinolones [CS]","60758-615","60758-615-25","60758-615_d019efbb-643d-44a1-992e-0222c1abd4d5","HUMAN PRESCRIPTION DRUG","gatifloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20150415","","NDA AUTHORIZED GENERIC","NDA022548","Pacific Pharma, Inc.","5","mg/mL","","N","20251231"
"4203","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","60760006906","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","60760-069","60760-069-06","60760-069_ded422a2-f3ae-3f19-e053-2995a90a0fc9","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20220201","","ANDA","ANDA090624","St. Mary's Medical Park Pharmacy","800; 160","mg/1; mg/1","","N","20251231"
"4204","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","60760006914","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","60760-069","60760-069-14","60760-069_ded422a2-f3ae-3f19-e053-2995a90a0fc9","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20220201","","ANDA","ANDA090624","St. Mary's Medical Park Pharmacy","800; 160","mg/1; mg/1","","N","20251231"
"4205","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","60760006920","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","60760-069","60760-069-20","60760-069_ded422a2-f3ae-3f19-e053-2995a90a0fc9","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20220201","","ANDA","ANDA090624","St. Mary's Medical Park Pharmacy","800; 160","mg/1; mg/1","","N","20251231"
"4206","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","60760019414","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","60760-194","60760-194-14","60760-194_87207a12-af6f-a01a-e053-2991aa0ab12f","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20190419","","ANDA","ANDA077066","St. Mary's Medical Park Pharmacy","25; 75","mg/1; mg/1","","N","20251231"
"4207","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","60760048728","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","60760-487","60760-487-28","60760-487_f19d8225-1125-2705-e053-2995a90ae289","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20200916","","ANDA","ANDA207402","St. Mary's Medical Park Pharmacy","150","mg/1","","N","20251231"
"4208","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","60760048760","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","60760-487","60760-487-60","60760-487_f19d8225-1125-2705-e053-2995a90ae289","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20200916","","ANDA","ANDA207402","St. Mary's Medical Park Pharmacy","150","mg/1","","N","20251231"
"4209","METRONIDAZOLE","metronidazole","60760053914","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","60760-539","60760-539-14","60760-539_f2f3e2ab-6dbd-dc2f-e053-2a95a90a3b93","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20220617","","ANDA","ANDA206560","ST. MARY'S MEDICAL PARK PHARMACY","500","mg/1","","N","20251231"
"4210","METRONIDAZOLE","metronidazole","60760053940","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","60760-539","60760-539-40","60760-539_f2f3e2ab-6dbd-dc2f-e053-2a95a90a3b93","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20220617","","ANDA","ANDA206560","ST. MARY'S MEDICAL PARK PHARMACY","500","mg/1","","N","20251231"
"4211","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","60760054114","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","60760-541","60760-541-14","60760-541_f2f3d86e-37de-974c-e053-2995a90abc71","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20220622","","ANDA","ANDA090624","ST. MARY'S MEDICAL PARK PHARMACY","800; 160","mg/1; mg/1","","N","20251231"
"4212","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","60760054120","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","60760-541","60760-541-20","60760-541_f2f3d86e-37de-974c-e053-2995a90abc71","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20220622","","ANDA","ANDA090624","ST. MARY'S MEDICAL PARK PHARMACY","800; 160","mg/1; mg/1","","N","20251231"
"4213","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","60760054106","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","60760-541","60760-541-06","60760-541_f2f3d86e-37de-974c-e053-2995a90abc71","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20220622","","ANDA","ANDA090624","ST. MARY'S MEDICAL PARK PHARMACY","800; 160","mg/1; mg/1","","N","20251231"
"4214","TOBRAMYCIN","Tobramycin","60760058305","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","60760-583","60760-583-05","60760-583_22067279-5207-ee87-e063-6294a90ae998","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION/ DROPS","OPHTHALMIC","20190912","","ANDA","ANDA207444","St. Mary's Medical Park Pharmacy","3","mg/mL","","N","20251231"
"4215","METRONIDAZOLE","Metronidazole","60760066414","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","60760-664","60760-664-14","60760-664_c21278d8-a74c-7014-e053-2a95a90a823c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20210325","","ANDA","ANDA203974","St. Mary's Medical Park Pharmacy","500","mg/1","","N","20251231"
"4216","METRONIDAZOLE","Metronidazole","60760066440","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","60760-664","60760-664-40","60760-664_c21278d8-a74c-7014-e053-2a95a90a823c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20210325","","ANDA","ANDA203974","St. Mary's Medical Park Pharmacy","500","mg/1","","N","20251231"
"4217","ERYTHROMYCIN","Erythromycin","60760067035","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","60760-670","60760-670-35","60760-670_2cc7203b-1bf0-ccda-e063-6394a90ac207","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","20231018","","ANDA","ANDA064030","ST. MARY'S MEDICAL PARK PHARMACY","5","mg/g","","N","20261231"
"4218","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","60760067610","Quinolone Antimicrobial [EPC], Quinolones [CS]","60760-676","60760-676-10","60760-676_c32cef90-e57e-2a0e-e053-2a95a90ae037","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20210521","","ANDA","ANDA208921","St. Mary's Medical Park Pharmacy","500","mg/1","","N","20251231"
"4219","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","60760067620","Quinolone Antimicrobial [EPC], Quinolones [CS]","60760-676","60760-676-20","60760-676_c32cef90-e57e-2a0e-e053-2a95a90ae037","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20210521","","ANDA","ANDA208921","St. Mary's Medical Park Pharmacy","500","mg/1","","N","20251231"
"4220","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","60760068910","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","60760-689","60760-689-10","60760-689_28db7596-f14c-dd07-e063-6294a90a5da9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","ST. MARY'S MEDICAL PARK PHARMACY","500","mg/1","","N","20251231"
"4221","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","60760068920","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","60760-689","60760-689-20","60760-689_28db7596-f14c-dd07-e063-6294a90a5da9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","ST. MARY'S MEDICAL PARK PHARMACY","500","mg/1","","N","20251231"
"4222","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","60760069010","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","60760-690","60760-690-10","60760-690_348e9276-54df-fa85-e063-6394a90a5d26","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","ST. MARY'S MEDICAL PARK PHARMACY","250","mg/1","","N","20261231"
"4223","FLUCONAZOLE","Fluconazole","60760080301","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","60760-803","60760-803-01","60760-803_f19d9517-284a-516f-e053-2995a90ad6e1","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210802","","ANDA","ANDA077253","St. Mary's Medical Park Pharmacy","150","mg/1","","N","20251231"
"4224","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","60760082730","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","60760-827","60760-827-30","60760-827_1dd9d768-9964-cbd2-e063-6294a90a6d0d","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","ST. MARY'S MEDICAL PARK PHARMACY","300","mg/1","","N","20251231"
"4225","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","60760082828","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","60760-828","60760-828-28","60760-828_235b037d-3c33-49e4-e063-6394a90ab07a","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","ST. MARY'S MEDICAL PARK PHARMACY","150","mg/1","","N","20251231"
"4226","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","60760082860","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","60760-828","60760-828-60","60760-828_235b037d-3c33-49e4-e063-6394a90ab07a","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","ST. MARY'S MEDICAL PARK PHARMACY","150","mg/1","","N","20251231"
"4227","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","60760085314","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","60760-853","60760-853-14","60760-853_099439f3-879a-7747-e063-6394a90a3706","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","ST. MARY'S MEDICAL PARK PHARMACY","25; 75","mg/1; mg/1","","N","20251231"
"4228","OFLOXACIN","ofloxacin","60760091705","Quinolone Antimicrobial [EPC], Quinolones [CS]","60760-917","60760-917-05","60760-917_2d55b26d-9d13-ca29-e063-6294a90ab237","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20190301","","ANDA","ANDA076513","ST. MARY'S MEDICAL PARK PHARMACY","3","mg/mL","","N","20261231"
"4229","FLUCONAZOLE","Fluconazole","60760095001","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","60760-950","60760-950-01","60760-950_1263d776-8e97-85c3-e063-6394a90aec27","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","ST. MARY'S MEDICAL PARK PHARMACY","150","mg/1","","N","20251231"
"4230","MUPIROCIN","Mupirocin","60760096022","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","60760-960","60760-960-22","60760-960_235c4f84-d0d2-b754-e063-6394a90a769f","HUMAN PRESCRIPTION DRUG","mupirocin","","OINTMENT","TOPICAL","20091030","","ANDA","ANDA065123","ST. MARY'S MEDICAL PARK PHARMACY","20","mg/g","","N","20251231"
"4231","SILVER SULFADIAZINE","Silver Sulfadiazine","60760096250","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","60760-962","60760-962-50","60760-962_24b0240a-89eb-db37-e063-6394a90a98da","HUMAN PRESCRIPTION DRUG","SSD Cream","","CREAM","TOPICAL","20110504","","NDA","NDA018578","ST. MARY'S MEDICAL PARK PHARMACY","10","g/1000g","","N","20251231"
"4232","OFLOXACIN","Ofloxacin","60760097005","Quinolone Antimicrobial [EPC], Quinolones [CS]","60760-970","60760-970-05","60760-970_27c26e00-7805-ea5d-e063-6394a90a2b10","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20141215","","ANDA","ANDA078559","ST. MARY'S MEDICAL PARK PHARMACY","3","mg/mL","","N","20251231"
"4233","PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE","penicillin G benzathine and penicillin G procaine","60793060010","Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS]","60793-600","60793-600-10","60793-600_b5d01048-1d94-4a82-9a67-fdddd23235a9","HUMAN PRESCRIPTION DRUG","BICILLIN CR","","INJECTION, SUSPENSION","INTRAMUSCULAR","19530518","","NDA","NDA050138","Pfizer Laboratories Div Pfizer Inc","600000; 600000","[iU]/2mL; [iU]/2mL","","N","20251231"
"4234","PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE","penicillin G benzathine and penicillin G procaine","60793060110","Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS]","60793-601","60793-601-10","60793-601_b5d01048-1d94-4a82-9a67-fdddd23235a9","HUMAN PRESCRIPTION DRUG","BICILLIN CR","","INJECTION, SUSPENSION","INTRAMUSCULAR","19530518","","NDA","NDA050138","Pfizer Laboratories Div Pfizer Inc","600000; 600000","[iU]/2mL; [iU]/2mL","","N","20251231"
"4235","PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE","penicillin G benzathine and penicillin G procaine","60793060210","Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS]","60793-602","60793-602-10","60793-602_195a9cf6-47b7-4564-a39e-7b2396db4229","HUMAN PRESCRIPTION DRUG","BICILLIN C-R 900/300","","INJECTION, SUSPENSION","INTRAMUSCULAR","19530518","","NDA","NDA050138","Pfizer Laboratories Div Pfizer Inc","900000; 300000","[iU]/2mL; [iU]/2mL","","N","20251231"
"4236","PENICILLIN G BENZATHINE","penicillin G benzathine","60793070010","Penicillin-class Antibacterial [EPC], Penicillins [CS]","60793-700","60793-700-10","60793-700_4b3694af-9d77-487f-8838-b75aec6636da","HUMAN PRESCRIPTION DRUG","BICILLIN L-A","","INJECTION, SUSPENSION","INTRAMUSCULAR","19520627","","NDA","NDA050141","Pfizer Laboratories Div Pfizer Inc","600000","[iU]/mL","","N","20251231"
"4237","PENICILLIN G BENZATHINE","penicillin G benzathine","60793070110","Penicillin-class Antibacterial [EPC], Penicillins [CS]","60793-701","60793-701-10","60793-701_4b3694af-9d77-487f-8838-b75aec6636da","HUMAN PRESCRIPTION DRUG","BICILLIN L-A","","INJECTION, SUSPENSION","INTRAMUSCULAR","19520627","","NDA","NDA050141","Pfizer Laboratories Div Pfizer Inc","1200000","[iU]/2mL","","N","20251231"
"4238","PENICILLIN G BENZATHINE","penicillin G benzathine","60793070210","Penicillin-class Antibacterial [EPC], Penicillins [CS]","60793-702","60793-702-10","60793-702_4b3694af-9d77-487f-8838-b75aec6636da","HUMAN PRESCRIPTION DRUG","BICILLIN L-A","","INJECTION, SUSPENSION","INTRAMUSCULAR","19520627","","NDA","NDA050141","Pfizer Laboratories Div Pfizer Inc","2400000","[iU]/4mL","","N","20251231"
"4239","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","61010440001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","61010-4400","61010-4400-1","61010-4400_10aa39d8-0c61-1391-e063-6294a90a5925","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20191101","","OTC MONOGRAPH DRUG","M004","Safetec of America, Inc.","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"4240","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","61010440002","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","61010-4400","61010-4400-2","61010-4400_10aa39d8-0c61-1391-e063-6294a90a5925","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20191101","","OTC MONOGRAPH DRUG","M004","Safetec of America, Inc.","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"4241","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride","61010440101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","61010-4401","61010-4401-1","61010-4401_118650cb-1aeb-b30a-e063-6394a90aff5a","HUMAN OTC DRUG","Triple Antibiotic with Pain Relief","","OINTMENT","TOPICAL","20191101","","OTC MONOGRAPH DRUG","M004","Safetec of America, Inc.","500; 5; 5000; 10","[iU]/g; mg/g; [iU]/g; mg/g","","N","20251231"
"4242","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","61010560001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","61010-5600","61010-5600-1","61010-5600_10d3b150-077e-cb76-e063-6394a90ab356","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20110808","","OTC MONOGRAPH DRUG","M004","Safetec of America, Inc.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"4243","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","61010560002","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","61010-5600","61010-5600-2","61010-5600_10d3b150-077e-cb76-e063-6394a90ab356","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20110808","","OTC MONOGRAPH DRUG","M004","Safetec of America, Inc.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"4244","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","61010560003","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","61010-5600","61010-5600-3","61010-5600_10d3b150-077e-cb76-e063-6394a90ab356","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20110808","","OTC MONOGRAPH DRUG","M004","Safetec of America, Inc.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"4245","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","61010560004","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","61010-5600","61010-5600-4","61010-5600_10d3b150-077e-cb76-e063-6394a90ab356","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20110808","","OTC MONOGRAPH DRUG","M004","Safetec of America, Inc.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"4246","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","61010560304","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","61010-5603","61010-5603-4","61010-5603_10d3b150-07a5-cb76-e063-6394a90ab356","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20070330","","OTC MONOGRAPH DRUG","M004","Safetec of America, Inc.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"4247","NEOMYCIN SULFATE","neomycin sulfate","61010670002","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","61010-6700","61010-6700-2","61010-6700_10dff217-0d5f-cc47-e063-6294a90a632d","HUMAN OTC DRUG","Single Antibiotic with Neomycin","","OINTMENT","TOPICAL","20081113","","OTC MONOGRAPH DRUG","M004","Safetec of America","3.5","mg/g","","N","20251231"
"4248","NEOMYCIN SULFATE","neomycin sulfate","61010670003","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","61010-6700","61010-6700-3","61010-6700_10dff217-0d5f-cc47-e063-6294a90a632d","HUMAN OTC DRUG","Single Antibiotic with Neomycin","","OINTMENT","TOPICAL","20081113","","OTC MONOGRAPH DRUG","M004","Safetec of America","3.5","mg/g","","N","20251231"
"4249","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL","61040013411","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","61040-134","61040-134-11","61040-134_28ed7671-0458-3dc5-e063-6394a90a10de","HUMAN OTC DRUG","SOFSKIN TRIPLE ANTIBIOTIC","PLUS PAIN RELIEF","OINTMENT","TOPICAL","20240715","","OTC MONOGRAPH DRUG","M004","GOPALDAS VISRAM AND COMPANY LIMITED","500; 5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"4250","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","61047012003","Allylamine Antifungal [EPC], Allylamine [CS]","61047-120","61047-120-03","61047-120_36491c12-d9a6-5bfe-e063-6294a90ac8e3","HUMAN OTC DRUG","Lamisil AT Cream","","CREAM","TOPICAL","20200220","","NDA","NDA020980","Voyant Beauty Inc.","1","g/100g","","N","20261231"
"4251","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","61047012002","Allylamine Antifungal [EPC], Allylamine [CS]","61047-120","61047-120-02","61047-120_36491c12-d9a6-5bfe-e063-6294a90ac8e3","HUMAN OTC DRUG","Lamisil AT Cream","","CREAM","TOPICAL","20200220","","NDA","NDA020980","Voyant Beauty Inc.","1","g/100g","","N","20261231"
"4252","TERBINAFINE HYDROCHLORIDE","Terbinafine hydrochloride","61047013901","Allylamine Antifungal [EPC], Allylamine [CS]","61047-139","61047-139-01","61047-139_2abbf4a1-a401-b36c-e063-6394a90a41a8","HUMAN OTC DRUG","LAMISIL AT TERBINAFINE HYDROCHLORIDE","","CREAM","TOPICAL","20240821","","NDA","NDA020980","Voyant Beauty, Inc.","1","g/100g","","N","20261231"
"4253","TERBINAFINE HYDROCHLORIDE","Terbinafine hydrochloride","61047013902","Allylamine Antifungal [EPC], Allylamine [CS]","61047-139","61047-139-02","61047-139_2abbf4a1-a401-b36c-e063-6394a90a41a8","HUMAN OTC DRUG","LAMISIL AT TERBINAFINE HYDROCHLORIDE","","CREAM","TOPICAL","20240821","","NDA","NDA020980","Voyant Beauty, Inc.","1","g/100g","","N","20261231"
"4254","CLOTRIMAZOLE","Clotrimazole","61269022041","Azole Antifungal [EPC], Azoles [CS]","61269-220","61269-220-41","61269-220_1e5b4178-017f-429d-b0d9-bc11863cd67e","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","20210629","","ANDA","ANDA074165","H2-Pharma, LLC","10","mg/g","","N","20251231"
"4255","CLOTRIMAZOLE","Clotrimazole","61269022063","Azole Antifungal [EPC], Azoles [CS]","61269-220","61269-220-63","61269-220_1e5b4178-017f-429d-b0d9-bc11863cd67e","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","20210629","","ANDA","ANDA074165","H2-Pharma, LLC","10","mg/g","","N","20251231"
"4256","BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE","BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, and TETRACYCLINE HYDROCHLORIDE","61269038012","Bismuth [CS], Bismuth [EPC], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","61269-380","61269-380-12","61269-380_07e2c55d-707f-4e3f-be0e-385da673b8ee","HUMAN PRESCRIPTION DRUG","PYLERA","","CAPSULE","ORAL","20231001","","NDA","NDA050786","H2-Pharma, LLC","140; 125; 125","mg/1; mg/1; mg/1","","N","20261231"
"4257","BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE","BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE","61269038512","Bismuth [CS], Bismuth [EPC], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","61269-385","61269-385-12","61269-385_a9eb5847-5f53-4684-8642-25303b3ce111","HUMAN PRESCRIPTION DRUG","BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE","","CAPSULE","ORAL","20230731","","NDA","NDA050786","H2-Pharma, LLC","140; 125; 125","mg/1; mg/1; mg/1","","N","20251231"
"4258","VALGANCICLOVIR HYDROCHLORIDE","valganciclovir","61269048060","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","61269-480","61269-480-60","61269-480_9a57e7d6-5fe4-42c6-9b01-ebd9d46004ee","HUMAN PRESCRIPTION DRUG","Valcyte","","TABLET, FILM COATED","ORAL","20010329","","NDA","NDA021304","H2-Pharma, LLC","450","mg/1","","N","20261231"
"4259","VALGANCICLOVIR HYDROCHLORIDE","valganciclovir hydrochloride","61269048510","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","61269-485","61269-485-10","61269-485_9a57e7d6-5fe4-42c6-9b01-ebd9d46004ee","HUMAN PRESCRIPTION DRUG","Valcyte","","POWDER, FOR SOLUTION","ORAL","20090828","","NDA","NDA022257","H2-Pharma, LLC","50","mg/mL","","N","20261231"
"4260","MICONAZOLE NITRATE","Miconazole Nitrate","61269073063","Azole Antifungal [EPC], Azoles [CS]","61269-730","61269-730-63","61269-730_03eea790-4814-4dd3-8cbf-20a3bc96ea0d","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20210412","","ANDA","ANDA074164","H2-Pharma, LLC","20","mg/g","","N","20251231"
"4261","MICONAZOLE NITRATE","Miconazole Nitrate","61269073041","Azole Antifungal [EPC], Azoles [CS]","61269-730","61269-730-41","61269-730_03eea790-4814-4dd3-8cbf-20a3bc96ea0d","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20210412","","ANDA","ANDA074164","H2-Pharma, LLC","20","mg/g","","N","20251231"
"4262","MICONAZOLE NITRATE","Miconazole Nitrate","61269073542","Azole Antifungal [EPC], Azoles [CS]","61269-735","61269-735-42","61269-735_f500946e-44ef-46ea-89e6-fd3f712d7481","HUMAN OTC DRUG","Miconazole Nitrate","","CREAM","TOPICAL","20210629","20251231","OTC MONOGRAPH DRUG","M005","H2-Pharma, LLC","20","mg/g","","N",""
"4263","MICONAZOLE NITRATE","Miconazole Nitrate","61269073514","Azole Antifungal [EPC], Azoles [CS]","61269-735","61269-735-14","61269-735_f500946e-44ef-46ea-89e6-fd3f712d7481","HUMAN OTC DRUG","Miconazole Nitrate","","CREAM","TOPICAL","20210629","20251231","OTC MONOGRAPH DRUG","M005","H2-Pharma, LLC","20","mg/g","","N",""
"4264","MICONAZOLE NITRATE","Miconazole Nitrate","61269073556","Azole Antifungal [EPC], Azoles [CS]","61269-735","61269-735-56","61269-735_f500946e-44ef-46ea-89e6-fd3f712d7481","HUMAN OTC DRUG","Miconazole Nitrate","","CREAM","TOPICAL","20210629","20251231","OTC MONOGRAPH DRUG","M005","H2-Pharma, LLC","20","mg/g","","N",""
"4265","MICONAZOLE NITRATE","Miconazole Nitrate","61269073607","Azole Antifungal [EPC], Azoles [CS]","61269-736","61269-736-07","61269-736_88b435a1-7647-40c8-b23d-7193917b517b","HUMAN OTC DRUG","Miconazole 7","","SUPPOSITORY","VAGINAL","20210524","20250731","ANDA","ANDA073507","H2-Pharma, LLC","100","mg/1","","N",""
"4266","TRIFLURIDINE","trifluridine","61314004475","Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC]","61314-044","61314-044-75","61314-044_d0e32882-06fe-4062-adae-3751ffc9979f","HUMAN PRESCRIPTION DRUG","Trifluridine","","SOLUTION","OPHTHALMIC","20010514","","ANDA","ANDA074311","Sandoz Inc","10","mg/mL","","N","20251231"
"4267","POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","Polymyxin B Sulfate and Trimethoprim","61314062810","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","61314-628","61314-628-10","61314-628_85cac791-8812-41fb-8809-8c64bfc6214c","HUMAN PRESCRIPTION DRUG","Polymyxin B Sulfate and Trimethoprim","","SOLUTION","OPHTHALMIC","19980416","","ANDA","ANDA064211","Sandoz Inc","10000; 1","[USP'U]/mL; mg/mL","","N","20251231"
"4268","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and dexamethasone","61314063006","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","61314-630","61314-630-06","61314-630_c28e6969-112d-49ae-b037-f09954e99f3e","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Dexamethasone","","SUSPENSION","OPHTHALMIC","19960221","","ANDA","ANDA062341","Sandoz Inc.","1; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"4269","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin and Polymyxin B Sulfates and Dexamethasone","61314063136","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","61314-631","61314-631-36","61314-631_91b9784c-1234-492b-99b1-dd456ef437b5","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Dexamethasone","","OINTMENT","OPHTHALMIC","19960221","","NDA AUTHORIZED GENERIC","NDA050065","Sandoz Inc","1; 3.5; 10000","mg/g; mg/g; [iU]/g","","N","20251231"
"4270","GENTAMICIN SULFATE","Gentamicin Sulfate","61314063305","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","61314-633","61314-633-05","61314-633_a628d79b-79de-49ec-b116-c605ba0fb991","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","SOLUTION","OPHTHALMIC","19960405","","ANDA","ANDA062196","Sandoz Inc","3","mg/mL","","N","20251231"
"4271","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and hydrocortisone","61314064175","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","61314-641","61314-641-75","61314-641_15cc1b8f-5a7f-4cfb-8c65-9d35f7c0f30f","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SUSPENSION","OPHTHALMIC","20030509","","ANDA","ANDA062874","Sandoz Inc","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"4272","TOBRAMYCIN","Tobramycin","61314064305","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","61314-643","61314-643-05","61314-643_505c82ff-86c3-4269-96cb-faae872c7539","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","OPHTHALMIC","19950109","","ANDA","ANDA062535","Sandoz Inc","3","mg/mL","","N","20251231"
"4273","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and hydrocortisone","61314064511","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","61314-645","61314-645-11","61314-645_99d0c7c1-3bf0-4491-b093-551555f7e80c","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SUSPENSION","AURICULAR (OTIC)","20030317","","ANDA","ANDA062488","Sandoz Inc.","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"4274","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and hydrocortisone","61314064610","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","61314-646","61314-646-10","61314-646_a3e39398-1292-491a-a063-4f9406be7dce","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SOLUTION","AURICULAR (OTIC)","20030318","","ANDA","ANDA062423","Sandoz Inc","10; 3.5; 10000","mg/mL; mg/mL; [iU]/mL","","N","20251231"
"4275","DEXAMETHASONE; TOBRAMYCIN","Tobramycin and Dexamethasone","61314064705","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","61314-647","61314-647-05","61314-647_8b9edb26-5c28-4b77-a417-167f5ad372d1","HUMAN PRESCRIPTION DRUG","Tobramycin and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","20090102","","NDA AUTHORIZED GENERIC","NDA050592","Sandoz Inc","1; 3","mg/mL; mg/mL","","N","20261231"
"4276","DEXAMETHASONE; TOBRAMYCIN","Tobramycin and Dexamethasone","61314064725","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","61314-647","61314-647-25","61314-647_8b9edb26-5c28-4b77-a417-167f5ad372d1","HUMAN PRESCRIPTION DRUG","Tobramycin and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","20090102","","NDA AUTHORIZED GENERIC","NDA050592","Sandoz Inc","1; 3","mg/mL; mg/mL","","N","20261231"
"4277","DEXAMETHASONE; TOBRAMYCIN","Tobramycin and Dexamethasone","61314064710","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","61314-647","61314-647-10","61314-647_8b9edb26-5c28-4b77-a417-167f5ad372d1","HUMAN PRESCRIPTION DRUG","Tobramycin and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","20090102","","NDA AUTHORIZED GENERIC","NDA050592","Sandoz Inc","1; 3","mg/mL; mg/mL","","N","20261231"
"4278","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","61314065605","Quinolone Antimicrobial [EPC], Quinolones [CS]","61314-656","61314-656-05","61314-656_1c86f423-a99a-4e4d-9502-42799a9d40e6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20040507","","NDA AUTHORIZED GENERIC","NDA019992","Sandoz Inc","3","mg/mL","","N","20251231"
"4279","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","61314065610","Quinolone Antimicrobial [EPC], Quinolones [CS]","61314-656","61314-656-10","61314-656_1c86f423-a99a-4e4d-9502-42799a9d40e6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20040507","","NDA AUTHORIZED GENERIC","NDA019992","Sandoz Inc","3","mg/mL","","N","20251231"
"4280","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","61314065625","Quinolone Antimicrobial [EPC], Quinolones [CS]","61314-656","61314-656-25","61314-656_1c86f423-a99a-4e4d-9502-42799a9d40e6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20040507","","NDA AUTHORIZED GENERIC","NDA019992","Sandoz Inc","3","mg/mL","","N","20251231"
"4281","GATIFLOXACIN","gatifloxacin","61314067225","Quinolone Antimicrobial [EPC], Quinolones [CS]","61314-672","61314-672-25","61314-672_20dfbbfa-5c67-4ac4-a90a-a7dd29395e71","HUMAN PRESCRIPTION DRUG","Gatifloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20161003","","ANDA","ANDA204227","Sandoz Inc","5","mg/mL","","N","20251231"
"4282","SULFACETAMIDE SODIUM","Sulfacetamide Sodium","61314070101","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","61314-701","61314-701-01","61314-701_6936177e-fec2-4ec0-b81d-af6d0bd43dc6","HUMAN PRESCRIPTION DRUG","Sulfacetamide Sodium","","SOLUTION","OPHTHALMIC","20030325","","ANDA","ANDA089560","Sandoz Inc.","100","mg/mL","","N","20251231"
"4283","CEFACLOR","Cefaclor","61442017105","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","61442-171","61442-171-05","61442-171_3417e20b-604b-3cdd-e063-6394a90ac707","HUMAN PRESCRIPTION DRUG","Cefaclor","","CAPSULE","ORAL","20080731","","ANDA","ANDA065146","Carlsbad Technology, Inc.","250","mg/1","","N","20261231"
"4284","CEFACLOR","Cefaclor","61442017130","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","61442-171","61442-171-30","61442-171_3417e20b-604b-3cdd-e063-6394a90ac707","HUMAN PRESCRIPTION DRUG","Cefaclor","","CAPSULE","ORAL","20080731","","ANDA","ANDA065146","Carlsbad Technology, Inc.","250","mg/1","","N","20261231"
"4285","CEFACLOR","Cefaclor","61442017101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","61442-171","61442-171-01","61442-171_3417e20b-604b-3cdd-e063-6394a90ac707","HUMAN PRESCRIPTION DRUG","Cefaclor","","CAPSULE","ORAL","20080731","","ANDA","ANDA065146","Carlsbad Technology, Inc.","250","mg/1","","N","20261231"
"4286","CEFACLOR","Cefaclor","61442017201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","61442-172","61442-172-01","61442-172_3417e20b-604b-3cdd-e063-6394a90ac707","HUMAN PRESCRIPTION DRUG","Cefaclor","","CAPSULE","ORAL","20080731","","ANDA","ANDA065146","Carlsbad Technology, Inc.","500","mg/1","","N","20261231"
"4287","CEFACLOR","Cefaclor","61442017230","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","61442-172","61442-172-30","61442-172_3417e20b-604b-3cdd-e063-6394a90ac707","HUMAN PRESCRIPTION DRUG","Cefaclor","","CAPSULE","ORAL","20080731","","ANDA","ANDA065146","Carlsbad Technology, Inc.","500","mg/1","","N","20261231"
"4288","CEFACLOR","Cefaclor","61442017205","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","61442-172","61442-172-05","61442-172_3417e20b-604b-3cdd-e063-6394a90ac707","HUMAN PRESCRIPTION DRUG","Cefaclor","","CAPSULE","ORAL","20080731","","ANDA","ANDA065146","Carlsbad Technology, Inc.","500","mg/1","","N","20261231"
"4289","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","61442022210","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","61442-222","61442-222-10","61442-222_2d6a2060-1f59-696d-e063-6394a90a2796","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Carlsbad Technology, Inc.","250","mg/1","","N","20261231"
"4290","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","61442022201","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","61442-222","61442-222-01","61442-222_2d6a2060-1f59-696d-e063-6394a90a2796","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Carlsbad Technology, Inc.","250","mg/1","","N","20261231"
"4291","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","61442022301","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","61442-223","61442-223-01","61442-223_2d6a2060-1f59-696d-e063-6394a90a2796","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Carlsbad Technology, Inc.","500","mg/1","","N","20261231"
"4292","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","61442022305","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","61442-223","61442-223-05","61442-223_2d6a2060-1f59-696d-e063-6394a90a2796","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Carlsbad Technology, Inc.","500","mg/1","","N","20261231"
"4293","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","61442022450","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","61442-224","61442-224-50","61442-224_2d6a2060-1f59-696d-e063-6394a90a2796","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Carlsbad Technology, Inc.","750","mg/1","","N","20261231"
"4294","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","61442022404","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","61442-224","61442-224-04","61442-224_2d6a2060-1f59-696d-e063-6394a90a2796","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Carlsbad Technology, Inc.","750","mg/1","","N","20261231"
"4295","SILVER SULFADIAZINE","silver sulfadiazine","61570013125","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","61570-131","61570-131-25","61570-131_0c251e48-c62b-432a-b221-d240c4913f41","HUMAN PRESCRIPTION DRUG","SILVADENE","","CREAM","TOPICAL","19731126","","NDA","NDA017381","Pfizer Laboratories Div Pfizer Inc","10","mg/g","","N","20251231"
"4296","SILVER SULFADIAZINE","silver sulfadiazine","61570013140","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","61570-131","61570-131-40","61570-131_0c251e48-c62b-432a-b221-d240c4913f41","HUMAN PRESCRIPTION DRUG","SILVADENE","","CREAM","TOPICAL","19731126","","NDA","NDA017381","Pfizer Laboratories Div Pfizer Inc","10","mg/g","","N","20251231"
"4297","SILVER SULFADIAZINE","silver sulfadiazine","61570013120","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","61570-131","61570-131-20","61570-131_0c251e48-c62b-432a-b221-d240c4913f41","HUMAN PRESCRIPTION DRUG","SILVADENE","","CREAM","TOPICAL","19731126","","NDA","NDA017381","Pfizer Laboratories Div Pfizer Inc","10","mg/g","","N","20251231"
"4298","SILVER SULFADIAZINE","silver sulfadiazine","61570013185","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","61570-131","61570-131-85","61570-131_0c251e48-c62b-432a-b221-d240c4913f41","HUMAN PRESCRIPTION DRUG","SILVADENE","","CREAM","TOPICAL","19731126","","NDA","NDA017381","Pfizer Laboratories Div Pfizer Inc","10","mg/g","","N","20251231"
"4299","SILVER SULFADIAZINE","silver sulfadiazine","61570013198","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","61570-131","61570-131-98","61570-131_0c251e48-c62b-432a-b221-d240c4913f41","HUMAN PRESCRIPTION DRUG","SILVADENE","","CREAM","TOPICAL","19731126","","NDA","NDA017381","Pfizer Laboratories Div Pfizer Inc","10","mg/g","","N","20251231"
"4300","SILVER SULFADIAZINE","silver sulfadiazine","61570013155","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","61570-131","61570-131-55","61570-131_0c251e48-c62b-432a-b221-d240c4913f41","HUMAN PRESCRIPTION DRUG","SILVADENE","","CREAM","TOPICAL","19731126","","NDA","NDA017381","Pfizer Laboratories Div Pfizer Inc","10","mg/g","","N","20251231"
"4301","SILVER SULFADIAZINE","silver sulfadiazine","61570013150","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","61570-131","61570-131-50","61570-131_0c251e48-c62b-432a-b221-d240c4913f41","HUMAN PRESCRIPTION DRUG","SILVADENE","","CREAM","TOPICAL","19731126","","NDA","NDA017381","Pfizer Laboratories Div Pfizer Inc","10","mg/g","","N","20251231"
"4302","ACONITUM NAPELLUS; ECHINACEA PURPUREA; FERRIC FERROCYANIDE; GELSEMIUM SEMPERVIRENS ROOT; HOPS; LEAD; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; QUININE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFURIC ACID","Aconitum nap, Arg nit, Chininum pur, Echinacea purp, Plum met, Sepia, Sulphuricum ac","61626011204","Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Chelating Activity [MoA], Decorporation Agent [EPC], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]","61626-0112","61626-0112-4","61626-0112_b96b096e-67b9-b334-e053-2995a90a34c9","HUMAN PRESCRIPTION DRUG","Visceral Polarity","","LIQUID","ORAL","20181204","","UNAPPROVED HOMEOPATHIC","","NET Remedies","12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12","[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL","","N","20251231"
"4303","ALLYLTHIOUREA; CALOMEL; CINCHONA OFFICINALIS BARK; FERRUM PHOSPHORICUM; POTASSIUM CHLORIDE; QUININE SULFATE; SALICYLIC ACID","CINCHONA OFFICINALIS BARK,SALICYLIC ACID,QUININE SULFATE,FERRUM PHOSPHORICUM,POTASSIUM CHLORIDE,CALOMEL,ALLYLTHIOUREA,.","61727031521","Antimalarial [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]","61727-315","61727-315-21","61727-315_82fbfc25-3f57-460f-e053-2991aa0aad29","HUMAN OTC DRUG","Tinnitus Relief","","PELLET","SUBLINGUAL","20120724","","UNAPPROVED HOMEOPATHIC","","Homeocare Laboratories","4; 4; 9; 4; 4; 9; 15","[hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g","","N","20251231"
"4304","MICONAZOLE","Miconazole","61825030314","Azole Antifungal [EPC], Azoles [CS]","61825-303","61825-303-14","61825-303_0e7b8449-3f4c-4045-e063-6394a90aaca2","HUMAN PRESCRIPTION DRUG","Oravig","","TABLET","BUCCAL","20211231","","NDA","NDA022404","Galt Pharmaceuticals, LLC","50","mg/1","","N","20251231"
"4305","METRONIDAZOLE","METRONIDAZOLE","61919003210","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","61919-032","61919-032-10","61919-032_0e87aa19-bbe8-d384-e063-6294a90a9d0b","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","TABLET, FILM COATED","ORAL","20190821","","ANDA","ANDA203458","Direct_Rx","500","mg/1","","N","20251231"
"4306","METRONIDAZOLE","METRONIDAZOLE","61919003230","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","61919-032","61919-032-30","61919-032_0e87aa19-bbe8-d384-e063-6294a90a9d0b","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","TABLET, FILM COATED","ORAL","20190821","","ANDA","ANDA203458","Direct_Rx","500","mg/1","","N","20251231"
"4307","METRONIDAZOLE","METRONIDAZOLE","61919003204","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","61919-032","61919-032-04","61919-032_0e87aa19-bbe8-d384-e063-6294a90a9d0b","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","TABLET, FILM COATED","ORAL","20190821","","ANDA","ANDA203458","Direct_Rx","500","mg/1","","N","20251231"
"4308","METRONIDAZOLE","METRONIDAZOLE","61919003214","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","61919-032","61919-032-14","61919-032_0e87aa19-bbe8-d384-e063-6294a90a9d0b","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","TABLET, FILM COATED","ORAL","20190821","","ANDA","ANDA203458","Direct_Rx","500","mg/1","","N","20251231"
"4309","GENTAMICIN SULFATE","gentamicin sulfate","61919010605","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","61919-106","61919-106-05","61919-106_0e997972-7ec7-5a7a-e063-6294a90aceac","HUMAN PRESCRIPTION DRUG","gentamicin sulfate","","SOLUTION/ DROPS","OPHTHALMIC","20140101","","ANDA","ANDA062452","DIRECT RX","3","mg/mL","","N","20251231"
"4310","AMOXICILLIN","AMOXICILLIN","61919040132","Penicillin-class Antibacterial [EPC], Penicillins [CS]","61919-401","61919-401-32","61919-401_0e877b33-af19-d857-e063-6394a90a08ea","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","POWDER, FOR SUSPENSION","ORAL","20140101","","ANDA","ANDA065334","DIRECT RX","400","mg/5mL","","N","20251231"
"4311","FLUCONAZOLE","Fluconazole","61919049303","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","61919-493","61919-493-03","61919-493_0e88c9e2-8dbd-917c-e063-6294a90a6ec9","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20190408","","ANDA","ANDA208963","Direct Rx","200","mg/1","","N","20251231"
"4312","TOBRAMYCIN","TOBRAMYCIN","61919064205","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","61919-642","61919-642-05","61919-642_0e98b2f4-6caf-f58b-e063-6394a90ab0ab","HUMAN PRESCRIPTION DRUG","TOBRAMYCIN","","SOLUTION/ DROPS","OPHTHALMIC","20190423","","ANDA","ANDA207444","DirectRX","3","mg/mL","","N","20251231"
"4313","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfameth/Trimeth-DS","61919064506","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","61919-645","61919-645-06","61919-645_1509603c-a7d9-f11e-e063-6294a90a5955","HUMAN PRESCRIPTION DRUG","Sulfameth/Trimeth-DS","","TABLET","ORAL","20190813","","ANDA","ANDA090624","Direct_Rx","800; 160","mg/1; mg/1","","N","20251231"
"4314","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfameth/Trimeth-DS","61919064530","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","61919-645","61919-645-30","61919-645_1509603c-a7d9-f11e-e063-6294a90a5955","HUMAN PRESCRIPTION DRUG","Sulfameth/Trimeth-DS","","TABLET","ORAL","20190813","","ANDA","ANDA090624","Direct_Rx","800; 160","mg/1; mg/1","","N","20251231"
"4315","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfameth/Trimeth-DS","61919064556","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","61919-645","61919-645-56","61919-645_1509603c-a7d9-f11e-e063-6294a90a5955","HUMAN PRESCRIPTION DRUG","Sulfameth/Trimeth-DS","","TABLET","ORAL","20190813","","ANDA","ANDA090624","Direct_Rx","800; 160","mg/1; mg/1","","N","20251231"
"4316","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfameth/Trimeth-DS","61919064560","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","61919-645","61919-645-60","61919-645_1509603c-a7d9-f11e-e063-6294a90a5955","HUMAN PRESCRIPTION DRUG","Sulfameth/Trimeth-DS","","TABLET","ORAL","20190813","","ANDA","ANDA090624","Direct_Rx","800; 160","mg/1; mg/1","","N","20251231"
"4317","NITROFURANTOIN","Nitrofurantoin Macrocrystals","61919084220","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","61919-842","61919-842-20","61919-842_10d10916-c040-b33a-e063-6294a90a0e4c","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Macrocrystals","","CAPSULE","ORAL","20240207","","ANDA","ANDA217272","Direct_Rx","100","mg/1","","N","20251231"
"4318","MICONAZOLE NITRATE","ANTIMICROBIAL DRUG PRODUCTS","61924023405","Azole Antifungal [EPC], Azoles [CS]","61924-234","61924-234-05","61924-234_288802cd-338c-cead-e063-6394a90a6edf","HUMAN OTC DRUG","DERMAFUNGAL","","CREAM","TOPICAL","20051212","","OTC MONOGRAPH DRUG","M005","DermaRite industries, LLC",".02","g/100g","","N","20251231"
"4319","MICONAZOLE NITRATE","ANTIMICROBIAL DRUG PRODUCTS","61924023404","Azole Antifungal [EPC], Azoles [CS]","61924-234","61924-234-04","61924-234_288802cd-338c-cead-e063-6394a90a6edf","HUMAN OTC DRUG","DERMAFUNGAL","","CREAM","TOPICAL","20051212","","OTC MONOGRAPH DRUG","M005","DermaRite industries, LLC",".02","g/100g","","N","20251231"
"4320","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","61971011501","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","61971-115","61971-115-01","61971-115_69d5e1fe-d9e9-4afa-bd62-8df032a34d32","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20060606","","ANDA","ANDA076817","Vista Pharmaceuticals, Inc.","400; 80","mg/1; mg/1","","N","20251231"
"4321","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","61971011505","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","61971-115","61971-115-05","61971-115_69d5e1fe-d9e9-4afa-bd62-8df032a34d32","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20060606","","ANDA","ANDA076817","Vista Pharmaceuticals, Inc.","400; 80","mg/1; mg/1","","N","20251231"
"4322","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","61971012005","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","61971-120","61971-120-05","61971-120_69d5e1fe-d9e9-4afa-bd62-8df032a34d32","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20060822","","ANDA","ANDA076817","Vista Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"4323","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","61971012001","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","61971-120","61971-120-01","61971-120_69d5e1fe-d9e9-4afa-bd62-8df032a34d32","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20060822","","ANDA","ANDA076817","Vista Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"4324","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc and Polymyxin B Sulfate","62011009701","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","62011-0097","62011-0097-1","62011-0097_0f8eb8b6-6867-e8d1-e063-6394a90a8359","HUMAN OTC DRUG","Double Antibiotic","","OINTMENT","TOPICAL","20120321","20260630","OTC MONOGRAPH DRUG","M004","Strategic Sourcing Services LLC","500; 10000","[USP'U]/g; [USP'U]/g","","N",""
"4325","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","62011009901","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","62011-0099","62011-0099-1","62011-0099_262fd224-58e3-a8f3-e063-6394a90a4313","HUMAN OTC DRUG","Triple Antibiotic Plus Pain Relief","","OINTMENT","TOPICAL","20120312","","OTC MONOGRAPH DRUG","M004","Strategic Sourcing Services LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"4326","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","62011032101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","62011-0321","62011-0321-1","62011-0321_262ed55f-ed4e-3e3c-e063-6394a90a9d9f","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","","OTC MONOGRAPH DRUG","M004","Strategic Sourcing Services LLC","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"4327","FLUCONAZOLE","FLUCONAZOLE","62135013030","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","62135-130","62135-130-30","62135-130_25892746-5194-5955-e063-6294a90a3b7f","HUMAN PRESCRIPTION DRUG","FLUCONAZOLE","","TABLET","ORAL","20040729","","ANDA","ANDA076665","Chartwell RX, LLC","50","mg/1","","N","20251231"
"4328","FLUCONAZOLE","FLUCONAZOLE","62135013130","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","62135-131","62135-131-30","62135-131_25892746-5194-5955-e063-6294a90a3b7f","HUMAN PRESCRIPTION DRUG","FLUCONAZOLE","","TABLET","ORAL","20040729","","ANDA","ANDA076665","Chartwell RX, LLC","100","mg/1","","N","20251231"
"4329","FLUCONAZOLE","FLUCONAZOLE","62135013277","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","62135-132","62135-132-77","62135-132_25892746-5194-5955-e063-6294a90a3b7f","HUMAN PRESCRIPTION DRUG","FLUCONAZOLE","","TABLET","ORAL","20040729","","ANDA","ANDA076665","Chartwell RX, LLC","150","mg/1","","N","20251231"
"4330","FLUCONAZOLE","FLUCONAZOLE","62135013330","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","62135-133","62135-133-30","62135-133_25892746-5194-5955-e063-6294a90a3b7f","HUMAN PRESCRIPTION DRUG","FLUCONAZOLE","","TABLET","ORAL","20040729","","ANDA","ANDA076665","Chartwell RX, LLC","200","mg/1","","N","20251231"
"4331","TETRACYCLINE HYDROCHLORIDE","tetracycline hydrochloride","62135022501","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","62135-225","62135-225-01","62135-225_00d7f688-41b8-3498-e063-6394a90a8a3c","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","19880812","","ANDA","ANDA062752","Chartwell RX, LLC.","250","mg/1","","N","20251231"
"4332","TETRACYCLINE HYDROCHLORIDE","tetracycline hydrochloride","62135022505","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","62135-225","62135-225-05","62135-225_00d7f688-41b8-3498-e063-6394a90a8a3c","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","19880812","","ANDA","ANDA062752","Chartwell RX, LLC.","250","mg/1","","N","20251231"
"4333","TETRACYCLINE HYDROCHLORIDE","tetracycline hydrochloride","62135022520","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","62135-225","62135-225-20","62135-225_00d7f688-41b8-3498-e063-6394a90a8a3c","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","19880812","","ANDA","ANDA062752","Chartwell RX, LLC.","250","mg/1","","N","20251231"
"4334","TETRACYCLINE HYDROCHLORIDE","tetracycline hydrochloride","62135022560","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","62135-225","62135-225-60","62135-225_00d7f688-41b8-3498-e063-6394a90a8a3c","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","19880812","","ANDA","ANDA062752","Chartwell RX, LLC.","250","mg/1","","N","20251231"
"4335","TETRACYCLINE HYDROCHLORIDE","tetracycline hydrochloride","62135026601","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","62135-266","62135-266-01","62135-266_00d7f688-41b8-3498-e063-6394a90a8a3c","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","19880812","","ANDA","ANDA062752","Chartwell RX, LLC.","500","mg/1","","N","20251231"
"4336","TETRACYCLINE HYDROCHLORIDE","tetracycline hydrochloride","62135026605","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","62135-266","62135-266-05","62135-266_00d7f688-41b8-3498-e063-6394a90a8a3c","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","19880812","","ANDA","ANDA062752","Chartwell RX, LLC.","500","mg/1","","N","20251231"
"4337","TETRACYCLINE HYDROCHLORIDE","tetracycline hydrochloride","62135026660","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","62135-266","62135-266-60","62135-266_00d7f688-41b8-3498-e063-6394a90a8a3c","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","19880812","","ANDA","ANDA062752","Chartwell RX, LLC.","500","mg/1","","N","20251231"
"4338","TETRACYCLINE HYDROCHLORIDE","tetracycline hydrochloride","62135026620","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","62135-266","62135-266-20","62135-266_00d7f688-41b8-3498-e063-6394a90a8a3c","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","19880812","","ANDA","ANDA062752","Chartwell RX, LLC.","500","mg/1","","N","20251231"
"4339","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin hydrochloride","62135030820","Quinolone Antimicrobial [EPC], Quinolones [CS]","62135-308","62135-308-20","62135-308_f2a0db9f-16a8-1603-e053-2995a90a79a3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210413","","ANDA","ANDA076896","Chartwell RX, LLC.","250","mg/1","","N","20251231"
"4340","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin hydrochloride","62135030828","Quinolone Antimicrobial [EPC], Quinolones [CS]","62135-308","62135-308-28","62135-308_f2a0db9f-16a8-1603-e053-2995a90a79a3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210413","","ANDA","ANDA076896","Chartwell RX, LLC.","250","mg/1","","N","20251231"
"4341","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin hydrochloride","62135030801","Quinolone Antimicrobial [EPC], Quinolones [CS]","62135-308","62135-308-01","62135-308_f2a0db9f-16a8-1603-e053-2995a90a79a3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210413","","ANDA","ANDA076896","Chartwell RX, LLC.","250","mg/1","","N","20251231"
"4342","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin hydrochloride","62135030901","Quinolone Antimicrobial [EPC], Quinolones [CS]","62135-309","62135-309-01","62135-309_f2a0db9f-16a8-1603-e053-2995a90a79a3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210413","","ANDA","ANDA076896","Chartwell RX, LLC.","500","mg/1","","N","20251231"
"4343","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin hydrochloride","62135030910","Quinolone Antimicrobial [EPC], Quinolones [CS]","62135-309","62135-309-10","62135-309_f2a0db9f-16a8-1603-e053-2995a90a79a3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210413","","ANDA","ANDA076896","Chartwell RX, LLC.","500","mg/1","","N","20251231"
"4344","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin hydrochloride","62135030920","Quinolone Antimicrobial [EPC], Quinolones [CS]","62135-309","62135-309-20","62135-309_f2a0db9f-16a8-1603-e053-2995a90a79a3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210413","","ANDA","ANDA076896","Chartwell RX, LLC.","500","mg/1","","N","20251231"
"4345","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin hydrochloride","62135030928","Quinolone Antimicrobial [EPC], Quinolones [CS]","62135-309","62135-309-28","62135-309_f2a0db9f-16a8-1603-e053-2995a90a79a3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210413","","ANDA","ANDA076896","Chartwell RX, LLC.","500","mg/1","","N","20251231"
"4346","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin hydrochloride","62135030905","Quinolone Antimicrobial [EPC], Quinolones [CS]","62135-309","62135-309-05","62135-309_f2a0db9f-16a8-1603-e053-2995a90a79a3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210413","","ANDA","ANDA076896","Chartwell RX, LLC.","500","mg/1","","N","20251231"
"4347","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin hydrochloride","62135031050","Quinolone Antimicrobial [EPC], Quinolones [CS]","62135-310","62135-310-50","62135-310_f2a0db9f-16a8-1603-e053-2995a90a79a3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210413","","ANDA","ANDA076896","Chartwell RX, LLC.","750","mg/1","","N","20251231"
"4348","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin hydrochloride","62135031020","Quinolone Antimicrobial [EPC], Quinolones [CS]","62135-310","62135-310-20","62135-310_f2a0db9f-16a8-1603-e053-2995a90a79a3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210413","","ANDA","ANDA076896","Chartwell RX, LLC.","750","mg/1","","N","20251231"
"4349","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin hydrochloride","62135031028","Quinolone Antimicrobial [EPC], Quinolones [CS]","62135-310","62135-310-28","62135-310_f2a0db9f-16a8-1603-e053-2995a90a79a3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210413","","ANDA","ANDA076896","Chartwell RX, LLC.","750","mg/1","","N","20251231"
"4350","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin hydrochloride","62135031106","Quinolone Antimicrobial [EPC], Quinolones [CS]","62135-311","62135-311-06","62135-311_f2a0db9f-16a8-1603-e053-2995a90a79a3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20220420","","ANDA","ANDA076896","Chartwell RX, LLC.","100","mg/1","","N","20251231"
"4351","RIFAMPIN","Rifampin","62135031530","Rifamycin Antibacterial [EPC], Rifamycins [CS]","62135-315","62135-315-30","62135-315_f9244302-8654-6016-e053-6294a90ad64c","HUMAN PRESCRIPTION DRUG","Rifampin","","CAPSULE","ORAL","20080420","","ANDA","ANDA065390","Chartwell RX, LLC","150","mg/1","","N","20251231"
"4352","RIFAMPIN","Rifampin","62135031660","Rifamycin Antibacterial [EPC], Rifamycins [CS]","62135-316","62135-316-60","62135-316_f9244302-8654-6016-e053-6294a90ad64c","HUMAN PRESCRIPTION DRUG","Rifampin","","CAPSULE","ORAL","20080420","","ANDA","ANDA065390","Chartwell RX, LLC","300","mg/1","","N","20251231"
"4353","POSACONAZOLE","Posaconazole Delayed-Release","62135042960","Azole Antifungal [EPC], Azoles [CS]","62135-429","62135-429-60","62135-429_f043ffa5-9564-4a98-e053-2995a90af810","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","TABLET","ORAL","20190828","","ANDA","ANDA212411","Chartwell RX, LLC","100","mg/1","","N","20251231"
"4354","LINEZOLID","linezolid","62135044220","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","62135-442","62135-442-20","62135-442_2599d926-e08d-6243-e063-6394a90a526f","HUMAN PRESCRIPTION DRUG","linezolid","","TABLET","ORAL","20190425","","ANDA","ANDA210702","Chartwell RX, LLC","600","mg/1","","N","20251231"
"4355","NEOMYCIN SULFATE","Neomycin Sulfate","62135044390","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","62135-443","62135-443-90","62135-443_0bbb09cc-b1ec-c182-e063-6294a90a771b","HUMAN PRESCRIPTION DRUG","Neomycin Sulfate","","TABLET","ORAL","20160610","","ANDA","ANDA204435","Chartwell RX, LLC","500","mg/1","","N","20251231"
"4356","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","62135046220","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","62135-462","62135-462-20","62135-462_242460b7-b39b-49ca-e063-6294a90a555a","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20220801","","ANDA","ANDA065064","Chartwell RX, LLC","500; 125","mg/1; mg/1","","N","20251231"
"4357","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","62135046320","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","62135-463","62135-463-20","62135-463_2424691e-91ff-a1b8-e063-6294a90a1cde","HUMAN PRESCRIPTION DRUG","amoxicillin and clavulanate potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","Chartwell RX, LLC","875; 125","mg/1; mg/1","","N","20251231"
"4358","CEPHALEXIN","Cephalexin","62135048042","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62135-480","62135-480-42","62135-480_2472a501-c0c7-07e6-e063-6394a90a6e79","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","20180228","","ANDA","ANDA065336","Chartwell RX, LLC","125","mg/5mL","","N","20251231"
"4359","CEPHALEXIN","Cephalexin","62135048049","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62135-480","62135-480-49","62135-480_2472a501-c0c7-07e6-e063-6394a90a6e79","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","20180228","","ANDA","ANDA065336","Chartwell RX, LLC","125","mg/5mL","","N","20251231"
"4360","CEPHALEXIN","Cephalexin","62135048149","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62135-481","62135-481-49","62135-481_2472a501-c0c7-07e6-e063-6394a90a6e79","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","20180228","","ANDA","ANDA065336","Chartwell RX, LLC","250","mg/5mL","","N","20251231"
"4361","CEPHALEXIN","Cephalexin","62135048142","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62135-481","62135-481-42","62135-481_2472a501-c0c7-07e6-e063-6394a90a6e79","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","20180228","","ANDA","ANDA065336","Chartwell RX, LLC","250","mg/5mL","","N","20251231"
"4362","ATOVAQUONE","Atovaquone","62135052824","Antimalarial [EPC], Antiprotozoal [EPC]","62135-528","62135-528-24","62135-528_19392345-2a5f-cbf6-e063-6394a90a61f1","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20170428","","ANDA","ANDA207833","Chartwell RX, LLC","750","mg/5mL","","N","20251231"
"4363","ATOVAQUONE","Atovaquone","62135052809","Antimalarial [EPC], Antiprotozoal [EPC]","62135-528","62135-528-09","62135-528_19392345-2a5f-cbf6-e063-6394a90a61f1","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20170428","","ANDA","ANDA207833","Chartwell RX, LLC","750","mg/5mL","","N","20251231"
"4364","TERBINAFINE HYDROCHLORIDE","Terbinafine","62135057230","Allylamine Antifungal [EPC], Allylamine [CS]","62135-572","62135-572-30","62135-572_2659c503-319a-b899-e063-6294a90aa6a6","HUMAN PRESCRIPTION DRUG","TERBINAFINE","","TABLET","ORAL","20070702","","ANDA","ANDA078199","Chartwell RX, LLC","250","mg/1","","N","20251231"
"4365","TERBINAFINE HYDROCHLORIDE","Terbinafine","62135057290","Allylamine Antifungal [EPC], Allylamine [CS]","62135-572","62135-572-90","62135-572_2659c503-319a-b899-e063-6294a90aa6a6","HUMAN PRESCRIPTION DRUG","TERBINAFINE","","TABLET","ORAL","20070702","","ANDA","ANDA078199","Chartwell RX, LLC","250","mg/1","","N","20251231"
"4366","CLARITHROMYCIN","Clarithromycin","62135061560","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","62135-615","62135-615-60","62135-615_f08573c8-02d4-3717-e053-2a95a90a2dda","HUMAN PRESCRIPTION DRUG","CLARITHROMYCIN","","TABLET, FILM COATED","ORAL","20070820","","ANDA","ANDA065384","Chartwell RX, LLC.","500","mg/1","","N","20251231"
"4367","CLARITHROMYCIN","Clarithromycin","62135061660","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","62135-616","62135-616-60","62135-616_f08573c8-02d4-3717-e053-2a95a90a2dda","HUMAN PRESCRIPTION DRUG","CLARITHROMYCIN","","TABLET, FILM COATED","ORAL","20070820","","ANDA","ANDA065384","Chartwell RX, LLC.","250","mg/1","","N","20251231"
"4368","TAVABOROLE","Tavaborole","62135066359","Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]","62135-663","62135-663-59","62135-663_056ba459-06c7-c5c1-e063-6394a90a54bc","HUMAN PRESCRIPTION DRUG","Tavaborole","","SOLUTION","TOPICAL","20210203","","ANDA","ANDA211963","Chartwell RX, LLC","43.5","mg/mL","","N","20251231"
"4369","AZITHROMYCIN MONOHYDRATE","Azithromycin","62135070451","Macrolide Antimicrobial [EPC], Macrolides [CS]","62135-704","62135-704-51","62135-704_15af5062-22b6-c8b6-e063-6294a90a7df3","HUMAN PRESCRIPTION DRUG","Azithromycin","","SUSPENSION","ORAL","20150515","","ANDA","ANDA065488","Chartwell RX, LLC","100","mg/5mL","","N","20251231"
"4370","AZITHROMYCIN MONOHYDRATE","Azithromycin","62135070552","Macrolide Antimicrobial [EPC], Macrolides [CS]","62135-705","62135-705-52","62135-705_15af5062-22b6-c8b6-e063-6294a90a7df3","HUMAN PRESCRIPTION DRUG","Azithromycin","","SUSPENSION","ORAL","20150515","","ANDA","ANDA065488","Chartwell RX, LLC","200","mg/5mL","","N","20251231"
"4371","AZITHROMYCIN MONOHYDRATE","Azithromycin","62135070551","Macrolide Antimicrobial [EPC], Macrolides [CS]","62135-705","62135-705-51","62135-705_15af5062-22b6-c8b6-e063-6294a90a7df3","HUMAN PRESCRIPTION DRUG","Azithromycin","","SUSPENSION","ORAL","20150515","","ANDA","ANDA065488","Chartwell RX, LLC","200","mg/5mL","","N","20251231"
"4372","AZITHROMYCIN MONOHYDRATE","Azithromycin","62135070543","Macrolide Antimicrobial [EPC], Macrolides [CS]","62135-705","62135-705-43","62135-705_15af5062-22b6-c8b6-e063-6294a90a7df3","HUMAN PRESCRIPTION DRUG","Azithromycin","","SUSPENSION","ORAL","20150515","","ANDA","ANDA065488","Chartwell RX, LLC","200","mg/5mL","","N","20251231"
"4373","CEPHALEXIN","Cephalexin","62135071074","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62135-710","62135-710-74","62135-710_2472af39-ccc7-f29b-e063-6394a90aaebd","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Chartwell RX, LLC","250","mg/1","","N","20251231"
"4374","CEPHALEXIN","cephalexin","62135071174","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62135-711","62135-711-74","62135-711_2472c9a9-0d24-baae-e063-6294a90a081b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Chartwell RX, LLC.","500","mg/1","","N","20251231"
"4375","CHLOROQUINE PHOSPHATE","chloroquine phosphate","62135071726","Antimalarial [EPC]","62135-717","62135-717-26","62135-717_240d5cf4-a521-be17-e063-6394a90aaae4","HUMAN PRESCRIPTION DRUG","CHLOROQUINE PHOSPHATE","","TABLET, COATED","ORAL","20230320","","ANDA","ANDA214756","Chartwell RX, LLC","500","mg/1","","N","20251231"
"4376","NYSTATIN","Nystatin","62135074190","Polyene Antifungal [EPC], Polyenes [CS]","62135-741","62135-741-90","62135-741_252624b6-f1db-77ed-e063-6294a90af141","HUMAN PRESCRIPTION DRUG","Nystatin","","TABLET, FILM COATED","ORAL","20111031","","ANDA","ANDA062474","Chartwell RX, LLC","500000","[USP'U]/1","","N","20251231"
"4377","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","62135074947","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","62135-749","62135-749-47","62135-749_316d17d0-4fb7-a200-e063-6394a90aa5e2","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20070124","","ANDA","ANDA077785","Chartwell RX, LLC","200; 40","mg/5mL; mg/5mL","","N","20261231"
"4378","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine","62135075290","Antimalarial [EPC], Antirheumatic Agent [EPC]","62135-752","62135-752-90","62135-752_19fdb044-9d26-a6ab-e063-6394a90acfdd","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine","","TABLET","ORAL","20180706","","ANDA","ANDA210543","Chartwell RX, LLC","200","mg/1","","N","20251231"
"4379","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","62135076401","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","62135-764","62135-764-01","62135-764_0f266520-6156-ae80-e063-6394a90a8dc6","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20050812","","ANDA","ANDA065243","Chartwell RX, LLC","75","mg/1","","N","20251231"
"4380","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","62135076501","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","62135-765","62135-765-01","62135-765_0f266520-6156-ae80-e063-6394a90a8dc6","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20050812","","ANDA","ANDA065243","Chartwell RX, LLC","150","mg/1","","N","20251231"
"4381","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","62135076601","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","62135-766","62135-766-01","62135-766_0f266520-6156-ae80-e063-6394a90a8dc6","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20050812","","ANDA","ANDA065243","Chartwell RX, LLC","300","mg/1","","N","20251231"
"4382","AMOXICILLIN","Amoxicillin","62135077638","Penicillin-class Antibacterial [EPC], Penicillins [CS]","62135-776","62135-776-38","62135-776_0da8289c-3368-ccc4-e063-6294a90ad740","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","POWDER, FOR SUSPENSION","ORAL","19781208","","ANDA","ANDA062059","Chartwell RX, LLC","125","mg/5mL","","N","20251231"
"4383","AMOXICILLIN","Amoxicillin","62135077642","Penicillin-class Antibacterial [EPC], Penicillins [CS]","62135-776","62135-776-42","62135-776_0da8289c-3368-ccc4-e063-6294a90ad740","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","POWDER, FOR SUSPENSION","ORAL","19781208","","ANDA","ANDA062059","Chartwell RX, LLC","125","mg/5mL","","N","20251231"
"4384","AMOXICILLIN","Amoxicillin","62135077668","Penicillin-class Antibacterial [EPC], Penicillins [CS]","62135-776","62135-776-68","62135-776_0da8289c-3368-ccc4-e063-6294a90ad740","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","POWDER, FOR SUSPENSION","ORAL","19781208","","ANDA","ANDA062059","Chartwell RX, LLC","125","mg/5mL","","N","20251231"
"4385","AMOXICILLIN","Amoxicillin","62135077742","Penicillin-class Antibacterial [EPC], Penicillins [CS]","62135-777","62135-777-42","62135-777_0da8289c-3368-ccc4-e063-6294a90ad740","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","POWDER, FOR SUSPENSION","ORAL","19781208","","ANDA","ANDA062059","Chartwell RX, LLC","250","mg/5mL","","N","20251231"
"4386","AMOXICILLIN","Amoxicillin","62135077768","Penicillin-class Antibacterial [EPC], Penicillins [CS]","62135-777","62135-777-68","62135-777_0da8289c-3368-ccc4-e063-6294a90ad740","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","POWDER, FOR SUSPENSION","ORAL","19781208","","ANDA","ANDA062059","Chartwell RX, LLC","250","mg/5mL","","N","20251231"
"4387","AMOXICILLIN","Amoxicillin","62135077738","Penicillin-class Antibacterial [EPC], Penicillins [CS]","62135-777","62135-777-38","62135-777_0da8289c-3368-ccc4-e063-6294a90ad740","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","POWDER, FOR SUSPENSION","ORAL","19781208","","ANDA","ANDA062059","Chartwell RX, LLC","250","mg/5mL","","N","20251231"
"4388","METRONIDAZOLE","Metronidazole","62135079590","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62135-795","62135-795-90","62135-795_2525b99d-5894-4f03-e063-6294a90ac0c3","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20171129","","ANDA","ANDA205245","Chartwell RX, LLC","250","mg/1","","N","20251231"
"4389","METRONIDAZOLE","Metronidazole","62135079690","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62135-796","62135-796-90","62135-796_2525b99d-5894-4f03-e063-6294a90ac0c3","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20171129","","ANDA","ANDA205245","Chartwell RX, LLC","500","mg/1","","N","20251231"
"4390","NYSTATIN","Nystatin","62135081324","Polyene Antifungal [EPC], Polyenes [CS]","62135-813","62135-813-24","62135-813_312bbb25-c5d0-ff31-e063-6394a90afc48","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","19710414","","NDA AUTHORIZED GENERIC","NDA050299","Chartwell RX, LLC","100000","U/mL","","N","20261231"
"4391","NYSTATIN","Nystatin","62135081346","Polyene Antifungal [EPC], Polyenes [CS]","62135-813","62135-813-46","62135-813_312bbb25-c5d0-ff31-e063-6394a90afc48","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","19710414","","NDA AUTHORIZED GENERIC","NDA050299","Chartwell RX, LLC","100000","U/mL","","N","20261231"
"4392","NYSTATIN","Nystatin","62135081347","Polyene Antifungal [EPC], Polyenes [CS]","62135-813","62135-813-47","62135-813_312bbb25-c5d0-ff31-e063-6394a90afc48","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","19710414","","NDA AUTHORIZED GENERIC","NDA050299","Chartwell RX, LLC","100000","U/mL","","N","20261231"
"4393","AMOXICILLIN","Amoxicillin","62135081542","Penicillin-class Antibacterial [EPC], Penicillins [CS]","62135-815","62135-815-42","62135-815_1be0aa8f-b634-9463-e063-6394a90a5646","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070618","","ANDA","ANDA065319","Chartwell RX, LLC","400","mg/5mL","","N","20251231"
"4394","AMOXICILLIN","Amoxicillin","62135082401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","62135-824","62135-824-01","62135-824_1531bbcb-3e3a-24a7-e063-6294a90a1fdf","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19780803","","ANDA","ANDA062058","Chartwell RX, LLC","250","mg/1","","N","20251231"
"4395","AMOXICILLIN","Amoxicillin","62135082405","Penicillin-class Antibacterial [EPC], Penicillins [CS]","62135-824","62135-824-05","62135-824_1531bbcb-3e3a-24a7-e063-6294a90a1fdf","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19780803","","ANDA","ANDA062058","Chartwell RX, LLC","250","mg/1","","N","20251231"
"4396","AMOXICILLIN","Amoxicillin","62135082560","Penicillin-class Antibacterial [EPC], Penicillins [CS]","62135-825","62135-825-60","62135-825_1531bbcb-3e3a-24a7-e063-6294a90a1fdf","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19780803","","ANDA","ANDA062058","Chartwell RX, LLC","500","mg/1","","N","20251231"
"4397","AMOXICILLIN","Amoxicillin","62135082505","Penicillin-class Antibacterial [EPC], Penicillins [CS]","62135-825","62135-825-05","62135-825_1531bbcb-3e3a-24a7-e063-6294a90a1fdf","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19780803","","ANDA","ANDA062058","Chartwell RX, LLC","500","mg/1","","N","20251231"
"4398","TINIDAZOLE","Tinidazole","62135083420","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62135-834","62135-834-20","62135-834_1d71c803-2d38-ccc8-e063-6294a90a7923","HUMAN PRESCRIPTION DRUG","Tinidazole","","TABLET, FILM COATED","ORAL","20120430","","ANDA","ANDA202044","Chartwell RX, LLC","250","mg/1","","N","20251231"
"4399","TINIDAZOLE","Tinidazole","62135083520","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62135-835","62135-835-20","62135-835_1d71c803-2d38-ccc8-e063-6294a90a7923","HUMAN PRESCRIPTION DRUG","Tinidazole","","TABLET, FILM COATED","ORAL","20120430","","ANDA","ANDA202044","Chartwell RX, LLC","500","mg/1","","N","20251231"
"4400","METRONIDAZOLE","Metronidazole","62135083650","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62135-836","62135-836-50","62135-836_128cb585-c2bf-5e15-e063-6394a90a04aa","HUMAN PRESCRIPTION DRUG","Metronidazole","","CAPSULE","ORAL","20040129","","ANDA","ANDA076522","Chartwell RX, LLC","375","mg/1","","N","20251231"
"4401","SULFADIAZINE","sulfADIAZINE","62135084260","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","62135-842","62135-842-60","62135-842_22e33608-9604-ec44-e063-6394a90a3d12","HUMAN PRESCRIPTION DRUG","sulfADIAZINE","","TABLET","ORAL","20240923","","ANDA","ANDA080084","Chartwell RX, LLC","500","mg/1","","N","20251231"
"4402","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","62135087324","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","62135-873","62135-873-24","62135-873_316d17d0-4fb7-a200-e063-6394a90aa5e2","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20070124","","ANDA","ANDA077785","Chartwell RX, LLC","800; 160","mg/20mL; mg/20mL","","N","20261231"
"4403","CLARITHROMYCIN","CLARITHROMYCIN","62135088360","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","62135-883","62135-883-60","62135-883_16781942-3c38-86ce-e063-6394a90a0e61","HUMAN PRESCRIPTION DRUG","CLARITHROMYCIN","","TABLET, FILM COATED, EXTENDED RELEASE","ORAL","20190910","","ANDA","ANDA208987","Chartwell RX, LLC","500","mg/1","","N","20251231"
"4404","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","62135089718","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","62135-897","62135-897-18","62135-897_10445eb8-e525-d945-e063-6294a90ae0f2","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20070125","","ANDA","ANDA078060","Chartwell RX, LLC","400; 80","mg/1; mg/1","","N","20251231"
"4405","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","62135089790","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","62135-897","62135-897-90","62135-897_10445eb8-e525-d945-e063-6294a90ae0f2","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20070125","","ANDA","ANDA078060","Chartwell RX, LLC","400; 80","mg/1; mg/1","","N","20251231"
"4406","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","62135089890","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","62135-898","62135-898-90","62135-898_10445eb8-e525-d945-e063-6294a90ae0f2","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20070125","","ANDA","ANDA078060","Chartwell RX, LLC","800; 160","mg/1; mg/1","","N","20251231"
"4407","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","62135089818","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","62135-898","62135-898-18","62135-898_10445eb8-e525-d945-e063-6294a90ae0f2","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20070125","","ANDA","ANDA078060","Chartwell RX, LLC","800; 160","mg/1; mg/1","","N","20251231"
"4408","MEFLOQUINE HYDROCHLORIDE","Mefloquine Hydrochloride","62135097325","Antimalarial [EPC]","62135-973","62135-973-25","62135-973_2732839a-191a-570f-e063-6294a90a40a4","HUMAN PRESCRIPTION DRUG","Mefloquine Hydrochloride","","TABLET","ORAL","20220220","","ANDA","ANDA076175","Chartwell RX, LLC","250","mg/1","","N","20251231"
"4409","MEFLOQUINE HYDROCHLORIDE","Mefloquine Hydrochloride","62135097311","Antimalarial [EPC]","62135-973","62135-973-11","62135-973_2732839a-191a-570f-e063-6294a90a40a4","HUMAN PRESCRIPTION DRUG","Mefloquine Hydrochloride","","TABLET","ORAL","20220220","","ANDA","ANDA076175","Chartwell RX, LLC","250","mg/1","","N","20251231"
"4410","ADENOSINE TRIPHOSPHATE DISODIUM; ARTEMISIA CINA PRE-FLOWERING TOP; BACOPA MONNIERI WHOLE; DOPAMINE HYDROCHLORIDE; EQUOL, (+/-)-; GAMBOGE; IODINE; LYCOPODIUM CLAVATUM SPORE; OXYTOCIN ACETATE; PANTOTHENIC ACID; PHOSPHORUS; QUININE SULFATE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SEDUM ROSEUM ROOT; SEROTONIN HYDROCHLORIDE; SUS SCROFA ADRENAL CORTEX; SUS SCROFA STOMACH; THYROID","Adenosinum Triphosphoricum Dinatrum, Adrenal Cortex (Suis), Bacopa Speciosa, Equol, Pantothenic Acid, Rhodiola, Stomach (Suis), Chininum Sulphuricum, Iodium, Lycopodium Clavatum, Phosphorus, Dopamine Hydrochloride, Thyroidinum (Suis), Cina, Serotonin (Hydrochloride), Oxytocin, Gambogia, Morgan Gaertner","62185005901","Antimalarial [EPC], Catecholamine [EPC], Catecholamines [CS], Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]","62185-0059","62185-0059-1","62185-0059_e1a19e6c-e10b-492f-8615-24d5012214c8","HUMAN OTC DRUG","Emotional Eating","","LIQUID","ORAL","20201222","20280309","UNAPPROVED HOMEOPATHIC","","Dr. Donna Restivo DC","6; 8; 6; 8; 6; 14; 6; 6; 12; 6; 6; 6; 30; 6; 8; 6; 6; 6","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N",""
"4411","TOBRAMYCIN","Tobramycin","62250011001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","62250-110","62250-110-01","62250-110_f2495e4f-4ffe-4e14-bcb3-f72f1da932a6","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION/ DROPS","OPHTHALMIC","20240401","","ANDA","ANDA212628","Belcher Pharmaceuticals, LLC","3","mg/mL","","N","20261231"
"4412","CEFIXIME","cefixime","62250066326","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62250-663","62250-663-26","62250-663_0d8154f9-78c4-4820-b424-76aac54b512b","HUMAN PRESCRIPTION DRUG","Cefixime","","POWDER, FOR SUSPENSION","ORAL","20170315","","ANDA","ANDA206938","Belcher Pharmaceuticals,LLC","100","mg/5mL","","N","20261231"
"4413","CEFIXIME","cefixime","62250066328","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62250-663","62250-663-28","62250-663_0d8154f9-78c4-4820-b424-76aac54b512b","HUMAN PRESCRIPTION DRUG","Cefixime","","POWDER, FOR SUSPENSION","ORAL","20170315","","ANDA","ANDA206938","Belcher Pharmaceuticals,LLC","100","mg/5mL","","N","20261231"
"4414","CEFIXIME","cefixime","62250066327","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62250-663","62250-663-27","62250-663_0d8154f9-78c4-4820-b424-76aac54b512b","HUMAN PRESCRIPTION DRUG","Cefixime","","POWDER, FOR SUSPENSION","ORAL","20170315","","ANDA","ANDA206938","Belcher Pharmaceuticals,LLC","100","mg/5mL","","N","20261231"
"4415","CEFIXIME","cefixime","62250066426","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62250-664","62250-664-26","62250-664_0d8154f9-78c4-4820-b424-76aac54b512b","HUMAN PRESCRIPTION DRUG","Cefixime","","POWDER, FOR SUSPENSION","ORAL","20170315","","ANDA","ANDA206938","Belcher Pharmaceuticals,LLC","200","mg/5mL","","N","20261231"
"4416","CEFIXIME","cefixime","62250066427","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62250-664","62250-664-27","62250-664_0d8154f9-78c4-4820-b424-76aac54b512b","HUMAN PRESCRIPTION DRUG","Cefixime","","POWDER, FOR SUSPENSION","ORAL","20170315","","ANDA","ANDA206938","Belcher Pharmaceuticals,LLC","200","mg/5mL","","N","20261231"
"4417","CEFIXIME","cefixime","62250066428","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62250-664","62250-664-28","62250-664_0d8154f9-78c4-4820-b424-76aac54b512b","HUMAN PRESCRIPTION DRUG","Cefixime","","POWDER, FOR SUSPENSION","ORAL","20170315","","ANDA","ANDA206938","Belcher Pharmaceuticals,LLC","200","mg/5mL","","N","20261231"
"4418","CEFIXIME","cefixime","62250066825","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62250-668","62250-668-25","62250-668_37181b30-ea2d-47f6-84ea-9ba489d6ad5a","HUMAN PRESCRIPTION DRUG","Cefixime","","POWDER, FOR SUSPENSION","ORAL","20170315","","ANDA","ANDA206939","Belcher Pharmaceuticals,LLC","500","mg/5mL","","N","20261231"
"4419","CEFIXIME","cefixime","62250066824","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62250-668","62250-668-24","62250-668_37181b30-ea2d-47f6-84ea-9ba489d6ad5a","HUMAN PRESCRIPTION DRUG","Cefixime","","POWDER, FOR SUSPENSION","ORAL","20170315","","ANDA","ANDA206939","Belcher Pharmaceuticals,LLC","500","mg/5mL","","N","20261231"
"4420","CEPHALEXIN","Cephalexin","62250080102","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62250-801","62250-801-02","62250-801_ffaaf46e-773a-48e5-9185-69ac07b9482b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20221222","","ANDA","ANDA062713","Belcher Pharmaceuticals, LLC","250","mg/1","","N","20261231"
"4421","CEPHALEXIN","Cephalexin","62250080108","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62250-801","62250-801-08","62250-801_ffaaf46e-773a-48e5-9185-69ac07b9482b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20221222","","ANDA","ANDA062713","Belcher Pharmaceuticals, LLC","250","mg/1","","N","20261231"
"4422","CEPHALEXIN","Cephalexin","62250080202","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62250-802","62250-802-02","62250-802_ffaaf46e-773a-48e5-9185-69ac07b9482b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20221222","","ANDA","ANDA062713","Belcher Pharmaceuticals, LLC","500","mg/1","","N","20261231"
"4423","CEPHALEXIN","Cephalexin","62250080208","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","62250-802","62250-802-08","62250-802_ffaaf46e-773a-48e5-9185-69ac07b9482b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20221222","","ANDA","ANDA062713","Belcher Pharmaceuticals, LLC","500","mg/1","","N","20261231"
"4424","METRONIDAZOLE","Metronidazole","62332001630","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-016","62332-016-30","62332-016_d9dfe831-5b39-4e51-bf18-3846c3469888","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4425","METRONIDAZOLE","Metronidazole","62332001661","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-016","62332-016-61","62332-016_d9dfe831-5b39-4e51-bf18-3846c3469888","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4426","METRONIDAZOLE","Metronidazole","62332001671","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-016","62332-016-71","62332-016_d9dfe831-5b39-4e51-bf18-3846c3469888","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4427","METRONIDAZOLE","Metronidazole","62332001691","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-016","62332-016-91","62332-016_d9dfe831-5b39-4e51-bf18-3846c3469888","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4428","METRONIDAZOLE","Metronidazole","62332001650","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-016","62332-016-50","62332-016_d9dfe831-5b39-4e51-bf18-3846c3469888","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4429","METRONIDAZOLE","Metronidazole","62332001631","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-016","62332-016-31","62332-016_d9dfe831-5b39-4e51-bf18-3846c3469888","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4430","METRONIDAZOLE","Metronidazole","62332001731","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-017","62332-017-31","62332-017_d9dfe831-5b39-4e51-bf18-3846c3469888","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"4431","METRONIDAZOLE","Metronidazole","62332001750","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-017","62332-017-50","62332-017_d9dfe831-5b39-4e51-bf18-3846c3469888","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"4432","METRONIDAZOLE","Metronidazole","62332001771","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-017","62332-017-71","62332-017_d9dfe831-5b39-4e51-bf18-3846c3469888","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"4433","METRONIDAZOLE","Metronidazole","62332001791","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-017","62332-017-91","62332-017_d9dfe831-5b39-4e51-bf18-3846c3469888","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"4434","METRONIDAZOLE","Metronidazole","62332001730","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-017","62332-017-30","62332-017_d9dfe831-5b39-4e51-bf18-3846c3469888","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Alembic Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"4435","METRONIDAZOLE","metronidazole","62332001831","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-018","62332-018-31","62332-018_ace1651e-8d41-43b4-bdd2-611321f2e137","HUMAN PRESCRIPTION DRUG","Metronidazole","","CAPSULE","ORAL","20161209","","ANDA","ANDA079065","Alembic Pharmaceuticals Inc.","375","mg/1","","N","20261231"
"4436","METRONIDAZOLE","metronidazole","62332001850","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-018","62332-018-50","62332-018_ace1651e-8d41-43b4-bdd2-611321f2e137","HUMAN PRESCRIPTION DRUG","Metronidazole","","CAPSULE","ORAL","20161209","","ANDA","ANDA079065","Alembic Pharmaceuticals Inc.","375","mg/1","","N","20261231"
"4437","METRONIDAZOLE","metronidazole","62332001830","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-018","62332-018-30","62332-018_ace1651e-8d41-43b4-bdd2-611321f2e137","HUMAN PRESCRIPTION DRUG","Metronidazole","","CAPSULE","ORAL","20161209","","ANDA","ANDA079065","Alembic Pharmaceuticals Inc.","375","mg/1","","N","20261231"
"4438","METRONIDAZOLE","metronidazole","62332001891","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-018","62332-018-91","62332-018_ace1651e-8d41-43b4-bdd2-611321f2e137","HUMAN PRESCRIPTION DRUG","Metronidazole","","CAPSULE","ORAL","20161209","","ANDA","ANDA079065","Alembic Pharmaceuticals Inc.","375","mg/1","","N","20261231"
"4439","METRONIDAZOLE","metronidazole","62332001871","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-018","62332-018-71","62332-018_ace1651e-8d41-43b4-bdd2-611321f2e137","HUMAN PRESCRIPTION DRUG","Metronidazole","","CAPSULE","ORAL","20161209","","ANDA","ANDA079065","Alembic Pharmaceuticals Inc.","375","mg/1","","N","20261231"
"4440","LINEZOLID","Linezolid","62332018320","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","62332-183","62332-183-20","62332-183_008b01d8-4425-4317-a172-4cc2a9e4e39d","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151222","","ANDA","ANDA205233","Alembic Pharmaceuticals Inc.","600","mg/1","","N","20251231"
"4441","LINEZOLID","Linezolid","62332018391","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","62332-183","62332-183-91","62332-183_008b01d8-4425-4317-a172-4cc2a9e4e39d","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151222","","ANDA","ANDA205233","Alembic Pharmaceuticals Inc.","600","mg/1","","N","20251231"
"4442","LINEZOLID","Linezolid","62332018330","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","62332-183","62332-183-30","62332-183_008b01d8-4425-4317-a172-4cc2a9e4e39d","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151222","","ANDA","ANDA205233","Alembic Pharmaceuticals Inc.","600","mg/1","","N","20251231"
"4443","LINEZOLID","Linezolid","62332018331","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","62332-183","62332-183-31","62332-183_008b01d8-4425-4317-a172-4cc2a9e4e39d","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151222","","ANDA","ANDA205233","Alembic Pharmaceuticals Inc.","600","mg/1","","N","20251231"
"4444","ITRACONAZOLE","itraconazole","62332020404","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","62332-204","62332-204-04","62332-204_585449d8-bba8-44fb-9544-e83636d972e0","HUMAN PRESCRIPTION DRUG","ITRACONAZOLE","","CAPSULE","ORAL","20161216","","ANDA","ANDA206741","Alembic Pharmaceuticals Inc.","100","mg/1","","N","20261231"
"4445","ITRACONAZOLE","itraconazole","62332020410","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","62332-204","62332-204-10","62332-204_585449d8-bba8-44fb-9544-e83636d972e0","HUMAN PRESCRIPTION DRUG","ITRACONAZOLE","","CAPSULE","ORAL","20161216","","ANDA","ANDA206741","Alembic Pharmaceuticals Inc.","100","mg/1","","N","20261231"
"4446","ITRACONAZOLE","itraconazole","62332020471","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","62332-204","62332-204-71","62332-204_585449d8-bba8-44fb-9544-e83636d972e0","HUMAN PRESCRIPTION DRUG","ITRACONAZOLE","","CAPSULE","ORAL","20161216","","ANDA","ANDA206741","Alembic Pharmaceuticals Inc.","100","mg/1","","N","20261231"
"4447","ITRACONAZOLE","itraconazole","62332020490","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","62332-204","62332-204-90","62332-204_585449d8-bba8-44fb-9544-e83636d972e0","HUMAN PRESCRIPTION DRUG","ITRACONAZOLE","","CAPSULE","ORAL","20161216","","ANDA","ANDA206741","Alembic Pharmaceuticals Inc.","100","mg/1","","N","20261231"
"4448","ITRACONAZOLE","itraconazole","62332020430","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","62332-204","62332-204-30","62332-204_585449d8-bba8-44fb-9544-e83636d972e0","HUMAN PRESCRIPTION DRUG","ITRACONAZOLE","","CAPSULE","ORAL","20161216","","ANDA","ANDA206741","Alembic Pharmaceuticals Inc.","100","mg/1","","N","20261231"
"4449","AZITHROMYCIN DIHYDRATE","Azithromycin","62332025106","Macrolide Antimicrobial [EPC], Macrolides [CS]","62332-251","62332-251-06","62332-251_2c5eb246-11d9-4f22-9c07-b6fd80ae65bf","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20200129","","ANDA","ANDA211791","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4450","AZITHROMYCIN DIHYDRATE","Azithromycin","62332025171","Macrolide Antimicrobial [EPC], Macrolides [CS]","62332-251","62332-251-71","62332-251_2c5eb246-11d9-4f22-9c07-b6fd80ae65bf","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20200129","","ANDA","ANDA211791","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4451","AZITHROMYCIN DIHYDRATE","Azithromycin","62332025191","Macrolide Antimicrobial [EPC], Macrolides [CS]","62332-251","62332-251-91","62332-251_2c5eb246-11d9-4f22-9c07-b6fd80ae65bf","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20200129","","ANDA","ANDA211791","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4452","AZITHROMYCIN DIHYDRATE","Azithromycin","62332025118","Macrolide Antimicrobial [EPC], Macrolides [CS]","62332-251","62332-251-18","62332-251_2c5eb246-11d9-4f22-9c07-b6fd80ae65bf","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20200129","","ANDA","ANDA211791","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4453","AZITHROMYCIN DIHYDRATE","Azithromycin","62332025130","Macrolide Antimicrobial [EPC], Macrolides [CS]","62332-251","62332-251-30","62332-251_2c5eb246-11d9-4f22-9c07-b6fd80ae65bf","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20200129","","ANDA","ANDA211791","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4454","AZITHROMYCIN DIHYDRATE","Azithromycin","62332025209","Macrolide Antimicrobial [EPC], Macrolides [CS]","62332-252","62332-252-09","62332-252_a6585638-3730-443c-895f-b54980943d21","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20200129","","ANDA","ANDA211792","Alembic Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"4455","AZITHROMYCIN DIHYDRATE","Azithromycin","62332025203","Macrolide Antimicrobial [EPC], Macrolides [CS]","62332-252","62332-252-03","62332-252_a6585638-3730-443c-895f-b54980943d21","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20200129","","ANDA","ANDA211792","Alembic Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"4456","AZITHROMYCIN DIHYDRATE","Azithromycin","62332025230","Macrolide Antimicrobial [EPC], Macrolides [CS]","62332-252","62332-252-30","62332-252_a6585638-3730-443c-895f-b54980943d21","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20200129","","ANDA","ANDA211792","Alembic Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"4457","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","62332025310","Macrolide Antimicrobial [EPC], Macrolides [CS]","62332-253","62332-253-10","62332-253_c043ed24-ba88-4465-a0bd-da8531778957","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","TABLET, FILM COATED","ORAL","20200128","","ANDA","ANDA211793","Alembic Pharmaceuticals Inc.","600","mg/1","","N","20251231"
"4458","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","62332025330","Macrolide Antimicrobial [EPC], Macrolides [CS]","62332-253","62332-253-30","62332-253_c043ed24-ba88-4465-a0bd-da8531778957","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","TABLET, FILM COATED","ORAL","20200128","","ANDA","ANDA211793","Alembic Pharmaceuticals Inc.","600","mg/1","","N","20251231"
"4459","CLARITHROMYCIN","Clarithromycin","62332034460","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","62332-344","62332-344-60","62332-344_ea098e34-02fb-4604-9b93-f8543b8fef4b","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20220201","","ANDA","ANDA210459","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4460","CLARITHROMYCIN","Clarithromycin","62332034430","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","62332-344","62332-344-30","62332-344_ea098e34-02fb-4604-9b93-f8543b8fef4b","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20220201","","ANDA","ANDA210459","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4461","CLARITHROMYCIN","Clarithromycin","62332034491","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","62332-344","62332-344-91","62332-344_ea098e34-02fb-4604-9b93-f8543b8fef4b","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20220201","","ANDA","ANDA210459","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4462","CLARITHROMYCIN","Clarithromycin","62332034530","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","62332-345","62332-345-30","62332-345_ea098e34-02fb-4604-9b93-f8543b8fef4b","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20220201","","ANDA","ANDA210459","Alembic Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"4463","CLARITHROMYCIN","Clarithromycin","62332034591","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","62332-345","62332-345-91","62332-345_ea098e34-02fb-4604-9b93-f8543b8fef4b","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20220201","","ANDA","ANDA210459","Alembic Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"4464","CLARITHROMYCIN","Clarithromycin","62332034560","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","62332-345","62332-345-60","62332-345_ea098e34-02fb-4604-9b93-f8543b8fef4b","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20220201","","ANDA","ANDA210459","Alembic Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"4465","NITROFURANTOIN","NITROFURANTOIN","62332038931","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","62332-389","62332-389-31","62332-389_4b5516b0-5fe8-45f0-a7f9-3bf05081e74f","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20210701","","ANDA","ANDA211935","Alembic Pharmaceuticals Inc.","25","mg/1","","N","20251231"
"4466","NITROFURANTOIN","NITROFURANTOIN","62332038991","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","62332-389","62332-389-91","62332-389_4b5516b0-5fe8-45f0-a7f9-3bf05081e74f","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20210701","","ANDA","ANDA211935","Alembic Pharmaceuticals Inc.","25","mg/1","","N","20251231"
"4467","NITROFURANTOIN","NITROFURANTOIN","62332039091","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","62332-390","62332-390-91","62332-390_4b5516b0-5fe8-45f0-a7f9-3bf05081e74f","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20210701","","ANDA","ANDA211935","Alembic Pharmaceuticals Inc.","50","mg/1","","N","20251231"
"4468","NITROFURANTOIN","NITROFURANTOIN","62332039031","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","62332-390","62332-390-31","62332-390_4b5516b0-5fe8-45f0-a7f9-3bf05081e74f","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20210701","","ANDA","ANDA211935","Alembic Pharmaceuticals Inc.","50","mg/1","","N","20251231"
"4469","NITROFURANTOIN","NITROFURANTOIN","62332039131","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","62332-391","62332-391-31","62332-391_4b5516b0-5fe8-45f0-a7f9-3bf05081e74f","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20210701","","ANDA","ANDA211935","Alembic Pharmaceuticals Inc.","100","mg/1","","N","20251231"
"4470","NITROFURANTOIN","NITROFURANTOIN","62332039191","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","62332-391","62332-391-91","62332-391_4b5516b0-5fe8-45f0-a7f9-3bf05081e74f","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20210701","","ANDA","ANDA211935","Alembic Pharmaceuticals Inc.","100","mg/1","","N","20251231"
"4471","ERYTHROMYCIN","Erythromycin","62332039731","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","62332-397","62332-397-31","62332-397_b4e8041f-a6b6-4f91-afad-74183c368d3c","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230828","","ANDA","ANDA215661","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4472","ERYTHROMYCIN","Erythromycin","62332039791","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","62332-397","62332-397-91","62332-397_b4e8041f-a6b6-4f91-afad-74183c368d3c","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230828","","ANDA","ANDA215661","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4473","ERYTHROMYCIN","Erythromycin","62332039730","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","62332-397","62332-397-30","62332-397_b4e8041f-a6b6-4f91-afad-74183c368d3c","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230828","","ANDA","ANDA215661","Alembic Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"4474","ERYTHROMYCIN","Erythromycin","62332039831","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","62332-398","62332-398-31","62332-398_b4e8041f-a6b6-4f91-afad-74183c368d3c","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230828","","ANDA","ANDA215661","Alembic Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"4475","ERYTHROMYCIN","Erythromycin","62332039830","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","62332-398","62332-398-30","62332-398_b4e8041f-a6b6-4f91-afad-74183c368d3c","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230828","","ANDA","ANDA215661","Alembic Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"4476","ERYTHROMYCIN","Erythromycin","62332039891","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","62332-398","62332-398-91","62332-398_b4e8041f-a6b6-4f91-afad-74183c368d3c","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230828","","ANDA","ANDA215661","Alembic Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"4477","TAVABOROLE","Tavaborole","62332046704","Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]","62332-467","62332-467-04","62332-467_d35e58d2-869d-40bf-a00e-296a9d3bb659","HUMAN PRESCRIPTION DRUG","Tavaborole","","SOLUTION","TOPICAL","20201023","","ANDA","ANDA212188","Alembic Pharmaceuticals Inc.","43.5","mg/mL","","N","20251231"
"4478","TAVABOROLE","Tavaborole","62332046710","Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]","62332-467","62332-467-10","62332-467_d35e58d2-869d-40bf-a00e-296a9d3bb659","HUMAN PRESCRIPTION DRUG","Tavaborole","","SOLUTION","TOPICAL","20201023","","ANDA","ANDA212188","Alembic Pharmaceuticals Inc.","43.5","mg/mL","","N","20251231"
"4479","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin ophthalmic solution","62332050503","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","62332-505","62332-505-03","62332-505_57885d05-de45-4be8-b01d-d3596fb8a96d","HUMAN PRESCRIPTION DRUG","Moxifloxacin ophthalmic solution","","SOLUTION/ DROPS","OPHTHALMIC","20190213","","ANDA","ANDA209469","Alembic Pharmaceuticals Inc.","5","mg/mL","","N","20251231"
"4480","TOBRAMYCIN","Tobramycin Ophthalmic Solution","62332051805","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","62332-518","62332-518-05","62332-518_5d11cea7-cb06-4ab9-930d-190549b2f4ca","HUMAN PRESCRIPTION DRUG","Tobramycin Ophthalmic Solution","","SOLUTION/ DROPS","OPHTHALMIC","20190419","","ANDA","ANDA211847","Alembic Pharmaceuticals Inc.","3","mg/mL","","N","20251231"
"4481","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","62332058515","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","62332-585","62332-585-15","62332-585_c98a4886-c5f9-425b-8770-7a753ba25fa8","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20220315","","ANDA","ANDA214186","Alembic Pharmaceuticals Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"4482","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","62332058530","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","62332-585","62332-585-30","62332-585_c98a4886-c5f9-425b-8770-7a753ba25fa8","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20220315","","ANDA","ANDA214186","Alembic Pharmaceuticals Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"4483","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","62332058560","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","62332-585","62332-585-60","62332-585_c98a4886-c5f9-425b-8770-7a753ba25fa8","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20220315","","ANDA","ANDA214186","Alembic Pharmaceuticals Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"4484","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","62332060615","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","62332-606","62332-606-15","62332-606_94f72537-2162-4b52-b96d-7d07b0f2b888","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20210402","","ANDA","ANDA214090","Alembic Pharmaceuticals Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"4485","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","62332060630","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","62332-606","62332-606-30","62332-606_94f72537-2162-4b52-b96d-7d07b0f2b888","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20210402","","ANDA","ANDA214090","Alembic Pharmaceuticals Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"4486","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","62332060660","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","62332-606","62332-606-60","62332-606_94f72537-2162-4b52-b96d-7d07b0f2b888","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20210402","","ANDA","ANDA214090","Alembic Pharmaceuticals Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"4487","CLINDAMYCIN PHOSPHATE","CLINDAMYCIN PHOSPHATE","62332062360","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","62332-623","62332-623-60","62332-623_01033126-ec9f-4e01-ad1f-ff10f1928db4","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PHOSPHATE","","GEL","TOPICAL","20240404","","ANDA","ANDA212466","Alembic Pharmaceuticals Inc.","10","mg/g","","N","20251231"
"4488","CLINDAMYCIN PHOSPHATE","CLINDAMYCIN PHOSPHATE","62332062330","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","62332-623","62332-623-30","62332-623_01033126-ec9f-4e01-ad1f-ff10f1928db4","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PHOSPHATE","","GEL","TOPICAL","20240404","","ANDA","ANDA212466","Alembic Pharmaceuticals Inc.","10","mg/g","","N","20251231"
"4489","MUPIROCIN CALCIUM","MUPIROCIN","62332062415","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","62332-624","62332-624-15","62332-624_e03b4a3e-9ee3-4573-b5b1-f30494eab016","HUMAN PRESCRIPTION DRUG","MUPIROCIN","","CREAM","TOPICAL","20211201","","ANDA","ANDA213053","Alembic Pharmaceuticals Inc.","20","mg/g","","N","20251231"
"4490","MUPIROCIN CALCIUM","MUPIROCIN","62332062430","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","62332-624","62332-624-30","62332-624_e03b4a3e-9ee3-4573-b5b1-f30494eab016","HUMAN PRESCRIPTION DRUG","MUPIROCIN","","CREAM","TOPICAL","20211201","","ANDA","ANDA213053","Alembic Pharmaceuticals Inc.","20","mg/g","","N","20251231"
"4491","METRONIDAZOLE","Metronidazole","62332063060","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-630","62332-630-60","62332-630_c833efe6-b764-45f1-b1e9-5a250bce29c3","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20210906","","ANDA","ANDA212646","Alembic Pharmaceuticals Inc.","10","mg/g","","N","20251231"
"4492","METRONIDAZOLE","Metronidazole","62332063055","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-630","62332-630-55","62332-630_c833efe6-b764-45f1-b1e9-5a250bce29c3","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20210906","","ANDA","ANDA212646","Alembic Pharmaceuticals Inc.","10","mg/g","","N","20251231"
"4493","METRONIDAZOLE","Metronidazole","62332063045","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","62332-630","62332-630-45","62332-630_c833efe6-b764-45f1-b1e9-5a250bce29c3","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20210906","","ANDA","ANDA212646","Alembic Pharmaceuticals Inc.","10","mg/g","","N","20251231"
"4494","OXICONAZOLE NITRATE","oxiconazole nitrate","62559028506","Azole Antifungal [EPC], Azoles [CS]","62559-285","62559-285-06","62559-285_df66f7c6-20f6-436e-a5d5-784c3291388b","HUMAN PRESCRIPTION DRUG","Oxistat","","LOTION","TOPICAL","20220912","","NDA","NDA020209","ANI Pharmaceuticals, Inc.","10","mg/mL","","N","20251231"
"4495","OXICONAZOLE NITRATE","oxiconazole nitrate","62559028560","Azole Antifungal [EPC], Azoles [CS]","62559-285","62559-285-60","62559-285_df66f7c6-20f6-436e-a5d5-784c3291388b","HUMAN PRESCRIPTION DRUG","Oxistat","","LOTION","TOPICAL","20220912","","NDA","NDA020209","ANI Pharmaceuticals, Inc.","10","mg/mL","","N","20251231"
"4496","OXICONAZOLE NITRATE","oxiconazole nitrate","62559028530","Azole Antifungal [EPC], Azoles [CS]","62559-285","62559-285-30","62559-285_df66f7c6-20f6-436e-a5d5-784c3291388b","HUMAN PRESCRIPTION DRUG","Oxistat","","LOTION","TOPICAL","20220912","","NDA","NDA020209","ANI Pharmaceuticals, Inc.","10","mg/mL","","N","20251231"
"4497","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","62559031020","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","62559-310","62559-310-20","62559-310_d49b67a4-a629-448a-b704-7e5cf147201c","HUMAN PRESCRIPTION DRUG","Vancocin","","CAPSULE","ORAL","20141117","","NDA","NDA050606","ANI Pharmaceuticals, Inc.","125","mg/1","","N","20251231"
"4498","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","62559031120","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","62559-311","62559-311-20","62559-311_d49b67a4-a629-448a-b704-7e5cf147201c","HUMAN PRESCRIPTION DRUG","Vancocin","","CAPSULE","ORAL","20141117","","NDA","NDA050606","ANI Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"4499","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","62559039020","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","62559-390","62559-390-20","62559-390_649f6d29-4539-4293-9496-e682ea820193","HUMAN PRESCRIPTION DRUG","vancomycin hydrochloride","","CAPSULE","ORAL","20151026","","NDA AUTHORIZED GENERIC","NDA050606","ANI Pharmaceuticals, Inc.","125","mg/1","","N","20251231"
"4500","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","62559039050","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","62559-390","62559-390-50","62559-390_649f6d29-4539-4293-9496-e682ea820193","HUMAN PRESCRIPTION DRUG","vancomycin hydrochloride","","CAPSULE","ORAL","20151026","","NDA AUTHORIZED GENERIC","NDA050606","ANI Pharmaceuticals, Inc.","125","mg/1","","N","20251231"
"4501","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","62559039120","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","62559-391","62559-391-20","62559-391_649f6d29-4539-4293-9496-e682ea820193","HUMAN PRESCRIPTION DRUG","vancomycin hydrochloride","","CAPSULE","ORAL","20151026","","NDA AUTHORIZED GENERIC","NDA050606","ANI Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"4502","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","62559039150","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","62559-391","62559-391-50","62559-391_649f6d29-4539-4293-9496-e682ea820193","HUMAN PRESCRIPTION DRUG","vancomycin hydrochloride","","CAPSULE","ORAL","20151026","","NDA AUTHORIZED GENERIC","NDA050606","ANI Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"4503","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","62559044002","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","62559-440","62559-440-02","62559-440_11761c65-093e-46b9-964f-2565fa92444d","HUMAN PRESCRIPTION DRUG","Erythromycin Ethylsuccinate","","GRANULE, FOR SUSPENSION","ORAL","20160927","","ANDA","ANDA062055","ANI Pharmaceuticals, Inc.","200","mg/5mL","","N","20251231"
"4504","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","62559063001","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","62559-630","62559-630-01","62559-630_25635db5-a227-445d-850a-a98c5f4772ff","HUMAN PRESCRIPTION DRUG","Erythromycin Ethylsuccinate","","GRANULE, FOR SUSPENSION","ORAL","20190325","","ANDA","ANDA062055","ANI Pharmaceuticals, Inc.","200","mg/5mL","","N","20251231"
"4505","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","62559063101","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","62559-631","62559-631-01","62559-631_25635db5-a227-445d-850a-a98c5f4772ff","HUMAN PRESCRIPTION DRUG","Erythromycin Ethylsuccinate","","GRANULE, FOR SUSPENSION","ORAL","20190325","","ANDA","ANDA062055","ANI Pharmaceuticals, Inc.","400","mg/5mL","","N","20251231"
"4506","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","62559083080","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","62559-830","62559-830-80","62559-830_dfd7551d-fc60-4b61-9b84-b26581b47ee9","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","POWDER, FOR SOLUTION","ORAL","20190909","","ANDA","ANDA061667","ANI Pharmaceuticals, Inc.","250","mg/5mL","","N","20251231"
"4507","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","62559083003","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","62559-830","62559-830-03","62559-830_dfd7551d-fc60-4b61-9b84-b26581b47ee9","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","POWDER, FOR SOLUTION","ORAL","20190909","","ANDA","ANDA061667","ANI Pharmaceuticals, Inc.","250","mg/5mL","","N","20251231"
"4508","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","62559083055","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","62559-830","62559-830-55","62559-830_dfd7551d-fc60-4b61-9b84-b26581b47ee9","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","POWDER, FOR SOLUTION","ORAL","20190909","","ANDA","ANDA061667","ANI Pharmaceuticals, Inc.","250","mg/5mL","","N","20251231"
"4509","FLUCONAZOLE","Fluconazole","62559099030","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","62559-990","62559-990-30","62559-990_7071f3cc-13cd-41d6-b9de-7242e28bf691","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","ANI Pharmaceuticals, Inc.","50","mg/1","","N","20251231"
"4510","FLUCONAZOLE","Fluconazole","62559099130","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","62559-991","62559-991-30","62559-991_7071f3cc-13cd-41d6-b9de-7242e28bf691","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","ANI Pharmaceuticals, Inc.","100","mg/1","","N","20251231"
"4511","FLUCONAZOLE","Fluconazole","62559099212","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","62559-992","62559-992-12","62559-992_7071f3cc-13cd-41d6-b9de-7242e28bf691","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","ANI Pharmaceuticals, Inc.","150","mg/1","","N","20251231"
"4512","FLUCONAZOLE","Fluconazole","62559099330","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","62559-993","62559-993-30","62559-993_7071f3cc-13cd-41d6-b9de-7242e28bf691","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","ANI Pharmaceuticals, Inc.","200","mg/1","","N","20251231"
"4513","MICONAZOLE NITRATE","MICONAZOLE NITRATE","62654014701","Azole Antifungal [EPC], Azoles [CS]","62654-147","62654-147-01","62654-147_28d9ee71-5798-8236-e063-6294a90adbd4","HUMAN OTC DRUG","BOA VIDA Antifungal","","CREAM","TOPICAL","20180910","","OTC MONOGRAPH DRUG","M005","Central Solutions Inc","2","g/100g","","N","20251231"
"4514","AMPHOTERICIN B","Amphotericin B","62756023301","Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]","62756-233","62756-233-01","62756-233_59a4c568-88ae-41be-80bf-0c8c6805f9b8","HUMAN PRESCRIPTION DRUG","Amphotericin B","","INJECTABLE, LIPOSOMAL","INTRAVENOUS","20220209","","ANDA","ANDA212514","Sun Pharmaceutical Industries, Inc.","50","mg/1","","N","20251231"
"4515","AMPHOTERICIN B","Amphotericin B","62756023302","Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]","62756-233","62756-233-02","62756-233_59a4c568-88ae-41be-80bf-0c8c6805f9b8","HUMAN PRESCRIPTION DRUG","Amphotericin B","","INJECTABLE, LIPOSOMAL","INTRAVENOUS","20220209","","ANDA","ANDA212514","Sun Pharmaceutical Industries, Inc.","50","mg/1","","N","20251231"
"4516","CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE","Ciprofloxacin and dexamethasone","62756042790","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","62756-427","62756-427-90","62756-427_0ef8a636-e2f1-44b7-9a8e-f2da62fbd084","HUMAN PRESCRIPTION DRUG","Ciprofloxacin and dexamethasone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","20220901","","ANDA","ANDA210470","Sun Pharmaceutical Industries, Inc.","3; 1","mg/mL; mg/mL","","N","20261231"
"4517","AZITHROMYCIN MONOHYDRATE","Azithromycin","62756051244","Macrolide Antimicrobial [EPC], Macrolides [CS]","62756-512","62756-512-44","62756-512_822e078d-ea93-4a4b-b640-2cc7174f5b52","HUMAN PRESCRIPTION DRUG","Azithromycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200715","","ANDA","ANDA090923","Sun Pharmaceutical Industries, Inc.","500","mg/5mL","","N","20251231"
"4518","AMPHOTERICIN B","Amphotericin B","62756095401","Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]","62756-954","62756-954-01","62756-954_e58470e3-e0fe-4bf4-84d3-dfb8620f1ac0","HUMAN PRESCRIPTION DRUG","Amphotericin B","","INJECTABLE, LIPOSOMAL","INTRAVENOUS","20241201","","ANDA","ANDA212514","Sun Pharmaceutical Industries, Inc.","50","mg/1","","N","20261231"
"4519","AMPHOTERICIN B","Amphotericin B","62756095402","Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]","62756-954","62756-954-02","62756-954_e58470e3-e0fe-4bf4-84d3-dfb8620f1ac0","HUMAN PRESCRIPTION DRUG","Amphotericin B","","INJECTABLE, LIPOSOMAL","INTRAVENOUS","20241201","","ANDA","ANDA212514","Sun Pharmaceutical Industries, Inc.","50","mg/1","","N","20261231"
"4520","AZITHROMYCIN MONOHYDRATE","Azithromycin","63187000706","Macrolide Antimicrobial [EPC], Macrolides [CS]","63187-007","63187-007-06","63187-007_d6250595-3500-4c6f-8175-25a8a92e2d5e","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065225","Proficient Rx LP","250","mg/1","","N","20251231"
"4521","AZITHROMYCIN MONOHYDRATE","Azithromycin","63187000704","Macrolide Antimicrobial [EPC], Macrolides [CS]","63187-007","63187-007-04","63187-007_d6250595-3500-4c6f-8175-25a8a92e2d5e","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065225","Proficient Rx LP","250","mg/1","","N","20251231"
"4522","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187000810","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-008","63187-008-10","63187-008_2dd0e8d4-6ac3-433f-a41f-1e55d2b3f5ca","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20060822","","ANDA","ANDA076817","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4523","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187000820","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-008","63187-008-20","63187-008_2dd0e8d4-6ac3-433f-a41f-1e55d2b3f5ca","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20060822","","ANDA","ANDA076817","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4524","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187000806","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-008","63187-008-06","63187-008_2dd0e8d4-6ac3-433f-a41f-1e55d2b3f5ca","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20060822","","ANDA","ANDA076817","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4525","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187000840","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-008","63187-008-40","63187-008_2dd0e8d4-6ac3-433f-a41f-1e55d2b3f5ca","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20060822","","ANDA","ANDA076817","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4526","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187000814","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-008","63187-008-14","63187-008_2dd0e8d4-6ac3-433f-a41f-1e55d2b3f5ca","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20060822","","ANDA","ANDA076817","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4527","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187000828","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-008","63187-008-28","63187-008_2dd0e8d4-6ac3-433f-a41f-1e55d2b3f5ca","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20060822","","ANDA","ANDA076817","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4528","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63187001420","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-014","63187-014-20","63187-014_49e8b27c-0f31-4bba-adce-5c5cb9478494","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"4529","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63187001414","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-014","63187-014-14","63187-014_49e8b27c-0f31-4bba-adce-5c5cb9478494","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"4530","MUPIROCIN","Mupirocin","63187001522","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","63187-015","63187-015-22","63187-015_141d8892-7f38-43d4-8bc4-5a0bf6198717","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20110608","","ANDA","ANDA090480","Proficient Rx LP","20","mg/g","","N","20251231"
"4531","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187001706","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-017","63187-017-06","63187-017_91f426fc-3fc4-4c2f-a56d-10862e54d745","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","500","mg/1","","N","20251231"
"4532","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187001714","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-017","63187-017-14","63187-017_91f426fc-3fc4-4c2f-a56d-10862e54d745","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","500","mg/1","","N","20251231"
"4533","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187001728","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-017","63187-017-28","63187-017_91f426fc-3fc4-4c2f-a56d-10862e54d745","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","500","mg/1","","N","20251231"
"4534","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187001710","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-017","63187-017-10","63187-017_91f426fc-3fc4-4c2f-a56d-10862e54d745","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","500","mg/1","","N","20251231"
"4535","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187001760","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-017","63187-017-60","63187-017_91f426fc-3fc4-4c2f-a56d-10862e54d745","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","500","mg/1","","N","20251231"
"4536","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187001720","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-017","63187-017-20","63187-017_91f426fc-3fc4-4c2f-a56d-10862e54d745","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","500","mg/1","","N","20251231"
"4537","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187001730","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-017","63187-017-30","63187-017_91f426fc-3fc4-4c2f-a56d-10862e54d745","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","500","mg/1","","N","20251231"
"4538","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187001790","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-017","63187-017-90","63187-017_91f426fc-3fc4-4c2f-a56d-10862e54d745","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","500","mg/1","","N","20251231"
"4539","SILVER SULFADIAZINE","Silver Sulfadiazine","63187002325","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","63187-023","63187-023-25","63187-023_cd81836d-38df-44dc-80a1-fb7ec7ba83e1","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","Proficient Rx LP","10","mg/g","","N","20251231"
"4540","SILVER SULFADIAZINE","Silver Sulfadiazine","63187002351","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","63187-023","63187-023-51","63187-023_cd81836d-38df-44dc-80a1-fb7ec7ba83e1","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","Proficient Rx LP","10","mg/g","","N","20251231"
"4541","TOBRAMYCIN","Tobramycin","63187002405","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63187-024","63187-024-05","63187-024_6458f461-e408-4dcc-b7c3-f8fb9fbcb31d","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","OPHTHALMIC","19931129","","ANDA","ANDA064052","Proficient Rx LP","3","mg/mL","","N","20251231"
"4542","AMOXICILLIN","Amoxicillin","63187002915","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-029","63187-029-15","63187-029_e61645ee-b492-46b5-bb37-8df0e39e20d8","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","Proficient Rx LP","250","mg/5mL","","N","20251231"
"4543","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63187003220","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-032","63187-032-20","63187-032_83901ad8-02a3-41a4-8c1d-cda4378c3b15","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065101","Proficient Rx LP","500; 125","mg/1; mg/1","","N","20251231"
"4544","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63187003221","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-032","63187-032-21","63187-032_83901ad8-02a3-41a4-8c1d-cda4378c3b15","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065101","Proficient Rx LP","500; 125","mg/1; mg/1","","N","20251231"
"4545","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63187003206","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-032","63187-032-06","63187-032_83901ad8-02a3-41a4-8c1d-cda4378c3b15","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065101","Proficient Rx LP","500; 125","mg/1; mg/1","","N","20251231"
"4546","METRONIDAZOLE","Metronidazole","63187003514","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63187-035","63187-035-14","63187-035_b8ba0cbc-99a5-485f-ae3f-85a2b342c252","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Proficient Rx LP","500","mg/1","","N","20251231"
"4547","METRONIDAZOLE","Metronidazole","63187003521","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63187-035","63187-035-21","63187-035_b8ba0cbc-99a5-485f-ae3f-85a2b342c252","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Proficient Rx LP","500","mg/1","","N","20251231"
"4548","METRONIDAZOLE","Metronidazole","63187003528","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63187-035","63187-035-28","63187-035_b8ba0cbc-99a5-485f-ae3f-85a2b342c252","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Proficient Rx LP","500","mg/1","","N","20251231"
"4549","METRONIDAZOLE","Metronidazole","63187003530","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63187-035","63187-035-30","63187-035_b8ba0cbc-99a5-485f-ae3f-85a2b342c252","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Proficient Rx LP","500","mg/1","","N","20251231"
"4550","METRONIDAZOLE","Metronidazole","63187003504","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63187-035","63187-035-04","63187-035_b8ba0cbc-99a5-485f-ae3f-85a2b342c252","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Proficient Rx LP","500","mg/1","","N","20251231"
"4551","CEPHALEXIN","Cephalexin","63187004614","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-046","63187-046-14","63187-046_8202b9f1-6f03-4f64-a300-062d1679d0e8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","Proficient Rx LP","500","mg/1","","N","20251231"
"4552","CEPHALEXIN","Cephalexin","63187004615","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-046","63187-046-15","63187-046_8202b9f1-6f03-4f64-a300-062d1679d0e8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","Proficient Rx LP","500","mg/1","","N","20251231"
"4553","CEPHALEXIN","Cephalexin","63187004606","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-046","63187-046-06","63187-046_8202b9f1-6f03-4f64-a300-062d1679d0e8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","Proficient Rx LP","500","mg/1","","N","20251231"
"4554","CEPHALEXIN","Cephalexin","63187004628","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-046","63187-046-28","63187-046_8202b9f1-6f03-4f64-a300-062d1679d0e8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","Proficient Rx LP","500","mg/1","","N","20251231"
"4555","CEPHALEXIN","Cephalexin","63187004630","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-046","63187-046-30","63187-046_8202b9f1-6f03-4f64-a300-062d1679d0e8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","Proficient Rx LP","500","mg/1","","N","20251231"
"4556","CEPHALEXIN","Cephalexin","63187004640","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-046","63187-046-40","63187-046_8202b9f1-6f03-4f64-a300-062d1679d0e8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","Proficient Rx LP","500","mg/1","","N","20251231"
"4557","CEPHALEXIN","Cephalexin","63187004621","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-046","63187-046-21","63187-046_8202b9f1-6f03-4f64-a300-062d1679d0e8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","Proficient Rx LP","500","mg/1","","N","20251231"
"4558","CEPHALEXIN","Cephalexin","63187004620","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-046","63187-046-20","63187-046_8202b9f1-6f03-4f64-a300-062d1679d0e8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","Proficient Rx LP","500","mg/1","","N","20251231"
"4559","AZITHROMYCIN MONOHYDRATE","Azithromycin","63187009322","Macrolide Antimicrobial [EPC], Macrolides [CS]","63187-093","63187-093-22","63187-093_9d10dacc-ad17-48ec-b037-94987b2c40bc","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20101217","","ANDA","ANDA065246","Proficient Rx LP","200","mg/5mL","","N","20251231"
"4560","AZITHROMYCIN MONOHYDRATE","Azithromycin","63187009330","Macrolide Antimicrobial [EPC], Macrolides [CS]","63187-093","63187-093-30","63187-093_9d10dacc-ad17-48ec-b037-94987b2c40bc","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20101217","","ANDA","ANDA065246","Proficient Rx LP","200","mg/5mL","","N","20251231"
"4561","AZITHROMYCIN MONOHYDRATE","Azithromycin","63187009315","Macrolide Antimicrobial [EPC], Macrolides [CS]","63187-093","63187-093-15","63187-093_9d10dacc-ad17-48ec-b037-94987b2c40bc","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20101217","","ANDA","ANDA065246","Proficient Rx LP","200","mg/5mL","","N","20251231"
"4562","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","63187009515","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","63187-095","63187-095-15","63187-095_de8b4d67-65d0-4290-b680-b9b1373033c6","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20070103","","ANDA","ANDA076002","Proficient Rx LP",".5; 10","mg/g; mg/g","","N","20251231"
"4563","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","63187009545","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","63187-095","63187-095-45","63187-095_de8b4d67-65d0-4290-b680-b9b1373033c6","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20070103","","ANDA","ANDA076002","Proficient Rx LP",".5; 10","mg/g; mg/g","","N","20251231"
"4564","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","63187011115","Allylamine Antifungal [EPC], Allylamine [CS]","63187-111","63187-111-15","63187-111_96ea8a54-d84e-4ac6-9ce1-2624f20a4992","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Proficient Rx LP","1","g/100g","","N","20251231"
"4565","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","63187011130","Allylamine Antifungal [EPC], Allylamine [CS]","63187-111","63187-111-30","63187-111_96ea8a54-d84e-4ac6-9ce1-2624f20a4992","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Proficient Rx LP","1","g/100g","","N","20251231"
"4566","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","63187012721","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-127","63187-127-21","63187-127_146abd0d-3e2b-480f-a2f0-925e9c36cec4","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Proficient Rx LP","300","mg/1","","N","20251231"
"4567","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","63187012728","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-127","63187-127-28","63187-127_146abd0d-3e2b-480f-a2f0-925e9c36cec4","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Proficient Rx LP","300","mg/1","","N","20251231"
"4568","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","63187012730","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-127","63187-127-30","63187-127_146abd0d-3e2b-480f-a2f0-925e9c36cec4","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Proficient Rx LP","300","mg/1","","N","20251231"
"4569","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","63187012760","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-127","63187-127-60","63187-127_146abd0d-3e2b-480f-a2f0-925e9c36cec4","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Proficient Rx LP","300","mg/1","","N","20251231"
"4570","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","63187012790","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-127","63187-127-90","63187-127_146abd0d-3e2b-480f-a2f0-925e9c36cec4","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Proficient Rx LP","300","mg/1","","N","20251231"
"4571","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","63187012740","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-127","63187-127-40","63187-127_146abd0d-3e2b-480f-a2f0-925e9c36cec4","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Proficient Rx LP","300","mg/1","","N","20251231"
"4572","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","63187012720","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-127","63187-127-20","63187-127_146abd0d-3e2b-480f-a2f0-925e9c36cec4","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Proficient Rx LP","300","mg/1","","N","20251231"
"4573","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63187014121","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-141","63187-141-21","63187-141_2dfd4382-3405-48c3-b7e1-7c19d82901d8","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Proficient Rx LP","300","mg/1","","N","20251231"
"4574","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63187014128","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-141","63187-141-28","63187-141_2dfd4382-3405-48c3-b7e1-7c19d82901d8","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Proficient Rx LP","300","mg/1","","N","20251231"
"4575","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63187014120","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-141","63187-141-20","63187-141_2dfd4382-3405-48c3-b7e1-7c19d82901d8","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Proficient Rx LP","300","mg/1","","N","20251231"
"4576","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63187014144","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-141","63187-141-44","63187-141_2dfd4382-3405-48c3-b7e1-7c19d82901d8","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Proficient Rx LP","300","mg/1","","N","20251231"
"4577","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63187014160","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-141","63187-141-60","63187-141_2dfd4382-3405-48c3-b7e1-7c19d82901d8","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Proficient Rx LP","300","mg/1","","N","20251231"
"4578","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63187014130","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-141","63187-141-30","63187-141_2dfd4382-3405-48c3-b7e1-7c19d82901d8","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Proficient Rx LP","300","mg/1","","N","20251231"
"4579","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63187014140","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-141","63187-141-40","63187-141_2dfd4382-3405-48c3-b7e1-7c19d82901d8","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Proficient Rx LP","300","mg/1","","N","20251231"
"4580","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187014214","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-142","63187-142-14","63187-142_91f426fc-3fc4-4c2f-a56d-10862e54d745","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","250","mg/1","","N","20251231"
"4581","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187014220","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-142","63187-142-20","63187-142_91f426fc-3fc4-4c2f-a56d-10862e54d745","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","250","mg/1","","N","20251231"
"4582","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187014228","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-142","63187-142-28","63187-142_91f426fc-3fc4-4c2f-a56d-10862e54d745","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","250","mg/1","","N","20251231"
"4583","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187014210","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-142","63187-142-10","63187-142_91f426fc-3fc4-4c2f-a56d-10862e54d745","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","250","mg/1","","N","20251231"
"4584","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187014260","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-142","63187-142-60","63187-142_91f426fc-3fc4-4c2f-a56d-10862e54d745","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","250","mg/1","","N","20251231"
"4585","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187014290","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-142","63187-142-90","63187-142_91f426fc-3fc4-4c2f-a56d-10862e54d745","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","250","mg/1","","N","20251231"
"4586","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187014206","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-142","63187-142-06","63187-142_91f426fc-3fc4-4c2f-a56d-10862e54d745","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","250","mg/1","","N","20251231"
"4587","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187014230","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-142","63187-142-30","63187-142_91f426fc-3fc4-4c2f-a56d-10862e54d745","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","250","mg/1","","N","20251231"
"4588","MUPIROCIN","Mupirocin","63187015122","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","63187-151","63187-151-22","63187-151_a22d9ce1-ccc1-4955-939c-b74e110cffa5","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20050923","","ANDA","ANDA065170","Proficient Rx LP","20","mg/g","","N","20251231"
"4589","GENTAMICIN SULFATE","gentamicin sulfate","63187016305","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63187-163","63187-163-05","63187-163_9bc97257-3fe5-45aa-a544-78d044982cd4","HUMAN PRESCRIPTION DRUG","GENTAMICIN SULFATE","","SOLUTION/ DROPS","OPHTHALMIC","19980105","","ANDA","ANDA062452","Proficient Rx LP","3","mg/mL","","N","20251231"
"4590","OFLOXACIN","Ofloxacin","63187018405","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-184","63187-184-05","63187-184_494bc1d0-100f-46c4-b35f-8248fc20b727","HUMAN PRESCRIPTION DRUG","Ofloxacin Otic","","SOLUTION","AURICULAR (OTIC)","20040514","","ANDA","ANDA076527","Proficient Rx LP","3","mg/mL","","N","20251231"
"4591","AMOXICILLIN","Amoxicillin","63187018615","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-186","63187-186-15","63187-186_336edd44-77fc-48f7-987c-3432ae79ffa1","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA061931","Proficient Rx LP","250","mg/5mL","","N","20251231"
"4592","AMOXICILLIN","Amoxicillin","63187018600","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-186","63187-186-00","63187-186_336edd44-77fc-48f7-987c-3432ae79ffa1","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA061931","Proficient Rx LP","250","mg/5mL","","N","20251231"
"4593","AZITHROMYCIN MONOHYDRATE","Azithromycin","63187018903","Macrolide Antimicrobial [EPC], Macrolides [CS]","63187-189","63187-189-03","63187-189_d6250595-3500-4c6f-8175-25a8a92e2d5e","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065223","Proficient Rx LP","500","mg/1","","N","20251231"
"4594","AZITHROMYCIN MONOHYDRATE","Azithromycin","63187018904","Macrolide Antimicrobial [EPC], Macrolides [CS]","63187-189","63187-189-04","63187-189_d6250595-3500-4c6f-8175-25a8a92e2d5e","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065223","Proficient Rx LP","500","mg/1","","N","20251231"
"4595","POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","Trimethoprim sulfate and Polymyxin B sulfate","63187019310","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","63187-193","63187-193-10","63187-193_a0deddd4-f2c7-4594-ac0d-1ed4ce48b891","HUMAN PRESCRIPTION DRUG","Trimethoprim sulfate and Polymyxin B sulfate","","SOLUTION","OPHTHALMIC","19981217","","ANDA","ANDA065006","Proficient Rx LP","10000; 1","[USP'U]/mL; mg/mL","","N","20251231"
"4596","CEPHALEXIN","Cephalexin","63187020520","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-205","63187-205-20","63187-205_379fbc28-1afd-4114-8d06-207a0a33783a","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA062703","Proficient Rx LP","250","mg/5mL","","N","20251231"
"4597","CEPHALEXIN","Cephalexin","63187020500","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-205","63187-205-00","63187-205_379fbc28-1afd-4114-8d06-207a0a33783a","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA062703","Proficient Rx LP","250","mg/5mL","","N","20251231"
"4598","NITROFURANTOIN","Nitrofurantion Macrocrystals","63187024514","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","63187-245","63187-245-14","63187-245_63156793-74b0-444c-bb12-dbe7be60ec91","HUMAN PRESCRIPTION DRUG","Nitrofurantion Macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Proficient Rx LP","100","mg/1","","N","20251231"
"4599","NITROFURANTOIN","Nitrofurantion Macrocrystals","63187024520","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","63187-245","63187-245-20","63187-245_63156793-74b0-444c-bb12-dbe7be60ec91","HUMAN PRESCRIPTION DRUG","Nitrofurantion Macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Proficient Rx LP","100","mg/1","","N","20251231"
"4600","NITROFURANTOIN","Nitrofurantion Macrocrystals","63187024528","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","63187-245","63187-245-28","63187-245_63156793-74b0-444c-bb12-dbe7be60ec91","HUMAN PRESCRIPTION DRUG","Nitrofurantion Macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Proficient Rx LP","100","mg/1","","N","20251231"
"4601","NITROFURANTOIN","Nitrofurantion Macrocrystals","63187024510","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","63187-245","63187-245-10","63187-245_63156793-74b0-444c-bb12-dbe7be60ec91","HUMAN PRESCRIPTION DRUG","Nitrofurantion Macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Proficient Rx LP","100","mg/1","","N","20251231"
"4602","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63187024728","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-247","63187-247-28","63187-247_2dfd4382-3405-48c3-b7e1-7c19d82901d8","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Proficient Rx LP","150","mg/1","","N","20251231"
"4603","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63187024730","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-247","63187-247-30","63187-247_2dfd4382-3405-48c3-b7e1-7c19d82901d8","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Proficient Rx LP","150","mg/1","","N","20251231"
"4604","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63187024740","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-247","63187-247-40","63187-247_2dfd4382-3405-48c3-b7e1-7c19d82901d8","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Proficient Rx LP","150","mg/1","","N","20251231"
"4605","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63187024721","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-247","63187-247-21","63187-247_2dfd4382-3405-48c3-b7e1-7c19d82901d8","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Proficient Rx LP","150","mg/1","","N","20251231"
"4606","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63187024760","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-247","63187-247-60","63187-247_2dfd4382-3405-48c3-b7e1-7c19d82901d8","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Proficient Rx LP","150","mg/1","","N","20251231"
"4607","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63187024744","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-247","63187-247-44","63187-247_2dfd4382-3405-48c3-b7e1-7c19d82901d8","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Proficient Rx LP","150","mg/1","","N","20251231"
"4608","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63187024720","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63187-247","63187-247-20","63187-247_2dfd4382-3405-48c3-b7e1-7c19d82901d8","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Proficient Rx LP","150","mg/1","","N","20251231"
"4609","MUPIROCIN","Mupirocin","63187026122","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","63187-261","63187-261-22","63187-261_a0ee6d21-0deb-4308-9af0-314574a04072","HUMAN PRESCRIPTION DRUG","mupirocin","","OINTMENT","TOPICAL","20091030","","ANDA","ANDA065123","Proficient Rx LP","20","mg/g","","N","20251231"
"4610","AMOXICILLIN","Amoxicillin","63187026200","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-262","63187-262-00","63187-262_e6603270-d47e-47fc-bea9-0c1cea9f70aa","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","Proficient Rx LP","400","mg/5mL","","N","20251231"
"4611","AMOXICILLIN","Amoxicillin","63187026250","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-262","63187-262-50","63187-262_e6603270-d47e-47fc-bea9-0c1cea9f70aa","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","Proficient Rx LP","400","mg/5mL","","N","20251231"
"4612","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystalline","63187026310","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63187-263","63187-263-10","63187-263_46ff38b8-3cbb-4e18-b66f-703b572a37f6","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/ Macrocrystalline","","CAPSULE","ORAL","20110525","","NDA","NDA020064","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"4613","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystalline","63187026328","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63187-263","63187-263-28","63187-263_46ff38b8-3cbb-4e18-b66f-703b572a37f6","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/ Macrocrystalline","","CAPSULE","ORAL","20110525","","NDA","NDA020064","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"4614","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystalline","63187026360","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63187-263","63187-263-60","63187-263_46ff38b8-3cbb-4e18-b66f-703b572a37f6","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/ Macrocrystalline","","CAPSULE","ORAL","20110525","","NDA","NDA020064","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"4615","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystalline","63187026314","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63187-263","63187-263-14","63187-263_46ff38b8-3cbb-4e18-b66f-703b572a37f6","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/ Macrocrystalline","","CAPSULE","ORAL","20110525","","NDA","NDA020064","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"4616","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystalline","63187026330","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63187-263","63187-263-30","63187-263_46ff38b8-3cbb-4e18-b66f-703b572a37f6","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/ Macrocrystalline","","CAPSULE","ORAL","20110525","","NDA","NDA020064","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"4617","ERYTHROMYCIN","Erythromycin","63187026735","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","63187-267","63187-267-35","63187-267_4d6257b3-af7e-4c8a-bd1a-3b7906dbd981","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","19960718","","ANDA","ANDA064030","Proficient Rx LP","5","mg/g","","N","20251231"
"4618","OFLOXACIN","Ofloxacin","63187026805","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-268","63187-268-05","63187-268_331a9c17-9946-48a6-bc37-af84ecdea26a","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20040514","","ANDA","ANDA076622","Proficient Rx LP","3","mg/mL","","N","20251231"
"4619","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone","63187027010","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","63187-270","63187-270-10","63187-270_b775e7f3-60ea-4b65-a4a7-d196d391036f","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SOLUTION/ DROPS","AURICULAR (OTIC)","19951229","","ANDA","ANDA064053","Proficient Rx LP","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"4620","AMOXICILLIN","Amoxicillin","63187029515","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-295","63187-295-15","63187-295_59bdb6eb-6f58-457d-9d49-ade53d7b626d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","Proficient Rx LP","125","mg/5mL","","N","20251231"
"4621","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone","63187030810","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","63187-308","63187-308-10","63187-308_302d5baa-e97c-46cf-a72c-2c77b5a29b7e","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","19960828","","ANDA","ANDA064065","Proficient Rx LP","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"4622","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","63187032000","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-320","63187-320-00","63187-320_8c98b649-b901-4213-9713-757845f5997a","HUMAN PRESCRIPTION DRUG","amoxicillin and clavulanate potassium","","POWDER, FOR SUSPENSION","ORAL","19901022","","NDA","NDA050725","Proficient Rx LP","400; 57","mg/5mL; mg/5mL","","N","20251231"
"4623","AMOXICILLIN","Amoxicillin","63187032514","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-325","63187-325-14","63187-325_ee0246be-6005-448d-a230-42a1ea44fe2e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Proficient Rx LP","875","mg/1","","N","20251231"
"4624","AMOXICILLIN","Amoxicillin","63187032520","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-325","63187-325-20","63187-325_ee0246be-6005-448d-a230-42a1ea44fe2e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Proficient Rx LP","875","mg/1","","N","20251231"
"4625","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63187032720","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-327","63187-327-20","63187-327_83901ad8-02a3-41a4-8c1d-cda4378c3b15","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065101","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"4626","AMOXICILLIN","Amoxicillin","63187033500","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-335","63187-335-00","63187-335_ec3a6992-a66b-4fd9-8e43-eb1b616c673e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","Proficient Rx LP","400","mg/5mL","","N","20251231"
"4627","AMOXICILLIN","Amoxicillin","63187034330","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-343","63187-343-30","63187-343_c0a2fcb0-d8d4-4286-a139-1d3b2bcb74b3","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","19930101","","ANDA","ANDA064013","Proficient Rx LP","250","mg/1","","N","20251231"
"4628","CLARITHROMYCIN","Clarithromycin","63187037628","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","63187-376","63187-376-28","63187-376_03a2435e-288c-440a-8395-7ebf9192519f","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20151204","","ANDA","ANDA203584","Proficient Rx LP","500","mg/1","","N","20251231"
"4629","CLARITHROMYCIN","Clarithromycin","63187037630","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","63187-376","63187-376-30","63187-376_03a2435e-288c-440a-8395-7ebf9192519f","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20151204","","ANDA","ANDA203584","Proficient Rx LP","500","mg/1","","N","20251231"
"4630","CLARITHROMYCIN","Clarithromycin","63187037620","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","63187-376","63187-376-20","63187-376_03a2435e-288c-440a-8395-7ebf9192519f","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20151204","","ANDA","ANDA203584","Proficient Rx LP","500","mg/1","","N","20251231"
"4631","CLARITHROMYCIN","Clarithromycin","63187037690","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","63187-376","63187-376-90","63187-376_03a2435e-288c-440a-8395-7ebf9192519f","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20151204","","ANDA","ANDA203584","Proficient Rx LP","500","mg/1","","N","20251231"
"4632","CLARITHROMYCIN","Clarithromycin","63187037660","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","63187-376","63187-376-60","63187-376_03a2435e-288c-440a-8395-7ebf9192519f","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20151204","","ANDA","ANDA203584","Proficient Rx LP","500","mg/1","","N","20251231"
"4633","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin, Polymyxin B Sulfates, Dexamethasone","63187039535","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","63187-395","63187-395-35","63187-395_806ace25-3288-4a8f-8b6b-bac24cea03ce","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Dexamethasone","","OINTMENT","OPHTHALMIC","20140703","","ANDA","ANDA062938","Proficient Rx LP","1; 3.5; 10000","mg/g; mg/g; [USP'U]/g","","N","20251231"
"4634","AMOXICILLIN","Amoxicillin","63187039920","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-399","63187-399-20","63187-399_42add858-a128-4b54-9f2e-53644865200d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"4635","AMOXICILLIN","Amoxicillin","63187039921","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-399","63187-399-21","63187-399_42add858-a128-4b54-9f2e-53644865200d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"4636","AMOXICILLIN","Amoxicillin","63187039930","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-399","63187-399-30","63187-399_42add858-a128-4b54-9f2e-53644865200d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"4637","AMOXICILLIN","Amoxicillin","63187039914","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-399","63187-399-14","63187-399_42add858-a128-4b54-9f2e-53644865200d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"4638","AMOXICILLIN","Amoxicillin","63187039960","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-399","63187-399-60","63187-399_42add858-a128-4b54-9f2e-53644865200d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"4639","AMOXICILLIN","Amoxicillin","63187039990","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-399","63187-399-90","63187-399_42add858-a128-4b54-9f2e-53644865200d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"4640","AMOXICILLIN","Amoxicillin","63187039910","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-399","63187-399-10","63187-399_42add858-a128-4b54-9f2e-53644865200d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"4641","AMOXICILLIN","Amoxicillin","63187039940","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-399","63187-399-40","63187-399_42add858-a128-4b54-9f2e-53644865200d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"4642","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","63187042314","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-423","63187-423-14","63187-423_003e7a1f-9035-4e05-a945-df6303cc17a3","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021121","","ANDA","ANDA065093","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"4643","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","63187042320","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-423","63187-423-20","63187-423_003e7a1f-9035-4e05-a945-df6303cc17a3","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021121","","ANDA","ANDA065093","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"4644","NYSTATIN","Nystatin","63187046415","Polyene Antifungal [EPC], Polyenes [CS]","63187-464","63187-464-15","63187-464_2aeb648a-b45f-4dd7-93f0-610d7490b464","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20020903","","ANDA","ANDA062840","Proficient Rx LP","100000","[USP'U]/g","","N","20251231"
"4645","OFLOXACIN","Ofloxacin","63187047205","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-472","63187-472-05","63187-472_adddd480-d3b1-4497-8bad-b5c55c2bb8bb","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","AURICULAR (OTIC)","20080317","","ANDA","ANDA076128","Proficient Rx LP","3","mg/mL","","N","20251231"
"4646","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63187048828","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-488","63187-488-28","63187-488_aad9c785-d8dd-4b2a-8d48-82cd342e3c16","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20020314","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"4647","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63187048830","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-488","63187-488-30","63187-488_aad9c785-d8dd-4b2a-8d48-82cd342e3c16","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20020314","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"4648","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63187048840","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-488","63187-488-40","63187-488_aad9c785-d8dd-4b2a-8d48-82cd342e3c16","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20020314","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"4649","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63187048820","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-488","63187-488-20","63187-488_aad9c785-d8dd-4b2a-8d48-82cd342e3c16","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20020314","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"4650","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63187048814","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-488","63187-488-14","63187-488_aad9c785-d8dd-4b2a-8d48-82cd342e3c16","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20020314","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"4651","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone","63187049805","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","63187-498","63187-498-05","63187-498_fe6c9c95-3714-4bc9-8de6-52e327ae3bbd","HUMAN PRESCRIPTION DRUG","Neomycin Polymyxin B Sulfates and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","19950913","","ANDA","ANDA064135","Proficient Rx LP","1; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"4652","CLOTRIMAZOLE","Clotrimazole","63187050115","Azole Antifungal [EPC], Azoles [CS]","63187-501","63187-501-15","63187-501_b07d0172-22a5-4baf-a501-8c7c18b77ecb","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","19950601","","OTC MONOGRAPH DRUG","M005","Proficient Rx LP","1","g/100g","","N","20251231"
"4653","CLOTRIMAZOLE","Clotrimazole","63187050130","Azole Antifungal [EPC], Azoles [CS]","63187-501","63187-501-30","63187-501_b07d0172-22a5-4baf-a501-8c7c18b77ecb","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","19950601","","OTC MONOGRAPH DRUG","M005","Proficient Rx LP","1","g/100g","","N","20251231"
"4654","METRONIDAZOLE","Metronidazole","63187051114","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63187-511","63187-511-14","63187-511_38b36dca-b8a7-4ade-8307-15ce185b643e","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Proficient Rx LP","250","mg/1","","N","20251231"
"4655","METRONIDAZOLE","Metronidazole","63187051130","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63187-511","63187-511-30","63187-511_38b36dca-b8a7-4ade-8307-15ce185b643e","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Proficient Rx LP","250","mg/1","","N","20251231"
"4656","METRONIDAZOLE","Metronidazole","63187051160","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63187-511","63187-511-60","63187-511_38b36dca-b8a7-4ade-8307-15ce185b643e","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Proficient Rx LP","250","mg/1","","N","20251231"
"4657","METRONIDAZOLE","Metronidazole","63187051190","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63187-511","63187-511-90","63187-511_38b36dca-b8a7-4ade-8307-15ce185b643e","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Proficient Rx LP","250","mg/1","","N","20251231"
"4658","METRONIDAZOLE","Metronidazole","63187051128","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63187-511","63187-511-28","63187-511_38b36dca-b8a7-4ade-8307-15ce185b643e","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Proficient Rx LP","250","mg/1","","N","20251231"
"4659","METRONIDAZOLE","Metronidazole","63187051121","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63187-511","63187-511-21","63187-511_38b36dca-b8a7-4ade-8307-15ce185b643e","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Proficient Rx LP","250","mg/1","","N","20251231"
"4660","MUPIROCIN","Mupirocin","63187052522","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","63187-525","63187-525-22","63187-525_75ec5f25-865b-455a-b8d6-c942abce985a","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20031107","","ANDA","ANDA065085","Proficient Rx LP","20","mg/g","","N","20251231"
"4661","PENICILLIN V POTASSIUM","Penicillin V Potassium","63187053320","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-533","63187-533-20","63187-533_d9fdfb61-581b-4082-ac22-60dc2970ffa2","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","POWDER, FOR SOLUTION","ORAL","19900930","","ANDA","ANDA060456","Proficient Rx LP","250","mg/5mL","","N","20251231"
"4662","PENICILLIN V POTASSIUM","Penicillin V Potassium","63187053300","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-533","63187-533-00","63187-533_d9fdfb61-581b-4082-ac22-60dc2970ffa2","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","POWDER, FOR SOLUTION","ORAL","19900930","","ANDA","ANDA060456","Proficient Rx LP","250","mg/5mL","","N","20251231"
"4663","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","63187054200","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-542","63187-542-00","63187-542_51ae03ae-99b0-47e9-ae80-0e8e7b1fc7bc","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20040813","","ANDA","ANDA065098","Proficient Rx LP","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"4664","CLOTRIMAZOLE","Clotrimazole","63187055930","Azole Antifungal [EPC], Azoles [CS]","63187-559","63187-559-30","63187-559_755719db-f87c-4aa1-8743-578d2789fb31","HUMAN OTC DRUG","clotrimazole","","CREAM","TOPICAL","20110603","","OTC MONOGRAPH DRUG","M005","Proficient Rx LP","1","g/100g","","N","20251231"
"4665","CLOTRIMAZOLE","Clotrimazole","63187055915","Azole Antifungal [EPC], Azoles [CS]","63187-559","63187-559-15","63187-559_755719db-f87c-4aa1-8743-578d2789fb31","HUMAN OTC DRUG","clotrimazole","","CREAM","TOPICAL","20110603","","OTC MONOGRAPH DRUG","M005","Proficient Rx LP","1","g/100g","","N","20251231"
"4666","GENTAMICIN SULFATE","Gentamicin Sulfate","63187056005","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63187-560","63187-560-05","63187-560_d0354f86-c43a-4166-8fe2-710442ff548e","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","SOLUTION/ DROPS","OPHTHALMIC","19940511","","ANDA","ANDA064048","Proficient Rx LP","3","mg/mL","","N","20251231"
"4667","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and hydrocortisone","63187056810","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","63187-568","63187-568-10","63187-568_211667a9-4988-4c45-8678-c6ff4c1d4320","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SOLUTION","AURICULAR (OTIC)","20030318","","ANDA","ANDA062423","Proficient Rx LP","10; 3.5; 10000","mg/mL; mg/mL; [iU]/mL","","N","20251231"
"4668","FLUCONAZOLE","Fluconazole","63187058402","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","63187-584","63187-584-02","63187-584_9d64967b-38cf-462f-b8c2-9f019a4f876f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Proficient Rx LP","150","mg/1","","N","20251231"
"4669","FLUCONAZOLE","Fluconazole","63187058404","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","63187-584","63187-584-04","63187-584_9d64967b-38cf-462f-b8c2-9f019a4f876f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Proficient Rx LP","150","mg/1","","N","20251231"
"4670","FLUCONAZOLE","Fluconazole","63187058401","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","63187-584","63187-584-01","63187-584_9d64967b-38cf-462f-b8c2-9f019a4f876f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Proficient Rx LP","150","mg/1","","N","20251231"
"4671","FLUCONAZOLE","Fluconazole","63187058403","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","63187-584","63187-584-03","63187-584_9d64967b-38cf-462f-b8c2-9f019a4f876f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Proficient Rx LP","150","mg/1","","N","20251231"
"4672","AMOXICILLIN","Amoxicillin","63187059128","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-591","63187-591-28","63187-591_a694d973-bbd9-4bdf-82ee-fc4688c101d4","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Proficient Rx LP","250","mg/1","","N","20251231"
"4673","AMOXICILLIN","Amoxicillin","63187059130","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-591","63187-591-30","63187-591_a694d973-bbd9-4bdf-82ee-fc4688c101d4","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Proficient Rx LP","250","mg/1","","N","20251231"
"4674","AMOXICILLIN","Amoxicillin","63187059140","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-591","63187-591-40","63187-591_a694d973-bbd9-4bdf-82ee-fc4688c101d4","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Proficient Rx LP","250","mg/1","","N","20251231"
"4675","AMOXICILLIN","Amoxicillin","63187059121","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-591","63187-591-21","63187-591_a694d973-bbd9-4bdf-82ee-fc4688c101d4","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Proficient Rx LP","250","mg/1","","N","20251231"
"4676","AMOXICILLIN","Amoxicillin","63187059120","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-591","63187-591-20","63187-591_a694d973-bbd9-4bdf-82ee-fc4688c101d4","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Proficient Rx LP","250","mg/1","","N","20251231"
"4677","ERYTHROMYCIN","Erythromycin","63187060835","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","63187-608","63187-608-35","63187-608_bb8e6b6b-70fd-48b7-b43d-23180531dc9f","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","19940729","","ANDA","ANDA064067","Proficient Rx LP","5","mg/g","","N","20251231"
"4678","CEFDINIR MONOHYDRATE","Cefdinir","63187061600","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-616","63187-616-00","63187-616_aec22cad-186d-4dac-9fe3-c3b4d6075b2c","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070508","","ANDA","ANDA065332","Proficient Rx LP","250","mg/5mL","","N","20251231"
"4679","CEFDINIR MONOHYDRATE","Cefdinir","63187061660","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-616","63187-616-60","63187-616_aec22cad-186d-4dac-9fe3-c3b4d6075b2c","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070508","","ANDA","ANDA065332","Proficient Rx LP","250","mg/5mL","","N","20251231"
"4680","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Polymyxin B Sulfate, Bacitracin Zinc and Neomycin Sulfate","63187062301","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","63187-623","63187-623-01","63187-623_02709ca8-e71e-4003-b038-7c1440fe392f","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","19950111","","OTC MONOGRAPH DRUG","M004","Proficient Rx LP","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"4681","CLARITHROMYCIN","Clarithromycin","63187062514","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","63187-625","63187-625-14","63187-625_5e3f6cab-81be-4dd4-adb7-02dc14c3ca53","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Proficient Rx LP","500","mg/1","","N","20251231"
"4682","CLARITHROMYCIN","Clarithromycin","63187062530","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","63187-625","63187-625-30","63187-625_5e3f6cab-81be-4dd4-adb7-02dc14c3ca53","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Proficient Rx LP","500","mg/1","","N","20251231"
"4683","CLARITHROMYCIN","Clarithromycin","63187062590","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","63187-625","63187-625-90","63187-625_5e3f6cab-81be-4dd4-adb7-02dc14c3ca53","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Proficient Rx LP","500","mg/1","","N","20251231"
"4684","CLARITHROMYCIN","Clarithromycin","63187062528","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","63187-625","63187-625-28","63187-625_5e3f6cab-81be-4dd4-adb7-02dc14c3ca53","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Proficient Rx LP","500","mg/1","","N","20251231"
"4685","CLARITHROMYCIN","Clarithromycin","63187062560","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","63187-625","63187-625-60","63187-625_5e3f6cab-81be-4dd4-adb7-02dc14c3ca53","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Proficient Rx LP","500","mg/1","","N","20251231"
"4686","POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","Polymyxin B Sulfate and Trimethoprim Sulfate","63187063110","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","63187-631","63187-631-10","63187-631_38978a23-dfcb-4930-96a7-15f42fe54e56","HUMAN PRESCRIPTION DRUG","Polymyxin B Sulfate and Trimethoprim","","SOLUTION/ DROPS","OPHTHALMIC","19970214","","ANDA","ANDA064120","Proficient Rx LP","10000; 1","[USP'U]/mL; mg/mL","","N","20251231"
"4687","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and hydrocortisone","63187064810","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","63187-648","63187-648-10","63187-648_a0c2530c-4783-482e-9630-10eba7412c01","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SUSPENSION","AURICULAR (OTIC)","20030317","","ANDA","ANDA062488","Proficient Rx LP","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"4688","OFLOXACIN","Ofloxacin","63187066205","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-662","63187-662-05","63187-662_78fd4254-2047-414b-ab00-68d3427a3261","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20080701","","ANDA","ANDA076407","Proficient Rx LP","3","mg/mL","","N","20251231"
"4689","OFLOXACIN","Ofloxacin","63187066210","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-662","63187-662-10","63187-662_78fd4254-2047-414b-ab00-68d3427a3261","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20080701","","ANDA","ANDA076407","Proficient Rx LP","3","mg/mL","","N","20251231"
"4690","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone","63187066935","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","63187-669","63187-669-35","63187-669_84f8a211-aaba-4d86-b71c-9a0632217c9e","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Dexamethasone","","OINTMENT","OPHTHALMIC","19940725","","ANDA","ANDA064063","Proficient Rx LP","1; 3.5; 10000","mg/g; mg/g; [USP'U]/g","","N","20251231"
"4691","PENICILLIN V POTASSIUM","Penicillin V Potassium","63187067620","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-676","63187-676-20","63187-676_813e25e8-145f-40be-a7f1-fb8e0f2b0553","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Proficient Rx LP","250","mg/1","","N","20251231"
"4692","PENICILLIN V POTASSIUM","Penicillin V Potassium","63187067640","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-676","63187-676-40","63187-676_813e25e8-145f-40be-a7f1-fb8e0f2b0553","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Proficient Rx LP","250","mg/1","","N","20251231"
"4693","PENICILLIN V POTASSIUM","Penicillin V Potassium","63187067630","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-676","63187-676-30","63187-676_813e25e8-145f-40be-a7f1-fb8e0f2b0553","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Proficient Rx LP","250","mg/1","","N","20251231"
"4694","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187069506","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-695","63187-695-06","63187-695_04942785-402c-49ca-a03d-6b69609673a7","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4695","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187069510","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-695","63187-695-10","63187-695_04942785-402c-49ca-a03d-6b69609673a7","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4696","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187069528","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-695","63187-695-28","63187-695_04942785-402c-49ca-a03d-6b69609673a7","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4697","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187069540","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-695","63187-695-40","63187-695_04942785-402c-49ca-a03d-6b69609673a7","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4698","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187069514","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-695","63187-695-14","63187-695_04942785-402c-49ca-a03d-6b69609673a7","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4699","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187069520","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-695","63187-695-20","63187-695_04942785-402c-49ca-a03d-6b69609673a7","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4700","NYSTATIN","Nystatin","63187070330","Polyene Antifungal [EPC], Polyenes [CS]","63187-703","63187-703-30","63187-703_bbcffae3-b609-478f-9702-6ae78847cdba","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","19930128","","ANDA","ANDA064022","Proficient Rx LP","100000","[USP'U]/g","","N","20251231"
"4701","NYSTATIN","Nystatin","63187070315","Polyene Antifungal [EPC], Polyenes [CS]","63187-703","63187-703-15","63187-703_bbcffae3-b609-478f-9702-6ae78847cdba","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","19930128","","ANDA","ANDA064022","Proficient Rx LP","100000","[USP'U]/g","","N","20251231"
"4702","AMOXICILLIN","Amoxicillin","63187072914","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-729","63187-729-14","63187-729_8407c6b1-788b-479e-8c41-3d6fe2b7b8ec","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Proficient Rx LP","875","mg/1","","N","20251231"
"4703","AMOXICILLIN","Amoxicillin","63187072920","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-729","63187-729-20","63187-729_8407c6b1-788b-479e-8c41-3d6fe2b7b8ec","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Proficient Rx LP","875","mg/1","","N","20251231"
"4704","AMOXICILLIN","Amoxicillin","63187072928","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-729","63187-729-28","63187-729_8407c6b1-788b-479e-8c41-3d6fe2b7b8ec","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Proficient Rx LP","875","mg/1","","N","20251231"
"4705","AMOXICILLIN","Amoxicillin","63187072930","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-729","63187-729-30","63187-729_8407c6b1-788b-479e-8c41-3d6fe2b7b8ec","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Proficient Rx LP","875","mg/1","","N","20251231"
"4706","AMOXICILLIN","Amoxicillin","63187072940","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-729","63187-729-40","63187-729_8407c6b1-788b-479e-8c41-3d6fe2b7b8ec","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Proficient Rx LP","875","mg/1","","N","20251231"
"4707","AMOXICILLIN","Amoxicillin","63187072921","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-729","63187-729-21","63187-729_8407c6b1-788b-479e-8c41-3d6fe2b7b8ec","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Proficient Rx LP","875","mg/1","","N","20251231"
"4708","OFLOXACIN","Ofloxacin","63187073410","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-734","63187-734-10","63187-734_6fdf3036-94ca-4ad4-ae32-395156115512","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20141215","","ANDA","ANDA078559","Proficient Rx LP","3","mg/mL","","N","20251231"
"4709","OFLOXACIN","Ofloxacin","63187073405","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-734","63187-734-05","63187-734_6fdf3036-94ca-4ad4-ae32-395156115512","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20141215","","ANDA","ANDA078559","Proficient Rx LP","3","mg/mL","","N","20251231"
"4710","PENICILLIN V POTASSIUM","Penicillin V Potassium","63187075630","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-756","63187-756-30","63187-756_f537d5d2-a239-49e0-9811-3b5e6526f728","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Proficient Rx LP","500","mg/1","","N","20251231"
"4711","PENICILLIN V POTASSIUM","Penicillin V Potassium","63187075640","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-756","63187-756-40","63187-756_f537d5d2-a239-49e0-9811-3b5e6526f728","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Proficient Rx LP","500","mg/1","","N","20251231"
"4712","PENICILLIN V POTASSIUM","Penicillin V Potassium","63187075620","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-756","63187-756-20","63187-756_f537d5d2-a239-49e0-9811-3b5e6526f728","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Proficient Rx LP","500","mg/1","","N","20251231"
"4713","GENTAMICIN SULFATE","Gentamicin Sulfate","63187076405","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63187-764","63187-764-05","63187-764_a119d390-b228-4fce-b5a6-26a13833ace0","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","SOLUTION/ DROPS","OPHTHALMIC","20061213","","ANDA","ANDA064163","Proficient Rx LP","3","mg/mL","","N","20251231"
"4714","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63187077000","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-770","63187-770-00","63187-770_3e44326f-096a-4565-a82e-bd39ff0db60b","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20050113","","ANDA","ANDA065089","Proficient Rx LP","400; 57","mg/5mL; mg/5mL","","N","20251231"
"4715","KETOCONAZOLE","Ketoconazole","63187077430","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","63187-774","63187-774-30","63187-774_b8de64ec-7114-42c5-a6c6-ee1122b05bf9","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20021218","","ANDA","ANDA075638","Proficient Rx LP","20","mg/g","","N","20251231"
"4716","KETOCONAZOLE","Ketoconazole","63187077415","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","63187-774","63187-774-15","63187-774_b8de64ec-7114-42c5-a6c6-ee1122b05bf9","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20021218","","ANDA","ANDA075638","Proficient Rx LP","20","mg/g","","N","20251231"
"4717","KETOCONAZOLE","Ketoconazole","63187077460","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","63187-774","63187-774-60","63187-774_b8de64ec-7114-42c5-a6c6-ee1122b05bf9","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20021218","","ANDA","ANDA075638","Proficient Rx LP","20","mg/g","","N","20251231"
"4718","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187078210","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-782","63187-782-10","63187-782_5a945d95-78e5-470a-8567-5021043a3db6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4719","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187078220","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-782","63187-782-20","63187-782_5a945d95-78e5-470a-8567-5021043a3db6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4720","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187078228","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-782","63187-782-28","63187-782_5a945d95-78e5-470a-8567-5021043a3db6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4721","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187078240","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-782","63187-782-40","63187-782_5a945d95-78e5-470a-8567-5021043a3db6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4722","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187078214","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-782","63187-782-14","63187-782_5a945d95-78e5-470a-8567-5021043a3db6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4723","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63187078206","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63187-782","63187-782-06","63187-782_5a945d95-78e5-470a-8567-5021043a3db6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"4724","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","63187079235","Allylamine Antifungal [EPC], Allylamine [CS]","63187-792","63187-792-35","63187-792_1d3fd7ce-1ee9-413f-9c5d-73e9864327f3","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20140813","","ANDA","ANDA077137","Proficient Rx LP","250","mg/1","","N","20251231"
"4725","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","63187079260","Allylamine Antifungal [EPC], Allylamine [CS]","63187-792","63187-792-60","63187-792_1d3fd7ce-1ee9-413f-9c5d-73e9864327f3","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20140813","","ANDA","ANDA077137","Proficient Rx LP","250","mg/1","","N","20251231"
"4726","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","63187079230","Allylamine Antifungal [EPC], Allylamine [CS]","63187-792","63187-792-30","63187-792_1d3fd7ce-1ee9-413f-9c5d-73e9864327f3","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20140813","","ANDA","ANDA077137","Proficient Rx LP","250","mg/1","","N","20251231"
"4727","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","63187079245","Allylamine Antifungal [EPC], Allylamine [CS]","63187-792","63187-792-45","63187-792_1d3fd7ce-1ee9-413f-9c5d-73e9864327f3","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20140813","","ANDA","ANDA077137","Proficient Rx LP","250","mg/1","","N","20251231"
"4728","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","63187079290","Allylamine Antifungal [EPC], Allylamine [CS]","63187-792","63187-792-90","63187-792_1d3fd7ce-1ee9-413f-9c5d-73e9864327f3","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20140813","","ANDA","ANDA077137","Proficient Rx LP","250","mg/1","","N","20251231"
"4729","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63187080320","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-803","63187-803-20","63187-803_c7442c05-30ea-427d-b832-611e0d1c392f","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20020315","","ANDA","ANDA065064","Proficient Rx LP","500; 125","mg/1; mg/1","","N","20251231"
"4730","AMOXICILLIN; CLAVULANIC ACID","Amoxicillin and Clavulanate Potassium","63187082600","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-826","63187-826-00","63187-826_2797b8b4-eac7-419e-b7da-a6e7493661c7","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20071201","","ANDA","ANDA065191","Proficient Rx LP","400; 57","mg/5mL; mg/5mL","","N","20251231"
"4731","METRONIDAZOLE","Metronidazole","63187082704","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63187-827","63187-827-04","63187-827_4b0782a6-9805-42c3-b924-08b84c6cc2ca","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Proficient Rx LP","500","mg/1","","N","20251231"
"4732","METRONIDAZOLE","Metronidazole","63187082721","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63187-827","63187-827-21","63187-827_4b0782a6-9805-42c3-b924-08b84c6cc2ca","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Proficient Rx LP","500","mg/1","","N","20251231"
"4733","METRONIDAZOLE","Metronidazole","63187082730","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63187-827","63187-827-30","63187-827_4b0782a6-9805-42c3-b924-08b84c6cc2ca","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Proficient Rx LP","500","mg/1","","N","20251231"
"4734","METRONIDAZOLE","Metronidazole","63187082714","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63187-827","63187-827-14","63187-827_4b0782a6-9805-42c3-b924-08b84c6cc2ca","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Proficient Rx LP","500","mg/1","","N","20251231"
"4735","POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","Polymyxin B Sulfate and Trimethoprim","63187083410","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","63187-834","63187-834-10","63187-834_0ccbd919-79d8-4159-9b3e-c31230c157db","HUMAN PRESCRIPTION DRUG","Polymyxin B Sulfate and Trimethoprim","","SOLUTION","OPHTHALMIC","19980416","","ANDA","ANDA064211","Proficient Rx LP","10000; 1","[USP'U]/mL; mg/mL","","N","20251231"
"4736","CEFDINIR","Cefdinir","63187083560","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-835","63187-835-60","63187-835_5fcd955c-b46e-4949-b804-f81abe9d37b6","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20071214","","ANDA","ANDA065473","Proficient Rx LP","125","mg/5mL","","N","20251231"
"4737","CEFDINIR","Cefdinir","63187083500","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-835","63187-835-00","63187-835_5fcd955c-b46e-4949-b804-f81abe9d37b6","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20071214","","ANDA","ANDA065473","Proficient Rx LP","125","mg/5mL","","N","20251231"
"4738","NYSTATIN","Nystatin","63187084730","Polyene Antifungal [EPC], Polyenes [CS]","63187-847","63187-847-30","63187-847_d13c0ace-65a3-4d56-bfce-c4aa234af26b","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20060921","","ANDA","ANDA062225","Proficient Rx LP","100000","[USP'U]/g","","N","20251231"
"4739","NYSTATIN","Nystatin","63187084715","Polyene Antifungal [EPC], Polyenes [CS]","63187-847","63187-847-15","63187-847_d13c0ace-65a3-4d56-bfce-c4aa234af26b","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20060921","","ANDA","ANDA062225","Proficient Rx LP","100000","[USP'U]/g","","N","20251231"
"4740","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63187085720","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-857","63187-857-20","63187-857_665eb028-198a-4309-97c8-e4f97f1b7bba","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20040923","","ANDA","ANDA065162","Proficient Rx LP","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"4741","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63187085775","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-857","63187-857-75","63187-857_665eb028-198a-4309-97c8-e4f97f1b7bba","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20040923","","ANDA","ANDA065162","Proficient Rx LP","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"4742","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63187085712","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63187-857","63187-857-12","63187-857_665eb028-198a-4309-97c8-e4f97f1b7bba","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20040923","","ANDA","ANDA065162","Proficient Rx LP","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"4743","GENTAMICIN SULFATE","Gentamicin Sulfate","63187087335","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63187-873","63187-873-35","63187-873_57dbd129-b76f-49e6-b76a-eb86ad22273b","HUMAN PRESCRIPTION DRUG","Gentak","","OINTMENT","OPHTHALMIC","20060508","","ANDA","ANDA064093","Proficient Rx LP","3","mg/g","","N","20251231"
"4744","FLUCONAZOLE","Fluconazole","63187087801","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","63187-878","63187-878-01","63187-878_05e11a44-c072-4969-9175-1caa92458ad7","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20060125","","ANDA","ANDA077253","Proficient Rx LP","200","mg/1","","N","20251231"
"4745","FLUCONAZOLE","Fluconazole","63187087830","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","63187-878","63187-878-30","63187-878_05e11a44-c072-4969-9175-1caa92458ad7","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20060125","","ANDA","ANDA077253","Proficient Rx LP","200","mg/1","","N","20251231"
"4746","FLUCONAZOLE","Fluconazole","63187087802","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","63187-878","63187-878-02","63187-878_05e11a44-c072-4969-9175-1caa92458ad7","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20060125","","ANDA","ANDA077253","Proficient Rx LP","200","mg/1","","N","20251231"
"4747","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","Atovaquone and Proguanil Hydrochloride","63187087924","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","63187-879","63187-879-24","63187-879_feeccc5c-a98f-4de7-b664-d450f77ee462","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil Hydrochloride","","TABLET, FILM COATED","ORAL","20110818","","ANDA","ANDA091211","Proficient Rx LP","250; 100","mg/1; mg/1","","N","20251231"
"4748","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","Atovaquone and Proguanil Hydrochloride","63187087916","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","63187-879","63187-879-16","63187-879_feeccc5c-a98f-4de7-b664-d450f77ee462","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil Hydrochloride","","TABLET, FILM COATED","ORAL","20110818","","ANDA","ANDA091211","Proficient Rx LP","250; 100","mg/1; mg/1","","N","20251231"
"4749","AMOXICILLIN","Amoxicillin","63187088015","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-880","63187-880-15","63187-880_31883dd0-bd99-4cde-9ded-a4c2fc3be8cc","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065387","Proficient Rx LP","250","mg/5mL","","N","20251231"
"4750","CEFADROXIL","Cefadroxil","63187088330","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-883","63187-883-30","63187-883_da08672f-6155-4026-b283-a7738f7eb678","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20080423","","ANDA","ANDA065392","Proficient Rx LP","500","mg/1","","N","20251231"
"4751","CEFADROXIL","Cefadroxil","63187088340","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-883","63187-883-40","63187-883_da08672f-6155-4026-b283-a7738f7eb678","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20080423","","ANDA","ANDA065392","Proficient Rx LP","500","mg/1","","N","20251231"
"4752","CEFADROXIL","Cefadroxil","63187088306","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-883","63187-883-06","63187-883_da08672f-6155-4026-b283-a7738f7eb678","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20080423","","ANDA","ANDA065392","Proficient Rx LP","500","mg/1","","N","20251231"
"4753","CEFADROXIL","Cefadroxil","63187088320","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-883","63187-883-20","63187-883_da08672f-6155-4026-b283-a7738f7eb678","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20080423","","ANDA","ANDA065392","Proficient Rx LP","500","mg/1","","N","20251231"
"4754","TOBRAMYCIN","Tobramycin","63187090202","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63187-902","63187-902-02","63187-902_f1b5aa19-119f-4d5a-aa8d-8f3778a48753","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION/ DROPS","OPHTHALMIC","19960131","","ANDA","ANDA064096","Proficient Rx LP","3","mg/mL","","N","20251231"
"4755","TOBRAMYCIN","Tobramycin","63187090205","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63187-902","63187-902-05","63187-902_f1b5aa19-119f-4d5a-aa8d-8f3778a48753","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION/ DROPS","OPHTHALMIC","19960131","","ANDA","ANDA064096","Proficient Rx LP","3","mg/mL","","N","20251231"
"4756","PENICILLIN V POTASSIUM","Penicillin V Potassium","63187092640","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-926","63187-926-40","63187-926_651d3bac-e755-40ea-9ded-3dab23e0ffba","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Proficient Rx LP","500","mg/1","","N","20251231"
"4757","PENICILLIN V POTASSIUM","Penicillin V Potassium","63187092630","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-926","63187-926-30","63187-926_651d3bac-e755-40ea-9ded-3dab23e0ffba","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Proficient Rx LP","500","mg/1","","N","20251231"
"4758","PENICILLIN V POTASSIUM","Penicillin V Potassium","63187092620","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63187-926","63187-926-20","63187-926_651d3bac-e755-40ea-9ded-3dab23e0ffba","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Proficient Rx LP","500","mg/1","","N","20251231"
"4759","TOBRAMYCIN","Tobramycin","63187097305","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63187-973","63187-973-05","63187-973_3439b089-5661-47e1-87e9-7b18c7d61540","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","OPHTHALMIC","19950109","","ANDA","ANDA062535","Proficient Rx LP","3","mg/mL","","N","20251231"
"4760","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","63187098510","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-985","63187-985-10","63187-985_6d644d3b-aaa3-489f-b2e7-5a9a5e2ac903","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20040507","","NDA AUTHORIZED GENERIC","NDA019992","Proficient Rx LP","3","mg/mL","","N","20251231"
"4761","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","63187098505","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-985","63187-985-05","63187-985_6d644d3b-aaa3-489f-b2e7-5a9a5e2ac903","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20040507","","NDA AUTHORIZED GENERIC","NDA019992","Proficient Rx LP","3","mg/mL","","N","20251231"
"4762","CEFDINIR","Cefdinir","63187098920","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-989","63187-989-20","63187-989_a1a1f2d7-b989-41f7-a770-ae1b4b6231ce","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20070406","","ANDA","ANDA065330","Proficient Rx LP","300","mg/1","","N","20251231"
"4763","CEFDINIR","Cefdinir","63187098914","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-989","63187-989-14","63187-989_a1a1f2d7-b989-41f7-a770-ae1b4b6231ce","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20070406","","ANDA","ANDA065330","Proficient Rx LP","300","mg/1","","N","20251231"
"4764","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187099007","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-990","63187-990-07","63187-990_d0f31dff-c2dd-487d-a329-342765d135e3","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","750","mg/1","","N","20251231"
"4765","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187099014","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-990","63187-990-14","63187-990_d0f31dff-c2dd-487d-a329-342765d135e3","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","750","mg/1","","N","20251231"
"4766","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187099028","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-990","63187-990-28","63187-990_d0f31dff-c2dd-487d-a329-342765d135e3","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","750","mg/1","","N","20251231"
"4767","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187099030","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-990","63187-990-30","63187-990_d0f31dff-c2dd-487d-a329-342765d135e3","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","750","mg/1","","N","20251231"
"4768","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187099010","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-990","63187-990-10","63187-990_d0f31dff-c2dd-487d-a329-342765d135e3","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","750","mg/1","","N","20251231"
"4769","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","63187099006","Quinolone Antimicrobial [EPC], Quinolones [CS]","63187-990","63187-990-06","63187-990_d0f31dff-c2dd-487d-a329-342765d135e3","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Proficient Rx LP","750","mg/1","","N","20251231"
"4770","CEFUROXIME AXETIL","Cefuroxime axetil","63187099120","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-991","63187-991-20","63187-991_8251b1f4-6da1-461e-9512-fed77a1f402b","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","Proficient Rx LP","250","mg/1","","N","20251231"
"4771","CEFUROXIME AXETIL","Cefuroxime axetil","63187099160","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63187-991","63187-991-60","63187-991_8251b1f4-6da1-461e-9512-fed77a1f402b","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","Proficient Rx LP","250","mg/1","","N","20251231"
"4772","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","63187099514","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63187-995","63187-995-14","63187-995_ae7e968c-c9fd-48ec-b93b-72ff585d6e65","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"4773","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","63187099520","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63187-995","63187-995-20","63187-995_ae7e968c-c9fd-48ec-b93b-72ff585d6e65","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"4774","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","63187099510","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63187-995","63187-995-10","63187-995_ae7e968c-c9fd-48ec-b93b-72ff585d6e65","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"4775","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63304069203","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63304-692","63304-692-03","63304-692_339366d4-2060-1c29-e063-6394a90a1cb7","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Sun Pharmaceutical Industries, Inc.","150","mg/1","","N","20261231"
"4776","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63304069205","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63304-692","63304-692-05","63304-692_339366d4-2060-1c29-e063-6394a90a1cb7","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Sun Pharmaceutical Industries, Inc.","150","mg/1","","N","20261231"
"4777","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63304069201","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63304-692","63304-692-01","63304-692_339366d4-2060-1c29-e063-6394a90a1cb7","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Sun Pharmaceutical Industries, Inc.","150","mg/1","","N","20261231"
"4778","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63304069277","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63304-692","63304-692-77","63304-692_339366d4-2060-1c29-e063-6394a90a1cb7","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Sun Pharmaceutical Industries, Inc.","150","mg/1","","N","20261231"
"4779","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63304069303","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63304-693","63304-693-03","63304-693_339366d4-2060-1c29-e063-6394a90a1cb7","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Sun Pharmaceutical Industries, Inc.","300","mg/1","","N","20261231"
"4780","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63304069305","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63304-693","63304-693-05","63304-693_339366d4-2060-1c29-e063-6394a90a1cb7","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Sun Pharmaceutical Industries, Inc.","300","mg/1","","N","20261231"
"4781","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63304069316","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63304-693","63304-693-16","63304-693_339366d4-2060-1c29-e063-6394a90a1cb7","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Sun Pharmaceutical Industries, Inc.","300","mg/1","","N","20261231"
"4782","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63304069377","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63304-693","63304-693-77","63304-693_339366d4-2060-1c29-e063-6394a90a1cb7","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Sun Pharmaceutical Industries, Inc.","300","mg/1","","N","20261231"
"4783","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63304069301","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63304-693","63304-693-01","63304-693_339366d4-2060-1c29-e063-6394a90a1cb7","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Sun Pharmaceutical Industries, Inc.","300","mg/1","","N","20261231"
"4784","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","63304069362","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63304-693","63304-693-62","63304-693_339366d4-2060-1c29-e063-6394a90a1cb7","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Sun Pharmaceutical Industries, Inc.","300","mg/1","","N","20261231"
"4785","GENTAMICIN SULFATE","GENTAMICIN SULFATE","63323001096","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63323-010","63323-010-96","63323-010_48a57ed5-3809-49cc-a7ec-715e7e2c1720","HUMAN PRESCRIPTION DRUG","Gentamicin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20000810","","ANDA","ANDA062366","Fresenius Kabi USA, LLC","40","mg/mL","","N","20251231"
"4786","GENTAMICIN SULFATE","GENTAMICIN SULFATE","63323001095","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63323-010","63323-010-95","63323-010_48a57ed5-3809-49cc-a7ec-715e7e2c1720","HUMAN PRESCRIPTION DRUG","Gentamicin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20000810","","ANDA","ANDA062366","Fresenius Kabi USA, LLC","40","mg/mL","","N","20251231"
"4787","GENTAMICIN SULFATE","GENTAMICIN SULFATE","63323001002","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63323-010","63323-010-02","63323-010_48a57ed5-3809-49cc-a7ec-715e7e2c1720","HUMAN PRESCRIPTION DRUG","Gentamicin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20000810","","ANDA","ANDA062366","Fresenius Kabi USA, LLC","40","mg/mL","","N","20251231"
"4788","GENTAMICIN SULFATE","GENTAMICIN SULFATE","63323001020","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63323-010","63323-010-20","63323-010_48a57ed5-3809-49cc-a7ec-715e7e2c1720","HUMAN PRESCRIPTION DRUG","Gentamicin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20000810","","ANDA","ANDA062366","Fresenius Kabi USA, LLC","40","mg/mL","","N","20251231"
"4789","GENTAMICIN SULFATE","GENTAMICIN SULFATE","63323001094","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63323-010","63323-010-94","63323-010_48a57ed5-3809-49cc-a7ec-715e7e2c1720","HUMAN PRESCRIPTION DRUG","Gentamicin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20000810","","ANDA","ANDA062366","Fresenius Kabi USA, LLC","40","mg/mL","","N","20251231"
"4790","CHLORAMPHENICOL SODIUM SUCCINATE","CHLORAMPHENICOL SODIUM SUCCINATE","63323001115","Amphenicol-class Antibacterial [EPC], Amphenicols [EXT]","63323-011","63323-011-15","63323-011_f0af962d-5024-47cf-b7a0-da9b5ff3c994","HUMAN PRESCRIPTION DRUG","Chloramphenicol Sodium Succinate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20010112","","ANDA","ANDA062365","Fresenius Kabi USA, LLC","1","g/10mL","","N","20251231"
"4791","PENTAMIDINE ISETHIONATE","PENTAMIDINE ISETHIONATE","63323011310","Antiprotozoal [EPC]","63323-113","63323-113-10","63323-113_5fe83fb0-2b64-40a2-a996-aaa6292e661e","HUMAN PRESCRIPTION DRUG","Pentam 300","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20010116","","NDA","NDA019264","Fresenius Kabi USA, LLC","300","mg/3mL","","N","20251231"
"4792","GENTAMICIN SULFATE","GENTAMICIN","63323017395","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63323-173","63323-173-95","63323-173_b5dcfd7a-3a61-404f-80b4-0876ba1076db","HUMAN PRESCRIPTION DRUG","Gentamicin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20041129","","ANDA","ANDA062366","Fresenius Kabi USA, LLC","10","mg/mL","","N","20251231"
"4793","GENTAMICIN SULFATE","GENTAMICIN","63323017394","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63323-173","63323-173-94","63323-173_b5dcfd7a-3a61-404f-80b4-0876ba1076db","HUMAN PRESCRIPTION DRUG","Gentamicin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20041129","","ANDA","ANDA062366","Fresenius Kabi USA, LLC","10","mg/mL","","N","20251231"
"4794","GENTAMICIN SULFATE","GENTAMICIN","63323017302","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63323-173","63323-173-02","63323-173_b5dcfd7a-3a61-404f-80b4-0876ba1076db","HUMAN PRESCRIPTION DRUG","Gentamicin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20041129","","ANDA","ANDA062366","Fresenius Kabi USA, LLC","10","mg/mL","","N","20251231"
"4795","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","63323020326","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63323-203","63323-203-26","63323-203_8270ac4f-3c40-4db1-8083-bebced4fee14","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20160817","","ANDA","ANDA062663","Fresenius Kabi USA, LLC","750","mg/15mL","","N","20261231"
"4796","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","63323020320","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63323-203","63323-203-20","63323-203_8270ac4f-3c40-4db1-8083-bebced4fee14","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20160817","","ANDA","ANDA062663","Fresenius Kabi USA, LLC","750","mg/15mL","","N","20261231"
"4797","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","63323022138","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63323-221","63323-221-38","63323-221_570be6c2-649c-46cc-8fcb-3a5a9bd1f7c5","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20000901","","ANDA","ANDA062663","Fresenius Kabi USA, LLC","500","mg/10mL","","N","20261231"
"4798","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","63323022148","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63323-221","63323-221-48","63323-221_570be6c2-649c-46cc-8fcb-3a5a9bd1f7c5","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20000901","","ANDA","ANDA062663","Fresenius Kabi USA, LLC","500","mg/10mL","","N","20261231"
"4799","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","63323022110","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63323-221","63323-221-10","63323-221_570be6c2-649c-46cc-8fcb-3a5a9bd1f7c5","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20000901","","ANDA","ANDA062663","Fresenius Kabi USA, LLC","500","mg/10mL","","N","20261231"
"4800","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","63323022116","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63323-221","63323-221-16","63323-221_570be6c2-649c-46cc-8fcb-3a5a9bd1f7c5","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20000901","","ANDA","ANDA062663","Fresenius Kabi USA, LLC","500","mg/10mL","","N","20261231"
"4801","CEFAZOLIN SODIUM","CEFAZOLIN SODIUM","63323023610","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63323-236","63323-236-10","63323-236_321ffc80-ee94-4a86-8c33-e966438d9fbb","HUMAN PRESCRIPTION DRUG","CEFAZOLIN","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20110715","","ANDA","ANDA065303","Fresenius Kabi USA, LLC","500","mg/2.2mL","","N","20251231"
"4802","CEFAZOLIN SODIUM","CEFAZOLIN SODIUM","63323023710","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63323-237","63323-237-10","63323-237_321ffc80-ee94-4a86-8c33-e966438d9fbb","HUMAN PRESCRIPTION DRUG","CEFAZOLIN","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20110715","","ANDA","ANDA065303","Fresenius Kabi USA, LLC","1","g/3mL","","N","20251231"
"4803","CEFAZOLIN SODIUM","Cefazolin Sodium","63323023861","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63323-238","63323-238-61","63323-238_9684b8e0-7438-41d9-89e1-b217b5568360","HUMAN PRESCRIPTION DRUG","Cefazolin","","POWDER, FOR SOLUTION","INTRAVENOUS","20110614","","ANDA","ANDA065306","Fresenius Kabi USA, LLC","10","g/1","","N","20251231"
"4804","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","63323028420","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63323-284","63323-284-20","63323-284_570be6c2-649c-46cc-8fcb-3a5a9bd1f7c5","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20000920","","ANDA","ANDA062663","Fresenius Kabi USA, LLC","1","g/20mL","","N","20261231"
"4805","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","63323028421","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63323-284","63323-284-21","63323-284_570be6c2-649c-46cc-8fcb-3a5a9bd1f7c5","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20000920","","ANDA","ANDA062663","Fresenius Kabi USA, LLC","1","g/20mL","","N","20261231"
"4806","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","63323028445","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63323-284","63323-284-45","63323-284_570be6c2-649c-46cc-8fcb-3a5a9bd1f7c5","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20000920","","ANDA","ANDA062663","Fresenius Kabi USA, LLC","1","g/20mL","","N","20261231"
"4807","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","63323028426","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63323-284","63323-284-26","63323-284_570be6c2-649c-46cc-8fcb-3a5a9bd1f7c5","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20000920","","ANDA","ANDA062663","Fresenius Kabi USA, LLC","1","g/20mL","","N","20261231"
"4808","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","63323029561","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63323-295","63323-295-61","63323-295_020618ad-8f1f-4189-a95c-254f05a077cc","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20010717","","ANDA","ANDA062663","Fresenius Kabi USA, LLC","5","g/100mL","","N","20251231"
"4809","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","63323029566","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63323-295","63323-295-66","63323-295_020618ad-8f1f-4189-a95c-254f05a077cc","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20010717","","ANDA","ANDA062663","Fresenius Kabi USA, LLC","5","g/100mL","","N","20251231"
"4810","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN SODIUM,TAZOBACTAM SODIUM","63323030030","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63323-300","63323-300-30","63323-300_59b329ea-8524-414d-ac6e-ef67d79536ce","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20091013","","ANDA","ANDA065523","Fresenius Kabi USA, LLC","3; .375","g/15mL; g/15mL","","N","20251231"
"4811","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN SODIUM,TAZOBACTAM SODIUM","63323030036","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63323-300","63323-300-36","63323-300_59b329ea-8524-414d-ac6e-ef67d79536ce","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20091013","","ANDA","ANDA065523","Fresenius Kabi USA, LLC","3; .375","g/15mL; g/15mL","","N","20251231"
"4812","TOBRAMYCIN SULFATE","TOBRAMYCIN SULFATE","63323030351","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63323-303","63323-303-51","63323-303_ea244093-d87f-4192-b5c4-59d7b7dbf669","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20051123","","NDA","NDA050789","Fresenius Kabi USA, LLC","1200","mg/30mL","","N","20251231"
"4813","TOBRAMYCIN SULFATE","TOBRAMYCIN SULFATE","63323030355","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63323-303","63323-303-55","63323-303_ea244093-d87f-4192-b5c4-59d7b7dbf669","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20051123","","NDA","NDA050789","Fresenius Kabi USA, LLC","1200","mg/30mL","","N","20251231"
"4814","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin Sodium and Tazobactam Sodium","63323030494","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63323-304","63323-304-94","63323-304_c76215c6-e9f9-447a-8ce2-ecba738b25d8","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20110531","","ANDA","ANDA090498","Fresenius Kabi USA, LLC","36; 4.5","g/180mL; g/180mL","","N","20251231"
"4815","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin Sodium and Tazobactam Sodium","63323030478","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63323-304","63323-304-78","63323-304_c76215c6-e9f9-447a-8ce2-ecba738b25d8","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20110531","","ANDA","ANDA090498","Fresenius Kabi USA, LLC","36; 4.5","g/180mL; g/180mL","","N","20251231"
"4816","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin Sodium and Tazobactam Sodium","63323030474","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63323-304","63323-304-74","63323-304_c76215c6-e9f9-447a-8ce2-ecba738b25d8","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20110531","","ANDA","ANDA090498","Fresenius Kabi USA, LLC","36; 4.5","g/180mL; g/180mL","","N","20251231"
"4817","TOBRAMYCIN SULFATE","TOBRAMYCIN SULFATE","63323030502","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63323-305","63323-305-02","63323-305_c55fcee9-70c7-4926-bee6-014c0b133249","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20041130","","ANDA","ANDA065122","Fresenius Kabi USA, LLC","10","mg/mL","","N","20251231"
"4818","TOBRAMYCIN SULFATE","TOBRAMYCIN SULFATE","63323030602","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63323-306","63323-306-02","63323-306_c55fcee9-70c7-4926-bee6-014c0b133249","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20051123","","ANDA","ANDA065122","Fresenius Kabi USA, LLC","40","mg/mL","","N","20251231"
"4819","TOBRAMYCIN SULFATE","TOBRAMYCIN SULFATE","63323030630","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63323-306","63323-306-30","63323-306_c55fcee9-70c7-4926-bee6-014c0b133249","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20051123","","ANDA","ANDA065122","Fresenius Kabi USA, LLC","40","mg/mL","","N","20251231"
"4820","TOBRAMYCIN SULFATE","TOBRAMYCIN SULFATE","63323030751","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63323-307","63323-307-51","63323-307_3e1d5ec4-f2f2-45b0-aca2-9911ddf58090","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION, SOLUTION","INTRAVENOUS","20041130","","ANDA","ANDA065120","Fresenius Kabi USA, LLC","40","mg/mL","","N","20251231"
"4821","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN SODIUM,TAZOBACTAM SODIUM","63323030926","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63323-309","63323-309-26","63323-309_59b329ea-8524-414d-ac6e-ef67d79536ce","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20091013","","ANDA","ANDA065523","Fresenius Kabi USA, LLC","2; .25","g/10mL; g/10mL","","N","20251231"
"4822","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN SODIUM,TAZOBACTAM SODIUM","63323030920","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63323-309","63323-309-20","63323-309_59b329ea-8524-414d-ac6e-ef67d79536ce","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20091013","","ANDA","ANDA065523","Fresenius Kabi USA, LLC","2; .25","g/10mL; g/10mL","","N","20251231"
"4823","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","63323031466","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63323-314","63323-314-66","63323-314_61ca1076-563b-48b2-9632-4f9a88f7639a","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20041130","","ANDA","ANDA062663","Fresenius Kabi USA, LLC","10","g/100mL","","N","20251231"
"4824","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","63323031461","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63323-314","63323-314-61","63323-314_61ca1076-563b-48b2-9632-4f9a88f7639a","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20041130","","ANDA","ANDA062663","Fresenius Kabi USA, LLC","10","g/100mL","","N","20251231"
"4825","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","63323031468","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63323-314","63323-314-68","63323-314_61ca1076-563b-48b2-9632-4f9a88f7639a","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20041130","","ANDA","ANDA062663","Fresenius Kabi USA, LLC","10","g/100mL","","N","20251231"
"4826","GANCICLOVIR SODIUM","GANCICLOVIR SODIUM","63323031594","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","63323-315","63323-315-94","63323-315_5f2d460e-f4cc-41fe-869a-43422caad85f","HUMAN PRESCRIPTION DRUG","Ganciclovir","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20100628","","ANDA","ANDA090658","Fresenius Kabi USA, LLC","500","mg/10mL","","N","20251231"
"4827","GANCICLOVIR SODIUM","GANCICLOVIR SODIUM","63323031510","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","63323-315","63323-315-10","63323-315_5f2d460e-f4cc-41fe-869a-43422caad85f","HUMAN PRESCRIPTION DRUG","Ganciclovir","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20100628","","ANDA","ANDA090658","Fresenius Kabi USA, LLC","500","mg/10mL","","N","20251231"
"4828","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN SODIUM,TAZOBACTAM SODIUM","63323032056","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63323-320","63323-320-56","63323-320_59b329ea-8524-414d-ac6e-ef67d79536ce","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20091013","","ANDA","ANDA065523","Fresenius Kabi USA, LLC","4; .5","g/20mL; g/20mL","","N","20251231"
"4829","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN SODIUM,TAZOBACTAM SODIUM","63323032050","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63323-320","63323-320-50","63323-320_59b329ea-8524-414d-ac6e-ef67d79536ce","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20091013","","ANDA","ANDA065523","Fresenius Kabi USA, LLC","4; .5","g/20mL; g/20mL","","N","20251231"
"4830","POLYMYXIN B SULFATE","POLYMYXIN B SULFATE","63323032110","Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","63323-321","63323-321-10","63323-321_545b3d1d-6c8f-44aa-b81e-b24fc99f9c82","HUMAN PRESCRIPTION DRUG","POLYMYXIN B","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC","20091117","","ANDA","ANDA065372","Fresenius Kabi USA, LLC","500000","[USP'U]/1","","N","20251231"
"4831","POLYMYXIN B SULFATE","POLYMYXIN B SULFATE","63323032112","Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","63323-321","63323-321-12","63323-321_545b3d1d-6c8f-44aa-b81e-b24fc99f9c82","HUMAN PRESCRIPTION DRUG","POLYMYXIN B","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC","20091117","","ANDA","ANDA065372","Fresenius Kabi USA, LLC","500000","[USP'U]/1","","N","20251231"
"4832","CILASTATIN SODIUM; IMIPENEM","Imipenem and Cilastatin Sodium","63323032294","Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]","63323-322","63323-322-94","63323-322_68d30458-8cd9-4fbe-9215-f36dec6c733b","HUMAN PRESCRIPTION DRUG","Imipenem and Cilastatin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20120103","","ANDA","ANDA090577","Fresenius Kabi USA, LLC","500; 500","mg/20mL; mg/20mL","","N","20251231"
"4833","CILASTATIN SODIUM; IMIPENEM","Imipenem and Cilastatin Sodium","63323032293","Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]","63323-322","63323-322-93","63323-322_68d30458-8cd9-4fbe-9215-f36dec6c733b","HUMAN PRESCRIPTION DRUG","Imipenem and Cilastatin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20120103","","ANDA","ANDA090577","Fresenius Kabi USA, LLC","500; 500","mg/20mL; mg/20mL","","N","20251231"
"4834","CILASTATIN SODIUM; IMIPENEM","Imipenem and Cilastatin Sodium","63323032225","Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]","63323-322","63323-322-25","63323-322_68d30458-8cd9-4fbe-9215-f36dec6c733b","HUMAN PRESCRIPTION DRUG","Imipenem and Cilastatin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20120103","","ANDA","ANDA090577","Fresenius Kabi USA, LLC","500; 500","mg/20mL; mg/20mL","","N","20251231"
"4835","CEFEPIME HYDROCHLORIDE","Cefepime","63323032620","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63323-326","63323-326-20","63323-326_8c2fbf43-34bd-49d1-bda8-a2191c8bc54b","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20100830","","ANDA","ANDA065441","Fresenius Kabi USA, LLC","1","g/1","","N","20251231"
"4836","NAFCILLIN SODIUM","NAFCILLIN SODIUM","63323032710","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63323-327","63323-327-10","63323-327_89168d2d-2dc0-3f50-e053-2a95a90a31be","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20110630","","ANDA","ANDA090002","Fresenius Kabi USA, LLC","1","g/4mL","","N","20251231"
"4837","NAFCILLIN SODIUM","NAFCILLIN SODIUM","63323032822","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63323-328","63323-328-22","63323-328_89168d2d-2dc0-3f50-e053-2a95a90a31be","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20110630","","ANDA","ANDA090002","Fresenius Kabi USA, LLC","2","g/8mL","","N","20251231"
"4838","NAFCILLIN SODIUM","NAFCILLIN SODIUM","63323032820","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63323-328","63323-328-20","63323-328_89168d2d-2dc0-3f50-e053-2a95a90a31be","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20110630","","ANDA","ANDA090002","Fresenius Kabi USA, LLC","2","g/8mL","","N","20251231"
"4839","NAFCILLIN SODIUM","NAFCILLIN","63323033060","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63323-330","63323-330-60","63323-330_8b27ca5e-a933-7606-e053-2a95a90a0a33","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20110427","","ANDA","ANDA090005","Fresenius Kabi USA, LLC","10","g/100mL","","N","20251231"
"4840","CEFEPIME HYDROCHLORIDE","Cefepime","63323034020","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63323-340","63323-340-20","63323-340_8c2fbf43-34bd-49d1-bda8-a2191c8bc54b","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20100830","","ANDA","ANDA065441","Fresenius Kabi USA, LLC","2","g/1","","N","20251231"
"4841","CEFOXITIN SODIUM","Cefoxitin Sodium","63323034129","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63323-341","63323-341-29","63323-341_9f457501-b963-49c0-89a3-4228eb493895","HUMAN PRESCRIPTION DRUG","Cefoxitin","","POWDER, FOR SOLUTION","INTRAVENOUS","20110706","","ANDA","ANDA065414","Fresenius Kabi USA, LLC","1","g/1","","N","20251231"
"4842","CEFOXITIN SODIUM","Cefoxitin Sodium","63323034125","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63323-341","63323-341-25","63323-341_9f457501-b963-49c0-89a3-4228eb493895","HUMAN PRESCRIPTION DRUG","Cefoxitin","","POWDER, FOR SOLUTION","INTRAVENOUS","20110706","","ANDA","ANDA065414","Fresenius Kabi USA, LLC","1","g/1","","N","20251231"
"4843","CEFOXITIN SODIUM","Cefoxitin Sodium","63323034225","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63323-342","63323-342-25","63323-342_9f457501-b963-49c0-89a3-4228eb493895","HUMAN PRESCRIPTION DRUG","Cefoxitin","","POWDER, FOR SOLUTION","INTRAVENOUS","20110706","","ANDA","ANDA065414","Fresenius Kabi USA, LLC","2","g/1","","N","20251231"
"4844","CEFOXITIN SODIUM","Cefoxitin Sodium","63323034229","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63323-342","63323-342-29","63323-342_9f457501-b963-49c0-89a3-4228eb493895","HUMAN PRESCRIPTION DRUG","Cefoxitin","","POWDER, FOR SOLUTION","INTRAVENOUS","20110706","","ANDA","ANDA065414","Fresenius Kabi USA, LLC","2","g/1","","N","20251231"
"4845","CEFTRIAXONE SODIUM","Ceftriaxone","63323034610","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63323-346","63323-346-10","63323-346_27777645-c5ae-4c89-abaf-ddb62dc7b859","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20110620","","ANDA","ANDA065329","Fresenius Kabi USA, LLC","1","g/1","","N","20251231"
"4846","CILASTATIN SODIUM; IMIPENEM","Imipenem and Cilastatin Sodium","63323034994","Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]","63323-349","63323-349-94","63323-349_2bb9b6ad-8e8d-4667-b108-b57a8c16318f","HUMAN PRESCRIPTION DRUG","Imipenem and Cilastatin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20120103","","ANDA","ANDA090577","Fresenius Kabi USA, LLC","250; 250","mg/20mL; mg/20mL","","N","20251231"
"4847","CILASTATIN SODIUM; IMIPENEM","Imipenem and Cilastatin Sodium","63323034925","Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]","63323-349","63323-349-25","63323-349_2bb9b6ad-8e8d-4667-b108-b57a8c16318f","HUMAN PRESCRIPTION DRUG","Imipenem and Cilastatin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20120103","","ANDA","ANDA090577","Fresenius Kabi USA, LLC","250; 250","mg/20mL; mg/20mL","","N","20251231"
"4848","CILASTATIN SODIUM; IMIPENEM","Imipenem and Cilastatin Sodium","63323034993","Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]","63323-349","63323-349-93","63323-349_2bb9b6ad-8e8d-4667-b108-b57a8c16318f","HUMAN PRESCRIPTION DRUG","Imipenem and Cilastatin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20120103","","ANDA","ANDA090577","Fresenius Kabi USA, LLC","250; 250","mg/20mL; mg/20mL","","N","20251231"
"4849","RIFAMPIN","RIFAMPIN","63323035120","Rifamycin Antibacterial [EPC], Rifamycins [CS]","63323-351","63323-351-20","63323-351_60eb9c46-3c34-455b-a740-c03884565072","HUMAN PRESCRIPTION DRUG","Rifampin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20140821","","ANDA","ANDA091181","Fresenius Kabi USA, LLC","600","mg/1","","N","20251231"
"4850","CASPOFUNGIN ACETATE","Caspofungin Acetate","63323035610","Echinocandin Antifungal [EPC], Lipopeptides [CS]","63323-356","63323-356-10","63323-356_effb4d5b-582a-4b93-a15a-aaeb773018ce","HUMAN PRESCRIPTION DRUG","Caspofungin Acetate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20161230","","NDA","NDA206110","Fresenius Kabi USA, LLC","5","mg/mL","","N","20251231"
"4851","CASPOFUNGIN ACETATE","Caspofungin Acetate","63323035810","Echinocandin Antifungal [EPC], Lipopeptides [CS]","63323-358","63323-358-10","63323-358_effb4d5b-582a-4b93-a15a-aaeb773018ce","HUMAN PRESCRIPTION DRUG","Caspofungin Acetate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20161230","","NDA","NDA206110","Fresenius Kabi USA, LLC","7","mg/mL","","N","20251231"
"4852","POLYMYXIN B SULFATE","Polymyxin B Sulfate","63323036744","Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","63323-367","63323-367-44","63323-367_5cf9b65b-6df4-42f8-b395-d0cf0a1003d3","HUMAN PRESCRIPTION DRUG","Polymyxin B","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS","20150909","","ANDA","ANDA202766","Fresenius Kabi USA, LLC","500000","[USP'U]/1","","N","20251231"
"4853","DAPTOMYCIN","Daptomycin","63323037119","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","63323-371","63323-371-19","63323-371_7b38aacb-d9c9-47db-a6fe-7e7d938fcd69","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180411","","ANDA","ANDA206077","Fresenius Kabi USA, LLC","500","mg/10mL","","N","20251231"
"4854","DAPTOMYCIN","Daptomycin","63323037110","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","63323-371","63323-371-10","63323-371_7b38aacb-d9c9-47db-a6fe-7e7d938fcd69","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180411","","ANDA","ANDA206077","Fresenius Kabi USA, LLC","500","mg/10mL","","N","20251231"
"4855","CEFOTETAN DISODIUM","CEFOTETAN DISODIUM","63323038510","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63323-385","63323-385-10","63323-385_a30c7fcf-f9c0-4b38-bfed-fbd3b1a3e2f8","HUMAN PRESCRIPTION DRUG","Cefotetan","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20091118","","ANDA","ANDA065374","Fresenius Kabi USA, LLC","1","g/10mL","","N","20261231"
"4856","CEFOTETAN DISODIUM","CEFOTETAN DISODIUM","63323038620","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63323-386","63323-386-20","63323-386_a30c7fcf-f9c0-4b38-bfed-fbd3b1a3e2f8","HUMAN PRESCRIPTION DRUG","Cefotetan","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20091118","","ANDA","ANDA065374","Fresenius Kabi USA, LLC","2","g/20mL","","N","20261231"
"4857","COLISTIMETHATE SODIUM","COLISTIMETHATE SODIUM","63323039306","Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","63323-393","63323-393-06","63323-393_4637a207-5042-4af6-a7a7-e63cd472b0d3","HUMAN PRESCRIPTION DRUG","Colistimethate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20091204","","ANDA","ANDA065364","Fresenius Kabi USA, LLC","150","mg/2mL","","N","20251231"
"4858","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN MONOHYDRATE","63323039814","Macrolide Antimicrobial [EPC], Macrolides [CS]","63323-398","63323-398-14","63323-398_68f27342-2536-4b06-95f5-24ae83ba7e12","HUMAN PRESCRIPTION DRUG","Azithromycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20060320","","ANDA","ANDA065179","Fresenius Kabi USA, LLC","500","mg/5mL","","N","20251231"
"4859","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN MONOHYDRATE","63323039812","Macrolide Antimicrobial [EPC], Macrolides [CS]","63323-398","63323-398-12","63323-398_68f27342-2536-4b06-95f5-24ae83ba7e12","HUMAN PRESCRIPTION DRUG","Azithromycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20060320","","ANDA","ANDA065179","Fresenius Kabi USA, LLC","500","mg/5mL","","N","20251231"
"4860","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN MONOHYDRATE","63323039810","Macrolide Antimicrobial [EPC], Macrolides [CS]","63323-398","63323-398-10","63323-398_68f27342-2536-4b06-95f5-24ae83ba7e12","HUMAN PRESCRIPTION DRUG","Azithromycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20060320","","ANDA","ANDA065179","Fresenius Kabi USA, LLC","500","mg/5mL","","N","20251231"
"4861","AZTREONAM","AZTREONAM","63323040124","Monobactam Antibacterial [EPC], Monobactams [CS]","63323-401","63323-401-24","63323-401_b6926b10-085f-4255-b4f1-24572a7ef57a","HUMAN PRESCRIPTION DRUG","Aztreonam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20091105","","ANDA","ANDA065439","Fresenius Kabi USA, LLC","1","g/1","","N","20251231"
"4862","AZTREONAM","AZTREONAM","63323040120","Monobactam Antibacterial [EPC], Monobactams [CS]","63323-401","63323-401-20","63323-401_b6926b10-085f-4255-b4f1-24572a7ef57a","HUMAN PRESCRIPTION DRUG","Aztreonam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20091105","","ANDA","ANDA065439","Fresenius Kabi USA, LLC","1","g/1","","N","20251231"
"4863","AZTREONAM","AZTREONAM","63323040126","Monobactam Antibacterial [EPC], Monobactams [CS]","63323-401","63323-401-26","63323-401_b6926b10-085f-4255-b4f1-24572a7ef57a","HUMAN PRESCRIPTION DRUG","Aztreonam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20091105","","ANDA","ANDA065439","Fresenius Kabi USA, LLC","1","g/1","","N","20251231"
"4864","AZTREONAM","AZTREONAM","63323040220","Monobactam Antibacterial [EPC], Monobactams [CS]","63323-402","63323-402-20","63323-402_8fe750bd-6416-428f-9184-7b15c7fe9d45","HUMAN PRESCRIPTION DRUG","Aztreonam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20091105","","ANDA","ANDA065439","Fresenius Kabi USA, LLC","2","g/1","","N","20251231"
"4865","AZTREONAM","AZTREONAM","63323040224","Monobactam Antibacterial [EPC], Monobactams [CS]","63323-402","63323-402-24","63323-402_8fe750bd-6416-428f-9184-7b15c7fe9d45","HUMAN PRESCRIPTION DRUG","Aztreonam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20091105","","ANDA","ANDA065439","Fresenius Kabi USA, LLC","2","g/1","","N","20251231"
"4866","AZTREONAM","AZTREONAM","63323040230","Monobactam Antibacterial [EPC], Monobactams [CS]","63323-402","63323-402-30","63323-402_8fe750bd-6416-428f-9184-7b15c7fe9d45","HUMAN PRESCRIPTION DRUG","Aztreonam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20091105","","ANDA","ANDA065439","Fresenius Kabi USA, LLC","2","g/1","","N","20251231"
"4867","MEROPENEM","Meropenem","63323050721","Carbapenems [CS], Penem Antibacterial [EPC]","63323-507","63323-507-21","63323-507_f5b64ff4-85ce-416b-865a-c35ff4cfda42","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20111014","","ANDA","ANDA091404","Fresenius Kabi USA, LLC","500","mg/10mL","","N","20251231"
"4868","MEROPENEM","Meropenem","63323050725","Carbapenems [CS], Penem Antibacterial [EPC]","63323-507","63323-507-25","63323-507_f5b64ff4-85ce-416b-865a-c35ff4cfda42","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20111014","","ANDA","ANDA091404","Fresenius Kabi USA, LLC","500","mg/10mL","","N","20251231"
"4869","MEROPENEM","Meropenem","63323050720","Carbapenems [CS], Penem Antibacterial [EPC]","63323-507","63323-507-20","63323-507_f5b64ff4-85ce-416b-865a-c35ff4cfda42","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20111014","","ANDA","ANDA091404","Fresenius Kabi USA, LLC","500","mg/10mL","","N","20251231"
"4870","MEROPENEM","Meropenem","63323050825","Carbapenems [CS], Penem Antibacterial [EPC]","63323-508","63323-508-25","63323-508_8fe3d813-4656-49d6-ad91-6a075f3d3a82","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20111026","","ANDA","ANDA091404","Fresenius Kabi USA, LLC","1","g/20mL","","N","20251231"
"4871","MEROPENEM","Meropenem","63323050830","Carbapenems [CS], Penem Antibacterial [EPC]","63323-508","63323-508-30","63323-508_8fe3d813-4656-49d6-ad91-6a075f3d3a82","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20111026","","ANDA","ANDA091404","Fresenius Kabi USA, LLC","1","g/20mL","","N","20251231"
"4872","MEROPENEM","Meropenem","63323050831","Carbapenems [CS], Penem Antibacterial [EPC]","63323-508","63323-508-31","63323-508_8fe3d813-4656-49d6-ad91-6a075f3d3a82","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20111026","","ANDA","ANDA091404","Fresenius Kabi USA, LLC","1","g/20mL","","N","20251231"
"4873","POSACONAZOLE","Posaconazole","63323068517","Azole Antifungal [EPC], Azoles [CS]","63323-685","63323-685-17","63323-685_3ed81dc8-a1e0-4513-be2a-7a16aea62198","HUMAN PRESCRIPTION DRUG","Posaconazole","","INJECTION, SOLUTION","INTRAVENOUS","20231226","","ANDA","ANDA209983","Fresensius Kabi USA, LLC","18","mg/mL","","N","20251231"
"4874","LINEZOLID","Linezolid","63323071313","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","63323-713","63323-713-13","63323-713_d151d608-d9c5-4b78-b99b-f0cb53e6c439","HUMAN PRESCRIPTION DRUG","Linezolid","","INJECTION, SOLUTION","INTRAVENOUS","20150622","","ANDA","ANDA204764","Fresenius Kabi USA, LLC","2","mg/mL","","N","20251231"
"4875","MICAFUNGIN SODIUM","Micafungin Sodium","63323072810","Echinocandin Antifungal [EPC], Lipopeptides [CS]","63323-728","63323-728-10","63323-728_277f28dd-4ca7-408b-b612-91d950170665","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200508","","ANDA","ANDA207344","Fresenius Kabi USA, LLC","50","mg/1","","N","20251231"
"4876","MICAFUNGIN SODIUM","Micafungin Sodium","63323072910","Echinocandin Antifungal [EPC], Lipopeptides [CS]","63323-729","63323-729-10","63323-729_e8fcf6a2-1a58-4a13-9290-1fc0d4fecfd1","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200508","","ANDA","ANDA207344","Fresenius Kabi USA, LLC","100","mg/1","","N","20251231"
"4877","MICAFUNGIN SODIUM","Micafungin Sodium","63323072912","Echinocandin Antifungal [EPC], Lipopeptides [CS]","63323-729","63323-729-12","63323-729_e8fcf6a2-1a58-4a13-9290-1fc0d4fecfd1","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200508","","ANDA","ANDA207344","Fresenius Kabi USA, LLC","100","mg/1","","N","20251231"
"4878","OXACILLIN SODIUM","Oxacillin Sodium","63323081100","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63323-811","63323-811-00","63323-811_f28ac591-52e8-4c3f-93a8-8b5174b97d97","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20201101","","ANDA","ANDA206199","Fresenius Kabi USA, LLC","10","g/100mL","","N","20251231"
"4879","OXACILLIN SODIUM","Oxacillin","63323081220","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63323-812","63323-812-20","63323-812_c7907a70-1efa-46eb-b046-fcf043fdb413","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20201101","","ANDA","ANDA206198","Fresenius Kabi USA, LLC","2","g/20mL","","N","20251231"
"4880","OXACILLIN SODIUM","Oxacillin","63323081320","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63323-813","63323-813-20","63323-813_c7907a70-1efa-46eb-b046-fcf043fdb413","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20201101","","ANDA","ANDA206198","Fresenius Kabi USA, LLC","1","g/20mL","","N","20251231"
"4881","AMIKACIN SULFATE","Amikacin Sulfate","63323081504","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63323-815","63323-815-04","63323-815_04612f35-e6fb-4937-bdfe-32105876c5b6","HUMAN PRESCRIPTION DRUG","Amikacin Sulfate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20151209","","ANDA","ANDA205604","Fresenius Kabi USA, LLC","250","mg/mL","","N","20251231"
"4882","AMIKACIN SULFATE","Amikacin Sulfate","63323081502","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","63323-815","63323-815-02","63323-815_04612f35-e6fb-4937-bdfe-32105876c5b6","HUMAN PRESCRIPTION DRUG","Amikacin Sulfate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20151209","","ANDA","ANDA205604","Fresenius Kabi USA, LLC","250","mg/mL","","N","20251231"
"4883","ERTAPENEM SODIUM","Ertapenem Sodium","63323082320","Carbapenems [CS], Penem Antibacterial [EPC]","63323-823","63323-823-20","63323-823_8a08dc4b-9129-4b04-b586-19ca10abeafb","HUMAN PRESCRIPTION DRUG","Ertapenem","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20191010","","ANDA","ANDA208790","Fresenius Kabi USA, LLC","1","g/1","","N","20251231"
"4884","MOXIFLOXACIN HYDROCHLORIDE","MOXIFLOXACIN HYDROCHLORIDE","63323085004","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63323-850","63323-850-04","63323-850_4070f637-059f-4e3d-8cf3-e5256a46ff3e","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","INJECTION, SOLUTION","INTRAVENOUS","20150318","","NDA","NDA205572","Fresenius Kabi USA, LLC","400","mg/250mL","","N","20251231"
"4885","PENTAMIDINE ISETHIONATE","PENTAMIDINE ISETHIONATE","63323087715","Antiprotozoal [EPC]","63323-877","63323-877-15","63323-877_d673c124-d95f-4751-a11a-a26de8740b3a","HUMAN PRESCRIPTION DRUG","NebuPent","","INHALANT","RESPIRATORY (INHALATION)","20110215","","NDA","NDA019887","Fresenius Kabi USA, LLC","300","mg/6mL","","N","20251231"
"4886","TIGECYCLINE","Tigecycline","63323096010","Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]","63323-960","63323-960-10","63323-960_0a2a6def-f494-41f8-8125-4296924b1753","HUMAN PRESCRIPTION DRUG","Tigecycline","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20161201","","NDA","NDA205645","Fresenius Kabi USA, LLC","50","mg/5mL","","N","20251231"
"4887","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","63323098121","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63323-981","63323-981-21","63323-981_0802b499-4d2a-43ad-8fea-ad80b6738a46","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180518","","ANDA","ANDA203719","Fresenius Kabi USA, LLC","2; .25","g/10mL; g/10mL","","N","20251231"
"4888","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","63323098153","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63323-981","63323-981-53","63323-981_0802b499-4d2a-43ad-8fea-ad80b6738a46","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180518","","ANDA","ANDA203719","Fresenius Kabi USA, LLC","2; .25","g/10mL; g/10mL","","N","20251231"
"4889","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","63323098254","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63323-982","63323-982-54","63323-982_6487ad37-921c-4994-bef4-38854cdecec9","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180518","","ANDA","ANDA203719","Fresenius Kabi USA, LLC","4; .5","g/20mL; g/20mL","","N","20251231"
"4890","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","63323098252","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63323-982","63323-982-52","63323-982_6487ad37-921c-4994-bef4-38854cdecec9","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180518","","ANDA","ANDA203719","Fresenius Kabi USA, LLC","4; .5","g/20mL; g/20mL","","N","20251231"
"4891","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","63323098321","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63323-983","63323-983-21","63323-983_0802b499-4d2a-43ad-8fea-ad80b6738a46","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180518","","ANDA","ANDA203719","Fresenius Kabi USA, LLC","3; .375","g/15mL; g/15mL","","N","20251231"
"4892","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","63323098353","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63323-983","63323-983-53","63323-983_0802b499-4d2a-43ad-8fea-ad80b6738a46","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180518","","ANDA","ANDA203719","Fresenius Kabi USA, LLC","3; .375","g/15mL; g/15mL","","N","20251231"
"4893","MICONAZOLE NITRATE","MICONAZOLE NITRATE","63347081001","Azole Antifungal [EPC], Azoles [CS]","63347-810","63347-810-01","63347-810_27a77fc1-4426-4d60-822b-3d85a0560f13","HUMAN OTC DRUG","Vite20","","LIQUID","TOPICAL","20160401","","OTC MONOGRAPH DRUG","M005","Blaine Labs Inc.",".3","mg/15mL","","N","20251231"
"4894","ACETIC ACID; ANHYDROUS CITRIC ACID; ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; CALCIUM SULFATE ANHYDROUS; CARPINUS BETULUS FLOWER; CEANOTHUS AMERICANUS LEAF; CERATOSTIGMA WILLMOTTIANUM FLOWER; GENTIANELLA AMARELLA FLOWER; HYDROFLUORIC ACID; JUGLANS REGIA FLOWERING TOP; LACTIC ACID, DL-; LACTIC ACID, L-; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OLEA EUROPAEA FLOWER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORIC ACID; QUININE ARSENITE; SODIUM CHLORIDE; SODIUM HEXAFLUOROSILICATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; ULMUS PROCERA FLOWERING TWIG","ACETICUM ACIDUM, ARNICA MONTANA, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CEANOTHUS AMERICANUS, CERATOSTIGMA ILLMOTTIANUM, CHININUM ARSENICOSUM, CITRICUM ACIDUM, ENGLISH ELM, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, HYDROFLUORICUM ACIDUM, JUGLANS REGIA, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SILICOFLUORICUM, NATRUM SULPHURICUM, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREA","63479010101","Acidifying Activity [MoA], Anti-coagulant [EPC], Antimalarial [EPC], Blood Coagulation Factor [EPC], Calcium Chelating Activity [MoA], Calcium [CS], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Decreased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]","63479-0101","63479-0101-1","63479-0101_0e7630cb-8c84-6d0e-e063-6394a90ace15","HUMAN OTC DRUG","A01","CELLULAR RECHARGE","SOLUTION/ DROPS","SUBLINGUAL","19941215","","UNAPPROVED HOMEOPATHIC","","Apex Energetics Inc.","30; 30; 12; 1; 12; 9; 4; 12; 12; 30; 9; 15; 15; 15; 12; 15; 1; 30; 15; 30; 8; 12; 10; 1; 15; 12","[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"4895","ACETIC ACID; AMERICAN GINSENG; ARNICA MONTANA; BALSAM PERU; BOS TAURUS PITUITARY GLAND, POSTERIOR; CARPINUS BETULUS FLOWER; CINCHONA OFFICINALIS BARK; CLEMATIS VITALBA FLOWER; DIBASIC POTASSIUM PHOSPHATE; EPINEPHRINE; GLYCYRRHIZA GLABRA; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PHOSPHORIC ACID; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; QUININE ARSENITE; SELENIUM; THYROID, UNSPECIFIED; TURNERA DIFFUSA LEAFY TWIG","ACETICUM ACIDUM, ADRENALINUM, AMERICAN GINSENG, ARNICA MONTANA, BALSAMUM PERUVIANUM, BOS TAURUS PITUITARUM POSTERIUM, CHERRY PLUM FLOWER, CHININUM ARSENICOSUM, CINCHONA OFFICINALIS, CLEMATIS VITALBA FLOWER, DAMIANA, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE FLOWER, GLYCYRRHIZA GLABRA, IMPATIENS GLANDULIFERA FLOWER, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYRENEES STAR OF BETHLEHEM, ROCKROSE FLOWER, SELENIUM METALLICUM, THYROIDINUM","63479020201","Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Antimalarial [EPC], Calculi Dissolution Agent [EPC], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]","63479-0202","63479-0202-1","63479-0202_0e769d13-23f1-f61f-e063-6294a90a8cd1","HUMAN OTC DRUG","B02","ADRENAL PEP","SOLUTION/ DROPS","SUBLINGUAL","19941215","","UNAPPROVED HOMEOPATHIC","","Apex Energetics Inc.","30; 2; 12; 9; 15; 8; 12; 8; 12; 6; 1; 8; 8; 12; 12; 8; 8; 30; 30; 8; 12; 15; 6; 1","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"4896","ACTAEA SPICATA ROOT; AMMONIUM BENZOATE; ARNICA MONTANA; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COMFREY ROOT; ECHINACEA PURPUREA; FORMICA RUFA; FRAXINUS EXCELSIOR LEAF; LACTIC ACID, DL-; LACTIC ACID, L-; PULSATILLA VULGARIS WHOLE; QUININE SULFATE; RHODODENDRON AUREUM LEAF; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; SOLANUM DULCAMARA WHOLE; TOXICODENDRON PUBESCENS LEAF; URIC ACID","ACTAEA SPICATA, AMMONIUM BENZOICUM, ARNICA MONTANA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CHELIDONIUM MAJUS, CHININUM SULPHURICUM, DULCAMARA LIGNOSA WHOLE, ECHINACEA PURPUREA, FORMICA RUFA, FRAXINUS EXCELSIOR LEAF, LACTICUM ACIDUM, LEDUM PALUSTRE, PULSATILLA VULGARIS, RHODODENDRON CHRYSANTHUM, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALE, URICUM ACIDUM","63479030401","Antimalarial [EPC]","63479-0304","63479-0304-1","63479-0304_0e76cd12-9f3e-c98f-e063-6394a90ad9fb","HUMAN OTC DRUG","C04","ARTHRO MUSCOTOX","SOLUTION/ DROPS","SUBLINGUAL","19941215","","UNAPPROVED HOMEOPATHIC","","Apex Energetics Inc.","12; 9; 30; 12; 1; 30; 1; 9; 1; 30; 1; 30; 15; 30; 9; 12; 6; 9; 30; 30; 15","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"4897","ACONITUM NAPELLUS; AMERICAN GINSENG; ARABICA COFFEE BEAN; COLCHICUM AUTUMNALE BULB; CRATAEGUS LAEVIGATA FRUIT; ECHINACEA PURPUREA; ESCHSCHOLZIA CALIFORNICA; GELSEMIUM SEMPERVIRENS ROOT; HOPS; LYCOPUS VIRGINICUS; PASSIFLORA INCARNATA TOP; QUININE ARSENITE; SCUTELLARIA LATERIFLORA WHOLE; STRYCHNINE PHOSPHATE DIHYDRATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THYROID, UNSPECIFIED; VISCUM ALBUM FRUITING TOP","ACONITUM NAPELLUS, ARALIA QUINQUEFOLIA, CHININUM ARSENICOSUM, COFFEA CRUDA, COLCHICUM AUTUMNALE, CRATAEGUS OXYACANTHA FRUIT, ECHINACEA PURPUREA, ESCHSCHOLTZIA CALIFORNICA, HUMULUS LUPULUS, IGNATIA AMARA, LYCOPUS VIRGINICUS, NUX VOMICA, PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, STRYCHNINUM PHOSPHORICUM, THYROIDINUM, VISCUM ALBUM FRUITING TOP, YELLOW JASMINE ROOT","63479050701","Allergens [CS], Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]","63479-0507","63479-0507-1","63479-0507_0e892003-98dd-bbc6-e063-6294a90a5233","HUMAN OTC DRUG","E07","TYPE A BALANCE","SOLUTION/ DROPS","SUBLINGUAL","20231016","","UNAPPROVED HOMEOPATHIC","","Apex Energetics Inc.","8; 15; 12; 12; 4; 3; 1; 12; 1; 1; 1; 6; 1; 12; 8; 12; 9; 3","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL","","N","20251231"
"4898","ACER NIGRUM WHOLE; AESCULUS HIPPOCASTANUM FLOWER; ALFALFA; ALOE VERA FLOWER; AMERICAN GINSENG; ANAGALLIS ARVENSIS EXTRACT; ARNICA MONTANA FLOWER; BORAGO OFFICINALIS FLOWER; CAPSICUM; CARPINUS BETULUS FLOWER; CHASTE TREE; CORNUS NUTTALLII WHOLE; FUCHSIA MAGELLANICA WHOLE; IRIS MISSOURIENSIS WHOLE; NELUMBO NUCIFERA FLOWER; OLEA EUROPAEA FLOWER; PHOSPHORIC ACID; PRUNELLA VULGARIS FLOWER; PRUNUS PERSICA FLOWER; QUININE ARSENITE; RUDBECKIA HIRTA WHOLE; STRYCHNOS NUX-VOMICA SEED; SYRINGA VULGARIS FLOWER; TROPAEOLUM MAJUS FLOWER; ULMUS PROCERA FLOWERING TWIG; UMBELLULARIA CALIFORNICA WHOLE; VERBENA OFFICINALIS FLOWERING TOP; ZINNIA ELEGANS WHOLE","ACER NIGRUM, AESCULUS HIPPOCASTANUM, AGNUS CASTUS, ALFALFA, ALOE VERA, AMERICAN GINSENG, ARNICA MONTANA, BORAGE FLOWER, CAYENNE, CHININUM ARSENICOSUM, CORNUS NUTTALLII, ENGLISH ELM, EUROPEAN HORNBEAM, EUROPEAN HORSE CHESTNUT, EUROPEAN OLIVE, FUCHSIA, IRIS MISSOURIENSIS, LILAC, NASTURTIUM, NELUMBO NUCIFERA, NUX VOMICA, PEACH FLOWER, PHOSPHORICUM ACIDUM, PRUNELLA VULGARIS, RUDBECKIA HIRTA, SCARLET PIMPERNEL, SPICEBUSH, VERBENA OFFICINALIS, ZINNIA ELEGANS","63479062001","Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]","63479-0620","63479-0620-1","63479-0620_0e7707c6-b7c9-adf7-e063-6294a90a60bc","HUMAN OTC DRUG","F20","VTLTY","SOLUTION/ DROPS","SUBLINGUAL","19960312","","UNAPPROVED HOMEOPATHIC","","Apex Energetics Inc.","12; 12; 4; 12; 4; 12; 12; 12; 12; 12; 4; 12; 12; 12; 12; 12; 12; 12; 12; 9; 12; 12; 12; 12; 12; 12; 12; 12","[hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL","","N","20251231"
"4899","ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CHELIDONIUM MAJUS; EPINEPHRINE; GOLD; HYPERICUM PERFORATUM; NICKEL; PASSIFLORA INCARNATA TOP; QUININE ARSENITE; SARSAPARILLA; SILICON DIOXIDE; SILVER NITRATE; SODIUM FLUORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; ZINC VALERATE DIHYDRATE","ADRENALINUM, ARGENTUM NITRICUM, ARNICA MONTANA, AURUM METALLICUM, AVENA SATIVA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, CHININUM ARSENICOSUM, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, NATRUM FLUORATUM, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARSAPARILLA, SILICEA, SOLIDAGO VIRGAUREA, THUJA OCCIDENTALIS, ZINCUM VALERIANICUM","63479140101","Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Antimalarial [EPC], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]","63479-1401","63479-1401-1","63479-1401_0e77063c-fc41-cee6-e063-6394a90a0d54","HUMAN OTC DRUG","N01","PROTOMER","SOLUTION/ DROPS","SUBLINGUAL","19970715","","UNAPPROVED HOMEOPATHIC","","Apex Energetics Inc.","12; 1; 1; 12; 1; 4; 30; 3; 15; 1; 12; 2; 20; 15; 12; 1; 12; 12","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"4900","ARTEMISIA CINA FLOWER; BARIUM IODIDE; BERBERIS VULGARIS ROOT BARK; CHENOPODIUM AMBROSIOIDES; CINCHONA OFFICINALIS BARK; CROTON TIGLIUM SEED; ECHINACEA ANGUSTIFOLIA; FRANGULA PURSHIANA BARK; GARLIC; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; ONION; QUININE ARSENITE; SANTONIN; SCROPHULARIA NODOSA; SENNA LEAF; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STAR ANISE; SULFUR; TANACETUM VULGARE TOP; TEUCRIUM MARUM","ALLIUM CEPA, ALLIUM SATIVUM, BARYTA IODATA, BERBERIS VULGARIS, CARDUUS MARIANUS, CHENOPODIUM ANTHELMINTICUM, CHININUM ARSENICOSUM, CINA, CINCHONA OFFICINALIS, CROTON TIGLIUM, ECHINACEA ANGUSTIFOLIA, HYDRASTIS CANADENSIS, ILLICIUM ANISATUM, LYCOPODIUM CLAVATUM, NATRUM PHOSPHORICUM, RHAMNUS PURSHIANA, SANTONINUM, SCROPHULARIA NODOSA, SENNA, SULPHUR, TANACETUM VULGARE, TEUCRIUM MARUM","63479141001","Allergens [CS], Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Vegetable Proteins [CS]","63479-1410","63479-1410-1","63479-1410_0e7729de-104d-e578-e063-6394a90a7de6","HUMAN OTC DRUG","N10","PARAKLENZ","SOLUTION/ DROPS","SUBLINGUAL","19941215","","UNAPPROVED HOMEOPATHIC","","Apex Energetics Inc.","6; 10; 1; 1; 9; 3; 1; 1; 1; 1; 12; 1; 1; 9; 8; 3; 1; 12; 2; 9; 8; 8","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"4901","COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE","colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate","63481052910","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","63481-529","63481-529-10","63481-529_c570a9f5-b572-454d-a349-5c35fd9c8f9e","HUMAN PRESCRIPTION DRUG","Cortisporin TC","","SUSPENSION","AURICULAR (OTIC)","20190603","","NDA","NDA050356","Endo USA, Inc.","3; 10; 3.3; .5","mg/mL; mg/mL; mg/mL; mg/mL","","N","20251231"
"4902","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","63629101002","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1010","63629-1010-2","63629-1010_fc632cb9-a546-07a9-e053-6394a90a63b9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4903","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","63629101003","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1010","63629-1010-3","63629-1010_fc632cb9-a546-07a9-e053-6394a90a63b9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4904","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","63629101004","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1010","63629-1010-4","63629-1010_fc632cb9-a546-07a9-e053-6394a90a63b9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4905","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","63629101006","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1010","63629-1010-6","63629-1010_fc632cb9-a546-07a9-e053-6394a90a63b9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4906","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","63629101007","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1010","63629-1010-7","63629-1010_fc632cb9-a546-07a9-e053-6394a90a63b9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4907","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","63629101008","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1010","63629-1010-8","63629-1010_fc632cb9-a546-07a9-e053-6394a90a63b9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4908","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","63629101001","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1010","63629-1010-1","63629-1010_fc632cb9-a546-07a9-e053-6394a90a63b9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4909","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","63629101005","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1010","63629-1010-5","63629-1010_fc632cb9-a546-07a9-e053-6394a90a63b9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4910","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629132600","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1326","63629-1326-0","63629-1326_c259ec99-1ba0-4596-9bd5-ea8bffaad102","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4911","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629132602","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1326","63629-1326-2","63629-1326_c259ec99-1ba0-4596-9bd5-ea8bffaad102","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4912","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629132603","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1326","63629-1326-3","63629-1326_c259ec99-1ba0-4596-9bd5-ea8bffaad102","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4913","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629132604","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1326","63629-1326-4","63629-1326_c259ec99-1ba0-4596-9bd5-ea8bffaad102","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4914","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629132606","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1326","63629-1326-6","63629-1326_c259ec99-1ba0-4596-9bd5-ea8bffaad102","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4915","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629132607","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1326","63629-1326-7","63629-1326_c259ec99-1ba0-4596-9bd5-ea8bffaad102","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4916","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629132608","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1326","63629-1326-8","63629-1326_c259ec99-1ba0-4596-9bd5-ea8bffaad102","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4917","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629132601","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1326","63629-1326-1","63629-1326_c259ec99-1ba0-4596-9bd5-ea8bffaad102","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4918","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629132609","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1326","63629-1326-9","63629-1326_c259ec99-1ba0-4596-9bd5-ea8bffaad102","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4919","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629132605","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1326","63629-1326-5","63629-1326_c259ec99-1ba0-4596-9bd5-ea8bffaad102","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4920","METRONIDAZOLE","Metronidazole","63629138600","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1386","63629-1386-0","63629-1386_7a0f2236-cf51-409f-94f9-ce62135b27ca","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4921","METRONIDAZOLE","Metronidazole","63629138603","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1386","63629-1386-3","63629-1386_7a0f2236-cf51-409f-94f9-ce62135b27ca","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4922","METRONIDAZOLE","Metronidazole","63629138604","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1386","63629-1386-4","63629-1386_7a0f2236-cf51-409f-94f9-ce62135b27ca","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4923","METRONIDAZOLE","Metronidazole","63629138601","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1386","63629-1386-1","63629-1386_7a0f2236-cf51-409f-94f9-ce62135b27ca","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4924","METRONIDAZOLE","Metronidazole","63629138602","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1386","63629-1386-2","63629-1386_7a0f2236-cf51-409f-94f9-ce62135b27ca","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4925","METRONIDAZOLE","Metronidazole","63629138607","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1386","63629-1386-7","63629-1386_7a0f2236-cf51-409f-94f9-ce62135b27ca","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4926","METRONIDAZOLE","Metronidazole","63629138608","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1386","63629-1386-8","63629-1386_7a0f2236-cf51-409f-94f9-ce62135b27ca","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4927","METRONIDAZOLE","Metronidazole","63629138609","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1386","63629-1386-9","63629-1386_7a0f2236-cf51-409f-94f9-ce62135b27ca","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4928","METRONIDAZOLE","Metronidazole","63629138606","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1386","63629-1386-6","63629-1386_7a0f2236-cf51-409f-94f9-ce62135b27ca","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4929","METRONIDAZOLE","Metronidazole","63629138605","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1386","63629-1386-5","63629-1386_7a0f2236-cf51-409f-94f9-ce62135b27ca","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4930","METRONIDAZOLE","Metronidazole","63629138802","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1388","63629-1388-2","63629-1388_e2a4bade-0163-4eed-8887-2fa27de3e0b8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4931","METRONIDAZOLE","Metronidazole","63629138803","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1388","63629-1388-3","63629-1388_e2a4bade-0163-4eed-8887-2fa27de3e0b8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4932","METRONIDAZOLE","Metronidazole","63629138804","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1388","63629-1388-4","63629-1388_e2a4bade-0163-4eed-8887-2fa27de3e0b8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4933","METRONIDAZOLE","Metronidazole","63629138801","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1388","63629-1388-1","63629-1388_e2a4bade-0163-4eed-8887-2fa27de3e0b8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4934","METRONIDAZOLE","Metronidazole","63629138806","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1388","63629-1388-6","63629-1388_e2a4bade-0163-4eed-8887-2fa27de3e0b8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4935","METRONIDAZOLE","Metronidazole","63629138807","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1388","63629-1388-7","63629-1388_e2a4bade-0163-4eed-8887-2fa27de3e0b8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4936","METRONIDAZOLE","Metronidazole","63629138808","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1388","63629-1388-8","63629-1388_e2a4bade-0163-4eed-8887-2fa27de3e0b8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4937","METRONIDAZOLE","Metronidazole","63629138805","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1388","63629-1388-5","63629-1388_e2a4bade-0163-4eed-8887-2fa27de3e0b8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4938","METRONIDAZOLE","Metronidazole","63629138809","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1388","63629-1388-9","63629-1388_e2a4bade-0163-4eed-8887-2fa27de3e0b8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4939","METRONIDAZOLE","Metronidazole","63629138800","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-1388","63629-1388-0","63629-1388_e2a4bade-0163-4eed-8887-2fa27de3e0b8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4940","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629172401","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1724","63629-1724-1","63629-1724_983cdd28-ed3c-4a67-8b8f-688e27da81d3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4941","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629172402","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1724","63629-1724-2","63629-1724_983cdd28-ed3c-4a67-8b8f-688e27da81d3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4942","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629172400","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1724","63629-1724-0","63629-1724_983cdd28-ed3c-4a67-8b8f-688e27da81d3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4943","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629172405","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1724","63629-1724-5","63629-1724_983cdd28-ed3c-4a67-8b8f-688e27da81d3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4944","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629172406","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1724","63629-1724-6","63629-1724_983cdd28-ed3c-4a67-8b8f-688e27da81d3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4945","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629172407","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1724","63629-1724-7","63629-1724_983cdd28-ed3c-4a67-8b8f-688e27da81d3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4946","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629172404","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1724","63629-1724-4","63629-1724_983cdd28-ed3c-4a67-8b8f-688e27da81d3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4947","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629172409","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1724","63629-1724-9","63629-1724_983cdd28-ed3c-4a67-8b8f-688e27da81d3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4948","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629172408","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1724","63629-1724-8","63629-1724_983cdd28-ed3c-4a67-8b8f-688e27da81d3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4949","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629172403","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-1724","63629-1724-3","63629-1724_983cdd28-ed3c-4a67-8b8f-688e27da81d3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4950","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","63629174800","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63629-1748","63629-1748-0","63629-1748_2b80e248-f12d-44f1-aa6d-c4548efda3d8","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"4951","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","63629174801","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63629-1748","63629-1748-1","63629-1748_2b80e248-f12d-44f1-aa6d-c4548efda3d8","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"4952","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","63629174803","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63629-1748","63629-1748-3","63629-1748_2b80e248-f12d-44f1-aa6d-c4548efda3d8","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"4953","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","63629174804","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63629-1748","63629-1748-4","63629-1748_2b80e248-f12d-44f1-aa6d-c4548efda3d8","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"4954","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","63629174805","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63629-1748","63629-1748-5","63629-1748_2b80e248-f12d-44f1-aa6d-c4548efda3d8","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"4955","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","63629174807","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63629-1748","63629-1748-7","63629-1748_2b80e248-f12d-44f1-aa6d-c4548efda3d8","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"4956","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","63629174808","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63629-1748","63629-1748-8","63629-1748_2b80e248-f12d-44f1-aa6d-c4548efda3d8","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"4957","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","63629174809","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63629-1748","63629-1748-9","63629-1748_2b80e248-f12d-44f1-aa6d-c4548efda3d8","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"4958","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","63629174806","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63629-1748","63629-1748-6","63629-1748_2b80e248-f12d-44f1-aa6d-c4548efda3d8","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"4959","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","63629174802","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63629-1748","63629-1748-2","63629-1748_2b80e248-f12d-44f1-aa6d-c4548efda3d8","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"4960","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63629176500","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63629-1765","63629-1765-0","63629-1765_a903d079-327d-475b-953f-045f458657e5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"4961","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63629176502","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63629-1765","63629-1765-2","63629-1765_a903d079-327d-475b-953f-045f458657e5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"4962","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63629176504","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63629-1765","63629-1765-4","63629-1765_a903d079-327d-475b-953f-045f458657e5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"4963","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63629176505","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63629-1765","63629-1765-5","63629-1765_a903d079-327d-475b-953f-045f458657e5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"4964","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63629176506","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63629-1765","63629-1765-6","63629-1765_a903d079-327d-475b-953f-045f458657e5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"4965","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63629176503","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63629-1765","63629-1765-3","63629-1765_a903d079-327d-475b-953f-045f458657e5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"4966","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63629176508","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63629-1765","63629-1765-8","63629-1765_a903d079-327d-475b-953f-045f458657e5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"4967","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63629176509","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63629-1765","63629-1765-9","63629-1765_a903d079-327d-475b-953f-045f458657e5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"4968","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63629176501","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63629-1765","63629-1765-1","63629-1765_a903d079-327d-475b-953f-045f458657e5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"4969","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","63629176507","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","63629-1765","63629-1765-7","63629-1765_a903d079-327d-475b-953f-045f458657e5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"4970","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","63629197001","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63629-1970","63629-1970-1","63629-1970_4c47f33a-d207-4eab-a67a-a1d99c1e9502","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","POWDER, FOR SOLUTION","ORAL","20190909","","ANDA","ANDA061667","Bryant Ranch Prepack","250","mg/5mL","","N","20251231"
"4971","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","63629197101","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63629-1971","63629-1971-1","63629-1971_293a528f-1edf-49aa-9107-c92fa94882ea","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","POWDER, FOR SOLUTION","ORAL","20190909","","ANDA","ANDA061667","Bryant Ranch Prepack","250","mg/5mL","","N","20251231"
"4972","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","63629197201","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","63629-1972","63629-1972-1","63629-1972_231a8c57-21bc-4719-9b50-d3e4e24dd978","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","POWDER, FOR SOLUTION","ORAL","20190909","","ANDA","ANDA061667","Bryant Ranch Prepack","250","mg/5mL","","N","20251231"
"4973","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","63629199301","Allylamine Antifungal [EPC], Allylamine [CS]","63629-1993","63629-1993-1","63629-1993_2b858a61-405a-4352-9da9-978bb1f5a29a","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4974","FLUCYTOSINE","Flucytosine","63629214701","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","63629-2147","63629-2147-1","63629-2147_2fdfffd2-8c18-40a4-9669-74ca97ac0b6c","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170726","","NDA AUTHORIZED GENERIC","NDA017001","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4975","FLUCYTOSINE","Flucytosine","63629214801","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","63629-2148","63629-2148-1","63629-2148_039931b0-6e1a-4795-be74-33877739f9a3","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170726","","NDA AUTHORIZED GENERIC","NDA017001","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"4976","RIBAVIRIN","Ribavirin","63629214901","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","63629-2149","63629-2149-1","63629-2149_719ef642-2ed4-44fc-9a24-f1e2d16cde24","HUMAN PRESCRIPTION DRUG","Ribavirin","","POWDER, FOR SOLUTION","RESPIRATORY (INHALATION)","20200415","","NDA","NDA018859","Bryant Ranch Prepack","6","g/1","","N","20251231"
"4977","POSACONAZOLE","posaconazole","63629223601","Azole Antifungal [EPC], Azoles [CS]","63629-2236","63629-2236-1","63629-2236_97286b24-40cd-43d6-8c55-43eed6c3cb83","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","TABLET, COATED","ORAL","20190830","","NDA AUTHORIZED GENERIC","NDA205053","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"4978","CLINDAMYCIN PALMITATE HYDROCHLORIDE","CLINDAMYCIN PALMITATE HYDROCHLORIDE","63629239101","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63629-2391","63629-2391-1","63629-2391_9fa1fe7d-c938-41cc-a2a7-5be0fa4dbc35","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PALMITATE HYDROCHLORIDE","(Pediatric)","GRANULE, FOR SOLUTION","ORAL","20120911","","ANDA","ANDA201821","Bryant Ranch Prepack","75","mg/5mL","","N","20251231"
"4979","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","63629246401","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","63629-2464","63629-2464-1","63629-2464_fc71d17e-601d-48b1-aee8-ae1cf1fcdd5a","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"4980","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","63629249501","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","63629-2495","63629-2495-1","63629-2495_501c648b-6b5f-4ad0-be76-479b0c95d3fd","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20190928","","ANDA","ANDA207741","Bryant Ranch Prepack","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"4981","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","63629249601","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","63629-2496","63629-2496-1","63629-2496_b5bc2c38-910a-47ec-a9d4-e53dec3b8547","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20190928","","ANDA","ANDA207741","Bryant Ranch Prepack","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"4982","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","63629249701","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","63629-2497","63629-2497-1","63629-2497_dbe7b437-6b8e-44e5-b7d5-aa3f96c50d4d","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20190928","","ANDA","ANDA207741","Bryant Ranch Prepack","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"4983","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","63629250001","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","63629-2500","63629-2500-1","63629-2500_9391d94d-e22c-47d4-a1c4-7240a9adaacf","HUMAN PRESCRIPTION DRUG","Erythromycin Ethylsuccinate","","GRANULE, FOR SUSPENSION","ORAL","20160928","","NDA","NDA050207","Bryant Ranch Prepack","200","mg/5mL","","N","20251231"
"4984","NYSTATIN","Nystatin","63629251501","Polyene Antifungal [EPC], Polyenes [CS]","63629-2515","63629-2515-1","63629-2515_93338b75-a637-411f-ba9a-fc9fe6dbf913","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20200624","","ANDA","ANDA207767","Bryant Ranch Prepack","100000","U/g","","N","20251231"
"4985","NYSTATIN","Nystatin","63629251601","Polyene Antifungal [EPC], Polyenes [CS]","63629-2516","63629-2516-1","63629-2516_76c4c131-29b4-4e9a-af1b-ca97c467e221","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20200624","","ANDA","ANDA207767","Bryant Ranch Prepack","100000","U/g","","N","20251231"
"4986","CLINDAMYCIN PALMITATE HYDROCHLORIDE","Clindamycin Palmitate Hydrochloride","63629252301","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63629-2523","63629-2523-1","63629-2523_d82ab990-9080-4bad-b24c-1db12b799dc6","HUMAN PRESCRIPTION DRUG","Clindamycin Palmitate Hydrochloride","","GRANULE, FOR SOLUTION","ORAL","20100121","","ANDA","ANDA090902","Bryant Ranch Prepack","75","mg/5mL","","N","20251231"
"4987","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629386801","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-3868","63629-3868-1","63629-3868_8dabad3c-3808-45cc-a58d-127e3a3d6d6b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"4988","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629386804","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-3868","63629-3868-4","63629-3868_8dabad3c-3808-45cc-a58d-127e3a3d6d6b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"4989","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629386805","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-3868","63629-3868-5","63629-3868_8dabad3c-3808-45cc-a58d-127e3a3d6d6b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"4990","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629386802","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-3868","63629-3868-2","63629-3868_8dabad3c-3808-45cc-a58d-127e3a3d6d6b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"4991","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629386803","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-3868","63629-3868-3","63629-3868_8dabad3c-3808-45cc-a58d-127e3a3d6d6b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"4992","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629386806","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-3868","63629-3868-6","63629-3868_8dabad3c-3808-45cc-a58d-127e3a3d6d6b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"4993","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","63629386807","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-3868","63629-3868-7","63629-3868_8dabad3c-3808-45cc-a58d-127e3a3d6d6b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"4994","RIFAMPIN","Rifampin","63629404202","Rifamycin Antibacterial [EPC], Rifamycins [CS]","63629-4042","63629-4042-2","63629-4042_839d0e00-074c-43fc-b1b2-59c696c7a505","HUMAN PRESCRIPTION DRUG","Rifampin","","CAPSULE","ORAL","19970528","20250630","ANDA","ANDA064150","Bryant Ranch Prepack","300","mg/1","","N",""
"4995","RIFAMPIN","Rifampin","63629404203","Rifamycin Antibacterial [EPC], Rifamycins [CS]","63629-4042","63629-4042-3","63629-4042_839d0e00-074c-43fc-b1b2-59c696c7a505","HUMAN PRESCRIPTION DRUG","Rifampin","","CAPSULE","ORAL","19970528","20250630","ANDA","ANDA064150","Bryant Ranch Prepack","300","mg/1","","N",""
"4996","RIFAMPIN","Rifampin","63629404201","Rifamycin Antibacterial [EPC], Rifamycins [CS]","63629-4042","63629-4042-1","63629-4042_839d0e00-074c-43fc-b1b2-59c696c7a505","HUMAN PRESCRIPTION DRUG","Rifampin","","CAPSULE","ORAL","19970528","20250630","ANDA","ANDA064150","Bryant Ranch Prepack","300","mg/1","","N",""
"4997","RIFAMPIN","Rifampin","63629404204","Rifamycin Antibacterial [EPC], Rifamycins [CS]","63629-4042","63629-4042-4","63629-4042_839d0e00-074c-43fc-b1b2-59c696c7a505","HUMAN PRESCRIPTION DRUG","Rifampin","","CAPSULE","ORAL","19970528","20250630","ANDA","ANDA064150","Bryant Ranch Prepack","300","mg/1","","N",""
"4998","CEPHALEXIN","Cephalexin","63629422201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-4222","63629-4222-1","63629-4222_a281a79d-0af2-4351-aefe-c964d90b2397","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"4999","DICLOXACILLIN SODIUM","Dicloxacillin Sodium","63629425601","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63629-4256","63629-4256-1","63629-4256_d27a4909-ffaf-4786-b02c-faa01fa80f24","HUMAN PRESCRIPTION DRUG","Dicloxacillin Sodium","","CAPSULE","ORAL","19900930","","ANDA","ANDA062286","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5000","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","63629446501","Antimalarial [EPC], Antirheumatic Agent [EPC]","63629-4465","63629-4465-1","63629-4465_55eb56c0-c585-4373-a3a4-9276aaeae6d6","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20221024","","ANDA","ANDA210441","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"5001","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","63629446502","Antimalarial [EPC], Antirheumatic Agent [EPC]","63629-4465","63629-4465-2","63629-4465_55eb56c0-c585-4373-a3a4-9276aaeae6d6","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20221024","","ANDA","ANDA210441","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"5002","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63629454101","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63629-4541","63629-4541-1","63629-4541_e7ea24fb-e180-462c-87bd-0d8c46f4d6ff","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","Bryant Ranch Prepack","875; 125","mg/1; mg/1","","N","20251231"
"5003","AMOXICILLIN","Amoxicillin","63629477701","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63629-4777","63629-4777-1","63629-4777_9d2e1288-6132-4cb5-9862-a42ab9421c85","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Bryant Ranch Prepack","875","mg/1","","N","20251231"
"5004","CEFDINIR","Cefdinir","63629510101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-5101","63629-5101-1","63629-5101_b7e16f4a-4494-4311-a947-c30f64684726","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","Bryant Ranch Prepack","300","mg/1","","N","20261231"
"5005","AMOXICILLIN","Amoxicillin","63629551201","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63629-5512","63629-5512-1","63629-5512_e4c3bf43-24df-4716-a842-b0e78312810d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"5006","AMOXICILLIN","Amoxicillin","63629573001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63629-5730","63629-5730-1","63629-5730_2dbe0ab6-f36b-4c21-82c1-ec72d1b6687d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"5007","AMOXICILLIN","Amoxicillin","63629573801","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63629-5738","63629-5738-1","63629-5738_4fece9ad-4471-496c-a67e-38b4c1945bff","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"5008","AMOXICILLIN","Amoxicillin","63629573901","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63629-5739","63629-5739-1","63629-5739_7f38a7aa-45bb-4d8c-9595-89fba63cdc96","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"5009","CEPHALEXIN","Cephalexin","63629574001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-5740","63629-5740-1","63629-5740_15a26986-58b8-444b-9759-2529bd41cd25","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"5010","CEPHALEXIN","Cephalexin","63629574101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-5741","63629-5741-1","63629-5741_9d5537a1-af64-4b52-9016-7b93f3f539b6","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"5011","CEPHALEXIN","Cephalexin","63629574201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-5742","63629-5742-1","63629-5742_b880ca78-d863-4a5d-8cc5-9e79906243ff","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"5012","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","63629584701","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","63629-5847","63629-5847-1","63629-5847_db49a583-751e-4a70-85eb-e940c6a33f47","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","Bryant Ranch Prepack","875; 125","mg/1; mg/1","","N","20261231"
"5013","AMOXICILLIN","Amoxicillin","63629758501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63629-7585","63629-7585-1","63629-7585_23891944-87f3-47dc-b49a-202595a22a96","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5014","AMOXICILLIN","Amoxicillin","63629758701","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63629-7587","63629-7587-1","63629-7587_ea480c9b-00b6-4ba5-8dae-348ad47cba1e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5015","CEPHALEXIN","Cephalexin","63629762101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-7621","63629-7621-1","63629-7621_12665dc3-c0ec-4ae9-9ba6-05eadd16199a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"5016","AMOXICILLIN","Amoxicillin","63629763301","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63629-7633","63629-7633-1","63629-7633_1f430e1f-f9c9-4eba-aeb7-35ce7d1d434f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"5017","CEPHALEXIN","Cephalexin","63629774001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-7740","63629-7740-1","63629-7740_221ed86d-f82b-463d-8f92-44179b952e8a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5018","CEPHALEXIN","Cephalexin","63629774201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-7742","63629-7742-1","63629-7742_93bdcd54-3773-42af-baf3-ebe75310e104","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5019","CEPHALEXIN","Cephalexin","63629774301","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-7743","63629-7743-1","63629-7743_62107f37-8740-47e8-98b3-90108908591a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5020","AMOXICILLIN","Amoxicillin","63629779801","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63629-7798","63629-7798-1","63629-7798_2aaadbaf-6950-4787-bb0a-4ab430db12d0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5021","AMOXICILLIN","Amoxicillin","63629780101","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63629-7801","63629-7801-1","63629-7801_936dc5c3-adb0-476e-b9a3-c6de10c8885f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5022","METRONIDAZOLE","Metronidazole","63629791602","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-7916","63629-7916-2","63629-7916_0086502b-b500-4fe7-8c02-83a783f7e422","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"5023","METRONIDAZOLE","Metronidazole","63629791603","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-7916","63629-7916-3","63629-7916_0086502b-b500-4fe7-8c02-83a783f7e422","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"5024","METRONIDAZOLE","Metronidazole","63629791601","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","63629-7916","63629-7916-1","63629-7916_0086502b-b500-4fe7-8c02-83a783f7e422","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"5025","CEPHALEXIN","Cephalexin","63629792701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-7927","63629-7927-1","63629-7927_8be9fafb-0162-453c-bf9c-6cc3373bfce1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"5026","PENICILLIN V POTASSIUM","Penicillin V Potassium","63629792801","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63629-7928","63629-7928-1","63629-7928_bbf259eb-a267-4610-8764-187249e79a95","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5027","CEFADROXIL","Cefadroxil","63629798701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-7987","63629-7987-1","63629-7987_f99a6e1c-b567-41f3-a4f9-918f77ec2d28","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5028","CEFADROXIL","Cefadroxil","63629798801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-7988","63629-7988-1","63629-7988_d87bf519-36f3-4e11-83a1-26af4bbeb279","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5029","CEPHALEXIN","Cephalexin","63629818401","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-8184","63629-8184-1","63629-8184_19d9d0bc-b6f1-4fbe-89a4-48c705954570","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5030","AZITHROMYCIN DIHYDRATE","Azithromycin","63629825101","Macrolide Antimicrobial [EPC], Macrolides [CS]","63629-8251","63629-8251-1","63629-8251_599dcee2-f09c-4130-bb7c-e477acf7db1d","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207398","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"5031","AZITHROMYCIN DIHYDRATE","Azithromycin","63629825104","Macrolide Antimicrobial [EPC], Macrolides [CS]","63629-8251","63629-8251-4","63629-8251_599dcee2-f09c-4130-bb7c-e477acf7db1d","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207398","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"5032","AZITHROMYCIN DIHYDRATE","Azithromycin","63629825102","Macrolide Antimicrobial [EPC], Macrolides [CS]","63629-8251","63629-8251-2","63629-8251_599dcee2-f09c-4130-bb7c-e477acf7db1d","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207398","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"5033","AZITHROMYCIN DIHYDRATE","Azithromycin","63629825103","Macrolide Antimicrobial [EPC], Macrolides [CS]","63629-8251","63629-8251-3","63629-8251_599dcee2-f09c-4130-bb7c-e477acf7db1d","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207398","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"5034","CEFADROXIL","Cefadroxil","63629825301","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-8253","63629-8253-1","63629-8253_672519a7-11a1-4d8e-b2ca-dc9598c2f179","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5035","NYSTATIN","nystatin","63629835001","Polyene Antifungal [EPC], Polyenes [CS]","63629-8350","63629-8350-1","63629-8350_178f2a77-aca7-49a5-9b00-764226c30a29","HUMAN PRESCRIPTION DRUG","nystatin","","TABLET, COATED","ORAL","20111031","","ANDA","ANDA062474","Bryant Ranch Prepack","500000","[USP'U]/1","","N","20251231"
"5036","NYSTATIN","nystatin","63629835002","Polyene Antifungal [EPC], Polyenes [CS]","63629-8350","63629-8350-2","63629-8350_178f2a77-aca7-49a5-9b00-764226c30a29","HUMAN PRESCRIPTION DRUG","nystatin","","TABLET, COATED","ORAL","20111031","","ANDA","ANDA062474","Bryant Ranch Prepack","500000","[USP'U]/1","","N","20251231"
"5037","NYSTATIN","nystatin","63629835003","Polyene Antifungal [EPC], Polyenes [CS]","63629-8350","63629-8350-3","63629-8350_178f2a77-aca7-49a5-9b00-764226c30a29","HUMAN PRESCRIPTION DRUG","nystatin","","TABLET, COATED","ORAL","20111031","","ANDA","ANDA062474","Bryant Ranch Prepack","500000","[USP'U]/1","","N","20251231"
"5038","NYSTATIN","nystatin","63629835004","Polyene Antifungal [EPC], Polyenes [CS]","63629-8350","63629-8350-4","63629-8350_178f2a77-aca7-49a5-9b00-764226c30a29","HUMAN PRESCRIPTION DRUG","nystatin","","TABLET, COATED","ORAL","20111031","","ANDA","ANDA062474","Bryant Ranch Prepack","500000","[USP'U]/1","","N","20251231"
"5039","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin","63629835701","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-8357","63629-8357-1","63629-8357_27864513-a113-4ec1-9e78-41bc762172bc","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","TABLET, FILM COATED","ORAL","20140305","","ANDA","ANDA076938","Bryant Ranch Prepack","400","mg/1","","N","20251231"
"5040","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin","63629835702","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-8357","63629-8357-2","63629-8357_27864513-a113-4ec1-9e78-41bc762172bc","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","TABLET, FILM COATED","ORAL","20140305","","ANDA","ANDA076938","Bryant Ranch Prepack","400","mg/1","","N","20251231"
"5041","NYSTATIN","NYSTATIN","63629852001","Polyene Antifungal [EPC], Polyenes [CS]","63629-8520","63629-8520-1","63629-8520_e505ff47-c84a-4e72-a249-5232d13f216d","HUMAN PRESCRIPTION DRUG","NYSTATIN","","SUSPENSION","ORAL","20200814","","ANDA","ANDA062832","Bryant Ranch Prepack","100000","[USP'U]/mL","","N","20251231"
"5042","LINEZOLID","Linezolid","63629857601","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","63629-8576","63629-8576-1","63629-8576_30f6c6b2-4633-4cf9-b316-eb4f301a355f","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151221","","ANDA","ANDA204239","Bryant Ranch Prepack","600","mg/1","","N","20261231"
"5043","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","63629862801","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63629-8628","63629-8628-1","63629-8628_00b610fd-f5aa-6140-e063-6394a90a13d8","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","AEROSOL, FOAM","TOPICAL","20100331","","ANDA","ANDA090785","Bryant Ranch Prepack","10","mg/g","","N","20251231"
"5044","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","63629862901","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63629-8629","63629-8629-1","63629-8629_00b63f17-6efe-ac54-e063-6394a90a4832","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","AEROSOL, FOAM","TOPICAL","20100331","","ANDA","ANDA090785","Bryant Ranch Prepack","10","mg/g","","N","20251231"
"5045","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","63629863001","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63629-8630","63629-8630-1","63629-8630_85465c9f-0f22-48e7-9d9c-ea9d41a4bcb7","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PHOSPHATE","","GEL","TOPICAL","20210120","","ANDA","ANDA212104","Bryant Ranch Prepack","10","mg/g","","N","20251231"
"5046","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","63629863101","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63629-8631","63629-8631-1","63629-8631_00b610eb-ba17-de05-e063-6294a90aa7ca","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PHOSPHATE","","GEL","TOPICAL","20210120","","ANDA","ANDA212104","Bryant Ranch Prepack","10","mg/g","","N","20251231"
"5047","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","63629863201","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63629-8632","63629-8632-1","63629-8632_82336e93-d012-4057-87c4-4202b5ccdcb8","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","LOTION","TOPICAL","20210331","","ANDA","ANDA214604","Bryant Ranch Prepack","10","mg/mL","","N","20251231"
"5048","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","63629863301","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63629-8633","63629-8633-1","63629-8633_461682e6-ce1c-46e6-94cc-9624073cf79b","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20130917","","ANDA","ANDA064050","Bryant Ranch Prepack","10","mg/mL","","N","20251231"
"5049","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","63629863401","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63629-8634","63629-8634-1","63629-8634_b8c1f5fb-4c7f-42ac-ae89-28f1a02da34c","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20130917","","ANDA","ANDA064050","Bryant Ranch Prepack","10","mg/mL","","N","20251231"
"5050","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate, Benzoyl Peroxide","63629863501","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63629-8635","63629-8635-1","63629-8635_00b68cb4-a998-8fe9-e063-6294a90abd17","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Benzoyl Peroxide","","GEL","TOPICAL","20190912","","ANDA","ANDA205397","Bryant Ranch Prepack","25; 10","mg/g; mg/g","","N","20251231"
"5051","ECONAZOLE NITRATE","Econazole Nitrate","63629864501","Azole Antifungal [EPC], Azoles [CS]","63629-8645","63629-8645-1","63629-8645_201fe53f-7964-4e94-a1f4-07341eeca5aa","HUMAN PRESCRIPTION DRUG","Econazole Nitrate","","CREAM","TOPICAL","20060808","","ANDA","ANDA076479","Bryant Ranch Prepack","10","mg/g","","N","20261231"
"5052","ECONAZOLE NITRATE","Econazole Nitrate","63629864601","Azole Antifungal [EPC], Azoles [CS]","63629-8646","63629-8646-1","63629-8646_2f1bd23c-d3ae-40cf-a8ec-4df1934b51fa","HUMAN PRESCRIPTION DRUG","Econazole Nitrate","","CREAM","TOPICAL","20060808","","ANDA","ANDA076479","Bryant Ranch Prepack","10","mg/g","","N","20251231"
"5053","ECONAZOLE NITRATE","Econazole Nitrate","63629864701","Azole Antifungal [EPC], Azoles [CS]","63629-8647","63629-8647-1","63629-8647_e55d252a-ff23-4fe5-b884-2dc696ffb7be","HUMAN PRESCRIPTION DRUG","Econazole Nitrate","","CREAM","TOPICAL","20060808","","ANDA","ANDA076479","Bryant Ranch Prepack","10","mg/g","","N","20261231"
"5054","ERYTHROMYCIN","Erythromycin","63629864801","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","63629-8648","63629-8648-1","63629-8648_00b80232-6c14-5ed0-e063-6394a90a2704","HUMAN PRESCRIPTION DRUG","Ery","","SWAB","TOPICAL","20080707","","ANDA","ANDA064126","Bryant Ranch Prepack","20","mg/mL","","N","20251231"
"5055","ERYTHROMYCIN","Erythromycin","63629865201","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","63629-8652","63629-8652-1","63629-8652_e614ce96-5d35-40b6-894b-4640aa76a077","HUMAN PRESCRIPTION DRUG","Erythromycin","","GEL","TOPICAL","20080612","","ANDA","ANDA063211","Bryant Ranch Prepack","20","mg/g","","N","20251231"
"5056","ERYTHROMYCIN","Erythromycin","63629865301","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","63629-8653","63629-8653-1","63629-8653_18c0dd25-f6be-49f0-b83e-ee20d3bb5117","HUMAN PRESCRIPTION DRUG","Erythromycin","","GEL","TOPICAL","20080612","","ANDA","ANDA063211","Bryant Ranch Prepack","20","mg/g","","N","20251231"
"5057","KETOCONAZOLE","Ketoconazole","63629867501","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","63629-8675","63629-8675-1","63629-8675_01cb5b3b-9fb1-44a8-92a1-1954ba3968a6","HUMAN PRESCRIPTION DRUG","Ketoconazole","","SHAMPOO, SUSPENSION","TOPICAL","20100119","","ANDA","ANDA076419","Bryant Ranch Prepack","20","mg/mL","","N","20251231"
"5058","KETOCONAZOLE","ketoconazole","63629867601","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","63629-8676","63629-8676-1","63629-8676_8443f3a1-8b03-4f97-9759-e1b925b3ae37","HUMAN PRESCRIPTION DRUG","ketoconazole","","AEROSOL, FOAM","TOPICAL","20110830","","ANDA","ANDA091550","Bryant Ranch Prepack","2","g/100g","","N","20251231"
"5059","KETOCONAZOLE","ketoconazole","63629867701","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","63629-8677","63629-8677-1","63629-8677_6e2c78c5-12df-445d-a2ec-d25482b4ecd8","HUMAN PRESCRIPTION DRUG","ketoconazole","","AEROSOL, FOAM","TOPICAL","20110830","","ANDA","ANDA091550","Bryant Ranch Prepack","2","g/100g","","N","20251231"
"5060","MUPIROCIN","Mupirocin","63629868701","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","63629-8687","63629-8687-1","63629-8687_228603d0-e8ef-4769-8e79-3c7bbc6c88c4","HUMAN PRESCRIPTION DRUG","mupirocin","","OINTMENT","TOPICAL","20091030","","ANDA","ANDA065123","Bryant Ranch Prepack","20","mg/g","","N","20251231"
"5061","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin, triamcinolone acetonide","63629868801","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","63629-8688","63629-8688-1","63629-8688_bb018102-081e-494a-997b-34da965825c3","HUMAN PRESCRIPTION DRUG","NYSTATIN AND TRIAMCINOLONE ACETONIDE","","CREAM","TOPICAL","20171127","","ANDA","ANDA208479","Bryant Ranch Prepack","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"5062","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin, triamcinolone acetonide","63629868901","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","63629-8689","63629-8689-1","63629-8689_4bbdb8df-29a8-4f30-bac9-89ecd6b1917e","HUMAN PRESCRIPTION DRUG","NYSTATIN AND TRIAMCINOLONE ACETONIDE","","CREAM","TOPICAL","20171127","","ANDA","ANDA208479","Bryant Ranch Prepack","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"5063","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin, triamcinolone acetonide","63629869001","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","63629-8690","63629-8690-1","63629-8690_577f1c83-dc4a-4f30-9ca4-6ce233b9044c","HUMAN PRESCRIPTION DRUG","NYSTATIN AND TRIAMCINOLONE ACETONIDE","","CREAM","TOPICAL","20171127","","ANDA","ANDA208479","Bryant Ranch Prepack","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"5064","NYSTATIN","Nystatin","63629869401","Polyene Antifungal [EPC], Polyenes [CS]","63629-8694","63629-8694-1","63629-8694_2d472fb0-8fd5-452f-be67-fff44ce1dcc7","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20060921","","ANDA","ANDA062225","Bryant Ranch Prepack","100000","[USP'U]/g","","N","20251231"
"5065","NYSTATIN","Nystatin","63629869501","Polyene Antifungal [EPC], Polyenes [CS]","63629-8695","63629-8695-1","63629-8695_87837bc0-0c5a-4959-8b57-0bc7b93b729c","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20060921","","ANDA","ANDA062225","Bryant Ranch Prepack","100000","[USP'U]/g","","N","20251231"
"5066","NYSTATIN","Nystatin","63629869601","Polyene Antifungal [EPC], Polyenes [CS]","63629-8696","63629-8696-1","63629-8696_222b31d9-7cb1-4d2d-a36b-1b5652ae148e","HUMAN PRESCRIPTION DRUG","Nystop","","POWDER","TOPICAL","19960816","","ANDA","ANDA064118","Bryant Ranch Prepack","100000","[USP'U]/g","","N","20261231"
"5067","NYSTATIN","Nystatin","63629869701","Polyene Antifungal [EPC], Polyenes [CS]","63629-8697","63629-8697-1","63629-8697_bc867e0d-e4f6-47bc-b074-8417f83fbdc0","HUMAN PRESCRIPTION DRUG","Nystop","","POWDER","TOPICAL","19960816","","ANDA","ANDA064118","Bryant Ranch Prepack","100000","[USP'U]/g","","N","20251231"
"5068","NYSTATIN","Nystatin","63629869801","Polyene Antifungal [EPC], Polyenes [CS]","63629-8698","63629-8698-1","63629-8698_ee4f3b06-fcad-448d-904a-4702934e7117","HUMAN PRESCRIPTION DRUG","Nystop","","POWDER","TOPICAL","19960816","","ANDA","ANDA064118","Bryant Ranch Prepack","100000","[USP'U]/g","","N","20251231"
"5069","OFLOXACIN","Ofloxacin","63629871601","Quinolone Antimicrobial [EPC], Quinolones [CS]","63629-8716","63629-8716-1","63629-8716_2cb89c34-8e6b-4717-bcd1-eb9fe31358f3","HUMAN PRESCRIPTION DRUG","Ofloxacin Otic","","SOLUTION","AURICULAR (OTIC)","20040514","","ANDA","ANDA076527","Bryant Ranch Prepack","3","mg/mL","","N","20251231"
"5070","VORICONAZOLE","voriconazole","63629873401","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","63629-8734","63629-8734-1","63629-8734_d7d66c66-0efb-4ad0-9245-2ed7790b0e0a","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20111212","","ANDA","ANDA200265","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"5071","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","63629875801","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","63629-8758","63629-8758-1","63629-8758_8541c19c-8391-4025-929f-30518e34ee72","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20031216","","ANDA","ANDA076002","Bryant Ranch Prepack",".5; 10","mg/g; mg/g","","N","20251231"
"5072","SILVER SULFADIAZINE","Silver Sulfadiazine","63629876801","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","63629-8768","63629-8768-1","63629-8768_e5731b14-359d-4f54-8882-6242d42b7f78","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","Bryant Ranch Prepack","10","mg/g","","N","20251231"
"5073","SILVER SULFADIAZINE","Silver Sulfadiazine","63629876901","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","63629-8769","63629-8769-1","63629-8769_721c886d-d2c9-4af9-ab36-c322b24d8a7a","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","Bryant Ranch Prepack","10","mg/g","","N","20251231"
"5074","SILVER SULFADIAZINE","Silver Sulfadiazine","63629877001","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","63629-8770","63629-8770-1","63629-8770_f9a94d1a-38db-4025-bb84-94c420ecdc22","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","Bryant Ranch Prepack","10","mg/g","","N","20261231"
"5075","SILVER SULFADIAZINE","Silver Sulfadiazine","63629877101","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","63629-8771","63629-8771-1","63629-8771_194ff4e6-668a-47cc-9acc-369741f28181","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","Bryant Ranch Prepack","10","mg/g","","N","20251231"
"5076","SILVER SULFADIAZINE","Silver Sulfadiazine","63629877201","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","63629-8772","63629-8772-1","63629-8772_f8773374-403d-45d8-bb79-174fe87b4766","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","Bryant Ranch Prepack","10","mg/g","","N","20251231"
"5077","SILVER SULFADIAZINE","Silver Sulfadiazine","63629877301","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","63629-8773","63629-8773-1","63629-8773_f63c800f-63a1-498e-9814-28b41de0c3b2","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","Bryant Ranch Prepack","10","mg/g","","N","20261231"
"5078","CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE","ciprofloxacin and dexamethasone","63629879701","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","63629-8797","63629-8797-1","63629-8797_1fdea66b-522b-440f-acbf-3c33727a7506","HUMAN PRESCRIPTION DRUG","Ciprofloxacin and Dexamethasone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","20200810","","NDA AUTHORIZED GENERIC","NDA021537","Bryant Ranch Prepack","3; 1","mg/mL; mg/mL","","N","20251231"
"5079","KETOCONAZOLE","Ketoconazole","63629881901","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","63629-8819","63629-8819-1","63629-8819_d29922c6-7e4f-493c-97a7-182e7f415deb","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20190208","","ANDA","ANDA075581","Bryant Ranch Prepack","20","mg/g","","N","20251231"
"5080","KETOCONAZOLE","Ketoconazole","63629882001","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","63629-8820","63629-8820-1","63629-8820_21bd4467-5a52-41b8-b583-6bff890cf499","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20190208","","ANDA","ANDA075581","Bryant Ranch Prepack","20","mg/g","","N","20251231"
"5081","TERCONAZOLE","terconazole","63629883701","Azole Antifungal [EPC], Azoles [CS]","63629-8837","63629-8837-1","63629-8837_af185941-86b7-4bbd-a7d1-526e5cdaa709","HUMAN PRESCRIPTION DRUG","Terconazole","Vaginal Cream 0.8%","CREAM","VAGINAL","20050201","","NDA","NDA021735","Bryant Ranch Prepack","8","mg/g","","N","20251231"
"5082","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and hydrocortisone","63629884401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","63629-8844","63629-8844-1","63629-8844_3cbca028-fffd-43f8-87da-ac303bd88564","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SUSPENSION","AURICULAR (OTIC)","20030317","","ANDA","ANDA062488","Bryant Ranch Prepack","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"5083","CEPHALEXIN","Cephalexin","63629885401","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-8854","63629-8854-1","63629-8854_0c0d0f25-9405-4ffd-b08b-9606531dc66a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"5084","CEPHALEXIN","Cephalexin","63629885501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-8855","63629-8855-1","63629-8855_c4ed67ad-f34e-4516-90b3-5e75884b5474","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"5085","CEPHALEXIN","Cephalexin","63629885601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-8856","63629-8856-1","63629-8856_ee0ba13c-83bc-4e04-ae49-cbcd7b33675c","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5086","CEPHALEXIN","Cephalexin","63629885701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-8857","63629-8857-1","63629-8857_d2689188-05bf-4783-91c1-c6711f7f76f5","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Bryant Ranch Prepack","250","mg/5mL","","N","20251231"
"5087","CEPHALEXIN","Cephalexin","63629885801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-8858","63629-8858-1","63629-8858_1c0fd0cc-6a43-4af7-a550-3ec25d98d2e5","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Bryant Ranch Prepack","250","mg/5mL","","N","20251231"
"5088","CEFDINIR","Cefdinir","63629896801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-8968","63629-8968-1","63629-8968_9dee21a5-d21f-4454-a856-c5f3b2db8ea6","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"5089","FLUCONAZOLE","Fluconazole","63629897001","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","63629-8970","63629-8970-1","63629-8970_f0a93e29-d92a-4f5c-835c-5cfd2e134f8d","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","50","mg/1","","N","20251231"
"5090","FLUCONAZOLE","Fluconazole","63629909101","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","63629-9091","63629-9091-1","63629-9091_877aea10-b019-4eeb-8a1e-e6ac583df966","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"5091","PENICILLIN V POTASSIUM","Penicillin V Potassium","63629911001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","63629-9110","63629-9110-1","63629-9110_b6bb14f3-c916-4abd-b967-862eb4f858eb","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5092","FLUCONAZOLE","Fluconazole","63629913401","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","63629-9134","63629-9134-1","63629-9134_6884e445-29ae-4168-9512-299bea7c57c1","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"5093","FLUCYTOSINE","Flucytosine","63629915601","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","63629-9156","63629-9156-1","63629-9156_67b52766-0b1d-4a46-b141-f9687b9f3929","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170726","","NDA AUTHORIZED GENERIC","NDA017001","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"5094","FLUCYTOSINE","Flucytosine","63629915701","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","63629-9157","63629-9157-1","63629-9157_d93e7f82-c906-4b11-acdb-00918793f62c","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170726","","NDA AUTHORIZED GENERIC","NDA017001","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5095","CEPHALEXIN","Cephalexin","63629919801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9198","63629-9198-1","63629-9198_e1757ad3-d704-457e-bc31-64de13f90a07","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"5096","CEPHALEXIN","Cephalexin","63629919901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9199","63629-9199-1","63629-9199_4235cd4d-bc60-4a2f-94e5-359fc73d75e5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"5097","CEPHALEXIN","Cephalexin","63629920001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9200","63629-9200-1","63629-9200_e800d572-2296-4986-9ae7-8d7dd5a70820","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5098","CEPHALEXIN","Cephalexin","63629920101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9201","63629-9201-1","63629-9201_43556d12-b0e7-4b4b-9325-3aaf76348c2d","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5099","CEPHALEXIN","Cephalexin","63629920201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9202","63629-9202-1","63629-9202_f060d65e-8ed0-43a8-85c4-eafc8d7e2a22","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"5100","CEPHALEXIN","Cephalexin","63629920301","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9203","63629-9203-1","63629-9203_89d108cc-0d9f-4e14-94a6-81fdc11c2479","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"5101","CEPHALEXIN","Cephalexin","63629920401","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9204","63629-9204-1","63629-9204_b7e7ec11-dee5-4ed2-ad3d-be967d311e26","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Bryant Ranch Prepack","125","mg/5mL","","N","20251231"
"5102","CEPHALEXIN","Cephalexin","63629920501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9205","63629-9205-1","63629-9205_7885387e-3b1a-414c-873e-667b38e9a681","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Bryant Ranch Prepack","125","mg/5mL","","N","20251231"
"5103","CEPHALEXIN","Cephalexin","63629920601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9206","63629-9206-1","63629-9206_73448cfa-20f5-4e38-9df0-4da47a647f8f","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Bryant Ranch Prepack","250","mg/5mL","","N","20251231"
"5104","CEPHALEXIN","Cephalexin","63629920701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9207","63629-9207-1","63629-9207_f1e8edf5-5ad5-4e90-9f40-7b3a36df7f85","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Bryant Ranch Prepack","250","mg/5mL","","N","20251231"
"5105","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","63629925901","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","63629-9259","63629-9259-1","63629-9259_eceb6f7a-4aff-430e-841c-30737afacdb0","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide and Sulfur","","LIQUID","TOPICAL","20211115","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","100; 50","mg/g; mg/g","","N","20251231"
"5106","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","63629926001","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","63629-9260","63629-9260-1","63629-9260_59225ad3-b07e-4955-b60c-6d0846b0f165","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide and Sulfur","","LIQUID","TOPICAL","20211115","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","100; 50","mg/g; mg/g","","N","20251231"
"5107","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","63629926101","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","63629-9261","63629-9261-1","63629-9261_3af28b45-9550-401e-b852-2e488d8b1496","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide and Sulfur","","LIQUID","TOPICAL","20211115","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","100; 50","mg/g; mg/g","","N","20251231"
"5108","SULFACETAMIDE SODIUM","Sodium Sulfacetamide","63629926201","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","63629-9262","63629-9262-1","63629-9262_667328e8-e4f5-44f5-8295-a7d92fd56a40","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide","","LIQUID","TOPICAL","20220115","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","100","mg/g","","N","20251231"
"5109","SULFACETAMIDE SODIUM","Sodium Sulfacetamide","63629926301","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","63629-9263","63629-9263-1","63629-9263_0b7ac96d-ebc8-4f3e-ad66-ff554ec25138","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide","","LIQUID","TOPICAL","20220115","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","100","mg/g","","N","20251231"
"5110","SULFACETAMIDE SODIUM","Sodium Sulfacetamide","63629926401","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","63629-9264","63629-9264-1","63629-9264_0641c84f-25fc-4821-aec1-b0d46ce0c7ca","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide","","LIQUID","TOPICAL","20220115","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","100","mg/g","","N","20251231"
"5111","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","63629930901","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63629-9309","63629-9309-1","63629-9309_f562bf25-9ad3-46ad-833a-ad4ae236a085","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PHOSPHATE","","GEL","TOPICAL","20210120","","ANDA","ANDA212104","Bryant Ranch Prepack","10","mg/g","","N","20251231"
"5112","CEPHALEXIN","Cephalexin","63629943501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9435","63629-9435-1","63629-9435_7195fd35-b3a7-4206-ac9b-dc5537eb3021","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"5113","CEPHALEXIN","Cephalexin","63629943601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9436","63629-9436-1","63629-9436_d406866e-4206-4036-858e-bbe09ba7c25e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"5114","CEFUROXIME AXETIL","Cefuroxime axetil","63629944601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9446","63629-9446-1","63629-9446_98c257e2-f4e7-4786-bad3-fabbd0081ada","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"5115","CEFUROXIME AXETIL","Cefuroxime axetil","63629944701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9447","63629-9447-1","63629-9447_165e0286-8087-41a5-861e-2776adc42fc4","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"5116","CEFUROXIME AXETIL","Cefuroxime axetil","63629944801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9448","63629-9448-1","63629-9448_df6291c0-dfdd-4cd4-9e9c-e1c355cf1cd0","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5117","CEFUROXIME AXETIL","Cefuroxime axetil","63629944901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9449","63629-9449-1","63629-9449_492ed4c5-b3b8-4974-9aad-f4ef48c7c44f","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"5118","CEFADROXIL","Cefadroxil","63629945601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","63629-9456","63629-9456-1","63629-9456_b4980587-a7e5-471a-ba6c-9eed113c91bc","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20080423","","ANDA","ANDA065392","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"5119","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","63629945901","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","63629-9459","63629-9459-1","63629-9459_bb5a656c-041b-4572-8271-54850fdc7a91","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","LOTION","TOPICAL","20210331","","ANDA","ANDA214604","Bryant Ranch Prepack","10","mg/mL","","N","20251231"
"5120","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","63629957001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","63629-9570","63629-9570-1","63629-9570_87cba2b3-4471-42dd-9234-ec6e71639f95","HUMAN PRESCRIPTION DRUG","TOBRAMYCIN AND DEXAMETHASONE","","SUSPENSION/ DROPS","OPHTHALMIC","20220317","","ANDA","ANDA212715","Bryant Ranch Prepack","1; 3","mg/mL; mg/mL","","N","20251231"
"5121","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","63629957101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","63629-9571","63629-9571-1","63629-9571_3f1161dc-5f48-47eb-bb62-802f5f6c9a67","HUMAN PRESCRIPTION DRUG","TOBRAMYCIN AND DEXAMETHASONE","","SUSPENSION/ DROPS","OPHTHALMIC","20220317","","ANDA","ANDA212715","Bryant Ranch Prepack","1; 3","mg/mL; mg/mL","","N","20261231"
"5122","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","63629957201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","63629-9572","63629-9572-1","63629-9572_ab233ed9-6d75-4ff3-82fe-c6872fc8a839","HUMAN PRESCRIPTION DRUG","TOBRAMYCIN AND DEXAMETHASONE","","SUSPENSION/ DROPS","OPHTHALMIC","20220317","","ANDA","ANDA212715","Bryant Ranch Prepack","1; 3","mg/mL; mg/mL","","N","20251231"
"5123","KETOCONAZOLE","Ketoconazole","63646001004","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","63646-010","63646-010-04","63646-010_eea5b1d8-7b6e-4783-afb5-3049efb9e5b1","HUMAN PRESCRIPTION DRUG","Ketoconazole","","SHAMPOO, SUSPENSION","TOPICAL","20050411","","ANDA","ANDA076942","TOLMAR Inc.","20","mg/mL","","N","20251231"
"5124","MICONAZOLE NITRATE","Miconazole Nitrate","63736001518","Azole Antifungal [EPC], Azoles [CS]","63736-015","63736-015-18","63736-015_d4abb23b-028f-475c-ae32-85ab532a38a7","HUMAN OTC DRUG","Monistat 3","3 Day","CREAM","VAGINAL","19980330","","NDA","NDA020827","Insight Pharmaceuticals LLC","40","mg/g","","N","20251231"
"5125","MICONAZOLE NITRATE","Miconazole Nitrate","63736001525","Azole Antifungal [EPC], Azoles [CS]","63736-015","63736-015-25","63736-015_d4abb23b-028f-475c-ae32-85ab532a38a7","HUMAN OTC DRUG","Monistat 3","3 Day","CREAM","VAGINAL","19980330","","NDA","NDA020827","Insight Pharmaceuticals LLC","40","mg/g","","N","20251231"
"5126","MICONAZOLE NITRATE","Miconazole Nitrate","63736002515","Azole Antifungal [EPC], Azoles [CS]","63736-025","63736-025-15","63736-025_cc949d8b-964a-4479-829f-49003ac12baf","HUMAN OTC DRUG","Monistat 7","with Reusable Applicator","CREAM","VAGINAL","19930426","","NDA","NDA017450","Insight Pharmaceuticals LLC","20","mg/g","","N","20251231"
"5127","MICONAZOLE NITRATE","Miconazole Nitrate","63736002615","Azole Antifungal [EPC], Azoles [CS]","63736-026","63736-026-15","63736-026_a1b5cbdb-d256-47af-9df6-d80d9f9ac802","HUMAN OTC DRUG","MONISTAT 7","7-DAY DISPOSABLE APPLICATORS","CREAM","VAGINAL","19930426","","NDA","NDA017450","Insight Pharmaceuticals LLC","20","mg/g","","N","20251231"
"5128","TIOCONAZOLE","TIOCONAZOLE","63736041301","Azole Antifungal [EPC], Azoles [CS]","63736-413","63736-413-01","63736-413_c7b11d34-bd8a-4c84-aa4c-2cc6cf9037df","HUMAN OTC DRUG","MONISTAT TIOCONAZOLE 1","","OINTMENT","TOPICAL","20011121","","ANDA","ANDA075915","Insight Pharmaceuticals LLC","6.5","g/100g","","N","20251231"
"5129","VORICONAZOLE","Voriconazole","63739000833","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","63739-008","63739-008-33","63739-008_2b9c5378-33d7-6d41-e063-6294a90a6f54","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET","ORAL","20160531","20260228","ANDA","ANDA206181","Mckesson Corporation DBA SKY Packaginng","200","mg/1","","N",""
"5130","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir","63739007633","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","63739-076","63739-076-33","63739-076_2b9c37f0-1869-6f59-e063-6294a90a9b9b","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET, FILM COATED","ORAL","20220307","20251130","ANDA","ANDA205166","McKesson Corporation DBA SKY Packaging","450","mg/1","","N",""
"5131","FLUCONAZOLE","Fluconazole","63739011510","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","63739-115","63739-115-10","63739-115_29b6ce65-4ba9-a8ea-e063-6294a90a351b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20230919","20251130","ANDA","ANDA077731","McKesson Corporation DBA SKY Packaging","200","mg/1","","N",""
"5132","NYSTATIN","NYSTATIN","63739016056","Polyene Antifungal [EPC], Polyenes [CS]","63739-160","63739-160-56","63739-160_d6bbbe52-19ba-4663-87ee-f89d2242e043","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20240129","","ANDA","ANDA203621","McKesson Corporation dba SKY Packaging","100000","[USP'U]/mL","","N","20261231"
"5133","NYSTATIN","NYSTATIN","63739016070","Polyene Antifungal [EPC], Polyenes [CS]","63739-160","63739-160-70","63739-160_d6bbbe52-19ba-4663-87ee-f89d2242e043","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20240129","","ANDA","ANDA203621","McKesson Corporation dba SKY Packaging","100000","[USP'U]/mL","","N","20261231"
"5134","NYSTATIN","NYSTATIN","63739016010","Polyene Antifungal [EPC], Polyenes [CS]","63739-160","63739-160-10","63739-160_d6bbbe52-19ba-4663-87ee-f89d2242e043","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20240129","","ANDA","ANDA203621","McKesson Corporation dba SKY Packaging","100000","[USP'U]/mL","","N","20261231"
"5135","ATOVAQUONE","Atovaquone","63739020301","Antimalarial [EPC], Antiprotozoal [EPC]","63739-203","63739-203-01","63739-203_f94a1099-3e13-45b0-933c-65367ee36601","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20240708","20260228","ANDA","ANDA214272","McKesson Corporation dba SKY Packaging","750","mg/5mL","","N",""
"5136","ATOVAQUONE","Atovaquone","63739020303","Antimalarial [EPC], Antiprotozoal [EPC]","63739-203","63739-203-03","63739-203_f94a1099-3e13-45b0-933c-65367ee36601","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20240708","20260228","ANDA","ANDA214272","McKesson Corporation dba SKY Packaging","750","mg/5mL","","N",""
"5137","ATOVAQUONE","Atovaquone","63739020302","Antimalarial [EPC], Antiprotozoal [EPC]","63739-203","63739-203-02","63739-203_f94a1099-3e13-45b0-933c-65367ee36601","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20240708","20260228","ANDA","ANDA214272","McKesson Corporation dba SKY Packaging","750","mg/5mL","","N",""
"5138","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","63739077710","Antimalarial [EPC], Antirheumatic Agent [EPC]","63739-777","63739-777-10","63739-777_2a3224a5-f502-d273-e063-6294a90a4794","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","20250831","ANDA","ANDA040657","McKesson Corporation dba SKY Packaging","200","mg/1","","N",""
"5139","MICONAZOLE NITRATE","MICONAZOLE NITRATE","63742009802","Azole Antifungal [EPC], Azoles [CS]","63742-098","63742-098-02","63742-098_36eb334e-246c-249f-e063-6294a90ab811","HUMAN OTC DRUG","Fungus Master","","LOTION","TOPICAL","20250606","","OTC MONOGRAPH DRUG","M005","Clinical Resolution Laboratory, Inc.","20","mg/g","","N","20261231"
"5140","MICONAZOLE NITRATE","MICONAZOLE NITRATE","63742009801","Azole Antifungal [EPC], Azoles [CS]","63742-098","63742-098-01","63742-098_36eb334e-246c-249f-e063-6294a90ab811","HUMAN OTC DRUG","Fungus Master","","LOTION","TOPICAL","20250606","","OTC MONOGRAPH DRUG","M005","Clinical Resolution Laboratory, Inc.","20","mg/g","","N","20261231"
"5141","MICONAZOLE NITRATE","Athletes Foot Powder Spray Talc Free","63868018046","Azole Antifungal [EPC], Azoles [CS]","63868-180","63868-180-46","63868-180_29044829-c1c9-080c-e063-6394a90a6fe1","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, POWDER","TOPICAL","20171219","","OTC MONOGRAPH DRUG","M005","Chain Drug Marketing Association","2.6","g/130g","","N","20251231"
"5142","MICONAZOLE NITRATE","Miconazole Nitrate","63868019845","Azole Antifungal [EPC], Azoles [CS]","63868-198","63868-198-45","63868-198_d353be3c-4a6d-4c33-b443-1a5fe60a7531","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20100701","","ANDA","ANDA074164","QUALITY CHOICE (Chain Drug Marketing Association)","20","mg/g","","N","20251231"
"5143","CLOTRIMAZOLE","Clotrimazole","63868025915","Azole Antifungal [EPC], Azoles [CS]","63868-259","63868-259-15","63868-259_1a89b24d-aa35-4c4d-8160-15365d266a1b","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","20141015","20260101","ANDA","ANDA074165","QUALITY CHOICE (Chain Drug Marketing Association)","10","mg/g","","N",""
"5144","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir hydrochloride","64380015301","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","64380-153","64380-153-01","64380-153_7b815816-a0ba-42d0-ba80-02894fa91b4b","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET, FILM COATED","ORAL","20220912","","ANDA","ANDA200790","Strides Pharma Science Limited","450","mg/1","","N","20251231"
"5145","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir hydrochloride","64380016101","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","64380-161","64380-161-01","64380-161_058fa4c8-4170-4506-a930-dcacb28d9eff","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET, FILM COATED","ORAL","20250616","","ANDA","ANDA200790","Strides Pharma Science Limited","450","mg/1","","N","20261231"
"5146","KETOCONAZOLE","KETOCONAZOLE","64380082706","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","64380-827","64380-827-06","64380-827_bf07547c-c86d-404d-90ef-9aaf3636783b","HUMAN PRESCRIPTION DRUG","KETOCONAZOLE","","TABLET","ORAL","20180626","","ANDA","ANDA210457","Strides Pharma Science Limited","200","mg/1","","N","20251231"
"5147","KETOCONAZOLE","KETOCONAZOLE","64380082707","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","64380-827","64380-827-07","64380-827_bf07547c-c86d-404d-90ef-9aaf3636783b","HUMAN PRESCRIPTION DRUG","KETOCONAZOLE","","TABLET","ORAL","20180626","","ANDA","ANDA210457","Strides Pharma Science Limited","200","mg/1","","N","20251231"
"5148","CLOTRIMAZOLE","Antifungal 1% Clotrimazole Cream","64412201001","Azole Antifungal [EPC], Azoles [CS]","64412-2010","64412-2010-1","64412-2010_2969a99e-d730-355f-e063-6394a90a9df8","HUMAN OTC DRUG","Antifungal 1% Clotrimazole Cream","","CREAM","TOPICAL","20241001","","OTC MONOGRAPH DRUG","M005","Twincraft Inc.","1","g/100mL","","N","20251231"
"5149","ACETIC ACID; ALUMINUM; ARCTIUM LAPPA ROOT; ASPIRIN; ATROPA BELLADONNA; BENZENE; CHLORAMPHENICOL; CHLORPROMAZINE; CORTICOTROPIN HUMAN; CORTISONE ACETATE; ELYMUS REPENS ROOT; ESTRONE; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; KEROSENE; LEAD; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PHENACETIN; PHENYL SALICYLATE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PORK LIVER; POTASSIUM IODIDE; SARSAPARILLA; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER","Homeopathic Liquid","64578006001","Allergens [CS], Allergens [CS], Amphenicol-class Antibacterial [EPC], Amphenicols [EXT], Anti-Inflammatory Agents, Non-Steroidal [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Phenothiazine [EPC], Phenothiazines [CS], Plant Proteins [CS], Plant Proteins [CS], Platelet Aggregation Inhibitor [EPC], Seed Storage Proteins [CS]","64578-0060","64578-0060-1","64578-0060_275c8d22-ffcc-e898-e063-6394a90aace5","HUMAN OTC DRUG","Medi-Chord","","LIQUID","ORAL","20170921","","UNAPPROVED HOMEOPATHIC","","Energetix Corporation","18; 18; 4; 18; 12; 12; 18; 18; 18; 18; 4; 18; 4; 4; 18; 15; 12; 12; 18; 18; 12; 4; 9; 12; 4; 12; 9; 9; 4","[hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL","","N","20251231"
"5150","ACETIC ACID; ALUMINUM OXIDE; ARCTIUM LAPPA ROOT; ASPIRIN; BENZENE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS HYPOTHALAMUS; CENTELLA ASIATICA; CHELIDONIUM MAJUS; CHELONE GLABRA; CHLORAMPHENICOL; CHLORPROMAZINE; CHOLESTEROL; CORTISONE ACETATE; ESTRONE; GAMBOGE; KEROSENE; MILK THISTLE; PARAFFIN; PHENACETIN; PHOSPHORUS; PORK LIVER; SILICON DIOXIDE; SODIUM SULFATE; TARAXACUM OFFICINALE; THYROID, UNSPECIFIED","Homeopathic Liquid","64578006401","Amphenicol-class Antibacterial [EPC], Amphenicols [EXT], Anti-Inflammatory Agents, Non-Steroidal [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Phenothiazine [EPC], Phenothiazines [CS], Platelet Aggregation Inhibitor [EPC]","64578-0064","64578-0064-1","64578-0064_d3e9ead9-1324-4fb1-b978-7684fb5ee453","HUMAN OTC DRUG","Hepata-Chord","","LIQUID","ORAL","20141117","","UNAPPROVED HOMEOPATHIC","","Energetix Corp","18; 18; 4; 18; 12; 4; 12; 5; 4; 12; 18; 18; 12; 18; 18; 12; 18; 4; 18; 18; 12; 9; 12; 12; 4; 9","[hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL","","N","20251231"
"5151","ACETIC ACID; ALUMINUM OXIDE; ARSENIC TRIOXIDE; ASPIRIN; BORAGE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CHLORAMPHENICOL; CHLORPROMAZINE; CHOLESTEROL; COD LIVER OIL; CORTICOTROPIN HUMAN; CORTISONE ACETATE; ESTRONE; FUMARIC ACID; KEROSENE; LEAD; LYCOPODIUM CLAVATUM SPORE; PHENACETIN; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM IODIDE; SILICON DIOXIDE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SUCROSE; TARAXACUM OFFICINALE; THYROID, UNSPECIFIED; TURNERA DIFFUSA LEAFY TWIG","Aceticum ac, Acetylsal ac, Adrenocorticotrophin, Alumina, Arsenicum alb, Borago, Ceanothus, Chelidonium maj, Chionanthus, Chloramphenicolum, Chlorpromazinum, Cholesterinum, Cortisone aceticum, Damiana, Folliculinum, Fumaricum ac, Kali iod, Lycopodium, Nat sulphuricum, Nux vom, Oleum morrhuae, Petroleum, Phenacetinum, Phosphoricum ac, Phosphorus, Plumb met, Saccharum off, Silicea, Taraxacum, Thyroidinum.","64578014501","Allergens [CS], Amphenicol-class Antibacterial [EPC], Amphenicols [EXT], Anti-Inflammatory Agents, Non-Steroidal [CS], Cell-mediated Immunity [PE], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Phenothiazine [EPC], Phenothiazines [CS], Plant Proteins [CS], Platelet Aggregation Inhibitor [EPC], Seed Storage Proteins [CS]","64578-0145","64578-0145-1","64578-0145_29044b48-5eed-2487-e063-6394a90a3811","HUMAN OTC DRUG","Lipo-Chord","","LIQUID","ORAL","20170818","","UNAPPROVED HOMEOPATHIC","","Energetix Corporation","18; 18; 30; 18; 6; 6; 12; 6; 18; 18; 12; 12; 18; 18; 18; 30; 18; 30; 30; 18; 30; 30; 30; 30; 30; 30; 30; 4; 9; 12","[hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL","","N","20251231"
"5152","ACETIC ACID; ALUMINUM OXIDE; ARCTIUM LAPPA ROOT; ASPIRIN; BENZENE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS HYPOTHALAMUS; CENTELLA ASIATICA; CHELIDONIUM MAJUS; CHELONE GLABRA; CHLORAMPHENICOL; CHLORPROMAZINE; CHOLESTEROL; CORTISONE ACETATE; ESTRONE; GAMBOGE; KEROSENE; MILK THISTLE; PHENACETIN; PHOSPHORUS; PORK LIVER; SILICON DIOXIDE; SODIUM SULFATE; TARAXACUM OFFICINALE; THYROID, UNSPECIFIED","Homeopathic Liquid","64578017601","Amphenicol-class Antibacterial [EPC], Amphenicols [EXT], Anti-Inflammatory Agents, Non-Steroidal [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Phenothiazine [EPC], Phenothiazines [CS], Platelet Aggregation Inhibitor [EPC]","64578-0176","64578-0176-1","64578-0176_2978c996-d368-daff-e063-6394a90abe0b","HUMAN OTC DRUG","Hepata-Chord","","LIQUID","ORAL","20230324","","UNAPPROVED HOMEOPATHIC","","Energetix Corporation","18; 18; 4; 18; 12; 4; 12; 5; 4; 12; 18; 18; 12; 18; 18; 12; 18; 4; 18; 12; 9; 12; 12; 4; 9","[hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL","","N","20251231"
"5153","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin sodium and tazobactam sodium","64679001201","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","64679-012","64679-012-01","64679-012_21ebb1d8-1bf3-0229-e063-6394a90a9855","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20170322","","ANDA","ANDA206996","Wockhardt USA LLC.","4; .5","g/20mL; g/20mL","","N","20251231"
"5154","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin sodium and tazobactam sodium","64679003401","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","64679-034","64679-034-01","64679-034_21ebb1d8-1bf3-0229-e063-6394a90a9855","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20170322","","ANDA","ANDA206996","Wockhardt USA LLC.","2; .25","g/10mL; g/10mL","","N","20251231"
"5155","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin sodium and tazobactam sodium","64679005601","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","64679-056","64679-056-01","64679-056_21ebb1d8-1bf3-0229-e063-6394a90a9855","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20170322","","ANDA","ANDA206996","Wockhardt USA LLC.","3; .375","g/15mL; g/15mL","","N","20251231"
"5156","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin sodium and tazobactam sodium","64679067901","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","64679-679","64679-679-01","64679-679_21d765f6-d6aa-32be-e063-6394a90a171b","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20170320","","ANDA","ANDA207146","Wockhardt USA LLC.","36; 4.5","g/180mL; g/180mL","","N","20251231"
"5157","OXACILLIN SODIUM","Oxacillin","64679069801","Penicillin-class Antibacterial [EPC], Penicillins [CS]","64679-698","64679-698-01","64679-698_0acabc7b-fd52-fd74-e063-6294a90aa8cc","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170731","","ANDA","ANDA207147","Wockhardt USA LLC.","1","g/20mL","","N","20251231"
"5158","OXACILLIN SODIUM","Oxacillin","64679069803","Penicillin-class Antibacterial [EPC], Penicillins [CS]","64679-698","64679-698-03","64679-698_0acabc7b-fd52-fd74-e063-6294a90aa8cc","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170731","","ANDA","ANDA207147","Wockhardt USA LLC.","1","g/20mL","","N","20251231"
"5159","OXACILLIN SODIUM","Oxacillin","64679069901","Penicillin-class Antibacterial [EPC], Penicillins [CS]","64679-699","64679-699-01","64679-699_0acabc7b-fd52-fd74-e063-6294a90aa8cc","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170731","","ANDA","ANDA207147","Wockhardt USA LLC.","2","g/20mL","","N","20251231"
"5160","OXACILLIN SODIUM","Oxacillin","64679069903","Penicillin-class Antibacterial [EPC], Penicillins [CS]","64679-699","64679-699-03","64679-699_0acabc7b-fd52-fd74-e063-6294a90aa8cc","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170731","","ANDA","ANDA207147","Wockhardt USA LLC.","2","g/20mL","","N","20251231"
"5161","OXACILLIN SODIUM","Oxacillin","64679070003","Penicillin-class Antibacterial [EPC], Penicillins [CS]","64679-700","64679-700-03","64679-700_0aa37a7b-8534-d9d5-e063-6294a90a23be","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20171124","","ANDA","ANDA207148","Wockhardt USA LLC.","10","g/100mL","","N","20251231"
"5162","OXACILLIN SODIUM","Oxacillin","64679070001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","64679-700","64679-700-01","64679-700_0aa37a7b-8534-d9d5-e063-6294a90a23be","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20171124","","ANDA","ANDA207148","Wockhardt USA LLC.","10","g/100mL","","N","20251231"
"5163","TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE","trifluridine and tipiracil","64842102001","Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]","64842-1020","64842-1020-1","64842-1020_14a0ddcf-8820-4a2f-85e2-354226697866","HUMAN PRESCRIPTION DRUG","LONSURF","","TABLET, FILM COATED","ORAL","20150922","","NDA","NDA207981","Taiho Pharmaceutical Co., Ltd.","8.19; 20","mg/1; mg/1","","N","20251231"
"5164","TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE","trifluridine and tipiracil","64842102002","Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]","64842-1020","64842-1020-2","64842-1020_14a0ddcf-8820-4a2f-85e2-354226697866","HUMAN PRESCRIPTION DRUG","LONSURF","","TABLET, FILM COATED","ORAL","20150922","","NDA","NDA207981","Taiho Pharmaceutical Co., Ltd.","8.19; 20","mg/1; mg/1","","N","20251231"
"5165","TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE","trifluridine and tipiracil","64842102003","Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]","64842-1020","64842-1020-3","64842-1020_14a0ddcf-8820-4a2f-85e2-354226697866","HUMAN PRESCRIPTION DRUG","LONSURF","","TABLET, FILM COATED","ORAL","20150922","","NDA","NDA207981","Taiho Pharmaceutical Co., Ltd.","8.19; 20","mg/1; mg/1","","N","20251231"
"5166","TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE","trifluridine and tipiracil","64842102502","Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]","64842-1025","64842-1025-2","64842-1025_14a0ddcf-8820-4a2f-85e2-354226697866","HUMAN PRESCRIPTION DRUG","LONSURF","","TABLET, FILM COATED","ORAL","20150922","","NDA","NDA207981","Taiho Pharmaceutical Co., Ltd.","6.14; 15","mg/1; mg/1","","N","20251231"
"5167","TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE","trifluridine and tipiracil","64842102503","Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]","64842-1025","64842-1025-3","64842-1025_14a0ddcf-8820-4a2f-85e2-354226697866","HUMAN PRESCRIPTION DRUG","LONSURF","","TABLET, FILM COATED","ORAL","20150922","","NDA","NDA207981","Taiho Pharmaceutical Co., Ltd.","6.14; 15","mg/1; mg/1","","N","20251231"
"5168","TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE","trifluridine and tipiracil","64842102501","Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC], Thymidine Phosphorylase Inhibitor [EPC], Thymidine Phosphorylase Inhibitors [MoA]","64842-1025","64842-1025-1","64842-1025_14a0ddcf-8820-4a2f-85e2-354226697866","HUMAN PRESCRIPTION DRUG","LONSURF","","TABLET, FILM COATED","ORAL","20150922","","NDA","NDA207981","Taiho Pharmaceutical Co., Ltd.","6.14; 15","mg/1; mg/1","","N","20251231"
"5169","CIPROFLOXACIN","Ciprofloxacin","64950038114","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","64950-381","64950-381-14","64950-381_3f726b10-ef7b-47d6-96c9-e1a7ee5461d9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Otic","","SOLUTION/ DROPS","AURICULAR (OTIC)","20241201","","ANDA","ANDA217887","Genus Lifesciences",".5","mg/.25mL","","N","20261231"
"5170","CHLOROQUINE PHOSPHATE","Chloroquine Phosphate","64980017701","Antimalarial [EPC]","64980-177","64980-177-01","64980-177_6b685f04-1046-4556-98cd-51e58ea8e5cb","HUMAN PRESCRIPTION DRUG","Chloroquine Phosphate","","TABLET","ORAL","20110701","","ANDA","ANDA091621","Rising Pharma Holdings, Inc.","250","mg/1","","N","20251231"
"5171","CHLOROQUINE PHOSPHATE","Chloroquine Phosphate","64980017705","Antimalarial [EPC]","64980-177","64980-177-05","64980-177_6b685f04-1046-4556-98cd-51e58ea8e5cb","HUMAN PRESCRIPTION DRUG","Chloroquine Phosphate","","TABLET","ORAL","20110701","","ANDA","ANDA091621","Rising Pharma Holdings, Inc.","250","mg/1","","N","20251231"
"5172","CHLOROQUINE PHOSPHATE","Chloroquine Phosphate","64980017750","Antimalarial [EPC]","64980-177","64980-177-50","64980-177_6b685f04-1046-4556-98cd-51e58ea8e5cb","HUMAN PRESCRIPTION DRUG","Chloroquine Phosphate","","TABLET","ORAL","20110701","","ANDA","ANDA091621","Rising Pharma Holdings, Inc.","250","mg/1","","N","20251231"
"5173","CHLOROQUINE PHOSPHATE","Chloroquine Phosphate","64980017710","Antimalarial [EPC]","64980-177","64980-177-10","64980-177_6b685f04-1046-4556-98cd-51e58ea8e5cb","HUMAN PRESCRIPTION DRUG","Chloroquine Phosphate","","TABLET","ORAL","20110701","","ANDA","ANDA091621","Rising Pharma Holdings, Inc.","250","mg/1","","N","20251231"
"5174","CHLOROQUINE PHOSPHATE","Chloroquine Phosphate","64980017801","Antimalarial [EPC]","64980-178","64980-178-01","64980-178_6d4407d6-9669-4bf6-91cf-05ec2d70c96a","HUMAN PRESCRIPTION DRUG","Chloroquine Phosphate","","TABLET","ORAL","20110701","","ANDA","ANDA090612","Rising Pharma Holdings, Inc.","500","mg/1","","N","20251231"
"5175","CHLOROQUINE PHOSPHATE","Chloroquine Phosphate","64980017802","Antimalarial [EPC]","64980-178","64980-178-02","64980-178_6d4407d6-9669-4bf6-91cf-05ec2d70c96a","HUMAN PRESCRIPTION DRUG","Chloroquine Phosphate","","TABLET","ORAL","20110701","","ANDA","ANDA090612","Rising Pharma Holdings, Inc.","500","mg/1","","N","20251231"
"5176","CHLOROQUINE PHOSPHATE","Chloroquine Phosphate","64980017810","Antimalarial [EPC]","64980-178","64980-178-10","64980-178_6d4407d6-9669-4bf6-91cf-05ec2d70c96a","HUMAN PRESCRIPTION DRUG","Chloroquine Phosphate","","TABLET","ORAL","20110701","","ANDA","ANDA090612","Rising Pharma Holdings, Inc.","500","mg/1","","N","20251231"
"5177","CHLOROQUINE PHOSPHATE","Chloroquine Phosphate","64980017805","Antimalarial [EPC]","64980-178","64980-178-05","64980-178_6d4407d6-9669-4bf6-91cf-05ec2d70c96a","HUMAN PRESCRIPTION DRUG","Chloroquine Phosphate","","TABLET","ORAL","20110701","","ANDA","ANDA090612","Rising Pharma Holdings, Inc.","500","mg/1","","N","20251231"
"5178","METRONIDAZOLE","Metronidazole","64980023505","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","64980-235","64980-235-05","64980-235_0e31a067-d128-4d12-8e76-84cb2519ca3a","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20160222","","ANDA","ANDA205245","Rising Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"5179","METRONIDAZOLE","Metronidazole","64980023525","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","64980-235","64980-235-25","64980-235_0e31a067-d128-4d12-8e76-84cb2519ca3a","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20160222","","ANDA","ANDA205245","Rising Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"5180","METRONIDAZOLE","Metronidazole","64980023501","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","64980-235","64980-235-01","64980-235_0e31a067-d128-4d12-8e76-84cb2519ca3a","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20160222","","ANDA","ANDA205245","Rising Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"5181","METRONIDAZOLE","Metronidazole","64980023601","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","64980-236","64980-236-01","64980-236_0e31a067-d128-4d12-8e76-84cb2519ca3a","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20160222","","ANDA","ANDA205245","Rising Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"5182","METRONIDAZOLE","Metronidazole","64980023650","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","64980-236","64980-236-50","64980-236_0e31a067-d128-4d12-8e76-84cb2519ca3a","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20160222","","ANDA","ANDA205245","Rising Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"5183","METRONIDAZOLE","Metronidazole","64980023605","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","64980-236","64980-236-05","64980-236_0e31a067-d128-4d12-8e76-84cb2519ca3a","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20160222","","ANDA","ANDA205245","Rising Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"5184","BENZOYL PEROXIDE; ERYTHROMYCIN","Erythromycin and Benzoyl Peroxide","64980032801","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","64980-328","64980-328-01","64980-328_76091cc9-8c79-4455-8fdb-3dfee11ca87c","HUMAN PRESCRIPTION DRUG","Erythromycin and Benzoyl Peroxide","","GEL","TOPICAL","20161018","","ANDA","ANDA065385","Rising Pharma Holdings, Inc.","50; 30","mg/g; mg/g","","N","20251231"
"5185","BENZOYL PEROXIDE; ERYTHROMYCIN","Erythromycin and Benzoyl Peroxide","64980032802","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","64980-328","64980-328-02","64980-328_76091cc9-8c79-4455-8fdb-3dfee11ca87c","HUMAN PRESCRIPTION DRUG","Erythromycin and Benzoyl Peroxide","","GEL","TOPICAL","20161018","","ANDA","ANDA065385","Rising Pharma Holdings, Inc.","50; 30","mg/g; mg/g","","N","20251231"
"5186","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","64980040250","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","64980-402","64980-402-50","64980-402_803b37ff-46c6-4dcb-9d9f-a118c4c4601b","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","GRANULE, FOR SUSPENSION","ORAL","20070608","","ANDA","ANDA065409","Rising Pharma Holdings, Inc.","50","mg/5mL","","N","20261231"
"5187","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","64980040210","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","64980-402","64980-402-10","64980-402_803b37ff-46c6-4dcb-9d9f-a118c4c4601b","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","GRANULE, FOR SUSPENSION","ORAL","20070608","","ANDA","ANDA065409","Rising Pharma Holdings, Inc.","50","mg/5mL","","N","20261231"
"5188","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","64980040310","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","64980-403","64980-403-10","64980-403_803b37ff-46c6-4dcb-9d9f-a118c4c4601b","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","GRANULE, FOR SUSPENSION","ORAL","20070608","","ANDA","ANDA065409","Rising Pharma Holdings, Inc.","100","mg/5mL","","N","20261231"
"5189","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","64980040350","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","64980-403","64980-403-50","64980-403_803b37ff-46c6-4dcb-9d9f-a118c4c4601b","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","GRANULE, FOR SUSPENSION","ORAL","20070608","","ANDA","ANDA065409","Rising Pharma Holdings, Inc.","100","mg/5mL","","N","20261231"
"5190","TINIDAZOLE","Tinidazole","64980042602","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","64980-426","64980-426-02","64980-426_37044541-dbe9-4d1b-b052-ddf0559f39aa","HUMAN PRESCRIPTION DRUG","Tindazole","","TABLET, FILM COATED","ORAL","20131009","","ANDA","ANDA202489","Rising Pharma Holdings, Inc.","250","mg/1","","N","20251231"
"5191","TINIDAZOLE","Tinidazole","64980042712","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","64980-427","64980-427-12","64980-427_37044541-dbe9-4d1b-b052-ddf0559f39aa","HUMAN PRESCRIPTION DRUG","Tindazole","","TABLET, FILM COATED","ORAL","20131009","","ANDA","ANDA202489","Rising Pharma Holdings, Inc.","500","mg/1","","N","20251231"
"5192","OFLOXACIN","Ofloxacin","64980043201","Quinolone Antimicrobial [EPC], Quinolones [CS]","64980-432","64980-432-01","64980-432_53f7e16a-6146-4c09-b3bf-4af9984f5b15","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","AURICULAR (OTIC)","20220701","","ANDA","ANDA215038","Rising Pharma Holdings, Inc.","3","mg/mL","","N","20251231"
"5193","OFLOXACIN","Ofloxacin","64980043205","Quinolone Antimicrobial [EPC], Quinolones [CS]","64980-432","64980-432-05","64980-432_53f7e16a-6146-4c09-b3bf-4af9984f5b15","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","AURICULAR (OTIC)","20220701","","ANDA","ANDA215038","Rising Pharma Holdings, Inc.","3","mg/mL","","N","20251231"
"5194","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin and polymyxin B sulfates and hydrocortisone otic","64980044801","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","64980-448","64980-448-01","64980-448_4b15047c-4c19-4562-ba03-5c1aff192a2f","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension","","SUSPENSION","AURICULAR (OTIC)","20190315","","NDA AUTHORIZED GENERIC","NDA060613","Rising Pharma Holdings, Inc.","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"5195","CLINDAMYCIN PALMITATE HYDROCHLORIDE","CLINDAMYCIN PALMITATE HYDROCHLORIDE","64980051110","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","64980-511","64980-511-10","64980-511_dbaca08e-0bce-412b-b46f-2a92bc597d8e","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PALMITATE HYDROCHLORIDE","(Pediatric)","GRANULE, FOR SOLUTION","ORAL","20120911","","ANDA","ANDA201821","Rising Pharma Holdings, Inc.","75","mg/5mL","","N","20261231"
"5196","OFLOXACIN","Ofloxacin","64980051501","Quinolone Antimicrobial [EPC], Quinolones [CS]","64980-515","64980-515-01","64980-515_8a9b999e-89bc-44ec-b974-729f66dc0bfa","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20141215","","ANDA","ANDA078559","Rising Pharma Holdings, Inc.","3","mg/mL","","N","20261231"
"5197","OFLOXACIN","Ofloxacin","64980051505","Quinolone Antimicrobial [EPC], Quinolones [CS]","64980-515","64980-515-05","64980-515_8a9b999e-89bc-44ec-b974-729f66dc0bfa","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20141215","","ANDA","ANDA078559","Rising Pharma Holdings, Inc.","3","mg/mL","","N","20261231"
"5198","NITAZOXANIDE","Nitazoxanide","64980052621","Antiprotozoal [EPC]","64980-526","64980-526-21","64980-526_5a76eb85-8fbe-440d-a287-832e4e33aa53","HUMAN PRESCRIPTION DRUG","Nitazoxanide","","TABLET, FILM COATED","ORAL","20201127","","ANDA","ANDA213820","Rising Pharma Holdings, Inc.","500","mg/1","","N","20261231"
"5199","NITAZOXANIDE","Nitazoxanide","64980052660","Antiprotozoal [EPC]","64980-526","64980-526-60","64980-526_5a76eb85-8fbe-440d-a287-832e4e33aa53","HUMAN PRESCRIPTION DRUG","Nitazoxanide","","TABLET, FILM COATED","ORAL","20201127","","ANDA","ANDA213820","Rising Pharma Holdings, Inc.","500","mg/1","","N","20261231"
"5200","NITAZOXANIDE","Nitazoxanide","64980052681","Antiprotozoal [EPC]","64980-526","64980-526-81","64980-526_5a76eb85-8fbe-440d-a287-832e4e33aa53","HUMAN PRESCRIPTION DRUG","Nitazoxanide","","TABLET, FILM COATED","ORAL","20201127","","ANDA","ANDA213820","Rising Pharma Holdings, Inc.","500","mg/1","","N","20261231"
"5201","NITAZOXANIDE","Nitazoxanide","64980052603","Antiprotozoal [EPC]","64980-526","64980-526-03","64980-526_5a76eb85-8fbe-440d-a287-832e4e33aa53","HUMAN PRESCRIPTION DRUG","Nitazoxanide","","TABLET, FILM COATED","ORAL","20201127","","ANDA","ANDA213820","Rising Pharma Holdings, Inc.","500","mg/1","","N","20261231"
"5202","LINEZOLID","Linezolid","64980056102","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","64980-561","64980-561-02","64980-561_e7ccafc3-f287-4339-97d5-883922f99c74","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET","ORAL","20231120","","ANDA","ANDA078845","Rising Pharma Holdings, Inc.","600","mg/1","","N","20251231"
"5203","LINEZOLID","Linezolid","64980056103","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","64980-561","64980-561-03","64980-561_e7ccafc3-f287-4339-97d5-883922f99c74","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET","ORAL","20231120","","ANDA","ANDA078845","Rising Pharma Holdings, Inc.","600","mg/1","","N","20251231"
"5204","NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","64980059324","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","64980-593","64980-593-24","64980-593_dfecf83b-2b30-4505-9044-bec3dce43a39","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","SUSPENSION","ORAL","20230511","","ANDA","ANDA212607","Rising Pharma Holdings, Inc.","25","mg/5mL","","N","20251231"
"5205","OFLOXACIN","Ofloxacin Ophthalmic Solution USP, 0.3%","65145014101","Quinolone Antimicrobial [EPC], Quinolones [CS]","65145-141","65145-141-01","65145-141_b7001e6b-0d32-4256-8352-058bc49b9782","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20250205","","ANDA","ANDA217904","Caplin Steriles Limited","3","mg/mL","","N","20261231"
"5206","OFLOXACIN","Ofloxacin Ophthalmic Solution USP, 0.3%","65145014201","Quinolone Antimicrobial [EPC], Quinolones [CS]","65145-142","65145-142-01","65145-142_b7001e6b-0d32-4256-8352-058bc49b9782","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20250205","","ANDA","ANDA217904","Caplin Steriles Limited","3","mg/mL","","N","20261231"
"5207","OFLOXACIN","Ofloxacin Otic","65145014301","Quinolone Antimicrobial [EPC], Quinolones [CS]","65145-143","65145-143-01","65145-143_47f838f6-cc86-41f5-924a-f6f5c4ddc43e","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","AURICULAR (OTIC)","20241216","","ANDA","ANDA217903","Caplin Steriles Limited","3","mg/mL","","N","20251231"
"5208","OFLOXACIN","Ofloxacin Otic solution","65145014401","Quinolone Antimicrobial [EPC], Quinolones [CS]","65145-144","65145-144-01","65145-144_47f838f6-cc86-41f5-924a-f6f5c4ddc43e","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","AURICULAR (OTIC)","20241216","","ANDA","ANDA217903","Caplin Steriles Limited","3","mg/mL","","N","20251231"
"5209","ITRACONAZOLE","Itraconazole","65162008734","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","65162-087","65162-087-34","65162-087_fabca3d3-1b0c-48a3-bd56-5e5a11b1fb3b","HUMAN PRESCRIPTION DRUG","Itraconazole","","SOLUTION","ORAL","20140430","","ANDA","ANDA205573","Amneal Pharmaceuticals LLC","10","mg/mL","","N","20261231"
"5210","ITRACONAZOLE","Itraconazole","65162008774","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","65162-087","65162-087-74","65162-087_fabca3d3-1b0c-48a3-bd56-5e5a11b1fb3b","HUMAN PRESCRIPTION DRUG","Itraconazole","","SOLUTION","ORAL","20140430","","ANDA","ANDA205573","Amneal Pharmaceuticals LLC","10","mg/mL","","N","20261231"
"5211","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65162027105","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65162-271","65162-271-05","65162-271_6cbe0ea0-5ed0-4941-ad3c-4396a56fdfc6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100225","","ANDA","ANDA076899","Amneal Pharmaceuticals LLC","400; 80","mg/1; mg/1","","N","20261231"
"5212","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65162027110","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65162-271","65162-271-10","65162-271_6cbe0ea0-5ed0-4941-ad3c-4396a56fdfc6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100225","","ANDA","ANDA076899","Amneal Pharmaceuticals LLC","400; 80","mg/1; mg/1","","N","20261231"
"5213","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65162027150","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65162-271","65162-271-50","65162-271_6cbe0ea0-5ed0-4941-ad3c-4396a56fdfc6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100225","","ANDA","ANDA076899","Amneal Pharmaceuticals LLC","400; 80","mg/1; mg/1","","N","20261231"
"5214","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65162027111","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65162-271","65162-271-11","65162-271_6cbe0ea0-5ed0-4941-ad3c-4396a56fdfc6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100225","","ANDA","ANDA076899","Amneal Pharmaceuticals LLC","400; 80","mg/1; mg/1","","N","20261231"
"5215","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65162027201","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65162-272","65162-272-01","65162-272_6cbe0ea0-5ed0-4941-ad3c-4396a56fdfc6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Amneal Pharmaceuticals LLC","800; 160","mg/1; mg/1","","N","20261231"
"5216","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65162027210","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65162-272","65162-272-10","65162-272_6cbe0ea0-5ed0-4941-ad3c-4396a56fdfc6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Amneal Pharmaceuticals LLC","800; 160","mg/1; mg/1","","N","20261231"
"5217","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65162027225","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65162-272","65162-272-25","65162-272_6cbe0ea0-5ed0-4941-ad3c-4396a56fdfc6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Amneal Pharmaceuticals LLC","800; 160","mg/1; mg/1","","N","20261231"
"5218","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65162027250","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65162-272","65162-272-50","65162-272_6cbe0ea0-5ed0-4941-ad3c-4396a56fdfc6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Amneal Pharmaceuticals LLC","800; 160","mg/1; mg/1","","N","20261231"
"5219","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65162027224","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65162-272","65162-272-24","65162-272_6cbe0ea0-5ed0-4941-ad3c-4396a56fdfc6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Amneal Pharmaceuticals LLC","800; 160","mg/1; mg/1","","N","20261231"
"5220","CLINDAMYCIN PALMITATE HYDROCHLORIDE","Clindamycin Palmitate Hydrochloride","65162046819","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","65162-468","65162-468-19","65162-468_4480ac35-28fd-48fc-b0eb-52349d30ad8e","HUMAN PRESCRIPTION DRUG","Clindamycin Palmitate Hydrochloride","(Pediatric)","POWDER, FOR SOLUTION","ORAL","20130902","","ANDA","ANDA203513","Amneal Pharmaceuticals LLC","75","mg/5mL","","N","20251231"
"5221","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","65162047810","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","65162-478","65162-478-10","65162-478_b03ee3ee-eb6a-4d3f-9987-0a8fb7c14bae","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20170525","","ANDA","ANDA207372","Amneal Pharmaceuticals LLC","25; 75","mg/1; mg/1","","N","20251231"
"5222","DEMECLOCYCLINE HYDROCHLORIDE","Demeclocycline","65162055410","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","65162-554","65162-554-10","65162-554_4cd13048-b500-48bc-b998-e47aafff605e","HUMAN PRESCRIPTION DRUG","Demeclocycline Hydrochloride","","TABLET","ORAL","20080227","","ANDA","ANDA065425","Amneal Pharmaceuticals LLC","150","mg/1","","N","20251231"
"5223","DEMECLOCYCLINE HYDROCHLORIDE","Demeclocycline","65162055548","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","65162-555","65162-555-48","65162-555_4cd13048-b500-48bc-b998-e47aafff605e","HUMAN PRESCRIPTION DRUG","Demeclocycline Hydrochloride","","TABLET","ORAL","20080227","","ANDA","ANDA065425","Amneal Pharmaceuticals LLC","300","mg/1","","N","20251231"
"5224","ITRACONAZOLE","Itraconazole","65162063003","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","65162-630","65162-630-03","65162-630_14950f16-445f-4f48-871f-31bc5328d099","HUMAN PRESCRIPTION DRUG","Itraconazole","","CAPSULE","ORAL","20160927","","ANDA","ANDA205080","Amneal Pharmaceuticals LLC","100","mg/1","","N","20261231"
"5225","NITROFURANTOIN","Nitrofurantoin","65162068988","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","65162-689","65162-689-88","65162-689_96cbbaac-bd28-443c-bc4c-967fa09a2f99","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","SUSPENSION","ORAL","20110324","","ANDA","ANDA201679","Amneal Pharmaceuticals LLC","25","mg/5mL","","N","20251231"
"5226","ATOVAQUONE","ATOVAQUONE","65162069388","Antimalarial [EPC], Antiprotozoal [EPC]","65162-693","65162-693-88","65162-693_665b98de-365d-437b-bcf0-c0ba5cf791a9","HUMAN PRESCRIPTION DRUG","ATOVAQUONE","","SUSPENSION","ORAL","20110209","","ANDA","ANDA202960","Amneal Pharmaceuticals LLC","750","mg/5mL","","N","20251231"
"5227","AZITHROMYCIN MONOHYDRATE","Azithromycin Monohydrate","65162070883","Macrolide Antimicrobial [EPC], Macrolides [CS]","65162-708","65162-708-83","65162-708_5d60c6e0-d9a5-48c7-9f14-9b37dfa6fc5f","HUMAN PRESCRIPTION DRUG","Azithromycin Monohydrate","","POWDER, FOR SUSPENSION","ORAL","20180723","","ANDA","ANDA205666","Amneal Pharmaceuticals LLC","100","mg/5mL","","N","20251231"
"5228","AZITHROMYCIN MONOHYDRATE","Azithromycin Monohydrate","65162075883","Macrolide Antimicrobial [EPC], Macrolides [CS]","65162-758","65162-758-83","65162-758_5d60c6e0-d9a5-48c7-9f14-9b37dfa6fc5f","HUMAN PRESCRIPTION DRUG","Azithromycin Monohydrate","","POWDER, FOR SUSPENSION","ORAL","20180723","","ANDA","ANDA205666","Amneal Pharmaceuticals LLC","200","mg/5mL","","N","20251231"
"5229","AZITHROMYCIN MONOHYDRATE","Azithromycin Monohydrate","65162075939","Macrolide Antimicrobial [EPC], Macrolides [CS]","65162-759","65162-759-39","65162-759_5d60c6e0-d9a5-48c7-9f14-9b37dfa6fc5f","HUMAN PRESCRIPTION DRUG","Azithromycin Monohydrate","","POWDER, FOR SUSPENSION","ORAL","20180723","","ANDA","ANDA205666","Amneal Pharmaceuticals LLC","200","mg/5mL","","N","20251231"
"5230","AZITHROMYCIN MONOHYDRATE","Azithromycin Monohydrate","65162076084","Macrolide Antimicrobial [EPC], Macrolides [CS]","65162-760","65162-760-84","65162-760_5d60c6e0-d9a5-48c7-9f14-9b37dfa6fc5f","HUMAN PRESCRIPTION DRUG","Azithromycin Monohydrate","","POWDER, FOR SUSPENSION","ORAL","20180723","","ANDA","ANDA205666","Amneal Pharmaceuticals LLC","200","mg/5mL","","N","20251231"
"5231","LINEZOLID","Linezolid","65162077702","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","65162-777","65162-777-02","65162-777_d42c6130-9194-41c9-a289-e3a54275a228","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET","ORAL","20150519","","ANDA","ANDA204536","Amneal Pharmaceuticals LLC","600","mg/1","","N","20251231"
"5232","LINEZOLID","Linezolid","65162077703","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","65162-777","65162-777-03","65162-777_d42c6130-9194-41c9-a289-e3a54275a228","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET","ORAL","20150519","","ANDA","ANDA204536","Amneal Pharmaceuticals LLC","600","mg/1","","N","20251231"
"5233","LINEZOLID","Linezolid","65162077710","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","65162-777","65162-777-10","65162-777_d42c6130-9194-41c9-a289-e3a54275a228","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET","ORAL","20150519","","ANDA","ANDA204536","Amneal Pharmaceuticals LLC","600","mg/1","","N","20251231"
"5234","QUININE SULFATE","Quinine","65162081109","Antimalarial [EPC]","65162-811","65162-811-09","65162-811_b1b6d20f-5e99-4205-9f40-fa4a8af3416d","HUMAN PRESCRIPTION DRUG","Quinine Sulfate","","CAPSULE","ORAL","20160729","","ANDA","ANDA203729","Amneal Pharmaceuticals LLC","324","mg/1","","N","20251231"
"5235","QUININE SULFATE","Quinine","65162081150","Antimalarial [EPC]","65162-811","65162-811-50","65162-811_b1b6d20f-5e99-4205-9f40-fa4a8af3416d","HUMAN PRESCRIPTION DRUG","Quinine Sulfate","","CAPSULE","ORAL","20160729","","ANDA","ANDA203729","Amneal Pharmaceuticals LLC","324","mg/1","","N","20251231"
"5236","QUININE SULFATE","Quinine","65162081103","Antimalarial [EPC]","65162-811","65162-811-03","65162-811_b1b6d20f-5e99-4205-9f40-fa4a8af3416d","HUMAN PRESCRIPTION DRUG","Quinine Sulfate","","CAPSULE","ORAL","20160729","","ANDA","ANDA203729","Amneal Pharmaceuticals LLC","324","mg/1","","N","20251231"
"5237","VORICONAZOLE","Voriconazole","65162091322","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65162-913","65162-913-22","65162-913_12633f28-49ec-44ca-ae20-d2f012403247","HUMAN PRESCRIPTION DRUG","Voriconazole","","POWDER, FOR SUSPENSION","ORAL","20131129","","ANDA","ANDA205034","Amneal Pharmaceuticals LLC","40","mg/mL","","N","20261231"
"5238","TOBRAMYCIN","Tobramycin","65162091446","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","65162-914","65162-914-46","65162-914_609a53df-fb3c-4349-8ada-22b985d2c4ac","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","RESPIRATORY (INHALATION)","20140713","","ANDA","ANDA205501","Amneal Pharmaceuticals LLC","300","mg/5mL","","N","20251231"
"5239","MICONAZOLE NITRATE","Miconazole nitrate","65197010305","Azole Antifungal [EPC], Azoles [CS]","65197-103","65197-103-05","65197-103_d9d5ec5c-ee44-42cd-9579-969f3ae1f166","HUMAN OTC DRUG","Micatin","","CREAM","TOPICAL","20090624","20261130","OTC MONOGRAPH DRUG","M005","WellSpring Pharmaceutical Corporation","20","mg/g","","N",""
"5240","BACITRACIN ZINC; LIDOCAINE HYDROCHLORIDE; POLYMYXIN B SULFATE","Lidocaine","65197082705","Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Decreased Cell Wall Synthesis & Repair [PE], Local Anesthesia [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","65197-827","65197-827-05","65197-827_4b43197b-b1f7-44b3-a750-7b10c685fa9a","HUMAN OTC DRUG","Bactine Max Antibiotic and Lidocaine Max Pain Relief","","OINTMENT","TOPICAL","20240115","","OTC MONOGRAPH DRUG","M017","WellSpring Pharmaceutical Corporation","500; .04; 10000","U/g; g/g; U/g","","N","20261231"
"5241","AMPICILLIN SODIUM","ampicillin sodium","65219001410","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65219-014","65219-014-10","65219-014_38c6c088-e4ab-4859-b4d9-89e846cf9d5f","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20191030","","ANDA","ANDA062719","Fresenius Kabi USA, LLC","250","mg/1","","N","20251231"
"5242","AMPICILLIN SODIUM","ampicillin sodium","65219001610","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65219-016","65219-016-10","65219-016_38c6c088-e4ab-4859-b4d9-89e846cf9d5f","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20200803","","ANDA","ANDA062719","Fresenius Kabi USA, LLC","500","mg/1","","N","20251231"
"5243","AMPICILLIN SODIUM","ampicillin sodium","65219001810","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65219-018","65219-018-10","65219-018_38c6c088-e4ab-4859-b4d9-89e846cf9d5f","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20200113","","ANDA","ANDA062719","Fresenius Kabi USA, LLC","1","g/1","","N","20251231"
"5244","AMPICILLIN SODIUM","ampicillin sodium","65219002023","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65219-020","65219-020-23","65219-020_38c6c088-e4ab-4859-b4d9-89e846cf9d5f","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20191031","","ANDA","ANDA062797","Fresenius Kabi USA, LLC","2","g/1","","N","20251231"
"5245","VORICONAZOLE","Voriconazole","65219019030","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65219-190","65219-190-30","65219-190_93859f2f-4d62-4b6f-94bc-a3f5d4ed9890","HUMAN PRESCRIPTION DRUG","Voriconazole","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20201201","","ANDA","ANDA211099","Fresenius Kabi USA, LLC","10","mg/mL","","N","20251231"
"5246","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","65219025628","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65219-256","65219-256-28","65219-256_630fa34d-c117-4a27-8bbe-b837d2093a53","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20171116","","ANDA","ANDA203720","Fresenius Kabi USA, LLC","36; 4.5","g/180mL; g/180mL","","N","20261231"
"5247","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","65219025624","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65219-256","65219-256-24","65219-256_630fa34d-c117-4a27-8bbe-b837d2093a53","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20171116","","ANDA","ANDA203720","Fresenius Kabi USA, LLC","36; 4.5","g/180mL; g/180mL","","N","20261231"
"5248","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","65219025600","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65219-256","65219-256-00","65219-256_630fa34d-c117-4a27-8bbe-b837d2093a53","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20171116","","ANDA","ANDA203720","Fresenius Kabi USA, LLC","36; 4.5","g/180mL; g/180mL","","N","20261231"
"5249","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","65219025955","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65219-259","65219-259-55","65219-259_76af03be-bc73-40f9-bde0-31fe9c359ca2","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180518","","ANDA","ANDA203719","Fresenius Kabi USA, LLC","4; .5","g/20mL; g/20mL","","N","20261231"
"5250","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","65219025945","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65219-259","65219-259-45","65219-259_76af03be-bc73-40f9-bde0-31fe9c359ca2","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180518","","ANDA","ANDA203719","Fresenius Kabi USA, LLC","4; .5","g/20mL; g/20mL","","N","20261231"
"5251","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","65219043420","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65219-434","65219-434-20","65219-434_76af03be-bc73-40f9-bde0-31fe9c359ca2","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230320","","ANDA","ANDA203719","Fresenius Kabi USA, LLC","2; .25","g/10mL; g/10mL","","N","20261231"
"5252","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin and Tazobactam","65219043620","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65219-436","65219-436-20","65219-436_76af03be-bc73-40f9-bde0-31fe9c359ca2","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230320","","ANDA","ANDA203719","Fresenius Kabi USA, LLC","3; .375","g/15mL; g/15mL","","N","20261231"
"5253","RIFAXIMIN","rifaximin","65649030103","Rifamycin Antibacterial [EPC], Rifamycins [CS]","65649-301","65649-301-03","65649-301_25e223f8-89cc-114c-e063-6394a90a6a5b","HUMAN PRESCRIPTION DRUG","XIFAXAN","","TABLET","ORAL","20040725","","NDA","NDA021361","Salix Pharmaceuticals, Inc.","200","mg/1","","N","20251231"
"5254","RIFAXIMIN","rifaximin","65649030302","Rifamycin Antibacterial [EPC], Rifamycins [CS]","65649-303","65649-303-02","65649-303_25e223f8-89cc-114c-e063-6394a90a6a5b","HUMAN PRESCRIPTION DRUG","XIFAXAN","","TABLET","ORAL","20100501","","NDA","NDA021361","Salix Pharmaceuticals, Inc.","550","mg/1","","N","20251231"
"5255","RIFAXIMIN","rifaximin","65649030303","Rifamycin Antibacterial [EPC], Rifamycins [CS]","65649-303","65649-303-03","65649-303_25e223f8-89cc-114c-e063-6394a90a6a5b","HUMAN PRESCRIPTION DRUG","XIFAXAN","","TABLET","ORAL","20100501","","NDA","NDA021361","Salix Pharmaceuticals, Inc.","550","mg/1","","N","20251231"
"5256","RIFAXIMIN","rifaximin","65649030305","Rifamycin Antibacterial [EPC], Rifamycins [CS]","65649-303","65649-303-05","65649-303_25e223f8-89cc-114c-e063-6394a90a6a5b","HUMAN PRESCRIPTION DRUG","XIFAXAN","","TABLET","ORAL","20100501","","NDA","NDA021361","Salix Pharmaceuticals, Inc.","550","mg/1","","N","20251231"
"5257","RIFAXIMIN","rifaximin","65649030301","Rifamycin Antibacterial [EPC], Rifamycins [CS]","65649-303","65649-303-01","65649-303_25e223f8-89cc-114c-e063-6394a90a6a5b","HUMAN PRESCRIPTION DRUG","XIFAXAN","","TABLET","ORAL","20100501","","NDA","NDA021361","Salix Pharmaceuticals, Inc.","550","mg/1","","N","20251231"
"5258","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","65841063301","Antimalarial [EPC], Antirheumatic Agent [EPC]","65841-633","65841-633-01","65841-633_1cd93092-a640-4e63-bdf9-fee57205fc1c","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Zydus Lifesciences Limited","200","mg/1","","N","20251231"
"5259","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","65841063305","Antimalarial [EPC], Antirheumatic Agent [EPC]","65841-633","65841-633-05","65841-633_1cd93092-a640-4e63-bdf9-fee57205fc1c","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Zydus Lifesciences Limited","200","mg/1","","N","20251231"
"5260","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","65841063330","Antimalarial [EPC], Antirheumatic Agent [EPC]","65841-633","65841-633-30","65841-633_1cd93092-a640-4e63-bdf9-fee57205fc1c","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Zydus Lifesciences Limited","200","mg/1","","N","20251231"
"5261","VORICONAZOLE","voriconazole","65841083005","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65841-830","65841-830-05","65841-830_4e76d2f9-3248-4ecd-b701-7156a47f3fae","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20160525","","ANDA","ANDA206747","Zydus Lifesciences Limited","50","mg/1","","N","20261231"
"5262","VORICONAZOLE","voriconazole","65841083006","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65841-830","65841-830-06","65841-830_4e76d2f9-3248-4ecd-b701-7156a47f3fae","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20160525","","ANDA","ANDA206747","Zydus Lifesciences Limited","50","mg/1","","N","20261231"
"5263","VORICONAZOLE","voriconazole","65841083010","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65841-830","65841-830-10","65841-830_4e76d2f9-3248-4ecd-b701-7156a47f3fae","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20160525","","ANDA","ANDA206747","Zydus Lifesciences Limited","50","mg/1","","N","20261231"
"5264","VORICONAZOLE","voriconazole","65841083016","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65841-830","65841-830-16","65841-830_4e76d2f9-3248-4ecd-b701-7156a47f3fae","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20160525","","ANDA","ANDA206747","Zydus Lifesciences Limited","50","mg/1","","N","20261231"
"5265","VORICONAZOLE","voriconazole","65841083077","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65841-830","65841-830-77","65841-830_4e76d2f9-3248-4ecd-b701-7156a47f3fae","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20160525","","ANDA","ANDA206747","Zydus Lifesciences Limited","50","mg/1","","N","20261231"
"5266","VORICONAZOLE","voriconazole","65841083001","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65841-830","65841-830-01","65841-830_4e76d2f9-3248-4ecd-b701-7156a47f3fae","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20160525","","ANDA","ANDA206747","Zydus Lifesciences Limited","50","mg/1","","N","20261231"
"5267","VORICONAZOLE","voriconazole","65841083101","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65841-831","65841-831-01","65841-831_4e76d2f9-3248-4ecd-b701-7156a47f3fae","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20160525","","ANDA","ANDA206747","Zydus Lifesciences Limited","200","mg/1","","N","20261231"
"5268","VORICONAZOLE","voriconazole","65841083105","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65841-831","65841-831-05","65841-831_4e76d2f9-3248-4ecd-b701-7156a47f3fae","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20160525","","ANDA","ANDA206747","Zydus Lifesciences Limited","200","mg/1","","N","20261231"
"5269","VORICONAZOLE","voriconazole","65841083106","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65841-831","65841-831-06","65841-831_4e76d2f9-3248-4ecd-b701-7156a47f3fae","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20160525","","ANDA","ANDA206747","Zydus Lifesciences Limited","200","mg/1","","N","20261231"
"5270","VORICONAZOLE","voriconazole","65841083116","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65841-831","65841-831-16","65841-831_4e76d2f9-3248-4ecd-b701-7156a47f3fae","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20160525","","ANDA","ANDA206747","Zydus Lifesciences Limited","200","mg/1","","N","20261231"
"5271","VORICONAZOLE","voriconazole","65841083177","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65841-831","65841-831-77","65841-831_4e76d2f9-3248-4ecd-b701-7156a47f3fae","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20160525","","ANDA","ANDA206747","Zydus Lifesciences Limited","200","mg/1","","N","20261231"
"5272","VORICONAZOLE","voriconazole","65841083110","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65841-831","65841-831-10","65841-831_4e76d2f9-3248-4ecd-b701-7156a47f3fae","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20160525","","ANDA","ANDA206747","Zydus Lifesciences Limited","200","mg/1","","N","20261231"
"5273","AMOXICILLIN","Amoxicillin","65862001401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-014","65862-014-01","65862-014_ee0e12cd-e881-4048-a0fb-74bd771cb9aa","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5274","AMOXICILLIN","Amoxicillin","65862001420","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-014","65862-014-20","65862-014_ee0e12cd-e881-4048-a0fb-74bd771cb9aa","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5275","AMOXICILLIN","Amoxicillin","65862001405","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-014","65862-014-05","65862-014_ee0e12cd-e881-4048-a0fb-74bd771cb9aa","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5276","AMOXICILLIN","Amoxicillin","65862001501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-015","65862-015-01","65862-015_ee0e12cd-e881-4048-a0fb-74bd771cb9aa","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Aurobindo Pharma Limited","875","mg/1","","N","20251231"
"5277","AMOXICILLIN","Amoxicillin","65862001505","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-015","65862-015-05","65862-015_ee0e12cd-e881-4048-a0fb-74bd771cb9aa","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Aurobindo Pharma Limited","875","mg/1","","N","20251231"
"5278","AMOXICILLIN","Amoxicillin","65862001520","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-015","65862-015-20","65862-015_ee0e12cd-e881-4048-a0fb-74bd771cb9aa","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Aurobindo Pharma Limited","875","mg/1","","N","20251231"
"5279","AMOXICILLIN","Amoxicillin","65862001605","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-016","65862-016-05","65862-016_4dc94f3c-990d-476f-a88e-df9967570eec","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5280","AMOXICILLIN","Amoxicillin","65862001620","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-016","65862-016-20","65862-016_4dc94f3c-990d-476f-a88e-df9967570eec","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5281","AMOXICILLIN","Amoxicillin","65862001630","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-016","65862-016-30","65862-016_4dc94f3c-990d-476f-a88e-df9967570eec","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5282","AMOXICILLIN","Amoxicillin","65862001650","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-016","65862-016-50","65862-016_4dc94f3c-990d-476f-a88e-df9967570eec","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5283","AMOXICILLIN","Amoxicillin","65862001601","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-016","65862-016-01","65862-016_4dc94f3c-990d-476f-a88e-df9967570eec","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5284","AMOXICILLIN","Amoxicillin","65862001705","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-017","65862-017-05","65862-017_4dc94f3c-990d-476f-a88e-df9967570eec","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5285","AMOXICILLIN","Amoxicillin","65862001720","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-017","65862-017-20","65862-017_4dc94f3c-990d-476f-a88e-df9967570eec","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5286","AMOXICILLIN","Amoxicillin","65862001730","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-017","65862-017-30","65862-017_4dc94f3c-990d-476f-a88e-df9967570eec","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5287","AMOXICILLIN","Amoxicillin","65862001701","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-017","65862-017-01","65862-017_4dc94f3c-990d-476f-a88e-df9967570eec","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5288","AMOXICILLIN","Amoxicillin","65862001750","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-017","65862-017-50","65862-017_4dc94f3c-990d-476f-a88e-df9967570eec","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5289","CEPHALEXIN","Cephalexin","65862001801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-018","65862-018-01","65862-018_51110cd1-498e-42ac-87a8-dc1e9f7e732b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5290","CEPHALEXIN","Cephalexin","65862001805","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-018","65862-018-05","65862-018_51110cd1-498e-42ac-87a8-dc1e9f7e732b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5291","CEPHALEXIN","Cephalexin","65862001820","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-018","65862-018-20","65862-018_51110cd1-498e-42ac-87a8-dc1e9f7e732b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5292","CEPHALEXIN","Cephalexin","65862001840","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-018","65862-018-40","65862-018_51110cd1-498e-42ac-87a8-dc1e9f7e732b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5293","CEPHALEXIN","Cephalexin","65862001905","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-019","65862-019-05","65862-019_51110cd1-498e-42ac-87a8-dc1e9f7e732b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5294","CEPHALEXIN","Cephalexin","65862001920","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-019","65862-019-20","65862-019_51110cd1-498e-42ac-87a8-dc1e9f7e732b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5295","CEPHALEXIN","Cephalexin","65862001940","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-019","65862-019-40","65862-019_51110cd1-498e-42ac-87a8-dc1e9f7e732b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5296","CEPHALEXIN","Cephalexin","65862001901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-019","65862-019-01","65862-019_51110cd1-498e-42ac-87a8-dc1e9f7e732b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5297","FLUCONAZOLE","Fluconazole","65862005830","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-058","65862-058-30","65862-058_d017859b-48a2-4b16-9f5a-84316c6e7f4b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Aurobindo Pharma Limited","50","mg/1","","N","20251231"
"5298","FLUCONAZOLE","Fluconazole","65862005901","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-059","65862-059-01","65862-059_d017859b-48a2-4b16-9f5a-84316c6e7f4b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Aurobindo Pharma Limited","100","mg/1","","N","20251231"
"5299","FLUCONAZOLE","Fluconazole","65862005905","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-059","65862-059-05","65862-059_d017859b-48a2-4b16-9f5a-84316c6e7f4b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Aurobindo Pharma Limited","100","mg/1","","N","20251231"
"5300","FLUCONAZOLE","Fluconazole","65862005930","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-059","65862-059-30","65862-059_d017859b-48a2-4b16-9f5a-84316c6e7f4b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Aurobindo Pharma Limited","100","mg/1","","N","20251231"
"5301","FLUCONAZOLE","Fluconazole","65862006011","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-060","65862-060-11","65862-060_d017859b-48a2-4b16-9f5a-84316c6e7f4b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Aurobindo Pharma Limited","150","mg/1","","N","20251231"
"5302","FLUCONAZOLE","Fluconazole","65862006101","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-061","65862-061-01","65862-061_d017859b-48a2-4b16-9f5a-84316c6e7f4b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Aurobindo Pharma Limited","200","mg/1","","N","20251231"
"5303","FLUCONAZOLE","Fluconazole","65862006105","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-061","65862-061-05","65862-061_d017859b-48a2-4b16-9f5a-84316c6e7f4b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Aurobindo Pharma Limited","200","mg/1","","N","20251231"
"5304","FLUCONAZOLE","Fluconazole","65862006130","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-061","65862-061-30","65862-061_d017859b-48a2-4b16-9f5a-84316c6e7f4b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Aurobindo Pharma Limited","200","mg/1","","N","20251231"
"5305","AMOXICILLIN","Amoxicillin","65862007050","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-070","65862-070-50","65862-070_3e3ca279-1838-4348-a01c-df10a8bcb8b9","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","Aurobindo Pharma Limited","200","mg/5mL","","N","20251231"
"5306","AMOXICILLIN","Amoxicillin","65862007075","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-070","65862-070-75","65862-070_3e3ca279-1838-4348-a01c-df10a8bcb8b9","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","Aurobindo Pharma Limited","200","mg/5mL","","N","20251231"
"5307","AMOXICILLIN","Amoxicillin","65862007001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-070","65862-070-01","65862-070_3e3ca279-1838-4348-a01c-df10a8bcb8b9","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","Aurobindo Pharma Limited","200","mg/5mL","","N","20251231"
"5308","AMOXICILLIN","Amoxicillin","65862007101","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-071","65862-071-01","65862-071_3e3ca279-1838-4348-a01c-df10a8bcb8b9","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","Aurobindo Pharma Limited","400","mg/5mL","","N","20251231"
"5309","AMOXICILLIN","Amoxicillin","65862007175","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-071","65862-071-75","65862-071_3e3ca279-1838-4348-a01c-df10a8bcb8b9","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","Aurobindo Pharma Limited","400","mg/5mL","","N","20251231"
"5310","AMOXICILLIN","Amoxicillin","65862007150","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-071","65862-071-50","65862-071_3e3ca279-1838-4348-a01c-df10a8bcb8b9","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","Aurobindo Pharma Limited","400","mg/5mL","","N","20251231"
"5311","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","65862007620","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-076","65862-076-20","65862-076_42b2ce51-719e-4e9c-b09b-74582c672c19","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Aurobindo Pharma Limited","250","mg/1","","N","20261231"
"5312","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","65862007630","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-076","65862-076-30","65862-076_42b2ce51-719e-4e9c-b09b-74582c672c19","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Aurobindo Pharma Limited","250","mg/1","","N","20261231"
"5313","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","65862007699","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-076","65862-076-99","65862-076_42b2ce51-719e-4e9c-b09b-74582c672c19","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Aurobindo Pharma Limited","250","mg/1","","N","20261231"
"5314","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","65862007601","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-076","65862-076-01","65862-076_42b2ce51-719e-4e9c-b09b-74582c672c19","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Aurobindo Pharma Limited","250","mg/1","","N","20261231"
"5315","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","65862007705","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-077","65862-077-05","65862-077_42b2ce51-719e-4e9c-b09b-74582c672c19","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Aurobindo Pharma Limited","500","mg/1","","N","20261231"
"5316","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","65862007720","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-077","65862-077-20","65862-077_42b2ce51-719e-4e9c-b09b-74582c672c19","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Aurobindo Pharma Limited","500","mg/1","","N","20261231"
"5317","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","65862007730","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-077","65862-077-30","65862-077_42b2ce51-719e-4e9c-b09b-74582c672c19","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Aurobindo Pharma Limited","500","mg/1","","N","20261231"
"5318","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","65862007799","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-077","65862-077-99","65862-077_42b2ce51-719e-4e9c-b09b-74582c672c19","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Aurobindo Pharma Limited","500","mg/1","","N","20261231"
"5319","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","65862007701","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-077","65862-077-01","65862-077_42b2ce51-719e-4e9c-b09b-74582c672c19","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Aurobindo Pharma Limited","500","mg/1","","N","20261231"
"5320","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","65862007805","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-078","65862-078-05","65862-078_42b2ce51-719e-4e9c-b09b-74582c672c19","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Aurobindo Pharma Limited","750","mg/1","","N","20261231"
"5321","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","65862007820","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-078","65862-078-20","65862-078_42b2ce51-719e-4e9c-b09b-74582c672c19","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Aurobindo Pharma Limited","750","mg/1","","N","20261231"
"5322","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","65862007850","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-078","65862-078-50","65862-078_42b2ce51-719e-4e9c-b09b-74582c672c19","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Aurobindo Pharma Limited","750","mg/1","","N","20261231"
"5323","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","65862007801","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-078","65862-078-01","65862-078_42b2ce51-719e-4e9c-b09b-74582c672c19","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Aurobindo Pharma Limited","750","mg/1","","N","20261231"
"5324","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","65862007898","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-078","65862-078-98","65862-078_42b2ce51-719e-4e9c-b09b-74582c672c19","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Aurobindo Pharma Limited","750","mg/1","","N","20261231"
"5325","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","65862007901","Allylamine Antifungal [EPC], Allylamine [CS]","65862-079","65862-079-01","65862-079_8f6e6ae9-4903-4823-b788-de387e8c6fb2","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5326","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","65862007930","Allylamine Antifungal [EPC], Allylamine [CS]","65862-079","65862-079-30","65862-079_8f6e6ae9-4903-4823-b788-de387e8c6fb2","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5327","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","65862007999","Allylamine Antifungal [EPC], Allylamine [CS]","65862-079","65862-079-99","65862-079_8f6e6ae9-4903-4823-b788-de387e8c6fb2","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5328","CEFADROXIL","Cefadroxil","65862008350","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-083","65862-083-50","65862-083_74923cbc-7511-447d-b6b2-b2d0e805a0f5","HUMAN PRESCRIPTION DRUG","Cefadroxil","","POWDER, FOR SUSPENSION","ORAL","20130425","","ANDA","ANDA065349","Aurobindo Pharma Limited","250","mg/5mL","","N","20251231"
"5329","CEFADROXIL","Cefadroxil","65862008301","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-083","65862-083-01","65862-083_74923cbc-7511-447d-b6b2-b2d0e805a0f5","HUMAN PRESCRIPTION DRUG","Cefadroxil","","POWDER, FOR SUSPENSION","ORAL","20130425","","ANDA","ANDA065349","Aurobindo Pharma Limited","250","mg/5mL","","N","20251231"
"5330","CEFADROXIL","Cefadroxil","65862008401","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-084","65862-084-01","65862-084_74923cbc-7511-447d-b6b2-b2d0e805a0f5","HUMAN PRESCRIPTION DRUG","Cefadroxil","","POWDER, FOR SUSPENSION","ORAL","20130425","","ANDA","ANDA065349","Aurobindo Pharma Limited","500","mg/5mL","","N","20251231"
"5331","CEFADROXIL","Cefadroxil","65862008450","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-084","65862-084-50","65862-084_74923cbc-7511-447d-b6b2-b2d0e805a0f5","HUMAN PRESCRIPTION DRUG","Cefadroxil","","POWDER, FOR SUSPENSION","ORAL","20130425","","ANDA","ANDA065349","Aurobindo Pharma Limited","500","mg/5mL","","N","20251231"
"5332","CEFADROXIL","Cefadroxil","65862008475","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-084","65862-084-75","65862-084_74923cbc-7511-447d-b6b2-b2d0e805a0f5","HUMAN PRESCRIPTION DRUG","Cefadroxil","","POWDER, FOR SUSPENSION","ORAL","20130425","","ANDA","ANDA065349","Aurobindo Pharma Limited","500","mg/5mL","","N","20251231"
"5333","CEFADROXIL","Cefadroxil","65862008550","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-085","65862-085-50","65862-085_58128541-059d-4ef1-9dbf-98fa1befdcf0","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5334","CEFADROXIL","Cefadroxil","65862008501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-085","65862-085-01","65862-085_58128541-059d-4ef1-9dbf-98fa1befdcf0","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5335","CEFPODOXIME PROXETIL","CEFPODOXIME PROXETIL","65862009501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-095","65862-095-01","65862-095_12ee6554-adfc-4c3b-b87e-3568576359a6","HUMAN PRESCRIPTION DRUG","CEFPODOXIME PROXETIL","","TABLET, FILM COATED","ORAL","20070611","","ANDA","ANDA065370","Aurobindo Pharma Limited","100","mg/1","","N","20251231"
"5336","CEFPODOXIME PROXETIL","CEFPODOXIME PROXETIL","65862009520","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-095","65862-095-20","65862-095_12ee6554-adfc-4c3b-b87e-3568576359a6","HUMAN PRESCRIPTION DRUG","CEFPODOXIME PROXETIL","","TABLET, FILM COATED","ORAL","20070611","","ANDA","ANDA065370","Aurobindo Pharma Limited","100","mg/1","","N","20251231"
"5337","CEFPODOXIME PROXETIL","CEFPODOXIME PROXETIL","65862009599","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-095","65862-095-99","65862-095_12ee6554-adfc-4c3b-b87e-3568576359a6","HUMAN PRESCRIPTION DRUG","CEFPODOXIME PROXETIL","","TABLET, FILM COATED","ORAL","20070611","","ANDA","ANDA065370","Aurobindo Pharma Limited","100","mg/1","","N","20251231"
"5338","CEFPODOXIME PROXETIL","CEFPODOXIME PROXETIL","65862009525","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-095","65862-095-25","65862-095_12ee6554-adfc-4c3b-b87e-3568576359a6","HUMAN PRESCRIPTION DRUG","CEFPODOXIME PROXETIL","","TABLET, FILM COATED","ORAL","20070611","","ANDA","ANDA065370","Aurobindo Pharma Limited","100","mg/1","","N","20251231"
"5339","CEFPODOXIME PROXETIL","CEFPODOXIME PROXETIL","65862009601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-096","65862-096-01","65862-096_12ee6554-adfc-4c3b-b87e-3568576359a6","HUMAN PRESCRIPTION DRUG","CEFPODOXIME PROXETIL","","TABLET, FILM COATED","ORAL","20070611","","ANDA","ANDA065370","Aurobindo Pharma Limited","200","mg/1","","N","20251231"
"5340","CEFPODOXIME PROXETIL","CEFPODOXIME PROXETIL","65862009620","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-096","65862-096-20","65862-096_12ee6554-adfc-4c3b-b87e-3568576359a6","HUMAN PRESCRIPTION DRUG","CEFPODOXIME PROXETIL","","TABLET, FILM COATED","ORAL","20070611","","ANDA","ANDA065370","Aurobindo Pharma Limited","200","mg/1","","N","20251231"
"5341","CEFPODOXIME PROXETIL","CEFPODOXIME PROXETIL","65862009699","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-096","65862-096-99","65862-096_12ee6554-adfc-4c3b-b87e-3568576359a6","HUMAN PRESCRIPTION DRUG","CEFPODOXIME PROXETIL","","TABLET, FILM COATED","ORAL","20070611","","ANDA","ANDA065370","Aurobindo Pharma Limited","200","mg/1","","N","20251231"
"5342","CEFPODOXIME PROXETIL","CEFPODOXIME PROXETIL","65862009625","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-096","65862-096-25","65862-096_12ee6554-adfc-4c3b-b87e-3568576359a6","HUMAN PRESCRIPTION DRUG","CEFPODOXIME PROXETIL","","TABLET, FILM COATED","ORAL","20070611","","ANDA","ANDA065370","Aurobindo Pharma Limited","200","mg/1","","N","20251231"
"5343","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","65862014050","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-140","65862-140-50","65862-140_95331369-8343-4244-8d82-03a1bc4af0c0","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","GRANULE, FOR SUSPENSION","ORAL","20070608","","ANDA","ANDA065409","Aurobindo Pharma Limited","50","mg/5mL","","N","20251231"
"5344","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","65862014075","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-140","65862-140-75","65862-140_95331369-8343-4244-8d82-03a1bc4af0c0","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","GRANULE, FOR SUSPENSION","ORAL","20070608","","ANDA","ANDA065409","Aurobindo Pharma Limited","50","mg/5mL","","N","20251231"
"5345","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","65862014001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-140","65862-140-01","65862-140_95331369-8343-4244-8d82-03a1bc4af0c0","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","GRANULE, FOR SUSPENSION","ORAL","20070608","","ANDA","ANDA065409","Aurobindo Pharma Limited","50","mg/5mL","","N","20251231"
"5346","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","65862014101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-141","65862-141-01","65862-141_95331369-8343-4244-8d82-03a1bc4af0c0","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","GRANULE, FOR SUSPENSION","ORAL","20070608","","ANDA","ANDA065409","Aurobindo Pharma Limited","100","mg/5mL","","N","20251231"
"5347","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","65862014175","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-141","65862-141-75","65862-141_95331369-8343-4244-8d82-03a1bc4af0c0","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","GRANULE, FOR SUSPENSION","ORAL","20070608","","ANDA","ANDA065409","Aurobindo Pharma Limited","100","mg/5mL","","N","20251231"
"5348","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","65862014150","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-141","65862-141-50","65862-141_95331369-8343-4244-8d82-03a1bc4af0c0","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","GRANULE, FOR SUSPENSION","ORAL","20070608","","ANDA","ANDA065409","Aurobindo Pharma Limited","100","mg/5mL","","N","20251231"
"5349","PENICILLIN V POTASSIUM","Penicillin V Potassium","65862017599","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-175","65862-175-99","65862-175_7b3fb934-771d-4f76-9abe-8002861dd633","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5350","PENICILLIN V POTASSIUM","Penicillin V Potassium","65862017501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-175","65862-175-01","65862-175_7b3fb934-771d-4f76-9abe-8002861dd633","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5351","PENICILLIN V POTASSIUM","Penicillin V Potassium","65862017605","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-176","65862-176-05","65862-176_7b3fb934-771d-4f76-9abe-8002861dd633","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5352","PENICILLIN V POTASSIUM","Penicillin V Potassium","65862017699","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-176","65862-176-99","65862-176_7b3fb934-771d-4f76-9abe-8002861dd633","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5353","PENICILLIN V POTASSIUM","Penicillin V Potassium","65862017601","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-176","65862-176-01","65862-176_7b3fb934-771d-4f76-9abe-8002861dd633","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5354","CEFDINIR","Cefdinir","65862017705","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-177","65862-177-05","65862-177_26399fd5-bcb0-4ab6-954a-ab3d5f20f2b3","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","Aurobindo Pharma Limited","300","mg/1","","N","20251231"
"5355","CEFDINIR","Cefdinir","65862017760","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-177","65862-177-60","65862-177_26399fd5-bcb0-4ab6-954a-ab3d5f20f2b3","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","Aurobindo Pharma Limited","300","mg/1","","N","20251231"
"5356","CEFDINIR","Cefdinir","65862017730","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-177","65862-177-30","65862-177_26399fd5-bcb0-4ab6-954a-ab3d5f20f2b3","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","Aurobindo Pharma Limited","300","mg/1","","N","20251231"
"5357","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","65862018501","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","65862-185","65862-185-01","65862-185_f87366fc-7b22-4528-a882-7622634d7ae5","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Aurobindo Pharma Limited","150","mg/1","","N","20251231"
"5358","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","65862018505","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","65862-185","65862-185-05","65862-185_f87366fc-7b22-4528-a882-7622634d7ae5","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Aurobindo Pharma Limited","150","mg/1","","N","20251231"
"5359","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","65862018605","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","65862-186","65862-186-05","65862-186_f87366fc-7b22-4528-a882-7622634d7ae5","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Aurobindo Pharma Limited","300","mg/1","","N","20251231"
"5360","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","65862018616","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","65862-186","65862-186-16","65862-186_f87366fc-7b22-4528-a882-7622634d7ae5","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Aurobindo Pharma Limited","300","mg/1","","N","20251231"
"5361","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","65862018601","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","65862-186","65862-186-01","65862-186_f87366fc-7b22-4528-a882-7622634d7ae5","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Aurobindo Pharma Limited","300","mg/1","","N","20251231"
"5362","RIBAVIRIN","Ribavirin","65862020768","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","65862-207","65862-207-68","65862-207_683ccd3f-445b-4488-b14c-8d5810d8633a","HUMAN PRESCRIPTION DRUG","Ribavirin","","TABLET, FILM COATED","ORAL","20090917","","ANDA","ANDA079111","Aurobindo Pharma Limited","200","mg/1","","N","20251231"
"5363","RIBAVIRIN","Ribavirin","65862020705","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","65862-207","65862-207-05","65862-207_683ccd3f-445b-4488-b14c-8d5810d8633a","HUMAN PRESCRIPTION DRUG","Ribavirin","","TABLET, FILM COATED","ORAL","20090917","","ANDA","ANDA079111","Aurobindo Pharma Limited","200","mg/1","","N","20251231"
"5364","CEFDINIR","Cefdinir","65862021801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-218","65862-218-01","65862-218_9cfbe4a1-045c-489f-8ca7-9d595997dab7","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20071214","","ANDA","ANDA065473","Aurobindo Pharma Limited","125","mg/5mL","","N","20251231"
"5365","CEFDINIR","Cefdinir","65862021860","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-218","65862-218-60","65862-218_9cfbe4a1-045c-489f-8ca7-9d595997dab7","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20071214","","ANDA","ANDA065473","Aurobindo Pharma Limited","125","mg/5mL","","N","20251231"
"5366","CEFDINIR","Cefdinir","65862021901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-219","65862-219-01","65862-219_9cfbe4a1-045c-489f-8ca7-9d595997dab7","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20071214","","ANDA","ANDA065473","Aurobindo Pharma Limited","250","mg/5mL","","N","20251231"
"5367","CEFDINIR","Cefdinir","65862021960","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-219","65862-219-60","65862-219_9cfbe4a1-045c-489f-8ca7-9d595997dab7","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20071214","","ANDA","ANDA065473","Aurobindo Pharma Limited","250","mg/5mL","","N","20251231"
"5368","CLARITHROMYCIN","Clarithromycin","65862022599","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","65862-225","65862-225-99","65862-225_4bb3048c-0a75-4818-9be5-4c81cfe9649c","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5369","CLARITHROMYCIN","Clarithromycin","65862022560","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","65862-225","65862-225-60","65862-225_4bb3048c-0a75-4818-9be5-4c81cfe9649c","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5370","CLARITHROMYCIN","Clarithromycin","65862022610","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","65862-226","65862-226-10","65862-226_4bb3048c-0a75-4818-9be5-4c81cfe9649c","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5371","CLARITHROMYCIN","Clarithromycin","65862022660","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","65862-226","65862-226-60","65862-226_4bb3048c-0a75-4818-9be5-4c81cfe9649c","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5372","CLARITHROMYCIN","Clarithromycin","65862022699","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","65862-226","65862-226-99","65862-226_4bb3048c-0a75-4818-9be5-4c81cfe9649c","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5373","RIBAVIRIN","Ribavirin","65862029018","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","65862-290","65862-290-18","65862-290_229cfa05-05e1-493e-87ba-0511fed12e66","HUMAN PRESCRIPTION DRUG","Ribavirin","","CAPSULE","ORAL","20090917","","ANDA","ANDA079117","Aurobindo Pharma Limited","200","mg/1","","N","20251231"
"5374","RIBAVIRIN","Ribavirin","65862029042","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","65862-290","65862-290-42","65862-290_229cfa05-05e1-493e-87ba-0511fed12e66","HUMAN PRESCRIPTION DRUG","Ribavirin","","CAPSULE","ORAL","20090917","","ANDA","ANDA079117","Aurobindo Pharma Limited","200","mg/1","","N","20251231"
"5375","RIBAVIRIN","Ribavirin","65862029056","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","65862-290","65862-290-56","65862-290_229cfa05-05e1-493e-87ba-0511fed12e66","HUMAN PRESCRIPTION DRUG","Ribavirin","","CAPSULE","ORAL","20090917","","ANDA","ANDA079117","Aurobindo Pharma Limited","200","mg/1","","N","20251231"
"5376","RIBAVIRIN","Ribavirin","65862029005","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","65862-290","65862-290-05","65862-290_229cfa05-05e1-493e-87ba-0511fed12e66","HUMAN PRESCRIPTION DRUG","Ribavirin","","CAPSULE","ORAL","20090917","","ANDA","ANDA079117","Aurobindo Pharma Limited","200","mg/1","","N","20251231"
"5377","RIBAVIRIN","Ribavirin","65862029084","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","65862-290","65862-290-84","65862-290_229cfa05-05e1-493e-87ba-0511fed12e66","HUMAN PRESCRIPTION DRUG","Ribavirin","","CAPSULE","ORAL","20090917","","ANDA","ANDA079117","Aurobindo Pharma Limited","200","mg/1","","N","20251231"
"5378","RIBAVIRIN","Ribavirin","65862029070","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","65862-290","65862-290-70","65862-290_229cfa05-05e1-493e-87ba-0511fed12e66","HUMAN PRESCRIPTION DRUG","Ribavirin","","CAPSULE","ORAL","20090917","","ANDA","ANDA079117","Aurobindo Pharma Limited","200","mg/1","","N","20251231"
"5379","FLUCONAZOLE","Fluconazole","65862029935","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-299","65862-299-35","65862-299_5305f9a9-119f-43e6-a48a-1598094d6c8f","HUMAN PRESCRIPTION DRUG","Fluconazole","","POWDER, FOR SUSPENSION","ORAL","20090918","","ANDA","ANDA079150","Aurobindo Pharma Limited","10","mg/mL","","N","20251231"
"5380","FLUCONAZOLE","Fluconazole","65862030035","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-300","65862-300-35","65862-300_5305f9a9-119f-43e6-a48a-1598094d6c8f","HUMAN PRESCRIPTION DRUG","Fluconazole","","POWDER, FOR SUSPENSION","ORAL","20090918","","ANDA","ANDA079150","Aurobindo Pharma Limited","40","mg/mL","","N","20251231"
"5381","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65862041905","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65862-419","65862-419-05","65862-419_e4ea8e99-58d4-4c1b-b84c-db0838610059","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Aurobindo Pharma Limited","400; 80","mg/1; mg/1","","N","20261231"
"5382","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65862041920","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65862-419","65862-419-20","65862-419_e4ea8e99-58d4-4c1b-b84c-db0838610059","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Aurobindo Pharma Limited","400; 80","mg/1; mg/1","","N","20261231"
"5383","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65862041999","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65862-419","65862-419-99","65862-419_e4ea8e99-58d4-4c1b-b84c-db0838610059","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Aurobindo Pharma Limited","400; 80","mg/1; mg/1","","N","20261231"
"5384","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65862041901","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65862-419","65862-419-01","65862-419_e4ea8e99-58d4-4c1b-b84c-db0838610059","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Aurobindo Pharma Limited","400; 80","mg/1; mg/1","","N","20261231"
"5385","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65862042005","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65862-420","65862-420-05","65862-420_e4ea8e99-58d4-4c1b-b84c-db0838610059","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Aurobindo Pharma Limited","800; 160","mg/1; mg/1","","N","20261231"
"5386","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65862042020","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65862-420","65862-420-20","65862-420_e4ea8e99-58d4-4c1b-b84c-db0838610059","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Aurobindo Pharma Limited","800; 160","mg/1; mg/1","","N","20261231"
"5387","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65862042099","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65862-420","65862-420-99","65862-420_e4ea8e99-58d4-4c1b-b84c-db0838610059","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Aurobindo Pharma Limited","800; 160","mg/1; mg/1","","N","20261231"
"5388","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65862042001","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65862-420","65862-420-01","65862-420_e4ea8e99-58d4-4c1b-b84c-db0838610059","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Aurobindo Pharma Limited","800; 160","mg/1; mg/1","","N","20261231"
"5389","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65862049601","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65862-496","65862-496-01","65862-496_49649c1f-a45f-446e-91ef-f1ebf9090363","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20100608","","ANDA","ANDA091348","Aurobindo Pharma Limited","200; 40","mg/5mL; mg/5mL","","N","20251231"
"5390","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65862049650","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65862-496","65862-496-50","65862-496_49649c1f-a45f-446e-91ef-f1ebf9090363","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20100608","","ANDA","ANDA091348","Aurobindo Pharma Limited","200; 40","mg/5mL; mg/5mL","","N","20251231"
"5391","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","65862049647","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","65862-496","65862-496-47","65862-496_49649c1f-a45f-446e-91ef-f1ebf9090363","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20100608","","ANDA","ANDA091348","Aurobindo Pharma Limited","200; 40","mg/5mL; mg/5mL","","N","20251231"
"5392","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","65862050105","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65862-501","65862-501-05","65862-501_687f12d4-0110-4964-91c5-142824136571","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091569","Aurobindo Pharma Limited","250; 125","mg/1; mg/1","","N","20261231"
"5393","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","65862050130","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65862-501","65862-501-30","65862-501_687f12d4-0110-4964-91c5-142824136571","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091569","Aurobindo Pharma Limited","250; 125","mg/1; mg/1","","N","20261231"
"5394","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","65862050220","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65862-502","65862-502-20","65862-502_687f12d4-0110-4964-91c5-142824136571","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091569","Aurobindo Pharma Limited","500; 125","mg/1; mg/1","","N","20261231"
"5395","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","65862050205","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65862-502","65862-502-05","65862-502_687f12d4-0110-4964-91c5-142824136571","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091569","Aurobindo Pharma Limited","500; 125","mg/1; mg/1","","N","20261231"
"5396","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","65862050301","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65862-503","65862-503-01","65862-503_687f12d4-0110-4964-91c5-142824136571","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","Aurobindo Pharma Limited","875; 125","mg/1; mg/1","","N","20261231"
"5397","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","65862050320","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65862-503","65862-503-20","65862-503_687f12d4-0110-4964-91c5-142824136571","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","Aurobindo Pharma Limited","875; 125","mg/1; mg/1","","N","20261231"
"5398","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","65862053350","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65862-533","65862-533-50","65862-533_4bd68235-4588-4e1a-9bac-b3d98481fd03","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","Aurobindo Pharma Limited","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"5399","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","65862053375","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65862-533","65862-533-75","65862-533_4bd68235-4588-4e1a-9bac-b3d98481fd03","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","Aurobindo Pharma Limited","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"5400","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","65862053301","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65862-533","65862-533-01","65862-533_4bd68235-4588-4e1a-9bac-b3d98481fd03","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","Aurobindo Pharma Limited","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"5401","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","65862053401","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65862-534","65862-534-01","65862-534_4bd68235-4588-4e1a-9bac-b3d98481fd03","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","Aurobindo Pharma Limited","400; 57","mg/5mL; mg/5mL","","N","20251231"
"5402","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","65862053475","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65862-534","65862-534-75","65862-534_4bd68235-4588-4e1a-9bac-b3d98481fd03","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","Aurobindo Pharma Limited","400; 57","mg/5mL; mg/5mL","","N","20251231"
"5403","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","65862053450","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65862-534","65862-534-50","65862-534_4bd68235-4588-4e1a-9bac-b3d98481fd03","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","Aurobindo Pharma Limited","400; 57","mg/5mL; mg/5mL","","N","20251231"
"5404","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","65862053502","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65862-535","65862-535-02","65862-535_3d50990e-9d7e-4a23-a135-97d5612ec0bc","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201091","Aurobindo Pharma Limited","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"5405","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","65862053513","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65862-535","65862-535-13","65862-535_3d50990e-9d7e-4a23-a135-97d5612ec0bc","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201091","Aurobindo Pharma Limited","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"5406","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","65862053575","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","65862-535","65862-535-75","65862-535_3d50990e-9d7e-4a23-a135-97d5612ec0bc","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201091","Aurobindo Pharma Limited","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"5407","CLINDAMYCIN PALMITATE HYDROCHLORIDE","Clindamycin Palmitate Hydrochloride (Pediatric)","65862059601","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","65862-596","65862-596-01","65862-596_78e0ae1e-9c06-4831-b962-e1aa65546110","HUMAN PRESCRIPTION DRUG","Clindamycin Palmitate Hydrochloride (Pediatric)","","SOLUTION","ORAL","20130430","","ANDA","ANDA202409","Aurobindo Pharma Limited","75","mg/5mL","","N","20251231"
"5408","CLINDAMYCIN PALMITATE HYDROCHLORIDE","Clindamycin Palmitate Hydrochloride (Pediatric)","65862059602","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","65862-596","65862-596-02","65862-596_78e0ae1e-9c06-4831-b962-e1aa65546110","HUMAN PRESCRIPTION DRUG","Clindamycin Palmitate Hydrochloride (Pediatric)","","SOLUTION","ORAL","20130430","","ANDA","ANDA202409","Aurobindo Pharma Limited","75","mg/5mL","","N","20251231"
"5409","MOXIFLOXACIN HYDROCHLORIDE","moxifloxacin hydrochloride","65862060330","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-603","65862-603-30","65862-603_636d9d0f-0680-4103-a1c1-58cad9fc5539","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN HYDROCHLORIDE","","TABLET, FILM COATED","ORAL","20140304","","ANDA","ANDA202632","Aurobindo Pharma Limited","400","mg/1","","N","20251231"
"5410","MOXIFLOXACIN HYDROCHLORIDE","moxifloxacin hydrochloride","65862060355","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-603","65862-603-55","65862-603_636d9d0f-0680-4103-a1c1-58cad9fc5539","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN HYDROCHLORIDE","","TABLET, FILM COATED","ORAL","20140304","","ANDA","ANDA202632","Aurobindo Pharma Limited","400","mg/1","","N","20251231"
"5411","MOXIFLOXACIN HYDROCHLORIDE","moxifloxacin hydrochloride","65862060399","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-603","65862-603-99","65862-603_636d9d0f-0680-4103-a1c1-58cad9fc5539","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN HYDROCHLORIDE","","TABLET, FILM COATED","ORAL","20140304","","ANDA","ANDA202632","Aurobindo Pharma Limited","400","mg/1","","N","20251231"
"5412","AZITHROMYCIN DIHYDRATE","Azithromycin","65862064101","Macrolide Antimicrobial [EPC], Macrolides [CS]","65862-641","65862-641-01","65862-641_973a74b9-c813-4af7-b9e8-eb1902c0658a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207370","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5413","AZITHROMYCIN DIHYDRATE","Azithromycin","65862064105","Macrolide Antimicrobial [EPC], Macrolides [CS]","65862-641","65862-641-05","65862-641_973a74b9-c813-4af7-b9e8-eb1902c0658a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207370","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5414","AZITHROMYCIN DIHYDRATE","Azithromycin","65862064150","Macrolide Antimicrobial [EPC], Macrolides [CS]","65862-641","65862-641-50","65862-641_973a74b9-c813-4af7-b9e8-eb1902c0658a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207370","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5415","AZITHROMYCIN DIHYDRATE","Azithromycin","65862064163","Macrolide Antimicrobial [EPC], Macrolides [CS]","65862-641","65862-641-63","65862-641_973a74b9-c813-4af7-b9e8-eb1902c0658a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207370","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5416","AZITHROMYCIN DIHYDRATE","Azithromycin","65862064169","Macrolide Antimicrobial [EPC], Macrolides [CS]","65862-641","65862-641-69","65862-641_973a74b9-c813-4af7-b9e8-eb1902c0658a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207370","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5417","AZITHROMYCIN DIHYDRATE","Azithromycin","65862064130","Macrolide Antimicrobial [EPC], Macrolides [CS]","65862-641","65862-641-30","65862-641_973a74b9-c813-4af7-b9e8-eb1902c0658a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207370","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5418","AZITHROMYCIN DIHYDRATE","Azithromycin","65862064264","Macrolide Antimicrobial [EPC], Macrolides [CS]","65862-642","65862-642-64","65862-642_973a74b9-c813-4af7-b9e8-eb1902c0658a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207398","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5419","AZITHROMYCIN DIHYDRATE","Azithromycin","65862064290","Macrolide Antimicrobial [EPC], Macrolides [CS]","65862-642","65862-642-90","65862-642_973a74b9-c813-4af7-b9e8-eb1902c0658a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207398","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5420","AZITHROMYCIN DIHYDRATE","Azithromycin","65862064230","Macrolide Antimicrobial [EPC], Macrolides [CS]","65862-642","65862-642-30","65862-642_973a74b9-c813-4af7-b9e8-eb1902c0658a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207398","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5421","METRONIDAZOLE","Metronidazole","65862069401","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","65862-694","65862-694-01","65862-694_f56928ba-4263-4212-ae2e-d89fcc7bea68","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5422","METRONIDAZOLE","Metronidazole","65862069405","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","65862-694","65862-694-05","65862-694_f56928ba-4263-4212-ae2e-d89fcc7bea68","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5423","METRONIDAZOLE","Metronidazole","65862069425","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","65862-694","65862-694-25","65862-694_f56928ba-4263-4212-ae2e-d89fcc7bea68","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5424","METRONIDAZOLE","Metronidazole","65862069499","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","65862-694","65862-694-99","65862-694_f56928ba-4263-4212-ae2e-d89fcc7bea68","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5425","METRONIDAZOLE","Metronidazole","65862069450","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","65862-694","65862-694-50","65862-694_f56928ba-4263-4212-ae2e-d89fcc7bea68","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5426","METRONIDAZOLE","Metronidazole","65862069501","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","65862-695","65862-695-01","65862-695_f56928ba-4263-4212-ae2e-d89fcc7bea68","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5427","METRONIDAZOLE","Metronidazole","65862069505","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","65862-695","65862-695-05","65862-695_f56928ba-4263-4212-ae2e-d89fcc7bea68","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5428","METRONIDAZOLE","Metronidazole","65862069599","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","65862-695","65862-695-99","65862-695_f56928ba-4263-4212-ae2e-d89fcc7bea68","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5429","METRONIDAZOLE","Metronidazole","65862069550","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","65862-695","65862-695-50","65862-695_f56928ba-4263-4212-ae2e-d89fcc7bea68","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5430","CEFUROXIME AXETIL","Cefuroxime Axetil","65862069860","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-698","65862-698-60","65862-698_5716a24a-653f-488a-bb44-85abffcbf92c","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","Aurobindo Pharma Limited","125","mg/1","","N","20251231"
"5431","CEFUROXIME AXETIL","Cefuroxime Axetil","65862069820","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-698","65862-698-20","65862-698_5716a24a-653f-488a-bb44-85abffcbf92c","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","Aurobindo Pharma Limited","125","mg/1","","N","20251231"
"5432","CEFUROXIME AXETIL","Cefuroxime Axetil","65862069920","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-699","65862-699-20","65862-699_5716a24a-653f-488a-bb44-85abffcbf92c","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5433","CEFUROXIME AXETIL","Cefuroxime Axetil","65862069960","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-699","65862-699-60","65862-699_5716a24a-653f-488a-bb44-85abffcbf92c","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","Aurobindo Pharma Limited","250","mg/1","","N","20251231"
"5434","CEFUROXIME AXETIL","Cefuroxime Axetil","65862070060","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-700","65862-700-60","65862-700_5716a24a-653f-488a-bb44-85abffcbf92c","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5435","CEFUROXIME AXETIL","Cefuroxime Axetil","65862070020","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-700","65862-700-20","65862-700_5716a24a-653f-488a-bb44-85abffcbf92c","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","Aurobindo Pharma Limited","500","mg/1","","N","20251231"
"5436","AMOXICILLIN","Amoxicillin","65862070601","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-706","65862-706-01","65862-706_f4a410c9-3a78-48f9-8195-915896a974ff","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20140915","","ANDA","ANDA204030","Aurobindo Pharma Limited","125","mg/5mL","","N","20251231"
"5437","AMOXICILLIN","Amoxicillin","65862070655","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-706","65862-706-55","65862-706_f4a410c9-3a78-48f9-8195-915896a974ff","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20140915","","ANDA","ANDA204030","Aurobindo Pharma Limited","125","mg/5mL","","N","20251231"
"5438","AMOXICILLIN","Amoxicillin","65862070680","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-706","65862-706-80","65862-706_f4a410c9-3a78-48f9-8195-915896a974ff","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20140915","","ANDA","ANDA204030","Aurobindo Pharma Limited","125","mg/5mL","","N","20251231"
"5439","AMOXICILLIN","Amoxicillin","65862070755","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-707","65862-707-55","65862-707_f4a410c9-3a78-48f9-8195-915896a974ff","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20140915","","ANDA","ANDA204030","Aurobindo Pharma Limited","250","mg/5mL","","N","20251231"
"5440","AMOXICILLIN","Amoxicillin","65862070780","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-707","65862-707-80","65862-707_f4a410c9-3a78-48f9-8195-915896a974ff","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20140915","","ANDA","ANDA204030","Aurobindo Pharma Limited","250","mg/5mL","","N","20251231"
"5441","AMOXICILLIN","Amoxicillin","65862070701","Penicillin-class Antibacterial [EPC], Penicillins [CS]","65862-707","65862-707-01","65862-707_f4a410c9-3a78-48f9-8195-915896a974ff","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20140915","","ANDA","ANDA204030","Aurobindo Pharma Limited","250","mg/5mL","","N","20251231"
"5442","CEFIXIME","cefixime","65862075150","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-751","65862-751-50","65862-751_141b12c3-31de-4ca7-ac89-d864975846ab","HUMAN PRESCRIPTION DRUG","Cefixime","","POWDER, FOR SUSPENSION","ORAL","20150414","","ANDA","ANDA204835","Aurobindo Pharma Limited","100","mg/5mL","","N","20251231"
"5443","CEFIXIME","cefixime","65862075101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-751","65862-751-01","65862-751_141b12c3-31de-4ca7-ac89-d864975846ab","HUMAN PRESCRIPTION DRUG","Cefixime","","POWDER, FOR SUSPENSION","ORAL","20150414","","ANDA","ANDA204835","Aurobindo Pharma Limited","100","mg/5mL","","N","20251231"
"5444","CEFIXIME","cefixime","65862075250","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-752","65862-752-50","65862-752_141b12c3-31de-4ca7-ac89-d864975846ab","HUMAN PRESCRIPTION DRUG","Cefixime","","POWDER, FOR SUSPENSION","ORAL","20150414","","ANDA","ANDA204835","Aurobindo Pharma Limited","200","mg/5mL","","N","20251231"
"5445","CEFIXIME","cefixime","65862075275","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","65862-752","65862-752-75","65862-752_141b12c3-31de-4ca7-ac89-d864975846ab","HUMAN PRESCRIPTION DRUG","Cefixime","","POWDER, FOR SUSPENSION","ORAL","20150414","","ANDA","ANDA204835","Aurobindo Pharma Limited","200","mg/5mL","","N","20251231"
"5446","VALGANCICLOVIR HYDROCHLORIDE","VALGANCICLOVIR HYDROCHLORIDE","65862075301","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","65862-753","65862-753-01","65862-753_0a3448ea-f412-4f8d-a32d-bd6695377bf9","HUMAN PRESCRIPTION DRUG","VALGANCICLOVIR HYDROCHLORIDE","","TABLET","ORAL","20160331","","ANDA","ANDA204750","Aurobindo Pharma Limited","450","mg/1","","N","20251231"
"5447","VALGANCICLOVIR HYDROCHLORIDE","VALGANCICLOVIR HYDROCHLORIDE","65862075318","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","65862-753","65862-753-18","65862-753_0a3448ea-f412-4f8d-a32d-bd6695377bf9","HUMAN PRESCRIPTION DRUG","VALGANCICLOVIR HYDROCHLORIDE","","TABLET","ORAL","20160331","","ANDA","ANDA204750","Aurobindo Pharma Limited","450","mg/1","","N","20251231"
"5448","VALGANCICLOVIR HYDROCHLORIDE","VALGANCICLOVIR HYDROCHLORIDE","65862075360","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","65862-753","65862-753-60","65862-753_0a3448ea-f412-4f8d-a32d-bd6695377bf9","HUMAN PRESCRIPTION DRUG","VALGANCICLOVIR HYDROCHLORIDE","","TABLET","ORAL","20160331","","ANDA","ANDA204750","Aurobindo Pharma Limited","450","mg/1","","N","20251231"
"5449","VALGANCICLOVIR HYDROCHLORIDE","VALGANCICLOVIR HYDROCHLORIDE","65862075399","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","65862-753","65862-753-99","65862-753_0a3448ea-f412-4f8d-a32d-bd6695377bf9","HUMAN PRESCRIPTION DRUG","VALGANCICLOVIR HYDROCHLORIDE","","TABLET","ORAL","20160331","","ANDA","ANDA204750","Aurobindo Pharma Limited","450","mg/1","","N","20251231"
"5450","VALGANCICLOVIR HYDROCHLORIDE","VALGANCICLOVIR HYDROCHLORIDE","65862075305","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","65862-753","65862-753-05","65862-753_0a3448ea-f412-4f8d-a32d-bd6695377bf9","HUMAN PRESCRIPTION DRUG","VALGANCICLOVIR HYDROCHLORIDE","","TABLET","ORAL","20160331","","ANDA","ANDA204750","Aurobindo Pharma Limited","450","mg/1","","N","20251231"
"5451","MOXIFLOXACIN HYDROCHLORIDE","MOXIFLOXACIN","65862084003","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","65862-840","65862-840-03","65862-840_95a06b0b-fd23-4b1b-9813-105678b10b6c","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN","","SOLUTION/ DROPS","OPHTHALMIC","20171004","","ANDA","ANDA206242","Aurobindo Pharma Limited","5","mg/mL","","N","20251231"
"5452","VORICONAZOLE","Voriconazole","65862089101","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-891","65862-891-01","65862-891_770ed501-43f6-498e-8d2c-27d82534a232","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, FILM COATED","ORAL","20160122","","ANDA","ANDA206837","Aurobindo Pharma Limited","50","mg/1","","N","20261231"
"5453","VORICONAZOLE","Voriconazole","65862089103","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-891","65862-891-03","65862-891_770ed501-43f6-498e-8d2c-27d82534a232","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, FILM COATED","ORAL","20160122","","ANDA","ANDA206837","Aurobindo Pharma Limited","50","mg/1","","N","20261231"
"5454","VORICONAZOLE","Voriconazole","65862089105","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-891","65862-891-05","65862-891_770ed501-43f6-498e-8d2c-27d82534a232","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, FILM COATED","ORAL","20160122","","ANDA","ANDA206837","Aurobindo Pharma Limited","50","mg/1","","N","20261231"
"5455","VORICONAZOLE","Voriconazole","65862089130","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-891","65862-891-30","65862-891_770ed501-43f6-498e-8d2c-27d82534a232","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, FILM COATED","ORAL","20160122","","ANDA","ANDA206837","Aurobindo Pharma Limited","50","mg/1","","N","20261231"
"5456","VORICONAZOLE","Voriconazole","65862089201","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-892","65862-892-01","65862-892_770ed501-43f6-498e-8d2c-27d82534a232","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, FILM COATED","ORAL","20160122","","ANDA","ANDA206837","Aurobindo Pharma Limited","200","mg/1","","N","20261231"
"5457","VORICONAZOLE","Voriconazole","65862089203","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-892","65862-892-03","65862-892_770ed501-43f6-498e-8d2c-27d82534a232","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, FILM COATED","ORAL","20160122","","ANDA","ANDA206837","Aurobindo Pharma Limited","200","mg/1","","N","20261231"
"5458","VORICONAZOLE","Voriconazole","65862089205","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-892","65862-892-05","65862-892_770ed501-43f6-498e-8d2c-27d82534a232","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, FILM COATED","ORAL","20160122","","ANDA","ANDA206837","Aurobindo Pharma Limited","200","mg/1","","N","20261231"
"5459","VORICONAZOLE","Voriconazole","65862089230","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","65862-892","65862-892-30","65862-892_770ed501-43f6-498e-8d2c-27d82534a232","HUMAN PRESCRIPTION DRUG","Voriconazole","","TABLET, FILM COATED","ORAL","20160122","","ANDA","ANDA206837","Aurobindo Pharma Limited","200","mg/1","","N","20261231"
"5460","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (Monohydrate/Macrocrystals)","65862092901","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","65862-929","65862-929-01","65862-929_33dc19bb-994d-4aad-a4b7-6697c1d8811b","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20230330","","ANDA","ANDA209225","Aurobindo Pharma Limited","25; 75","mg/1; mg/1","","N","20251231"
"5461","CLOTRIMAZOLE","Clotrimazole","65923005228","Azole Antifungal [EPC], Azoles [CS]","65923-052","65923-052-28","65923-052_29b7f210-2fe6-eb8b-e063-6394a90aebf2","HUMAN OTC DRUG","Family Care Antifungal","","CREAM","TOPICAL","20180101","","OTC MONOGRAPH DRUG","M005","United Exchange Corp.","10","mg/g","","N","20251231"
"5462","ACONITUM NAPELLUS; AETHUSA CYNAPIUM; AILANTHUS ALTISSIMA FLOWERING TWIG; AMBERGRIS; AMBROSIA ARTEMISIIFOLIA POLLEN; AMMONIUM CARBONATE; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; ARTEMISIA CINA PRE-FLOWERING TOP; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BORRELIA BURGDORFERI; BOTHROPS ATROX VENOM; BROMINE; CADMIUM SULFATE; CALCIUM SULFIDE; CAMPHOR (NATURAL); CEANOTHUS AMERICANUS LEAF; CHASTE TREE; CHELIDONIUM MAJUS; CICUTA VIROSA ROOT; CINCHONA OFFICINALIS BARK; CLAVICEPS PURPUREA SCLEROTIUM; COBALT; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; COPPER; CROTALUS HORRIDUS HORRIDUS VENOM; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; DATURA STRAMONIUM; DIEFFENBACHIA SEGUINE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; GOLD; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HEKLA LAVA; HELLEBORUS NIGER ROOT; HYDROCHLORIC ACID; HYDROFLUORIC ACID; HYDROGEN CYANIDE; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; LATHYRUS SATIVAS SEED; LEAD; LEDUM PALUSTRE TWIG; LOBELIA INFLATA; LYCOPERDON UTRIFORME FRUITING BODY; LYCOSA TARANTULA; MERCURIC CYANIDE; MERCURIUS SOLUBILIS; MICRURUS CORALLINUS VENOM; MILK THISTLE; MOSCHUS MOSCHIFERUS WHOLE; NAJA NAJA VENOM; NITRIC ACID; NUTMEG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHENOL; PHOSPHORIC ACID; PICRIC ACID; POTASSIUM BROMIDE; POTASSIUM CARBONATE; POTASSIUM IODIDE; PRUNUS LAUROCERASUS LEAF; QUININE SULFATE; RANCID BEEF; RUTA GRAVEOLENS FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; SARRACENIA PURPUREA; SEPIA OFFICINALIS JUICE; SODIUM CARBONATE; SOLANUM DULCAMARA TOP; SULFURIC ACID; TEUCRIUM MARUM; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; TURPENTINE OIL; VERATRUM ALBUM ROOT; VERATRUM VIRIDE ROOT; VIPERA BERUS VENOM","Abrot Acon Agn Ail Ambr Ambro Am-C Ant-C Apis Arn Ars Aur-A Aur Bapt Bar-C Bell BB Both Bov Brom Cadm-S Calad Calc Camph Carb-Ac Card-M Cean Chel Chinin-A Cina Chin Cic Cob Colch Con Crot-H Crot-T Cupr Dulc Elaps Eup-Per Fl-Ac Galph Graph Gunp Ham Hekla Hell Hep Hydr-Ac Hyos Hyper Kali-Br Kali-C Kali-I Lath Laur Led Lob Merc-Cy Merc Mez Mosch Mur-Ac Naja Nat-C Nit-Ac Nux-M Pyrog Ph-Ac Pic-Ac Plb Rhus-T Ruta Samb Sang Sarr Sep Stram Sul-Ac Tab Terent Ter Teucr Verat Verat-V Vip","66096071227","Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Antimalarial [EPC], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Pollen [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Insect Venom Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]","66096-712","66096-712-27","66096-712_d44ac4d7-4c0a-f937-e053-2995a90ac3dc","HUMAN OTC DRUG","Joette Calabrese Survivalist Kit","","PELLET","ORAL","20151026","","UNAPPROVED HOMEOPATHIC","","OHM PHARMA INC.","1; 200; 30; 30; 30; 30; 6; 1; 3; 3; 6; 3; 3; 200; 30; 200; 30; 30; 30; 6; 200; 30; 200; 6; 30; 3; 6; 30; 30; 3; 6; 6; 30; 200; 30; 30; 200; 30; 200; 200; 200; 30; 30; 30; 30; 30; 6; 1; 30; 30; 1; 30; 30; 30; 200; 6; 30; 30; 30; 30; 30; 30; 1; 6; 6; 200; 30; 200; 6; 30; 3; 200; 6; 30; 200; 30; 6; 30; 30; 30; 200; 30; 1; 6; 200; 30; 30","[hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1","","N","20251231"
"5463","QUININE SULFATE","CHININUM SULPHURICUM","66096081701","Antimalarial [EPC]","66096-817","66096-817-01","66096-817_d45e62d3-b510-530d-e053-2a95a90ac447","HUMAN OTC DRUG","Chininum Sulphuricum","","PELLET","ORAL","20191101","","UNAPPROVED HOMEOPATHIC","","OHM PHARMA INC.","6","[hp_C]/6[hp_C]","","N","20251231"
"5464","TELAVANCIN HYDROCHLORIDE","telavancin hydrochloride","66220031511","Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [EXT]","66220-315","66220-315-11","66220-315_4d14335c-e22a-4113-a112-fcbde33b727d","HUMAN PRESCRIPTION DRUG","VIBATIV","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210101","","NDA","NDA022110","Cumberland Pharmaceuticals Inc.","15","mg/mL","","N","20251231"
"5465","TELAVANCIN HYDROCHLORIDE","telavancin hydrochloride","66220031522","Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [EXT]","66220-315","66220-315-22","66220-315_4d14335c-e22a-4113-a112-fcbde33b727d","HUMAN PRESCRIPTION DRUG","VIBATIV","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210101","","NDA","NDA022110","Cumberland Pharmaceuticals Inc.","15","mg/mL","","N","20251231"
"5466","TELAVANCIN HYDROCHLORIDE","telavancin hydrochloride","66220031544","Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [EXT]","66220-315","66220-315-44","66220-315_4d14335c-e22a-4113-a112-fcbde33b727d","HUMAN PRESCRIPTION DRUG","VIBATIV","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210101","","NDA","NDA022110","Cumberland Pharmaceuticals Inc.","15","mg/mL","","N","20251231"
"5467","AMOXICILLIN","Amoxicillin","66267002230","Penicillin-class Antibacterial [EPC], Penicillins [CS]","66267-022","66267-022-30","66267-022_300048f5-f7a1-6efb-e063-6294a90a1775","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","19930101","","ANDA","ANDA064013","NuCare Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"5468","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","66267019606","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","66267-196","66267-196-06","66267-196_1fa6a784-9fb2-c3fa-e063-6394a90add4c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5469","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","66267019614","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","66267-196","66267-196-14","66267-196_1fa6a784-9fb2-c3fa-e063-6394a90add4c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5470","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","66267019620","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","66267-196","66267-196-20","66267-196_1fa6a784-9fb2-c3fa-e063-6394a90add4c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5471","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","66267019628","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","66267-196","66267-196-28","66267-196_1fa6a784-9fb2-c3fa-e063-6394a90add4c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5472","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","66267019610","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","66267-196","66267-196-10","66267-196_1fa6a784-9fb2-c3fa-e063-6394a90add4c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5473","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","66267019660","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","66267-196","66267-196-60","66267-196_1fa6a784-9fb2-c3fa-e063-6394a90add4c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5474","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","66267019690","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","66267-196","66267-196-90","66267-196_1fa6a784-9fb2-c3fa-e063-6394a90add4c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5475","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","66267019630","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","66267-196","66267-196-30","66267-196_1fa6a784-9fb2-c3fa-e063-6394a90add4c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5476","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","66267071602","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","66267-716","66267-716-02","66267-716_1fa75bd8-ed9b-d874-e063-6394a90a109b","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"5477","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","66267071606","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","66267-716","66267-716-06","66267-716_1fa75bd8-ed9b-d874-e063-6394a90a109b","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"5478","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","66267071604","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","66267-716","66267-716-04","66267-716_1fa75bd8-ed9b-d874-e063-6394a90a109b","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"5479","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","66267081602","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","66267-816","66267-816-02","66267-816_1fa78994-2830-fe39-e063-6394a90af951","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5480","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","66267081604","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","66267-816","66267-816-04","66267-816_1fa78994-2830-fe39-e063-6394a90af951","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5481","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","66267081606","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","66267-816","66267-816-06","66267-816_1fa78994-2830-fe39-e063-6394a90af951","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5482","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","66267085703","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","66267-857","66267-857-03","66267-857_1fa77d0a-40f4-b54e-e063-6294a90a0375","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021127","","ANDA","ANDA065117","NuCare Pharmaceuticals, Inc.","500; 125","mg/1; mg/1","","N","20251231"
"5483","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","66267085704","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","66267-857","66267-857-04","66267-857_1fa77d0a-40f4-b54e-e063-6294a90a0375","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021127","","ANDA","ANDA065117","NuCare Pharmaceuticals, Inc.","500; 125","mg/1; mg/1","","N","20251231"
"5484","AMOXICILLIN","Amoxicillin","66267087103","Penicillin-class Antibacterial [EPC], Penicillins [CS]","66267-871","66267-871-03","66267-871_1ac78fcc-124c-c45f-e063-6394a90afe34","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","19930101","","ANDA","ANDA064013","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"5485","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","66267091906","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","66267-919","66267-919-06","66267-919_1fa773d7-02b2-11c3-e063-6394a90ac730","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"5486","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","66267091910","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","66267-919","66267-919-10","66267-919_1fa773d7-02b2-11c3-e063-6394a90ac730","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"5487","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","66267091921","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","66267-919","66267-919-21","66267-919_1fa773d7-02b2-11c3-e063-6394a90ac730","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"5488","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","66267091960","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","66267-919","66267-919-60","66267-919_1fa773d7-02b2-11c3-e063-6394a90ac730","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"5489","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","66267091930","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","66267-919","66267-919-30","66267-919_1fa773d7-02b2-11c3-e063-6394a90ac730","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"5490","BACITRACIN ZINC; POLYMYXIN B SULFATE","bacitracin zinc and polymyxin b sulfates","66267092535","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","66267-925","66267-925-35","66267-925_1fa7a635-8d93-58f2-e063-6394a90ab77e","HUMAN PRESCRIPTION DRUG","polycin","","OINTMENT","OPHTHALMIC","20141112","","ANDA","ANDA065022","NuCare Pharmaceuticals,Inc.","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"5491","TOBRAMYCIN","Tobramycin","66267093605","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","66267-936","66267-936-05","66267-936_1fa7a632-1e3f-d55c-e063-6294a90a8b21","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","OPHTHALMIC","19931129","","ANDA","ANDA064052","NuCare Pharmaceuticals,Inc.","3","mg/mL","","N","20251231"
"5492","NYSTATIN","Nystatin","66267095230","Polyene Antifungal [EPC], Polyenes [CS]","66267-952","66267-952-30","66267-952_1fa7bc90-f394-592a-e063-6394a90acab9","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","19930128","","ANDA","ANDA064022","NuCare Pharmaceuticals,Inc.","100000","[USP'U]/g","","N","20251231"
"5493","NYSTATIN","Nystatin","66267095315","Polyene Antifungal [EPC], Polyenes [CS]","66267-953","66267-953-15","66267-953_1fa7bc90-f395-592a-e063-6394a90acab9","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20060921","","ANDA","ANDA062225","NuCare Pharmaceuticals,Inc.","100000","[USP'U]/g","","N","20251231"
"5494","GENTAMICIN SULFATE","Gentamicin Sulfate","66267097105","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","66267-971","66267-971-05","66267-971_1fa7c294-f28b-210b-e063-6294a90aebc9","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","SOLUTION/ DROPS","OPHTHALMIC","20061213","","ANDA","ANDA064163","NuCare Pharmaceuticals, Inc.","3","mg/mL","","N","20251231"
"5495","ERYTHROMYCIN","Erythromycin","66267097535","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","66267-975","66267-975-35","66267-975_1fa7c294-f28c-210b-e063-6294a90aebc9","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","19940729","","ANDA","ANDA064067","NuCare Pharmaceuticals,Inc.","5","mg/g","","N","20251231"
"5496","CLOTRIMAZOLE","CLOTRIMAZOLE","66267098015","Azole Antifungal [EPC], Azoles [CS]","66267-980","66267-980-15","66267-980_1fa7c294-f28e-210b-e063-6294a90aebc9","HUMAN OTC DRUG","Major Clotrimazole","","CREAM","TOPICAL","20041004","","OTC MONOGRAPH DRUG","M004","NuCare Pharmaceuticals,Inc.","10","mg/g","","N","20251231"
"5497","CEPHALEXIN","Cephalexin","66267098200","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","66267-982","66267-982-00","66267-982_1fa7ce69-a972-59e7-e063-6394a90af771","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA062703","NuCare Pharmaceuticals,Inc.","250","mg/5mL","","N","20251231"
"5498","AMOXICILLIN","Amoxicillin","66267099315","Penicillin-class Antibacterial [EPC], Penicillins [CS]","66267-993","66267-993-15","66267-993_31a7ca87-c6a6-1ab3-e063-6294a90ae5df","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","NuCare Pharmaceuticals,Inc.","250","mg/5mL","","N","20261231"
"5499","AMOXICILLIN","Amoxicillin","66267099400","Penicillin-class Antibacterial [EPC], Penicillins [CS]","66267-994","66267-994-00","66267-994_1fa7e9c4-72e5-8c30-e063-6394a90a09cf","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA061931","NuCare Pharmaceuticals,Inc.","250","mg/5mL","","N","20251231"
"5500","CEFAZOLIN SODIUM","CEFAZOLIN SODIUM","66288110001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","66288-1100","66288-1100-1","66288-1100_8476cb2d-2615-4637-ab51-363d639a6022","HUMAN PRESCRIPTION DRUG","CEFAZOLIN","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20070101","","ANDA","ANDA065141","Samson Medical Technologies, L.L.C.","100","g/1","","N","20261231"
"5501","CEFAZOLIN SODIUM","CEFAZOLIN SODIUM","66288130001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","66288-1300","66288-1300-1","66288-1300_8476cb2d-2615-4637-ab51-363d639a6022","HUMAN PRESCRIPTION DRUG","CEFAZOLIN","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20070101","","ANDA","ANDA065141","Samson Medical Technologies, L.L.C.","300","g/1","","N","20261231"
"5502","CEFOXITIN SODIUM","cefoxitin","66288410001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","66288-4100","66288-4100-1","66288-4100_b137208d-8dfd-4133-94c2-7287866a5525","HUMAN PRESCRIPTION DRUG","Cefoxitin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20160301","","ANDA","ANDA200938","SAMSON MEDICAL TECHNOLOGIES LLC","100","g/1","","N","20251231"
"5503","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","66288610001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","66288-6100","66288-6100-1","66288-6100_6aff16e3-f491-4175-a3f2-842bed6ebecb","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20140630","","ANDA","ANDA090057","Samson Medical Technologies, LLC","100","g/1","","N","20251231"
"5504","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","66288710001","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","66288-7100","66288-7100-1","66288-7100_d607785f-563a-4816-83c4-dfc38bbc29bd","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20160601","","ANDA","ANDA091532","SAMSON MEDICAL TECHNOLOGIES LLC","100","g/1","","N","20251231"
"5505","CEFEPIME HYDROCHLORIDE","CEFEPIME","66288810001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","66288-8100","66288-8100-1","66288-8100_c3258e86-4c07-4656-9767-ca959ecee86d","HUMAN PRESCRIPTION DRUG","CEFEPIME","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20181001","","ANDA","ANDA209408","SAMSON MEDICAL TECHNOLOGIES LLC","100","g/1","","N","20251231"
"5506","LINEZOLID","LINEZOLID","66298513701","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","66298-5137","66298-5137-1","66298-5137_1988348c-3b04-2b38-e063-6394a90ada27","HUMAN PRESCRIPTION DRUG","Zyvox","","INJECTION, SOLUTION","INTRAVENOUS","20180604","","NDA","NDA021131","Hp Halden Pharma AS","200","mg/100mL","","N","20251231"
"5507","LINEZOLID","linezolid","66298514001","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","66298-5140","66298-5140-1","66298-5140_19883774-59a8-7251-e063-6294a90a3f5e","HUMAN PRESCRIPTION DRUG","Zyvox","","INJECTION, SOLUTION","INTRAVENOUS","20180605","","NDA","NDA021131","Hp Halden Pharma AS","600","mg/300mL","","N","20251231"
"5508","LINEZOLID","LINEZOLID","66298713103","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","66298-7131","66298-7131-3","66298-7131_1d77a459-7013-fb55-e063-6294a90a0dc1","HUMAN PRESCRIPTION DRUG","Linezolid","","INJECTION, SOLUTION","INTRAVENOUS","20170727","","ANDA","ANDA204764","Hp Halden Pharma AS","2","mg/mL","","N","20251231"
"5509","LINEZOLID","LINEZOLID","66298780701","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","66298-7807","66298-7807-1","66298-7807_19877e50-8bfb-427d-e063-6294a90a150f","HUMAN PRESCRIPTION DRUG","Zyvox","","INJECTION","INTRAVENOUS","20180605","","NDA","NDA021131","Hp Halden Pharma AS","600","mg/300mL","","N","20251231"
"5510","MOXIFLOXACIN HYDROCHLORIDE","MOXIFLOXACIN HYDROCHLORIDE","66298850704","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","66298-8507","66298-8507-4","66298-8507_1d783072-b073-e384-e063-6394a90a7460","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","INJECTION, SOLUTION","INTRAVENOUS","20170802","","NDA","NDA205572","Hp Halden Pharma AS","400","mg/250mL","","N","20251231"
"5511","AMMONIUM CARBONATE; ESCHSCHOLZIA CALIFORNICA WHOLE; GRAPHITE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; QUININE ARSENITE; SUS SCROFA PANCREAS","Ammon carb, Calcarea carbonica, Chininum ars, Eschscholtzia, Graphites, Pancreas","66343009560","Antimalarial [EPC]","66343-095","66343-095-60","66343-095_28173f16-e59d-6a34-e063-6394a90a4642","HUMAN OTC DRUG","Emvita 8","","LIQUID","ORAL","20221221","","UNAPPROVED HOMEOPATHIC","","RUBIMED AG","800; 21; 16; 21; 18; 21","[hp_C]/60mL; [hp_X]/60mL; [hp_M]/60mL; [hp_X]/60mL; [hp_M]/60mL; [hp_X]/60mL","","N","20251231"
"5512","BARIUM CARBONATE; GRAPHITE; PULSATILLA VULGARIS WHOLE; QUININE ARSENITE; SUS SCROFA THYROID","Baryta carb, Chininum ars, Graphites, Pulsatilla, Thyroidinum","66343010460","Antimalarial [EPC]","66343-104","66343-104-60","66343-104_28176215-7cdd-f02f-e063-6394a90a8099","HUMAN OTC DRUG","Emvita 17","","LIQUID","ORAL","20221223","","UNAPPROVED HOMEOPATHIC","","RUBIMED AG","21; 18; 21; 800; 21","[hp_X]/60mL; [hp_M]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL","","N","20251231"
"5513","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","66685100100","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","66685-1001","66685-1001-0","66685-1001_93ac697a-4568-409f-9310-6cea67d8651c","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021121","20251130","ANDA","ANDA065093","Sandoz Inc","875; 125","mg/1; mg/1","","N",""
"5514","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","66685101201","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","66685-1012","66685-1012-1","66685-1012_93ac697a-4568-409f-9310-6cea67d8651c","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20040813","20250930","ANDA","ANDA065098","Sandoz Inc","400; 57","mg/5mL; mg/5mL","","N",""
"5515","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Triple Antibiotic","66715540500","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","66715-5405","66715-5405-0","66715-5405_0d98477b-aa34-ebb7-e063-6294a90a597f","HUMAN OTC DRUG","Triple Antibiotic Ointment, Circle K","","OINTMENT","TOPICAL","20231228","","OTC MONOGRAPH DRUG","M004","Lil' Drug Store products, Inc.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"5516","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, polymyxin b sulfate, and neomycin sulfate ointment","66715550500","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","66715-5505","66715-5505-0","66715-5505_0c7e49e0-7156-440d-e063-6294a90ae363","HUMAN OTC DRUG","Circle K Triple Antibiotic","","OINTMENT","TOPICAL","20210526","20260425","OTC MONOGRAPH DRUG","M004","Lil Drug Store Products, Inc","400; 3.5; 5000","[iU]/1; mg/1; [iU]/1","","N",""
"5517","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Triple Antibiotic","66715963100","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","66715-9631","66715-9631-0","66715-9631_0d98477b-aa34-ebb7-e063-6294a90a597f","HUMAN OTC DRUG","Triple Antibiotic Ointment, Lil Drug Store","","OINTMENT","TOPICAL","20231228","","OTC MONOGRAPH DRUG","M004","Lil' Drug Store products, Inc.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"5518","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, POLYMYXIN B SULFATE, and Neomycin Sulfate","66715973100","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","66715-9731","66715-9731-0","66715-9731_0c922b65-c084-ef59-e063-6294a90ad7f5","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20181015","20260425","OTC MONOGRAPH DRUG","M004","Lil' Drug Store Products, Inc.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N",""
"5519","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and dexamethasone","66758007038","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","66758-070","66758-070-38","66758-070_5776c435-ac60-49b6-8db1-23a3012b9155","HUMAN PRESCRIPTION DRUG","MAXITROL","","OINTMENT","OPHTHALMIC","19720117","","NDA","NDA050065","Sandoz Inc","1; 3.5; 10000","mg/g; mg/g; [USP'U]/g","","N","20251231"
"5520","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin hydrochloride","66758007138","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","66758-071","66758-071-38","66758-071_930a2e4b-dcac-4a27-a073-fd21622c1666","HUMAN PRESCRIPTION DRUG","CILOXAN","","OINTMENT","OPHTHALMIC","19980602","","NDA","NDA020369","Sandoz Inc","3","mg/g","","N","20261231"
"5521","CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE","ciprofloxacin hydrochloride and hydrocortisone","66758008770","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","66758-087","66758-087-70","66758-087_b26594a3-2adf-4954-8be0-5bd6f8de9671","HUMAN PRESCRIPTION DRUG","CIPRO","HC","SUSPENSION/ DROPS","AURICULAR (OTIC)","19990315","","NDA","NDA020805","Sandoz Inc","2; 10","mg/mL; mg/mL","","N","20251231"
"5522","LINEZOLID","Linezolid","66794021943","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","66794-219","66794-219-43","66794-219_24bdfd61-5bf6-430d-e063-6394a90aeec5","HUMAN PRESCRIPTION DRUG","Linezolid","","INJECTION, SOLUTION","INTRAVENOUS","20240308","","ANDA","ANDA207001","Piramal Critical Care Inc","600","mg/300mL","","N","20251231"
"5523","LINEZOLID","Linezolid","66794023643","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","66794-236","66794-236-43","66794-236_25f0890d-8bec-139d-e063-6394a90a5fbb","HUMAN PRESCRIPTION DRUG","Linezolid","","INJECTION","INTRAVENOUS","20240308","","ANDA","ANDA207001","Piramal Critical Care Inc.","600","mg/300mL","","N","20251231"
"5524","CIPROFLOXACIN; FLUOCINOLONE ACETONIDE","ciprofloxacin and fluocinolone acetonide","66992012814","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","66992-128","66992-128-14","66992-128_24143189-6fe9-75f8-e063-6394a90ac5ce","HUMAN PRESCRIPTION DRUG","OTOVEL","","SOLUTION","AURICULAR (OTIC)","20211004","","NDA","NDA208251","WraSer LLC",".75; .0625","mg/.25mL; mg/.25mL","","N","20251231"
"5525","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","66992045014","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","66992-450","66992-450-14","66992-450_241421f2-c6b0-78cc-e063-6394a90ae650","HUMAN PRESCRIPTION DRUG","CETRAXAL","","SOLUTION/ DROPS","AURICULAR (OTIC)","20090514","","NDA","NDA021918","Wraser Llc",".5","mg/.25mL","","N","20251231"
"5526","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","66993006027","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","66993-060","66993-060-27","66993-060_d1d19ab6-c938-43f1-a047-76d99caa004a","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil HCl","","TABLET, FILM COATED","ORAL","20120727","","NDA AUTHORIZED GENERIC","NDA021078","Prasco Laboratories","250; 100","mg/1; mg/1","","N","20251231"
"5527","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","atovaquone and proguanil hydrochloride","66993006002","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","66993-060","66993-060-02","66993-060_d1d19ab6-c938-43f1-a047-76d99caa004a","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil HCl","","TABLET, FILM COATED","ORAL","20120727","","NDA AUTHORIZED GENERIC","NDA021078","Prasco Laboratories","250; 100","mg/1; mg/1","","N","20251231"
"5528","TOBRAMYCIN","tobramycin inhalation","66993019594","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","66993-195","66993-195-94","66993-195_43a62e66-8821-40b6-85dd-0f29fe4adc8c","HUMAN PRESCRIPTION DRUG","Tobramycin Inhalation","","SOLUTION","RESPIRATORY (INHALATION)","20200915","","NDA AUTHORIZED GENERIC","NDA201820","Prasco, LLC","300","mg/4mL","","N","20251231"
"5529","SULFAMETHOXAZOLE; TRIMETHOPRIM","sulfamethoxazole and trimethoprim","66993072757","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","66993-727","66993-727-57","66993-727_cc7ce9be-e89e-4682-8d14-0902ba36b47a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20220705","","ANDA","ANDA077612","Prasco Laboratories","200; 40","mg/5mL; mg/5mL","","N","20251231"
"5530","METRONIDAZOLE","metronidazole","66993093661","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","66993-936","66993-936-61","66993-936_49c12f6c-f89d-4bdf-8732-ee5ef491e2fa","HUMAN PRESCRIPTION DRUG","metronidazole","","GEL","TOPICAL","20050630","20260630","NDA AUTHORIZED GENERIC","NDA021789","Prasco Laboratories","10","mg/g","","N",""
"5531","CLINDAMYCIN PHOSPHATE; TRETINOIN","clindamycin phosphate and tretinoin","66993095931","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]","66993-959","66993-959-31","66993-959_b75779c4-620c-4247-98c6-f0987d364b76","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Tretinion","","GEL","TOPICAL","20180628","20251031","NDA AUTHORIZED GENERIC","NDA050803","Prasco Laboratories","10; .25","mg/g; mg/g","","N",""
"5532","CLINDAMYCIN PHOSPHATE; TRETINOIN","clindamycin phosphate and tretinoin","66993095961","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]","66993-959","66993-959-61","66993-959_b75779c4-620c-4247-98c6-f0987d364b76","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Tretinion","","GEL","TOPICAL","20180628","20251031","NDA AUTHORIZED GENERIC","NDA050803","Prasco Laboratories","10; .25","mg/g; mg/g","","N",""
"5533","METRONIDAZOLE","METRONIDAZOLE","66993096045","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","66993-960","66993-960-45","66993-960_47d8cbcd-bd51-4931-a912-949721c2749d","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","CREAM","TOPICAL","20090618","20270531","NDA AUTHORIZED GENERIC","NDA020531","Prasco Laboratories","7.5","mg/g","","N",""
"5534","METRONIDAZOLE","metronidazole","66993096159","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","66993-961","66993-961-59","66993-961_b88a7597-62f2-41ac-b20d-d698042aab47","HUMAN PRESCRIPTION DRUG","metronidazole","","LOTION","TOPICAL","20090528","20260131","NDA AUTHORIZED GENERIC","NDA020901","Prasco Laboratories","7.5","mg/g","","N",""
"5535","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","67046100703","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67046-1007","67046-1007-3","67046-1007_26b924c7-0f35-948b-e063-6394a90aaf64","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20241112","","ANDA","ANDA207402","Coupler LLC","150","mg/1","","N","20251231"
"5536","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67046107003","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67046-1070","67046-1070-3","67046-1070_266e9c9f-2fae-071d-e063-6394a90aa179","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20241108","","ANDA","ANDA090624","Coupler LLC","800; 160","mg/1; mg/1","","N","20251231"
"5537","CEFUROXIME AXETIL","Cefuroxime Axetil","67046108103","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67046-1081","67046-1081-3","67046-1081_2c3a51b0-6e4a-9ae0-e063-6394a90acc40","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20250121","","ANDA","ANDA065308","Coupler LLC","500","mg/1","","N","20261231"
"5538","CEPHALEXIN","Cephalexin","67046112003","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67046-1120","67046-1120-3","67046-1120_266cfd4e-c884-c523-e063-6394a90a67c8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20241108","","ANDA","ANDA065253","Coupler LLC","500","mg/1","","N","20251231"
"5539","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","67046123603","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","67046-1236","67046-1236-3","67046-1236_266b5490-01f2-b211-e063-6394a90aee26","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20241108","","ANDA","ANDA065064","Coupler LLC","500; 125","mg/1; mg/1","","N","20251231"
"5540","METRONIDAZOLE","Metronidazole","67046126903","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67046-1269","67046-1269-3","67046-1269_26aae270-f038-5159-e063-6394a90a5376","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20241111","","ANDA","ANDA203458","Coupler LLC","250","mg/1","","N","20251231"
"5541","CEFDINIR","Cefdinir","67046129803","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67046-1298","67046-1298-3","67046-1298_26d04c0f-54de-488b-e063-6394a90a7dc9","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20241113","","ANDA","ANDA065434","Coupler LLC","300","mg/1","","N","20251231"
"5542","CEFUROXIME AXETIL","Cefuroxime Axetil","67046130703","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67046-1307","67046-1307-3","67046-1307_2c6191df-9524-9c51-e063-6294a90a236c","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20250123","","ANDA","ANDA065308","Coupler LLC","250","mg/1","","N","20261231"
"5543","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","67046130903","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","67046-1309","67046-1309-3","67046-1309_26a4e1d9-4390-75c1-e063-6394a90a73b7","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20241111","","ANDA","ANDA065063","Coupler LLC","875; 125","mg/1; mg/1","","N","20251231"
"5544","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","67046142003","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67046-1420","67046-1420-3","67046-1420_26a55772-1709-68a4-e063-6394a90a2298","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20241111","","ANDA","ANDA077859","Coupler LLC","500","mg/1","","N","20251231"
"5545","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","67046142303","Macrolide Antimicrobial [EPC], Macrolides [CS]","67046-1423","67046-1423-3","67046-1423_26a58131-86d8-aa0e-e063-6394a90a1b7b","HUMAN PRESCRIPTION DRUG","azithromycin dihydrate","","TABLET","ORAL","20241111","","ANDA","ANDA065399","Coupler LLC","500","mg/1","","N","20251231"
"5546","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","67046146003","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67046-1460","67046-1460-3","67046-1460_2d6ad6d6-c312-85a0-e063-6294a90ad062","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20250205","","ANDA","ANDA208921","Coupler LLC","250","mg/1","","N","20261231"
"5547","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","67046150203","Macrolide Antimicrobial [EPC], Macrolides [CS]","67046-1502","67046-1502-3","67046-1502_2cc99fae-a6c4-8893-e063-6394a90aa3ef","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20250128","","ANDA","ANDA208250","Coupler LLC","250","mg/1","","N","20261231"
"5548","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","67046150303","Macrolide Antimicrobial [EPC], Macrolides [CS]","67046-1503","67046-1503-3","67046-1503_2cc9449e-e4be-3667-e063-6294a90af6ba","HUMAN PRESCRIPTION DRUG","azithromycin dihydrate","","TABLET","ORAL","20250128","","ANDA","ANDA065400","Coupler LLC","600","mg/1","","N","20261231"
"5549","CLARITHROMYCIN","Clarithromycin","67046151503","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","67046-1515","67046-1515-3","67046-1515_2d6d01fe-a7b9-cbff-e063-6294a90a6bca","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20250205","","ANDA","ANDA065136","Coupler LLC","500","mg/1","","N","20261231"
"5550","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","67046152303","Antimalarial [EPC], Antirheumatic Agent [EPC]","67046-1523","67046-1523-3","67046-1523_2eeafa6f-9d36-b46d-e063-6394a90ade46","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20250224","","ANDA","ANDA040766","Coupler LLC","200","mg/1","","N","20261231"
"5551","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","67046152803","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67046-1528","67046-1528-3","67046-1528_2fff6ac3-455d-7df0-e063-6394a90a0672","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20250310","","ANDA","ANDA076639","Coupler LLC","750","mg/1","","N","20261231"
"5552","CEPHALEXIN","Cephalexin","67046153303","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67046-1533","67046-1533-3","67046-1533_30b709d6-c43d-c721-e063-6294a90abd61","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20250319","","ANDA","ANDA065253","Coupler, LLC","250","mg/1","","N","20261231"
"5553","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","67046153703","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67046-1537","67046-1537-3","67046-1537_3134401f-7258-6c37-e063-6294a90a8fa9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20250325","","ANDA","ANDA208921","Coupler LLC","500","mg/1","","N","20261231"
"5554","FLUCONAZOLE","Fluconazole","67046154603","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","67046-1546","67046-1546-3","67046-1546_325c5d26-634e-9deb-e063-6394a90aacfe","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20250409","","ANDA","ANDA077253","Coupler LLC","50","mg/1","","N","20261231"
"5555","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","67046206203","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67046-2062","67046-2062-3","67046-2062_26a4ec26-5a0a-8fea-e063-6294a90adb3a","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20241111","","ANDA","ANDA216957","Coupler LLC","150","mg/1","","N","20251231"
"5556","CLOTRIMAZOLE","Clotrimazole","67091019628","Azole Antifungal [EPC], Azoles [CS]","67091-196","67091-196-28","67091-196_29bcee0c-69d3-e7f3-e063-6394a90aef3c","HUMAN OTC DRUG","WinCo Foods Antifungal","","CREAM","TOPICAL","20210520","","OTC MONOGRAPH DRUG","M005","Winco Foods LLC","10","mg/g","","N","20251231"
"5557","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Poymyxin B Sulfate, and Pramoxine Hydrochrloride","67091027228","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67091-272","67091-272-28","67091-272_0e236329-0e8a-4e32-ab3b-fb2ffc94995c","HUMAN OTC DRUG","WinCo Maximum Strength Triple Antibiotic","","OINTMENT","TOPICAL","20150210","","OTC MONOGRAPH DRUG","M004","WinCo Foods, LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"5558","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate","67091027428","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67091-274","67091-274-28","67091-274_468dc373-c830-4381-ab39-2a1dfd1428f9","HUMAN OTC DRUG","WinCo Original Strength Triple Antibiotic","","OINTMENT","TOPICAL","20150212","","OTC MONOGRAPH DRUG","M004","WinCo Foods, LLC","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"5559","MICONAZOLE NITRATE","Antifungal Miconazole Powder Spray","67091039206","Azole Antifungal [EPC], Azoles [CS]","67091-392","67091-392-06","67091-392_297ae7f0-4cc4-425f-e063-6294a90a4ad7","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, SPRAY","TOPICAL","20210929","","OTC MONOGRAPH DRUG","M005","Winco Foods, LLC","2.6","g/130g","","N","20251231"
"5560","DAPTOMYCIN","Daptomycin","67184054901","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","67184-0549","67184-0549-1","67184-0549_b5353d4b-44da-4c86-b8ae-f94345c5c3c8","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210824","","ANDA","ANDA215316","Qilu Pharmaceutical Co., Ltd.","500","mg/10mL","","N","20251231"
"5561","AMIKACIN SULFATE","Amikacin Sulfate","67184056902","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","67184-0569","67184-0569-2","67184-0569_faeee7df-79ed-43a4-a85a-e1ef4405f16a","HUMAN PRESCRIPTION DRUG","Amikacin Sulfate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240319","","ANDA","ANDA218146","Qilu Pharmaceutical Co., Ltd.","250","mg/mL","","N","20251231"
"5562","AMIKACIN SULFATE","Amikacin Sulfate","67184057002","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","67184-0570","67184-0570-2","67184-0570_faeee7df-79ed-43a4-a85a-e1ef4405f16a","HUMAN PRESCRIPTION DRUG","Amikacin Sulfate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240319","","ANDA","ANDA218146","Qilu Pharmaceutical Co., Ltd.","250","mg/mL","","N","20251231"
"5563","CEFAZOLIN SODIUM","Cefazolin","67184100102","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67184-1001","67184-1001-2","67184-1001_0cc53b72-80e0-4a82-e063-6394a90a7fdf","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20151228","","ANDA","ANDA203661","Qilu Pharmaceutical Co., Ltd.","1","g/1","","N","20251231"
"5564","CEFEPIME HYDROCHLORIDE","CEFEPIME HYDROCHLORIDE","67184100201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67184-1002","67184-1002-1","67184-1002_34afba66-733f-4403-83d1-1b67b8a6633b","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20160201","","ANDA","ANDA203704","Qilu Pharmaceutical Co., Ltd.","500","mg/1","","N","20251231"
"5565","CEFEPIME HYDROCHLORIDE","CEFEPIME HYDROCHLORIDE","67184100301","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67184-1003","67184-1003-1","67184-1003_34afba66-733f-4403-83d1-1b67b8a6633b","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20160201","","ANDA","ANDA203704","Qilu Pharmaceutical Co., Ltd.","1","g/1","","N","20251231"
"5566","CEFEPIME HYDROCHLORIDE","CEFEPIME HYDROCHLORIDE","67184100401","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67184-1004","67184-1004-1","67184-1004_34afba66-733f-4403-83d1-1b67b8a6633b","HUMAN PRESCRIPTION DRUG","Cefepime","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20160201","","ANDA","ANDA203704","Qilu Pharmaceutical Co., Ltd.","2","g/1","","N","20251231"
"5567","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","67184100501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67184-1005","67184-1005-1","67184-1005_ffac7eac-e0b5-4d9f-b2ad-9bc704f82e31","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20160629","","ANDA","ANDA203702","Qilu Pharmaceutical Co., Ltd.","250","mg/1","","N","20251231"
"5568","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","67184100502","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67184-1005","67184-1005-2","67184-1005_ffac7eac-e0b5-4d9f-b2ad-9bc704f82e31","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20160629","","ANDA","ANDA203702","Qilu Pharmaceutical Co., Ltd.","250","mg/1","","N","20251231"
"5569","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","67184100601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67184-1006","67184-1006-1","67184-1006_ffac7eac-e0b5-4d9f-b2ad-9bc704f82e31","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20160629","","ANDA","ANDA203702","Qilu Pharmaceutical Co., Ltd.","500","mg/1","","N","20251231"
"5570","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","67184100602","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67184-1006","67184-1006-2","67184-1006_ffac7eac-e0b5-4d9f-b2ad-9bc704f82e31","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20160629","","ANDA","ANDA203702","Qilu Pharmaceutical Co., Ltd.","500","mg/1","","N","20251231"
"5571","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","67184100701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67184-1007","67184-1007-1","67184-1007_ffac7eac-e0b5-4d9f-b2ad-9bc704f82e31","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20160629","","ANDA","ANDA203702","Qilu Pharmaceutical Co., Ltd.","1","g/1","","N","20251231"
"5572","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","67184100801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67184-1008","67184-1008-1","67184-1008_ffac7eac-e0b5-4d9f-b2ad-9bc704f82e31","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20160629","","ANDA","ANDA203702","Qilu Pharmaceutical Co., Ltd.","2","g/1","","N","20251231"
"5573","CLOTRIMAZOLE","Clotrimazole","67234000901","Azole Antifungal [EPC], Azoles [CS]","67234-009","67234-009-01","67234-009_dd2b4eed-bbcd-4e28-9657-8b6b636d4fe5","HUMAN OTC DRUG","Athlete s Foot","Afac","CREAM","TOPICAL","20080122","","OTC MONOGRAPH DRUG","M005","Natureplex, LLC",".01","g/g","","N","20251231"
"5574","CLOTRIMAZOLE","Clotrimazole","67234001401","Azole Antifungal [EPC], Azoles [CS]","67234-014","67234-014-01","67234-014_c4a82ce8-4b6f-41f0-9575-8bca9340f0b8","HUMAN OTC DRUG","PRO-EX","Anti Fungal","CREAM","TOPICAL","20080122","","OTC MONOGRAPH DRUG","M005","Natureplex, LLC",".01","g/g","","N","20251231"
"5575","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, and POLYMYXIN B SULFATE","67234003101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67234-031","67234-031-01","67234-031_17f525d8-bcde-4cad-9086-45d650c99244","HUMAN OTC DRUG","TRIPLE ANTIBIOTIC","FIRST AID ANTIBIOTIC","OINTMENT","TOPICAL","20110803","","OTC MONOGRAPH DRUG","M004","Natureplex LLC","400; 3.5; 5000","U/9.4g; mg/9.4g; U/9.4g","","N","20251231"
"5576","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, and POLYMYXIN B SULFATE","67234003102","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67234-031","67234-031-02","67234-031_17f525d8-bcde-4cad-9086-45d650c99244","HUMAN OTC DRUG","TRIPLE ANTIBIOTIC","FIRST AID ANTIBIOTIC","OINTMENT","TOPICAL","20110803","","OTC MONOGRAPH DRUG","M004","Natureplex LLC","400; 3.5; 5000","U/9.4g; mg/9.4g; U/9.4g","","N","20251231"
"5577","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","NEOMYCIN SULFATE, POLYMYXIN B SULFATE, and PRAMOXINE HYDROCHLORIDE","67234006801","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67234-068","67234-068-01","67234-068_ca73da92-d4f8-471d-ab0d-16bca4640078","HUMAN OTC DRUG","NATUREPLEX ANTIBIOTIC plus PAIN RELIEF","","CREAM","TOPICAL","20181206","","OTC MONOGRAPH DRUG","M004","Natureplex","3.5; 10000; 10","mg/9.4g; [iU]/9.4g; mg/9.4g","","N","20251231"
"5578","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","NEOMYCIN SULFATE, POLYMYXIN B SULFATE, and PRAMOXINE HYDROCHLORIDE","67234006802","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67234-068","67234-068-02","67234-068_ca73da92-d4f8-471d-ab0d-16bca4640078","HUMAN OTC DRUG","NATUREPLEX ANTIBIOTIC plus PAIN RELIEF","","CREAM","TOPICAL","20181206","","OTC MONOGRAPH DRUG","M004","Natureplex","3.5; 10000; 10","mg/9.4g; [iU]/9.4g; mg/9.4g","","N","20251231"
"5579","BACITRACIN ZINC; POLYMYXIN B SULFATE","BACITRACIN ZINC and POLYMYXIN B SULFATE","67234007701","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67234-077","67234-077-01","67234-077_7ea2f689-e721-461c-aa87-0b8107889ae1","HUMAN OTC DRUG","NATUREPLEX ANTIBIOTIC","","CREAM","TOPICAL","20210928","","OTC MONOGRAPH DRUG","M004","Natureplex LLC","500; 10000","U/14g; U/14g","","N","20261231"
"5580","CEPHALEXIN","Cephalexin","67296003702","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0037","67296-0037-2","67296-0037_1a9e0dee-5b9b-a764-e063-6394a90a315e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5581","CEPHALEXIN","Cephalexin","67296003703","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0037","67296-0037-3","67296-0037_1a9e0dee-5b9b-a764-e063-6394a90a315e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5582","CEPHALEXIN","Cephalexin","67296003704","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0037","67296-0037-4","67296-0037_1a9e0dee-5b9b-a764-e063-6394a90a315e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5583","CEPHALEXIN","Cephalexin","67296003701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0037","67296-0037-1","67296-0037_1a9e0dee-5b9b-a764-e063-6394a90a315e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5584","CEPHALEXIN","Cephalexin","67296003705","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0037","67296-0037-5","67296-0037_1a9e0dee-5b9b-a764-e063-6394a90a315e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5585","CEPHALEXIN","Cephalexin","67296003707","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0037","67296-0037-7","67296-0037_1a9e0dee-5b9b-a764-e063-6394a90a315e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5586","METRONIDAZOLE","Metronidazole","67296007801","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-0078","67296-0078-1","67296-0078_3252e120-f0af-a095-e063-6394a90a87be","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Redpharm Drug, inc.","500","mg/1","","N","20261231"
"5587","METRONIDAZOLE","Metronidazole","67296007803","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-0078","67296-0078-3","67296-0078_3252e120-f0af-a095-e063-6394a90a87be","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Redpharm Drug, inc.","500","mg/1","","N","20261231"
"5588","METRONIDAZOLE","Metronidazole","67296007804","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-0078","67296-0078-4","67296-0078_3252e120-f0af-a095-e063-6394a90a87be","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070033","Redpharm Drug, inc.","500","mg/1","","N","20261231"
"5589","GENTAMICIN SULFATE","Gentamicin Sulfate","67296011401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","67296-0114","67296-0114-1","67296-0114_1ab0ecca-26f8-2b1b-e063-6294a90a2bbb","HUMAN PRESCRIPTION DRUG","Gentak","","OINTMENT","OPHTHALMIC","20060508","","ANDA","ANDA064093","Redpharm Drug","3","mg/g","","N","20251231"
"5590","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","67296014201","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-0142","67296-0142-1","67296-0142_1ac47712-341b-8ddd-e063-6394a90a6439","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20040507","","NDA AUTHORIZED GENERIC","NDA019992","Redpharm Drug","3","mg/mL","","N","20251231"
"5591","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","67296014401","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-0144","67296-0144-1","67296-0144_1b4b59fc-4605-39fa-e063-6394a90aa00b","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","RedPharm Drug, Inc.","300","mg/1","","N","20251231"
"5592","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","67296014403","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-0144","67296-0144-3","67296-0144_1b4b59fc-4605-39fa-e063-6394a90aa00b","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","RedPharm Drug, Inc.","300","mg/1","","N","20251231"
"5593","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","67296014402","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-0144","67296-0144-2","67296-0144_1b4b59fc-4605-39fa-e063-6394a90aa00b","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","RedPharm Drug, Inc.","300","mg/1","","N","20251231"
"5594","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296023701","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-0237","67296-0237-1","67296-0237_1b4b7291-9171-a448-e063-6394a90ae8e8","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20180101","","ANDA","ANDA075593","RedPharm Drug, Inc.","250","mg/1","","N","20251231"
"5595","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296023702","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-0237","67296-0237-2","67296-0237_1b4b7291-9171-a448-e063-6394a90ae8e8","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20180101","","ANDA","ANDA075593","RedPharm Drug, Inc.","250","mg/1","","N","20251231"
"5596","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296023704","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-0237","67296-0237-4","67296-0237_1b4b7291-9171-a448-e063-6394a90ae8e8","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20180101","","ANDA","ANDA075593","RedPharm Drug, Inc.","250","mg/1","","N","20251231"
"5597","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296023703","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-0237","67296-0237-3","67296-0237_1b4b7291-9171-a448-e063-6394a90ae8e8","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20180101","","ANDA","ANDA075593","RedPharm Drug, Inc.","250","mg/1","","N","20251231"
"5598","CEPHALEXIN","Cephalexin","67296024601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0246","67296-0246-1","67296-0246_1bb1c3b7-80fb-29b4-e063-6394a90a84c8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5599","CEPHALEXIN","Cephalexin","67296024603","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0246","67296-0246-3","67296-0246_1bb1c3b7-80fb-29b4-e063-6394a90a84c8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5600","CEPHALEXIN","Cephalexin","67296024604","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0246","67296-0246-4","67296-0246_1bb1c3b7-80fb-29b4-e063-6394a90a84c8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5601","CEPHALEXIN","Cephalexin","67296024605","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0246","67296-0246-5","67296-0246_1bb1c3b7-80fb-29b4-e063-6394a90a84c8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5602","CEPHALEXIN","Cephalexin","67296024602","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0246","67296-0246-2","67296-0246_1bb1c3b7-80fb-29b4-e063-6394a90a84c8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5603","CEPHALEXIN","Cephalexin","67296024609","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0246","67296-0246-9","67296-0246_1bb1c3b7-80fb-29b4-e063-6394a90a84c8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5604","CEPHALEXIN","Cephalexin","67296024606","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0246","67296-0246-6","67296-0246_1bb1c3b7-80fb-29b4-e063-6394a90a84c8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5605","AZITHROMYCIN MONOHYDRATE","Azithromycin","67296025403","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-0254","67296-0254-3","67296-0254_1ac490e8-011a-cfed-e063-6394a90aa310","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065225","Redpharm Drug","250","mg/1","","N","20251231"
"5606","CLINDAMYCIN HYDROCHLORIDE","clindamycin hydrochloride","67296026003","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-0260","67296-0260-3","67296-0260_1ad85144-c7b8-8a2f-e063-6294a90a7ada","HUMAN PRESCRIPTION DRUG","clindamycin hydrochloride","","CAPSULE","ORAL","19700522","","NDA AUTHORIZED GENERIC","NDA050162","Redpharm Drug","300","mg/1","","N","20251231"
"5607","CEPHALEXIN","Cephalexin","67296032002","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0320","67296-0320-2","67296-0320_21dde12a-a280-73c7-e063-6294a90ad854","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","RedPharm Drug","500","mg/1","","N","20251231"
"5608","CEPHALEXIN","Cephalexin","67296032008","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0320","67296-0320-8","67296-0320_21dde12a-a280-73c7-e063-6294a90ad854","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","RedPharm Drug","500","mg/1","","N","20251231"
"5609","OFLOXACIN","Ofloxacin","67296034401","Quinolone Antimicrobial [EPC], Quinolones [CS]","67296-0344","67296-0344-1","67296-0344_1b3cebc2-007a-2e29-e063-6394a90ae0fa","HUMAN PRESCRIPTION DRUG","Ofloxacin Otic","","SOLUTION","AURICULAR (OTIC)","20040514","","ANDA","ANDA076527","Redpharm Drug","3","mg/mL","","N","20251231"
"5610","GENTAMICIN SULFATE","gentamicin sulfate","67296037001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","67296-0370","67296-0370-1","67296-0370_1bc40c55-1911-da77-e063-6394a90aa8b7","HUMAN PRESCRIPTION DRUG","GENTAMICIN SULFATE","","SOLUTION/ DROPS","OPHTHALMIC","19980105","","ANDA","ANDA062452","Redpharm Drug","3","mg/mL","","N","20251231"
"5611","POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","Polymyxin B Sulfate and Trimethoprim","67296038501","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67296-0385","67296-0385-1","67296-0385_1bc41633-2b66-9903-e063-6394a90acfeb","HUMAN PRESCRIPTION DRUG","Polymyxin B Sulfate and Trimethoprim","","SOLUTION","OPHTHALMIC","19980416","","ANDA","ANDA064211","Redpharm Drug","10000; 1","[USP'U]/mL; mg/mL","","N","20251231"
"5612","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296038701","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-0387","67296-0387-1","67296-0387_1cdd8c6f-93f6-04da-e063-6294a90a12f9","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","19860825","","ANDA","ANDA071017","RedPharm Drug, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5613","TOBRAMYCIN","Tobramycin","67296039101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","67296-0391","67296-0391-1","67296-0391_1bc44733-47b9-6e1b-e063-6394a90a9f0d","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","OPHTHALMIC","19950109","","ANDA","ANDA062535","Redpharm Drug","3","mg/mL","","N","20251231"
"5614","SULFACETAMIDE SODIUM","Sulfacetamide Sodium","67296040301","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","67296-0403","67296-0403-1","67296-0403_1bc4199f-a4ec-8f70-e063-6294a90a93b8","HUMAN PRESCRIPTION DRUG","Sulfacetamide Sodium","","SOLUTION","OPHTHALMIC","20030325","","ANDA","ANDA089560","Redpharm Drug","100","mg/mL","","N","20251231"
"5615","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","67296042601","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","67296-0426","67296-0426-1","67296-0426_1c05f710-76f5-6967-e063-6394a90a83e7","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20010529","","ANDA","ANDA075673","Redpharm Drug",".5; 10","mg/g; mg/g","","N","20251231"
"5616","MUPIROCIN","Mupirocin","67296042801","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","67296-0428","67296-0428-1","67296-0428_1c05ff8b-1133-775e-e063-6294a90a04b5","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20050923","","ANDA","ANDA065170","Redpharm Drug","20","mg/g","","N","20251231"
"5617","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and dexamethasone","67296043501","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67296-0435","67296-0435-1","67296-0435_1c061695-86be-e4eb-e063-6294a90a6496","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Dexamethasone","","SUSPENSION","OPHTHALMIC","19960221","","ANDA","ANDA062341","Redpharm Drug","1; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"5618","KETOCONAZOLE","ketoconazole","67296044801","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","67296-0448","67296-0448-1","67296-0448_1c06062f-6ed3-e2f7-e063-6294a90a745c","HUMAN PRESCRIPTION DRUG","ketoconazole","","CREAM","TOPICAL","20040428","","ANDA","ANDA076294","Redpharm Drug","20","mg/g","","N","20251231"
"5619","GENTAMICIN SULFATE","Gentamicin Sulfate","67296045001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","67296-0450","67296-0450-1","67296-0450_1c064402-0229-5bb4-e063-6294a90a0bcf","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","SOLUTION","OPHTHALMIC","19960405","","ANDA","ANDA062196","Redpharm Drug","3","mg/mL","","N","20251231"
"5620","CLARITHROMYCIN","Clarithromycin","67296046401","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","67296-0464","67296-0464-1","67296-0464_1bdead85-b348-40e3-e063-6394a90a942d","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5621","CEFDINIR","Cefdinir","67296046901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0469","67296-0469-1","67296-0469_1c50dbdc-ff4d-8e13-e063-6294a90a69a7","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20070501","","ANDA","ANDA065264","RedPharm Drug, Inc.","300","mg/1","","N","20251231"
"5622","CEFDINIR","Cefdinir","67296046902","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0469","67296-0469-2","67296-0469_1c50dbdc-ff4d-8e13-e063-6294a90a69a7","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20070501","","ANDA","ANDA065264","RedPharm Drug, Inc.","300","mg/1","","N","20251231"
"5623","CEFDINIR","Cefdinir","67296046903","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0469","67296-0469-3","67296-0469_1c50dbdc-ff4d-8e13-e063-6294a90a69a7","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20070501","","ANDA","ANDA065264","RedPharm Drug, Inc.","300","mg/1","","N","20251231"
"5624","ECONAZOLE NITRATE","Econazole Nitrate","67296047901","Azole Antifungal [EPC], Azoles [CS]","67296-0479","67296-0479-1","67296-0479_1c064ea5-6247-d7f8-e063-6394a90ab0f1","HUMAN PRESCRIPTION DRUG","Econazole Nitrate","","CREAM","TOPICAL","20060808","","ANDA","ANDA076479","Redpharm Drug","10","mg/g","","N","20251231"
"5625","CEFADROXIL","Cefadroxil","67296049104","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0491","67296-0491-4","67296-0491_1c50d175-80bc-7152-e063-6294a90a18ae","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20080423","","ANDA","ANDA065392","Redpharm Drug","500","mg/1","","N","20251231"
"5626","CEFADROXIL","Cefadroxil","67296049101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0491","67296-0491-1","67296-0491_1c50d175-80bc-7152-e063-6294a90a18ae","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20080423","","ANDA","ANDA065392","Redpharm Drug","500","mg/1","","N","20251231"
"5627","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296052302","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-0523","67296-0523-2","67296-0523_1cf7dde0-d71d-886e-e063-6394a90a1cbf","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Redpharm Drug","500","mg/1","","N","20251231"
"5628","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296052303","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-0523","67296-0523-3","67296-0523_1cf7dde0-d71d-886e-e063-6394a90a1cbf","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Redpharm Drug","500","mg/1","","N","20251231"
"5629","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296052304","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-0523","67296-0523-4","67296-0523_1cf7dde0-d71d-886e-e063-6394a90a1cbf","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Redpharm Drug","500","mg/1","","N","20251231"
"5630","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296052305","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-0523","67296-0523-5","67296-0523_1cf7dde0-d71d-886e-e063-6394a90a1cbf","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Redpharm Drug","500","mg/1","","N","20251231"
"5631","CEFDINIR","Cefdinir","67296052601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0526","67296-0526-1","67296-0526_1c423211-885a-2bbd-e063-6394a90a42b6","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","Redpharm Drug","300","mg/1","","N","20251231"
"5632","KETOCONAZOLE","Ketoconazole","67296054001","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","67296-0540","67296-0540-1","67296-0540_1c424282-831b-3c5b-e063-6294a90ae79f","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20021218","","ANDA","ANDA075638","Redpharm Drug","20","mg/g","","N","20251231"
"5633","MUPIROCIN","Mupirocin","67296064601","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","67296-0646","67296-0646-1","67296-0646_238bcd4e-1f6d-8a5c-e063-6394a90a9cb3","HUMAN PRESCRIPTION DRUG","mupirocin","","OINTMENT","TOPICAL","20091030","","ANDA","ANDA065123","Redpharm Drug","20","mg/g","","N","20251231"
"5634","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc and Polymyxin B Sulfate","67296066101","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67296-0661","67296-0661-1","67296-0661_238bcca4-16dc-870f-e063-6394a90a41f9","HUMAN PRESCRIPTION DRUG","Bacitracin Zinc and Polymyxin B Sulfate","","OINTMENT","OPHTHALMIC","20080425","","ANDA","ANDA064046","Redpharm Drug","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"5635","DEXAMETHASONE; TOBRAMYCIN","Tobramycin and Dexamethasone","67296066501","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","67296-0665","67296-0665-1","67296-0665_238bec79-88d0-ae9f-e063-6394a90aaf1c","HUMAN PRESCRIPTION DRUG","Tobramycin and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","20090102","","NDA AUTHORIZED GENERIC","NDA050592","Redpharm Drug","1; 3","mg/mL; mg/mL","","N","20251231"
"5636","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296072401","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-0724","67296-0724-1","67296-0724_1cf81b8a-b1b8-bbc7-e063-6394a90a1fd6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20060822","","ANDA","ANDA076817","RedPharm Drug, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5637","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296072402","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-0724","67296-0724-2","67296-0724_1cf81b8a-b1b8-bbc7-e063-6394a90a1fd6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20060822","","ANDA","ANDA076817","RedPharm Drug, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5638","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296072406","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-0724","67296-0724-6","67296-0724_1cf81b8a-b1b8-bbc7-e063-6394a90a1fd6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20060822","","ANDA","ANDA076817","RedPharm Drug, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5639","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296072403","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-0724","67296-0724-3","67296-0724_1cf81b8a-b1b8-bbc7-e063-6394a90a1fd6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20060822","","ANDA","ANDA076817","RedPharm Drug, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5640","CEFUROXIME AXETIL","Cefuroxime axetil","67296074701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0747","67296-0747-1","67296-0747_1fbf8e10-d274-0fb7-e063-6394a90a2f4e","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","RedPharm Drug","500","mg/1","","N","20251231"
"5641","MUPIROCIN","Mupirocin","67296076701","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","67296-0767","67296-0767-1","67296-0767_1fbfc51d-3781-9a65-e063-6294a90a6576","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20031107","","ANDA","ANDA065085","RedPharm Drug","20","mg/g","","N","20251231"
"5642","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin and Polymyxin B Sulfates and Dexamethasone","67296082701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67296-0827","67296-0827-1","67296-0827_1fbfe451-61f4-8d16-e063-6394a90a8aa4","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Dexamethasone","","OINTMENT","OPHTHALMIC","19960221","","NDA AUTHORIZED GENERIC","NDA050065","RedPharm Drug","1; 3.5; 10000","mg/g; mg/g; [iU]/g","","N","20251231"
"5643","POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","polymyxin B sulfate, trimethoprim sulfate","67296085001","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67296-0850","67296-0850-1","67296-0850_1fc0730a-2170-a085-e063-6294a90a84f0","HUMAN PRESCRIPTION DRUG","POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE","","SOLUTION/ DROPS","OPHTHALMIC","19970429","","NDA AUTHORIZED GENERIC","NDA050567","RedPharm Drug","10000; 1","[USP'U]/mL; mg/mL","","N","20251231"
"5644","CEFDINIR","Cefdinir","67296086801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0868","67296-0868-1","67296-0868_1cfb1b60-5350-8946-e063-6294a90a6308","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20070509","","ANDA","ANDA065368","Redpharm Drug","300","mg/1","","N","20251231"
"5645","CEFDINIR","Cefdinir","67296086802","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0868","67296-0868-2","67296-0868_1cfb1b60-5350-8946-e063-6294a90a6308","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20070509","","ANDA","ANDA065368","Redpharm Drug","300","mg/1","","N","20251231"
"5646","CEFDINIR","Cefdinir","67296086803","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0868","67296-0868-3","67296-0868_1cfb1b60-5350-8946-e063-6294a90a6308","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20070509","","ANDA","ANDA065368","Redpharm Drug","300","mg/1","","N","20251231"
"5647","CEFDINIR","Cefdinir","67296086804","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0868","67296-0868-4","67296-0868_1cfb1b60-5350-8946-e063-6294a90a6308","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20070509","","ANDA","ANDA065368","Redpharm Drug","300","mg/1","","N","20251231"
"5648","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","67296090401","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","67296-0904","67296-0904-1","67296-0904_1cfc1321-fec0-07e3-e063-6394a90a3b36","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20180101","","ANDA","ANDA091568","RedPharm Drug, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"5649","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","67296090402","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","67296-0904","67296-0904-2","67296-0904_1cfc1321-fec0-07e3-e063-6394a90a3b36","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20180101","","ANDA","ANDA091568","RedPharm Drug, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"5650","ERYTHROMYCIN","Erythromycin","67296090501","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","67296-0905","67296-0905-1","67296-0905_1cfaecff-4a1f-5d7a-e063-6394a90aa893","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","19940729","","ANDA","ANDA064067","RedPharm Drug","5","mg/g","","N","20251231"
"5651","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","67296094002","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-0940","67296-0940-2","67296-0940_1cfc2990-6b90-4891-e063-6394a90a56a0","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Redpharm Drug","300","mg/1","","N","20251231"
"5652","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","67296094003","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-0940","67296-0940-3","67296-0940_1cfc2990-6b90-4891-e063-6394a90a56a0","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Redpharm Drug","300","mg/1","","N","20251231"
"5653","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","67296094001","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-0940","67296-0940-1","67296-0940_1cfc2990-6b90-4891-e063-6394a90a56a0","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Redpharm Drug","300","mg/1","","N","20251231"
"5654","CEPHALEXIN","Cephalexin","67296097601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0976","67296-0976-1","67296-0976_1cfcdaef-ceb3-9806-e063-6294a90ac8cf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20180101","","ANDA","ANDA090836","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5655","CEPHALEXIN","Cephalexin","67296097603","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0976","67296-0976-3","67296-0976_1cfcdaef-ceb3-9806-e063-6294a90ac8cf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20180101","","ANDA","ANDA090836","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5656","CEPHALEXIN","Cephalexin","67296097604","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0976","67296-0976-4","67296-0976_1cfcdaef-ceb3-9806-e063-6294a90ac8cf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20180101","","ANDA","ANDA090836","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5657","CEPHALEXIN","Cephalexin","67296097605","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0976","67296-0976-5","67296-0976_1cfcdaef-ceb3-9806-e063-6294a90ac8cf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20180101","","ANDA","ANDA090836","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5658","CEPHALEXIN","Cephalexin","67296097606","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0976","67296-0976-6","67296-0976_1cfcdaef-ceb3-9806-e063-6294a90ac8cf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20180101","","ANDA","ANDA090836","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5659","CEPHALEXIN","Cephalexin","67296097607","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0976","67296-0976-7","67296-0976_1cfcdaef-ceb3-9806-e063-6294a90ac8cf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20180101","","ANDA","ANDA090836","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5660","CEPHALEXIN","Cephalexin","67296097602","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-0976","67296-0976-2","67296-0976_1cfcdaef-ceb3-9806-e063-6294a90ac8cf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20180101","","ANDA","ANDA090836","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5661","AMOXICILLIN","Amoxicillin","67296098602","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-0986","67296-0986-2","67296-0986_1cfcdf2f-bd96-70c4-e063-6394a90af2ce","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20070301","","ANDA","ANDA065291","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5662","AMOXICILLIN","Amoxicillin","67296098603","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-0986","67296-0986-3","67296-0986_1cfcdf2f-bd96-70c4-e063-6394a90af2ce","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20070301","","ANDA","ANDA065291","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5663","AMOXICILLIN","Amoxicillin","67296098604","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-0986","67296-0986-4","67296-0986_1cfcdf2f-bd96-70c4-e063-6394a90af2ce","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20070301","","ANDA","ANDA065291","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5664","AMOXICILLIN","Amoxicillin","67296098606","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-0986","67296-0986-6","67296-0986_1cfcdf2f-bd96-70c4-e063-6394a90af2ce","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20070301","","ANDA","ANDA065291","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5665","AMOXICILLIN","Amoxicillin","67296098605","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-0986","67296-0986-5","67296-0986_1cfcdf2f-bd96-70c4-e063-6394a90af2ce","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20070301","","ANDA","ANDA065291","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5666","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone","67296100401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67296-1004","67296-1004-1","67296-1004_1cfeb0c7-4bdb-8c59-e063-6294a90a7466","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","19960828","","ANDA","ANDA064065","RedPharm Drug","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"5667","SILVER SULFADIAZINE","Silver Sulfadiazine","67296101301","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","67296-1013","67296-1013-1","67296-1013_1cfea680-a8a0-58e0-e063-6294a90a8652","HUMAN PRESCRIPTION DRUG","SSD Cream","","CREAM","TOPICAL","20110504","","NDA","NDA018578","RedPharm Drug","10","g/1000g","","N","20251231"
"5668","SULFACETAMIDE SODIUM","sulfacetamide sodium","67296106101","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","67296-1061","67296-1061-1","67296-1061_1cff37c6-0271-3313-e063-6294a90a5547","HUMAN PRESCRIPTION DRUG","Sulfacetamide Sodium","","SOLUTION/ DROPS","OPHTHALMIC","19941228","","ANDA","ANDA040066","RedPharm Drug","100","mg/mL","","N","20251231"
"5669","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296109701","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1097","67296-1097-1","67296-1097_1cff8fab-850d-d97d-e063-6294a90a46fd","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","RedPharm Drug, Inc.","250","mg/1","","N","20251231"
"5670","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296109706","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1097","67296-1097-6","67296-1097_1cff8fab-850d-d97d-e063-6294a90a46fd","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","RedPharm Drug, Inc.","250","mg/1","","N","20251231"
"5671","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296112901","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-1129","67296-1129-1","67296-1129_1d51092d-c3a9-4960-e063-6294a90a32e9","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20100608","","ANDA","ANDA091348","RedPharm Drug, Inc.","200; 40","mg/5mL; mg/5mL","","N","20251231"
"5672","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296112902","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-1129","67296-1129-2","67296-1129_1d51092d-c3a9-4960-e063-6294a90a32e9","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20100608","","ANDA","ANDA091348","RedPharm Drug, Inc.","200; 40","mg/5mL; mg/5mL","","N","20251231"
"5673","PENICILLIN V POTASSIUM","Penicillin V Potassium","67296113502","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1135","67296-1135-2","67296-1135_1d514001-2920-a2f4-e063-6394a90aa905","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","RedPharm Drug, Inc.","250","mg/1","","N","20251231"
"5674","PENICILLIN V POTASSIUM","Penicillin V Potassium","67296113504","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1135","67296-1135-4","67296-1135_1d514001-2920-a2f4-e063-6394a90aa905","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","RedPharm Drug, Inc.","250","mg/1","","N","20251231"
"5675","AMOXICILLIN","Amoxicillin","67296115602","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1156","67296-1156-2","67296-1156_1d511cb3-fe48-576f-e063-6394a90a2b9f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5676","AMOXICILLIN","Amoxicillin","67296115604","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1156","67296-1156-4","67296-1156_1d511cb3-fe48-576f-e063-6394a90a2b9f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5677","AMOXICILLIN","Amoxicillin","67296115605","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1156","67296-1156-5","67296-1156_1d511cb3-fe48-576f-e063-6394a90a2b9f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5678","AMOXICILLIN","Amoxicillin","67296115606","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1156","67296-1156-6","67296-1156_1d511cb3-fe48-576f-e063-6394a90a2b9f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5679","AMOXICILLIN","Amoxicillin","67296115603","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1156","67296-1156-3","67296-1156_1d511cb3-fe48-576f-e063-6394a90a2b9f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5680","AMOXICILLIN","Amoxicillin","67296115607","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1156","67296-1156-7","67296-1156_1d511cb3-fe48-576f-e063-6394a90a2b9f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5681","AZITHROMYCIN MONOHYDRATE","Azithromycin","67296116001","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-1160","67296-1160-1","67296-1160_1d51baee-9f48-3f11-e063-6394a90ae36f","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065225","RedPharm Drug","250","mg/1","","N","20251231"
"5682","AZITHROMYCIN MONOHYDRATE","Azithromycin","67296116003","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-1160","67296-1160-3","67296-1160_1d51baee-9f48-3f11-e063-6394a90ae36f","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065225","RedPharm Drug","250","mg/1","","N","20251231"
"5683","FLUCONAZOLE","Fluconazole","67296116701","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","67296-1167","67296-1167-1","67296-1167_1d51ddb4-e237-06ce-e063-6294a90a3a2a","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","RedPharm Drug","50","mg/1","","N","20251231"
"5684","FLUCONAZOLE","Fluconazole","67296116702","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","67296-1167","67296-1167-2","67296-1167_1d51ddb4-e237-06ce-e063-6294a90a3a2a","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","RedPharm Drug","50","mg/1","","N","20251231"
"5685","CEFDINIR","Cefdinir","67296121601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-1216","67296-1216-1","67296-1216_1d5375f3-2527-e027-e063-6394a90af514","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","RedPharm Drug, Inc.","300","mg/1","","N","20251231"
"5686","CEFDINIR","Cefdinir","67296121602","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-1216","67296-1216-2","67296-1216_1d5375f3-2527-e027-e063-6394a90af514","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","RedPharm Drug, Inc.","300","mg/1","","N","20251231"
"5687","CEFDINIR","Cefdinir","67296121603","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-1216","67296-1216-3","67296-1216_1d5375f3-2527-e027-e063-6394a90af514","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","RedPharm Drug, Inc.","300","mg/1","","N","20251231"
"5688","CEFDINIR","Cefdinir","67296121605","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-1216","67296-1216-5","67296-1216_1d5375f3-2527-e027-e063-6394a90af514","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","RedPharm Drug, Inc.","300","mg/1","","N","20251231"
"5689","OFLOXACIN","Ofloxacin","67296122301","Quinolone Antimicrobial [EPC], Quinolones [CS]","67296-1223","67296-1223-1","67296-1223_1d53808e-841b-67aa-e063-6294a90ac214","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20040514","","ANDA","ANDA076622","RedPharm Drug","3","mg/mL","","N","20251231"
"5690","ECONAZOLE NITRATE","Econazole Nitrate","67296123901","Azole Antifungal [EPC], Azoles [CS]","67296-1239","67296-1239-1","67296-1239_1d53c0e9-aafa-cd73-e063-6394a90a580b","HUMAN PRESCRIPTION DRUG","Econazole Nitrate","","CREAM","TOPICAL","20021126","","ANDA","ANDA076005","RedPharm Drug","10","mg/g","","N","20251231"
"5691","METRONIDAZOLE","Metronidazole","67296128301","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1283","67296-1283-1","67296-1283_1d54508b-022f-498f-e063-6394a90a8e03","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5692","METRONIDAZOLE","Metronidazole","67296128303","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1283","67296-1283-3","67296-1283_1d54508b-022f-498f-e063-6394a90a8e03","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5693","METRONIDAZOLE","Metronidazole","67296128304","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1283","67296-1283-4","67296-1283_1d54508b-022f-498f-e063-6394a90a8e03","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5694","METRONIDAZOLE","Metronidazole","67296128305","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1283","67296-1283-5","67296-1283_1d54508b-022f-498f-e063-6394a90a8e03","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5695","METRONIDAZOLE","Metronidazole","67296128302","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1283","67296-1283-2","67296-1283_1d54508b-022f-498f-e063-6394a90a8e03","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5696","PENICILLIN V POTASSIUM","Penicillin V Potassium","67296128902","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1289","67296-1289-2","67296-1289_1d543893-0168-e46b-e063-6394a90ac25a","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5697","PENICILLIN V POTASSIUM","Penicillin V Potassium","67296128903","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1289","67296-1289-3","67296-1289_1d543893-0168-e46b-e063-6394a90ac25a","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5698","PENICILLIN V POTASSIUM","Penicillin V Potassium","67296128904","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1289","67296-1289-4","67296-1289_1d543893-0168-e46b-e063-6394a90ac25a","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5699","PENICILLIN V POTASSIUM","Penicillin V Potassium","67296128901","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1289","67296-1289-1","67296-1289_1d543893-0168-e46b-e063-6394a90ac25a","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5700","PENICILLIN V POTASSIUM","Penicillin V Potassium","67296128905","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1289","67296-1289-5","67296-1289_1d543893-0168-e46b-e063-6394a90ac25a","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5701","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296131801","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1318","67296-1318-1","67296-1318_1d7014be-99ef-d54e-e063-6294a90abd23","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5702","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296131802","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1318","67296-1318-2","67296-1318_1d7014be-99ef-d54e-e063-6294a90abd23","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5703","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296131806","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1318","67296-1318-6","67296-1318_1d7014be-99ef-d54e-e063-6294a90abd23","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5704","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296131804","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1318","67296-1318-4","67296-1318_1d7014be-99ef-d54e-e063-6294a90abd23","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5705","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296132702","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-1327","67296-1327-2","67296-1327_d61134b4-ba15-26fc-e053-2995a90a5567","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","RedPharm Drug, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5706","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296132704","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-1327","67296-1327-4","67296-1327_d61134b4-ba15-26fc-e053-2995a90a5567","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","RedPharm Drug, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5707","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296132706","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-1327","67296-1327-6","67296-1327_d61134b4-ba15-26fc-e053-2995a90a5567","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","RedPharm Drug, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5708","NYSTATIN","Nystatin","67296135301","Polyene Antifungal [EPC], Polyenes [CS]","67296-1353","67296-1353-1","67296-1353_239fa261-6f42-2a9e-e063-6394a90a6ddc","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20060921","","ANDA","ANDA062225","Redpharm Drug","100000","[USP'U]/g","","N","20251231"
"5709","CLARITHROMYCIN","Clarithromycin","67296136002","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","67296-1360","67296-1360-2","67296-1360_1d843c2c-7f24-39dd-e063-6294a90a506e","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20151204","","ANDA","ANDA203584","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5710","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","67296136901","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","67296-1369","67296-1369-1","67296-1369_239fba33-2b77-d372-e063-6394a90a1109","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20151106","","ANDA","ANDA202894","Redpharm Drug",".5; 10","mg/g; mg/g","","N","20251231"
"5711","NYSTATIN","Nystatin","67296137801","Polyene Antifungal [EPC], Polyenes [CS]","67296-1378","67296-1378-1","67296-1378_239ffa40-af65-288a-e063-6394a90a90fb","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20060921","","ANDA","ANDA062225","Redpharm Drug","100000","[USP'U]/g","","N","20251231"
"5712","ERYTHROMYCIN","erythromycin","67296139501","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","67296-1395","67296-1395-1","67296-1395_1f1a1ec5-dfb8-b5c0-e063-6294a90a7e07","HUMAN PRESCRIPTION DRUG","erythromycin","","OINTMENT","OPHTHALMIC","20140508","","ANDA","ANDA062447","RedPharm Drug","5","mg/g","","N","20251231"
"5713","CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE","Ciprofloxacin and Dexamethasone","67296140608","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1406","67296-1406-8","67296-1406_1f1b9d08-3649-8ab9-e063-6394a90a25e3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin and Dexamethasone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","20200810","","ANDA","ANDA205548","RedPharm Drug","3; 1","mg/mL; mg/mL","","N","20251231"
"5714","METRONIDAZOLE","Metronidazole","67296141802","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1418","67296-1418-2","67296-1418_1f1beab3-d8ba-27a2-e063-6294a90a3671","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5715","METRONIDAZOLE","Metronidazole","67296141803","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1418","67296-1418-3","67296-1418_1f1beab3-d8ba-27a2-e063-6294a90a3671","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5716","METRONIDAZOLE","Metronidazole","67296141807","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1418","67296-1418-7","67296-1418_1f1beab3-d8ba-27a2-e063-6294a90a3671","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5717","METRONIDAZOLE","Metronidazole","67296141808","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1418","67296-1418-8","67296-1418_1f1beab3-d8ba-27a2-e063-6294a90a3671","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5718","AZITHROMYCIN DIHYDRATE","Azithromycin","67296143002","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-1430","67296-1430-2","67296-1430_1f1c52be-77a6-9d0e-e063-6394a90a5d05","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20051114","","ANDA","ANDA065212","RedPharm Drug","500","mg/1","","N","20251231"
"5719","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","67296144207","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","67296-1442","67296-1442-7","67296-1442_2c6228e2-dbad-01e7-e063-6394a90acbbc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Redpharm Drug, Inc.","25; 75","mg/1; mg/1","","N","20261231"
"5720","CEFDINIR","Cefdinir","67296144801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-1448","67296-1448-1","67296-1448_2c623bbf-8af9-a70c-e063-6294a90a6d94","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","Redpharm Drug, Inc.","300","mg/1","","N","20261231"
"5721","CEFDINIR","Cefdinir","67296144802","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-1448","67296-1448-2","67296-1448_2c623bbf-8af9-a70c-e063-6294a90a6d94","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","Redpharm Drug, Inc.","300","mg/1","","N","20261231"
"5722","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296147901","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1479","67296-1479-1","67296-1479_1f1e4713-b64a-be18-e063-6394a90a16b6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","RedPharm Drug, Inc.","250","mg/1","","N","20251231"
"5723","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296147906","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1479","67296-1479-6","67296-1479_1f1e4713-b64a-be18-e063-6394a90a16b6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","RedPharm Drug, Inc.","250","mg/1","","N","20251231"
"5724","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296147907","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1479","67296-1479-7","67296-1479_1f1e4713-b64a-be18-e063-6394a90a16b6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","RedPharm Drug, Inc.","250","mg/1","","N","20251231"
"5725","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296147902","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1479","67296-1479-2","67296-1479_1f1e4713-b64a-be18-e063-6394a90a16b6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","RedPharm Drug, Inc.","250","mg/1","","N","20251231"
"5726","PENICILLIN V POTASSIUM","Penicillin V Potassium","67296149204","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1492","67296-1492-4","67296-1492_1e9de0cb-be3c-3c94-e063-6394a90aaed0","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","Redpharm Drug, Inc.","250","mg/1","","N","20251231"
"5727","PENICILLIN V POTASSIUM","Penicillin V Potassium","67296149302","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1493","67296-1493-2","67296-1493_1e9dda1e-d4be-4204-e063-6394a90a5294","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","Redpharm Drug, Inc.","500","mg/1","","N","20251231"
"5728","PENICILLIN V POTASSIUM","Penicillin V Potassium","67296149304","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1493","67296-1493-4","67296-1493_1e9dda1e-d4be-4204-e063-6394a90a5294","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","Redpharm Drug, Inc.","500","mg/1","","N","20251231"
"5729","PENICILLIN V POTASSIUM","Penicillin V Potassium","67296149308","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1493","67296-1493-8","67296-1493_1e9dda1e-d4be-4204-e063-6394a90a5294","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","Redpharm Drug, Inc.","500","mg/1","","N","20251231"
"5730","PENICILLIN V POTASSIUM","Penicillin V Potassium","67296149303","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1493","67296-1493-3","67296-1493_1e9dda1e-d4be-4204-e063-6394a90a5294","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","Redpharm Drug, Inc.","500","mg/1","","N","20251231"
"5731","FLUCONAZOLE","Fluconazole","67296149808","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","67296-1498","67296-1498-8","67296-1498_1f33a21a-3248-d65c-e063-6294a90aa746","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Redpharm Drug, Inc.","100","mg/1","","N","20251231"
"5732","NYSTATIN","NYSTATIN","67296150103","Polyene Antifungal [EPC], Polyenes [CS]","67296-1501","67296-1501-3","67296-1501_1f33a21a-32a8-d65c-e063-6294a90aa746","HUMAN PRESCRIPTION DRUG","NYSTATIN","","POWDER","TOPICAL","20180423","","ANDA","ANDA208838","RedPharm Drug","100000","[USP'U]/g","","N","20251231"
"5733","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296150201","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-1502","67296-1502-1","67296-1502_1e9de6d7-65de-43c7-e063-6394a90a5260","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","19971229","","ANDA","ANDA074650","Redpharm Drug, Inc.","200; 40","mg/5mL; mg/5mL","","N","20251231"
"5734","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296150202","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-1502","67296-1502-2","67296-1502_1e9de6d7-65de-43c7-e063-6394a90a5260","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","19971229","","ANDA","ANDA074650","Redpharm Drug, Inc.","200; 40","mg/5mL; mg/5mL","","N","20251231"
"5735","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","67296150704","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-1507","67296-1507-4","67296-1507_1f33dea9-b39c-b5bf-e063-6294a90a5cfb","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","RedPharm Drug, Inc.","150","mg/1","","N","20251231"
"5736","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","67296150706","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-1507","67296-1507-6","67296-1507_1f33dea9-b39c-b5bf-e063-6294a90a5cfb","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","RedPharm Drug, Inc.","150","mg/1","","N","20251231"
"5737","AZITHROMYCIN DIHYDRATE","Azithromycin","67296151006","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-1510","67296-1510-6","67296-1510_1f33e6b9-e14d-0570-e063-6294a90ae8f4","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20051114","","ANDA","ANDA065211","RedPharm Drug Inc","250","mg/1","","N","20251231"
"5738","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","67296151302","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-1513","67296-1513-2","67296-1513_1e9dda1e-d4ba-4204-e063-6394a90a5294","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","","ANDA","ANDA208249","RedPharm Drug Inc","500","mg/1","","N","20251231"
"5739","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","67296151303","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-1513","67296-1513-3","67296-1513_1e9dda1e-d4ba-4204-e063-6394a90a5294","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","","ANDA","ANDA208249","RedPharm Drug Inc","500","mg/1","","N","20251231"
"5740","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","67296151305","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-1513","67296-1513-5","67296-1513_1e9dda1e-d4ba-4204-e063-6394a90a5294","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","","ANDA","ANDA208249","RedPharm Drug Inc","500","mg/1","","N","20251231"
"5741","NYSTATIN","Nystatin","67296151901","Polyene Antifungal [EPC], Polyenes [CS]","67296-1519","67296-1519-1","67296-1519_1f34a073-bd56-2e83-e063-6294a90af21e","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20190724","","ANDA","ANDA212557","RedPharm Drug, Inc","100000","U/g","","N","20251231"
"5742","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296157501","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1575","67296-1575-1","67296-1575_1dfc9514-0772-61c2-e063-6294a90adf0e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20180101","","ANDA","ANDA077859","RedPharm Drug, Inc.","250","mg/1","","N","20251231"
"5743","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296157505","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1575","67296-1575-5","67296-1575_1dfc9514-0772-61c2-e063-6294a90adf0e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20180101","","ANDA","ANDA077859","RedPharm Drug, Inc.","250","mg/1","","N","20251231"
"5744","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296157506","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1575","67296-1575-6","67296-1575_1dfc9514-0772-61c2-e063-6294a90adf0e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20180101","","ANDA","ANDA077859","RedPharm Drug, Inc.","250","mg/1","","N","20251231"
"5745","FLUCONAZOLE","fluconazole","67296160601","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","67296-1606","67296-1606-1","67296-1606_1fc0bf3f-5a90-a287-e063-6394a90a4c4f","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","RedPharm Drug","200","mg/1","","N","20251231"
"5746","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296161202","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-1612","67296-1612-2","67296-1612_1dfc9fa8-e466-f816-e063-6394a90a8c7c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20180101","","ANDA","ANDA090624","RedPharm Drug, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5747","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296161204","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-1612","67296-1612-4","67296-1612_1dfc9fa8-e466-f816-e063-6394a90a8c7c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20180101","","ANDA","ANDA090624","RedPharm Drug, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5748","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296161206","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-1612","67296-1612-6","67296-1612_1dfc9fa8-e466-f816-e063-6394a90a8c7c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20180101","","ANDA","ANDA090624","RedPharm Drug, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5749","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296161201","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-1612","67296-1612-1","67296-1612_1dfc9fa8-e466-f816-e063-6394a90a8c7c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20180101","","ANDA","ANDA090624","RedPharm Drug, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"5750","FLUCONAZOLE","Fluconazole","67296162701","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","67296-1627","67296-1627-1","67296-1627_1f3f1edc-4246-c9e7-e063-6394a90a4b6f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140620","","ANDA","ANDA076658","Redpharm Drug","150","mg/1","","N","20251231"
"5751","TOBRAMYCIN","Tobramycin","67296163905","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","67296-1639","67296-1639-5","67296-1639_1f3efd88-f2c9-2af2-e063-6294a90a41c6","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION/ DROPS","OPHTHALMIC","20200811","","ANDA","ANDA207444","Redpharm Drug","3","mg/mL","","N","20251231"
"5752","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","67296165001","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","67296-1650","67296-1650-1","67296-1650_1dfca8d9-dd29-fab0-e063-6394a90a310d","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20190101","","ANDA","ANDA204755","RedPharm Drug, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"5753","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","67296165002","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","67296-1650","67296-1650-2","67296-1650_1dfca8d9-dd29-fab0-e063-6394a90a310d","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20190101","","ANDA","ANDA204755","RedPharm Drug, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"5754","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","67296165009","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","67296-1650","67296-1650-9","67296-1650_1dfca8d9-dd29-fab0-e063-6394a90a310d","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20190101","","ANDA","ANDA204755","RedPharm Drug, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"5755","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296165701","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-1657","67296-1657-1","67296-1657_1dfcbde9-641f-7454-e063-6394a90ad1e9","HUMAN PRESCRIPTION DRUG","SULFATRIM","","SUSPENSION","ORAL","19830701","","NDA","NDA018615","RedPharm Drug, Inc.","200; 40","mg/5mL; mg/5mL","","N","20251231"
"5756","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296165702","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-1657","67296-1657-2","67296-1657_1dfcbde9-641f-7454-e063-6394a90ad1e9","HUMAN PRESCRIPTION DRUG","SULFATRIM","","SUSPENSION","ORAL","19830701","","NDA","NDA018615","RedPharm Drug, Inc.","200; 40","mg/5mL; mg/5mL","","N","20251231"
"5757","OFLOXACIN","Ofloxacin","67296167005","Quinolone Antimicrobial [EPC], Quinolones [CS]","67296-1670","67296-1670-5","67296-1670_1ece4eea-ca42-0556-e063-6294a90a1d89","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20141215","","ANDA","ANDA078559","RedPharm Drug","3","mg/mL","","N","20251231"
"5758","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin, triamcinolone acetonide","67296168401","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","67296-1684","67296-1684-1","67296-1684_1ecdb97e-64df-00cb-e063-6394a90aafde","HUMAN PRESCRIPTION DRUG","NYSTATIN AND TRIAMCINOLONE ACETONIDE","","CREAM","TOPICAL","20171127","","ANDA","ANDA208479","RedPharm Drug","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"5759","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","67296169406","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-1694","67296-1694-6","67296-1694_1ebe203b-fecc-799e-e063-6394a90aaf63","HUMAN PRESCRIPTION DRUG","Zithromax","","TABLET, FILM COATED","ORAL","20190517","","NDA","NDA050711","RedPharm Drug","250","mg/1","","N","20251231"
"5760","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","67296170203","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-1702","67296-1702-3","67296-1702_1ebcbff8-4ca1-6c97-e063-6394a90a14be","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20191101","","ANDA","ANDA207402","RedPharm Drug, Inc.","150","mg/1","","N","20251231"
"5761","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","67296170206","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-1702","67296-1702-6","67296-1702_1ebcbff8-4ca1-6c97-e063-6394a90a14be","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20191101","","ANDA","ANDA207402","RedPharm Drug, Inc.","150","mg/1","","N","20251231"
"5762","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","67296170204","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-1702","67296-1702-4","67296-1702_1ebcbff8-4ca1-6c97-e063-6394a90a14be","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20191101","","ANDA","ANDA207402","RedPharm Drug, Inc.","150","mg/1","","N","20251231"
"5763","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296170305","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1703","67296-1703-5","67296-1703_1ebdca4c-c02e-3891-e063-6294a90a0c89","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","SOLUTION","OPHTHALMIC","20181101","","ANDA","ANDA077568","RedPharm Drug","3","mg/mL","","N","20251231"
"5764","CEFADROXIL","Cefadroxil","67296172702","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-1727","67296-1727-2","67296-1727_1eba72df-6e34-9950-e063-6394a90a059c","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20191101","","ANDA","ANDA065352","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5765","METRONIDAZOLE","metronidazole","67296174702","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1747","67296-1747-2","67296-1747_1ebb06a8-5a03-1ef5-e063-6394a90a25cd","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5766","METRONIDAZOLE","metronidazole","67296174703","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1747","67296-1747-3","67296-1747_1ebb06a8-5a03-1ef5-e063-6394a90a25cd","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5767","METRONIDAZOLE","metronidazole","67296174707","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1747","67296-1747-7","67296-1747_1ebb06a8-5a03-1ef5-e063-6394a90a25cd","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5768","METRONIDAZOLE","metronidazole","67296174709","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1747","67296-1747-9","67296-1747_1ebb06a8-5a03-1ef5-e063-6394a90a25cd","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5769","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","67296174903","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-1749","67296-1749-3","67296-1749_1ebb0a1b-0cc9-138f-e063-6394a90a66b7","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20200101","","ANDA","ANDA207402","RedPharm Drug, Inc.","300","mg/1","","N","20251231"
"5770","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","67296174904","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-1749","67296-1749-4","67296-1749_1ebb0a1b-0cc9-138f-e063-6394a90a66b7","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20200101","","ANDA","ANDA207402","RedPharm Drug, Inc.","300","mg/1","","N","20251231"
"5771","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","67296174907","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-1749","67296-1749-7","67296-1749_1ebb0a1b-0cc9-138f-e063-6394a90a66b7","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20200101","","ANDA","ANDA207402","RedPharm Drug, Inc.","300","mg/1","","N","20251231"
"5772","MOXIFLOXACIN HYDROCHLORIDE","MOXIFLOXACIN","67296176403","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1764","67296-1764-3","67296-1764_1e1cecc8-5b41-2698-e063-6294a90acf2e","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN","","SOLUTION/ DROPS","OPHTHALMIC","20171004","","ANDA","ANDA206242","RedPharm Drug","5","mg/mL","","N","20251231"
"5773","AZITHROMYCIN DIHYDRATE","Azithromycin","67296177906","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-1779","67296-1779-6","67296-1779_1e1d539c-b824-75b5-e063-6294a90a89e0","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210000","RedPharm Drug","250","mg/1","","N","20251231"
"5774","AZITHROMYCIN DIHYDRATE","Azithromycin","67296178905","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-1789","67296-1789-5","67296-1789_1e1d801a-c5a2-8b52-e063-6394a90af8a6","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210001","RedPharm Drug","500","mg/1","","N","20251231"
"5775","CLINDAMYCIN HYDROCHLORIDE","clindamycin hydrochloride","67296179803","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-1798","67296-1798-3","67296-1798_1e1dde76-06be-ec94-e063-6294a90abd0f","HUMAN PRESCRIPTION DRUG","Cleocin Hydrochloride","","CAPSULE","ORAL","19700522","","NDA","NDA050162","RedPharm Drug, Inc.","300","mg/1","","N","20251231"
"5776","METRONIDAZOLE","metronidazole","67296180603","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1806","67296-1806-3","67296-1806_1e1e069e-d435-f4e0-e063-6294a90a3c86","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20191122","","ANDA","ANDA070772","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5777","METRONIDAZOLE","metronidazole","67296180608","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1806","67296-1806-8","67296-1806_1e1e069e-d435-f4e0-e063-6294a90a3c86","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20191122","","ANDA","ANDA070772","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5778","METRONIDAZOLE","metronidazole","67296180607","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1806","67296-1806-7","67296-1806_1e1e069e-d435-f4e0-e063-6294a90a3c86","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20191122","","ANDA","ANDA070772","RedPharm Drug, Inc.","500","mg/1","","N","20251231"
"5779","KETOCONAZOLE","Ketoconazole","67296180707","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","67296-1807","67296-1807-7","67296-1807_1e1e3ad1-fbb0-4742-e063-6394a90a2a59","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20190208","","ANDA","ANDA075581","RedPharm Drug","20","mg/g","","N","20251231"
"5780","OFLOXACIN","Ofloxacin Otic","67296181905","Quinolone Antimicrobial [EPC], Quinolones [CS]","67296-1819","67296-1819-5","67296-1819_1d873dfc-131f-ac25-e063-6394a90a6021","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","AURICULAR (OTIC)","20200317","","ANDA","ANDA211525","RedPharm Drug","3","mg/mL","","N","20251231"
"5781","CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE","ciprofloxacin and dexamethasone","67296182307","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1823","67296-1823-7","67296-1823_1d8779b5-e007-76f1-e063-6294a90a3e6f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin and Dexamethasone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","20200810","","NDA AUTHORIZED GENERIC","NDA021537","RedPharm Drug","3; 1","mg/mL; mg/mL","","N","20251231"
"5782","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","67296183106","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-1831","67296-1831-6","67296-1831_1d87ee05-6dfc-3227-e063-6394a90adb50","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","","ANDA","ANDA208250","RedPharm Drug","250","mg/1","","N","20251231"
"5783","TINIDAZOLE","Tinidazole","67296183608","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-1836","67296-1836-8","67296-1836_1d881e38-1cbb-8039-e063-6394a90aa368","HUMAN PRESCRIPTION DRUG","Tindazole","","TABLET, FILM COATED","ORAL","20131009","","ANDA","ANDA202489","Redpharm Drug, Inc.","500","mg/1","","N","20251231"
"5784","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","67296184801","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1848","67296-1848-1","67296-1848_2c62ea96-679a-d05f-e063-6394a90aa2d8","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Redpharm Drug","500","mg/1","","N","20261231"
"5785","OFLOXACIN","ofloxacin otic","67296186605","Quinolone Antimicrobial [EPC], Quinolones [CS]","67296-1866","67296-1866-5","67296-1866_1d89d884-090f-5fb2-e063-6394a90abfc1","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION","AURICULAR (OTIC)","20220715","","ANDA","ANDA216130","RedPharm Drug","3","mg/mL","","N","20251231"
"5786","AZITHROMYCIN DIHYDRATE","azithromycin","67296187006","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-1870","67296-1870-6","67296-1870_1d8ad2d6-f45e-9254-e063-6394a90a2d87","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20190513","","NDA AUTHORIZED GENERIC","NDA050711","RedPharm Drug, Inc.","250","mg/1","","N","20251231"
"5787","FLUCONAZOLE","Fluconazole","67296187501","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","67296-1875","67296-1875-1","67296-1875_1d8add09-d681-3e2d-e063-6394a90ae7af","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","RedPharm Drug","200","mg/1","","N","20251231"
"5788","CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE","Ciprofloxacin and dexamethasone","67296188808","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1888","67296-1888-8","67296-1888_1d8b8744-3c40-178e-e063-6394a90ab17b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin and dexamethasone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","20220901","","ANDA","ANDA210470","RedPharm Drug","3; 1","mg/mL; mg/mL","","N","20251231"
"5789","AMOXICILLIN","Amoxicillin","67296189402","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1894","67296-1894-2","67296-1894_2c63022a-8f56-0685-e063-6294a90aa775","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Redpharm Drug","250","mg/1","","N","20261231"
"5790","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296190407","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-1904","67296-1904-7","67296-1904_1dffbf2c-a874-f5c6-e063-6394a90a6496","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100913","","ANDA","ANDA076899","Redpharm Drug","800; 160","mg/1; mg/1","","N","20251231"
"5791","AMOXICILLIN","Amoxicillin","67296191403","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1914","67296-1914-3","67296-1914_3251e4b2-f17c-f99f-e063-6394a90a6af9","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20220915","","ANDA","ANDA062216","Redpharm Drug","500","mg/1","","N","20261231"
"5792","AMOXICILLIN","Amoxicillin","67296191404","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1914","67296-1914-4","67296-1914_3251e4b2-f17c-f99f-e063-6394a90a6af9","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20220915","","ANDA","ANDA062216","Redpharm Drug","500","mg/1","","N","20261231"
"5793","AMOXICILLIN","Amoxicillin","67296191406","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67296-1914","67296-1914-6","67296-1914_3251e4b2-f17c-f99f-e063-6394a90a6af9","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20220915","","ANDA","ANDA062216","Redpharm Drug","500","mg/1","","N","20261231"
"5794","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","67296191601","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-1916","67296-1916-1","67296-1916_1e047b6c-7520-3619-e063-6394a90a03fc","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20220208","","ANDA","ANDA214330","Redpharm Drug","200; 40","mg/5mL; mg/5mL","","N","20251231"
"5795","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","67296192107","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","67296-1921","67296-1921-7","67296-1921_2fbb57c5-df02-59ea-e063-6394a90a59c4","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","FOR SUSPENSION","ORAL","20220919","","NDA AUTHORIZED GENERIC","NDA050755","Redpharm Drug","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"5796","OFLOXACIN","Ofloxacin","67296192501","Quinolone Antimicrobial [EPC], Quinolones [CS]","67296-1925","67296-1925-1","67296-1925_2fbd51b2-0cd0-3ed9-e063-6394a90a85f6","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","AURICULAR (OTIC)","20080317","","ANDA","ANDA076128","Redpharm Drug","3","mg/mL","","N","20261231"
"5797","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","67296194202","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-1942","67296-1942-2","67296-1942_2fd24618-6a7b-0406-e063-6294a90af284","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","Redpharm Drug","500","mg/1","","N","20261231"
"5798","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","67296194205","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-1942","67296-1942-5","67296-1942_2fd24618-6a7b-0406-e063-6294a90af284","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","Redpharm Drug","500","mg/1","","N","20261231"
"5799","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","67296194203","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-1942","67296-1942-3","67296-1942_2fd24618-6a7b-0406-e063-6294a90af284","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","Redpharm Drug","500","mg/1","","N","20261231"
"5800","CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE","Ciprofloxacin and dexamethasone","67296194308","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-1943","67296-1943-8","67296-1943_2fd20fd5-f122-aa82-e063-6294a90a52a7","HUMAN PRESCRIPTION DRUG","Ciprofloxacin and dexamethasone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","20231101","","ANDA","ANDA215768","Redpharm Drug","3; 1","mg/mL; mg/mL","","N","20261231"
"5801","AZITHROMYCIN DIHYDRATE","Azithromycin","67296194505","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-1945","67296-1945-5","67296-1945_2fd2574a-e533-3b2b-e063-6394a90a9c37","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207398","Redpharm Drug","500","mg/1","","N","20261231"
"5802","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and hydrocortisone","67296205101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67296-2051","67296-2051-1","67296-2051_1e04bb0c-85b3-5c2e-e063-6394a90ac30d","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SOLUTION","AURICULAR (OTIC)","20030318","","ANDA","ANDA062423","RedPharm Drug","10; 3.5; 10000","mg/mL; mg/mL; [iU]/mL","","N","20251231"
"5803","CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE","ciprofloxacin hydrochloride and hydrocortisone","67296206501","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-2065","67296-2065-1","67296-2065_1e193761-0712-2020-e063-6394a90a5887","HUMAN PRESCRIPTION DRUG","CIPRO","HC","SUSPENSION/ DROPS","AURICULAR (OTIC)","19990315","","NDA","NDA020805","RedPharm Drug","2; 10","mg/mL; mg/mL","","N","20251231"
"5804","OFLOXACIN","ofloxacin","67296207605","Quinolone Antimicrobial [EPC], Quinolones [CS]","67296-2076","67296-2076-5","67296-2076_1e1996d6-99f6-45f9-e063-6294a90af190","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20230825","","ANDA","ANDA215886","RedPharm Drug","3","mg/mL","","N","20251231"
"5805","FLUCONAZOLE","Fluconazole","67296207701","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","67296-2077","67296-2077-1","67296-2077_1e1985b3-8710-47e7-e063-6294a90a843f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140313","","ANDA","ANDA077253","RedPharm Drug","100","mg/1","","N","20251231"
"5806","FLUCONAZOLE","Fluconazole","67296207702","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","67296-2077","67296-2077-2","67296-2077_1e1985b3-8710-47e7-e063-6294a90a843f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140313","","ANDA","ANDA077253","RedPharm Drug","100","mg/1","","N","20251231"
"5807","CEFUROXIME AXETIL","Cefuroxime Axetil","67296207901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-2079","67296-2079-1","67296-2079_1e19ce16-eeed-4555-e063-6294a90a47d1","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET, FILM COATED","ORAL","20060329","","ANDA","ANDA065308","Redpharm Drug","500","mg/1","","N","20251231"
"5808","SULFAMETHOXAZOLE; TRIMETHOPRIM","sulfamethoxazole and trimethoprim","67296208501","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67296-2085","67296-2085-1","67296-2085_1e19fee8-7bd7-a0c7-e063-6294a90a647a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20220705","","ANDA","ANDA077612","Redpharm drug","200; 40","mg/5mL; mg/5mL","","N","20251231"
"5809","METRONIDAZOLE","metronidazole","67296208707","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-2087","67296-2087-7","67296-2087_1e19fee8-7bdf-a0c7-e063-6294a90a647a","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","VAGINAL","20230712","","ANDA","ANDA216323","RedPharm Drug","7.5","mg/g","","N","20251231"
"5810","CEFUROXIME AXETIL","Cefuroxime Axetil","67296208801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67296-2088","67296-2088-1","67296-2088_1e19fa06-e7dc-b5a6-e063-6294a90ad4a1","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET","ORAL","20060329","","ANDA","ANDA065308","Redpharm Drug","500","mg/1","","N","20251231"
"5811","KETOCONAZOLE","Ketoconazole Cream, 2%","67296208901","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","67296-2089","67296-2089-1","67296-2089_1e19fa06-e7df-b5a6-e063-6294a90ad4a1","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20210527","","ANDA","ANDA212443","RedPharm Drug","20","mg/g","","N","20251231"
"5812","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","67296210309","Allylamine Antifungal [EPC], Allylamine [CS]","67296-2103","67296-2103-9","67296-2103_1e1adb03-401b-80b0-e063-6294a90a47a0","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","RedPharm Drug","250","mg/1","","N","20251231"
"5813","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","67296210504","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","67296-2105","67296-2105-4","67296-2105_1e1b3dbd-9c07-2721-e063-6394a90a1ab1","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Redpharm Drug","25; 75","mg/1; mg/1","","N","20251231"
"5814","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","67296210501","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","67296-2105","67296-2105-1","67296-2105_1e1b3dbd-9c07-2721-e063-6394a90a1ab1","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Redpharm Drug","25; 75","mg/1; mg/1","","N","20251231"
"5815","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","67296210603","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-2106","67296-2106-3","67296-2106_1e1b2b70-fd7c-da69-e063-6294a90ab8c5","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","RedPharm Drug","300","mg/1","","N","20251231"
"5816","NYSTATIN","NYSTATIN","67296211806","Polyene Antifungal [EPC], Polyenes [CS]","67296-2118","67296-2118-6","67296-2118_1e1bac72-32fa-2c5c-e063-6394a90a14d6","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20200717","","ANDA","ANDA203621","RedPharm Drug","100000","[USP'U]/mL","","N","20251231"
"5817","METRONIDAZOLE","metronidazole","67296212104","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-2121","67296-2121-4","67296-2121_3730f187-931b-9ae4-e063-6294a90a5167","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20060718","","ANDA","ANDA077819","Redpharm Drug","7.5","mg/g","","N","20261231"
"5818","ERYTHROMYCIN","Erythromycin","67296212803","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","67296-2128","67296-2128-3","67296-2128_37311d40-586c-ad96-e063-6294a90a5728","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","20231018","","ANDA","ANDA064030","Redpharm Drug","5","mg/g","","N","20261231"
"5819","MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE","Moxifloxacin","67296212903","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-2129","67296-2129-3","67296-2129_37311f6d-c362-a177-e063-6294a90acd2d","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20170701","","ANDA","ANDA202867","Redpharm Drug","5","mg/mL","","N","20261231"
"5820","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","67296213501","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-2135","67296-2135-1","67296-2135_373129a8-6ab4-5c37-e063-6394a90aa283","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Redpharm Drug","500","mg/1","","N","20261231"
"5821","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","67296213502","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-2135","67296-2135-2","67296-2135_373129a8-6ab4-5c37-e063-6394a90aa283","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Redpharm Drug","500","mg/1","","N","20261231"
"5822","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","67296213506","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67296-2135","67296-2135-6","67296-2135_373129a8-6ab4-5c37-e063-6394a90aa283","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Redpharm Drug","500","mg/1","","N","20261231"
"5823","AZITHROMYCIN DIHYDRATE","Azithromycin","67296214101","Macrolide Antimicrobial [EPC], Macrolides [CS]","67296-2141","67296-2141-1","67296-2141_3745a0ba-f14a-a4a4-e063-6394a90aad91","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20180806","","ANDA","ANDA211147","Redpharm Drug","200","mg/5mL","","N","20261231"
"5824","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","67296214304","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","67296-2143","67296-2143-4","67296-2143_3745b68b-bf22-e273-e063-6394a90a8fee","HUMAN PRESCRIPTION DRUG","vancomycin hydrochloride","","CAPSULE","ORAL","20151026","","NDA AUTHORIZED GENERIC","NDA050606","Redpharm Drug","125","mg/1","","N","20261231"
"5825","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","67296214904","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-2149","67296-2149-4","67296-2149_3731479b-67b9-f772-e063-6294a90a1efb","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Redpharm Drug","300","mg/1","","N","20261231"
"5826","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","67296214903","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","67296-2149","67296-2149-3","67296-2149_3731479b-67b9-f772-e063-6294a90a1efb","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Redpharm Drug","300","mg/1","","N","20261231"
"5827","NITROFURANTOIN","Nitrofurantoin Macrocrystals","67296215001","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","67296-2150","67296-2150-1","67296-2150_37314e56-848a-8372-e063-6394a90a4da2","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Macrocrystals","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","Redpharm Drug","100","mg/1","","N","20261231"
"5828","METRONIDAZOLE","Metronidazole","67296215202","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-2152","67296-2152-2","67296-2152_37315380-b590-0a37-e063-6294a90a96dc","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20180801","","ANDA","ANDA203458","Redpharm Drug","500","mg/1","","N","20261231"
"5829","METRONIDAZOLE","Metronidazole","67296215201","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","67296-2152","67296-2152-1","67296-2152_37315380-b590-0a37-e063-6294a90a96dc","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20180801","","ANDA","ANDA203458","Redpharm Drug","500","mg/1","","N","20261231"
"5830","OFLOXACIN","OFLOXACIN","67296215905","Quinolone Antimicrobial [EPC], Quinolones [CS]","67296-2159","67296-2159-5","67296-2159_3745661f-5d20-487d-e063-6294a90a5a68","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","SOLUTION","AURICULAR (OTIC)","20240301","","ANDA","ANDA217903","Redpharm Drug","3","mg/mL","","N","20261231"
"5831","MOXIFLOXACIN HYDROCHLORIDE","MOXIFLOXACIN HYDROCHLORIDE","67457032325","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","67457-323","67457-323-25","67457-323_6e90bd77-205a-4e19-8161-222e77c21f72","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN HYDROCHLORIDE","","INJECTION, SOLUTION","INTRAVENOUS","20171003","","ANDA","ANDA205833","Mylan Institutional LLC","400","mg/250mL","","N","20261231"
"5832","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","67457033950","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","67457-339","67457-339-50","67457-339_df08686a-292b-4b54-b3c8-60e7f53e2e31","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20131205","","ANDA","ANDA065397","Mylan Institutional LLC","500","mg/10mL","","N","20251231"
"5833","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","67457034001","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","67457-340","67457-340-01","67457-340_df08686a-292b-4b54-b3c8-60e7f53e2e31","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20131205","","ANDA","ANDA065397","Mylan Institutional LLC","1","g/20mL","","N","20251231"
"5834","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","67457034105","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","67457-341","67457-341-05","67457-341_4995368b-7dfc-4bb2-8b34-9da5ef6a9061","HUMAN PRESCRIPTION DRUG","vancomycin hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20131205","","ANDA","ANDA065432","Mylan Institutional LLC","5","g/100mL","","N","20251231"
"5835","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","67457034210","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","67457-342","67457-342-10","67457-342_c0b65e4b-6d28-4aa1-94f5-8f26888355b1","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20131205","","ANDA","ANDA091554","Mylan Institutional LLC","10","g/100mL","","N","20261231"
"5836","TOBRAMYCIN SULFATE","Tobramycin","67457042830","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","67457-428","67457-428-30","67457-428_7418acd9-03c9-40ed-bac0-1e0702c8114d","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION","INTRAMUSCULAR; INTRAVENOUS","20140219","","ANDA","ANDA065407","Mylan Institutional LLC","40","mg/mL","","N","20251231"
"5837","RIFAMPIN","Rifampin","67457044560","Rifamycin Antibacterial [EPC], Rifamycins [CS]","67457-445","67457-445-60","67457-445_94acfd2f-42e8-417d-8f4a-12b1fd6d2466","HUMAN PRESCRIPTION DRUG","Rifampin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20150121","","ANDA","ANDA065421","Mylan Institutional LLC","600","mg/10mL","","N","20251231"
"5838","TOBRAMYCIN SULFATE","Tobramycin","67457047322","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","67457-473","67457-473-22","67457-473_7418acd9-03c9-40ed-bac0-1e0702c8114d","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION","INTRAMUSCULAR; INTRAVENOUS","20140819","","ANDA","ANDA065407","Mylan Institutional LLC","40","mg/mL","","N","20251231"
"5839","POSACONAZOLE","posaconazole","67457066520","Azole Antifungal [EPC], Azoles [CS]","67457-665","67457-665-20","67457-665_834e282d-211e-4896-9be0-76e83f960859","HUMAN PRESCRIPTION DRUG","posaconazole","","SOLUTION","INTRAVENOUS","20240322","","ANDA","ANDA211500","Mylan Institutional LLC","18","mg/mL","","N","20251231"
"5840","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","67457070575","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","67457-705","67457-705-75","67457-705_a0a9dc82-4ffe-4798-8ec4-f4021bf6fc9f","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180831","","NDA","NDA209481","Mylan Institutional LLC","750","mg/15mL","","N","20251231"
"5841","SULFAMETHOXAZOLE; TRIMETHOPRIM","sulfamethoxazole and trimethoprim","67457077805","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67457-778","67457-778-05","67457-778_81d9227f-d613-4b43-b93d-25079f8f3f2e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","INJECTION","INTRAVENOUS","20171231","20251031","ANDA","ANDA206607","Mylan Institutional LLC","80; 16","mg/mL; mg/mL","","N",""
"5842","SULFAMETHOXAZOLE; TRIMETHOPRIM","sulfamethoxazole and trimethoprim","67457077930","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","67457-779","67457-779-30","67457-779_81d9227f-d613-4b43-b93d-25079f8f3f2e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","INJECTION","INTRAVENOUS","20171231","20250630","ANDA","ANDA206607","Mylan Institutional LLC","80; 16","mg/mL; mg/mL","","N",""
"5843","DAPTOMYCIN","daptomycin","67457081350","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","67457-813","67457-813-50","67457-813_d8aedf45-91a2-49a2-b367-add49c7527f0","HUMAN PRESCRIPTION DRUG","daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180904","","ANDA","ANDA205037","Mylan Institutional LLC","500","mg/10mL","","N","20251231"
"5844","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","67457082399","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","67457-823","67457-823-99","67457-823_a0a9dc82-4ffe-4798-8ec4-f4021bf6fc9f","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180831","","NDA","NDA209481","Mylan Institutional LLC","1.25","g/25mL","","N","20251231"
"5845","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","67457082499","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","67457-824","67457-824-99","67457-824_a0a9dc82-4ffe-4798-8ec4-f4021bf6fc9f","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20181206","","NDA","NDA209481","Mylan Institutional LLC","1.5","g/30mL","","N","20251231"
"5846","DAPTOMYCIN","daptomycin","67457094115","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","67457-941","67457-941-15","67457-941_95909792-972b-4c0c-b2ce-2be4bed36cff","HUMAN PRESCRIPTION DRUG","daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20231127","","ANDA","ANDA213966","Mylan Institutional LLC","500","mg/10mL","","N","20251231"
"5847","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate and polymyxin b sulfate","67777021708","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67777-217","67777-217-08","67777-217_0fa4276a-6913-b353-e063-6394a90a8af7","HUMAN OTC DRUG","bacitracin zinc, neomycin sulfate and polymyxin b sulfate","","OINTMENT","TOPICAL","20091201","","OTC MONOGRAPH DRUG","M004","Dynarex Corporation","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"5848","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate and polymyxin b sulfate","67777021713","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67777-217","67777-217-13","67777-217_0fa4276a-6913-b353-e063-6394a90a8af7","HUMAN OTC DRUG","bacitracin zinc, neomycin sulfate and polymyxin b sulfate","","OINTMENT","TOPICAL","20091201","","OTC MONOGRAPH DRUG","M004","Dynarex Corporation","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"5849","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate and polymyxin b sulfate","67777021715","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67777-217","67777-217-15","67777-217_0fa4276a-6913-b353-e063-6394a90a8af7","HUMAN OTC DRUG","bacitracin zinc, neomycin sulfate and polymyxin b sulfate","","OINTMENT","TOPICAL","20091201","","OTC MONOGRAPH DRUG","M004","Dynarex Corporation","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"5850","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate and polymyxin b sulfate","67777021717","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67777-217","67777-217-17","67777-217_0fa4276a-6913-b353-e063-6394a90a8af7","HUMAN OTC DRUG","bacitracin zinc, neomycin sulfate and polymyxin b sulfate","","OINTMENT","TOPICAL","20091201","","OTC MONOGRAPH DRUG","M004","Dynarex Corporation","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"5851","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate and polymyxin b sulfate","67777021711","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","67777-217","67777-217-11","67777-217_0fa4276a-6913-b353-e063-6394a90a8af7","HUMAN OTC DRUG","bacitracin zinc, neomycin sulfate and polymyxin b sulfate","","OINTMENT","TOPICAL","20091201","","OTC MONOGRAPH DRUG","M004","Dynarex Corporation","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"5852","NEOMYCIN SULFATE","Neomycin Ointment","67777021803","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","67777-218","67777-218-03","67777-218_0f9e087b-6e87-a3c7-e063-6394a90ac8d4","HUMAN OTC DRUG","Neomycin","","OINTMENT","TOPICAL","20240130","","OTC MONOGRAPH DRUG","M004","Dynarex Corporation","5","mg/g","","N","20251231"
"5853","NEOMYCIN SULFATE","Neomycin Ointment","67777021801","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","67777-218","67777-218-01","67777-218_0f9e087b-6e87-a3c7-e063-6394a90ac8d4","HUMAN OTC DRUG","Neomycin","","OINTMENT","TOPICAL","20240130","","OTC MONOGRAPH DRUG","M004","Dynarex Corporation","5","mg/g","","N","20251231"
"5854","CLOTRIMAZOLE","antifungal","67777023113","Azole Antifungal [EPC], Azoles [CS]","67777-231","67777-231-13","67777-231_2758be66-4129-317b-e063-6394a90a712a","HUMAN OTC DRUG","Dynarex Antifungal","","CREAM","TOPICAL","20100518","","OTC MONOGRAPH DRUG","M005","Dynarex Corporation","1","g/100g","","N","20251231"
"5855","CLOTRIMAZOLE","antifungal","67777023111","Azole Antifungal [EPC], Azoles [CS]","67777-231","67777-231-11","67777-231_2758be66-4129-317b-e063-6394a90a712a","HUMAN OTC DRUG","Dynarex Antifungal","","CREAM","TOPICAL","20100518","","OTC MONOGRAPH DRUG","M005","Dynarex Corporation","1","g/100g","","N","20251231"
"5856","MICONAZOLE NITRATE","1236-CCAntifungal Powder(Talc Free)","67777031304","Azole Antifungal [EPC], Azoles [CS]","67777-313","67777-313-04","67777-313_312ba573-4009-83e6-e063-6294a90a4a6d","HUMAN OTC DRUG","1236-CS Antifungal Powder (Talc Free)","","POWDER","TOPICAL","20250404","","OTC MONOGRAPH DRUG","M005","Dynarex Corporation","20","mg/g","","N","20261231"
"5857","MICONAZOLE NITRATE","Miconazole","67777031602","Azole Antifungal [EPC], Azoles [CS]","67777-316","67777-316-02","67777-316_27591cc7-3de3-0679-e063-6294a90a5b44","HUMAN OTC DRUG","Dynarex Antifungal Powder","","POWDER","TOPICAL","20160519","","OTC MONOGRAPH DRUG","M005","Dynarex Corporation","20","mg/g","","N","20251231"
"5858","AMPICILLIN SODIUM","Ampicillin Injection","67850002110","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67850-021","67850-021-10","67850-021_2878a8bb-e5ed-b695-e063-6394a90a0307","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20190306","","ANDA","ANDA090354","Methapharm Inc.","1","g/g","","N","20251231"
"5859","AMPICILLIN SODIUM","Ampicillin Injection","67850002210","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67850-022","67850-022-10","67850-022_2878a8bb-e5ed-b695-e063-6394a90a0307","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20190306","","ANDA","ANDA090354","Methapharm Inc.","2","g/2g","","N","20251231"
"5860","AMPICILLIN SODIUM","Ampicillin Injection","67850002310","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67850-023","67850-023-10","67850-023_2878a8bb-e5ed-b695-e063-6394a90a0307","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20190306","","ANDA","ANDA090354","Methapharm Inc.","250","mg/250mg","","N","20251231"
"5861","AMPICILLIN SODIUM","Ampicillin Injection","67850002410","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67850-024","67850-024-10","67850-024_2878a8bb-e5ed-b695-e063-6394a90a0307","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20190306","","ANDA","ANDA090354","Methapharm Inc.","500","mg/500mg","","N","20251231"
"5862","NAFCILLIN SODIUM","Nafcillin Injection","67850003110","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67850-031","67850-031-10","67850-031_2878daab-a24e-f142-e063-6394a90ae06b","HUMAN PRESCRIPTION DRUG","Nafcillin","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAMUSCULAR; INTRAVENOUS","20190305","","ANDA","ANDA090560","Methapharm Inc.","1","g/g","","N","20251231"
"5863","NAFCILLIN SODIUM","Nafcillin Injection","67850003210","Penicillin-class Antibacterial [EPC], Penicillins [CS]","67850-032","67850-032-10","67850-032_2878daab-a24e-f142-e063-6394a90ae06b","HUMAN PRESCRIPTION DRUG","Nafcillin","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAMUSCULAR; INTRAVENOUS","20190305","","ANDA","ANDA090560","Methapharm Inc.","2","g/2g","","N","20251231"
"5864","SILVER SULFADIAZINE","Silver Sulfadiazine","67877012410","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","67877-124","67877-124-10","67877-124_9fa269f3-f2ff-4054-81a8-04869262ce6d","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","Ascend Laboratories, LLC","10","mg/g","","N","20251231"
"5865","SILVER SULFADIAZINE","Silver Sulfadiazine","67877012420","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","67877-124","67877-124-20","67877-124_9fa269f3-f2ff-4054-81a8-04869262ce6d","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","Ascend Laboratories, LLC","10","mg/g","","N","20251231"
"5866","SILVER SULFADIAZINE","Silver Sulfadiazine","67877012425","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","67877-124","67877-124-25","67877-124_9fa269f3-f2ff-4054-81a8-04869262ce6d","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","Ascend Laboratories, LLC","10","mg/g","","N","20251231"
"5867","SILVER SULFADIAZINE","Silver Sulfadiazine","67877012405","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","67877-124","67877-124-05","67877-124_9fa269f3-f2ff-4054-81a8-04869262ce6d","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","Ascend Laboratories, LLC","10","mg/g","","N","20251231"
"5868","SILVER SULFADIAZINE","Silver Sulfadiazine","67877012450","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","67877-124","67877-124-50","67877-124_9fa269f3-f2ff-4054-81a8-04869262ce6d","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","Ascend Laboratories, LLC","10","mg/g","","N","20251231"
"5869","SILVER SULFADIAZINE","Silver Sulfadiazine","67877012485","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","67877-124","67877-124-85","67877-124_9fa269f3-f2ff-4054-81a8-04869262ce6d","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","Ascend Laboratories, LLC","10","mg/g","","N","20251231"
"5870","SILVER SULFADIAZINE","Silver Sulfadiazine","67877012440","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","67877-124","67877-124-40","67877-124_9fa269f3-f2ff-4054-81a8-04869262ce6d","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","19851223","","NDA","NDA018810","Ascend Laboratories, LLC","10","mg/g","","N","20251231"
"5871","CEFUROXIME AXETIL","Cefuroxime axetil","67877021520","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-215","67877-215-20","67877-215_57165b30-a551-409f-885e-ff7dfc4005a9","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","Ascend Laboratories, LLC","250","mg/1","","N","20251231"
"5872","CEFUROXIME AXETIL","Cefuroxime axetil","67877021560","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-215","67877-215-60","67877-215_57165b30-a551-409f-885e-ff7dfc4005a9","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","Ascend Laboratories, LLC","250","mg/1","","N","20251231"
"5873","CEFUROXIME AXETIL","Cefuroxime axetil","67877021584","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-215","67877-215-84","67877-215_57165b30-a551-409f-885e-ff7dfc4005a9","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","Ascend Laboratories, LLC","250","mg/1","","N","20251231"
"5874","CEFUROXIME AXETIL","Cefuroxime axetil","67877021501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-215","67877-215-01","67877-215_57165b30-a551-409f-885e-ff7dfc4005a9","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","Ascend Laboratories, LLC","250","mg/1","","N","20251231"
"5875","CEFUROXIME AXETIL","Cefuroxime axetil","67877021620","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-216","67877-216-20","67877-216_57165b30-a551-409f-885e-ff7dfc4005a9","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","Ascend Laboratories, LLC","500","mg/1","","N","20251231"
"5876","CEFUROXIME AXETIL","Cefuroxime axetil","67877021660","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-216","67877-216-60","67877-216_57165b30-a551-409f-885e-ff7dfc4005a9","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","Ascend Laboratories, LLC","500","mg/1","","N","20251231"
"5877","CEFUROXIME AXETIL","Cefuroxime axetil","67877021684","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-216","67877-216-84","67877-216_57165b30-a551-409f-885e-ff7dfc4005a9","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","Ascend Laboratories, LLC","500","mg/1","","N","20251231"
"5878","CEFUROXIME AXETIL","Cefuroxime axetil","67877021601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-216","67877-216-01","67877-216_57165b30-a551-409f-885e-ff7dfc4005a9","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","Ascend Laboratories, LLC","500","mg/1","","N","20251231"
"5879","CEPHALEXIN","Cephalexin","67877021901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-219","67877-219-01","67877-219_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Ascend Laboratories, LLC","500","mg/1","","N","20251231"
"5880","CEPHALEXIN","Cephalexin","67877021905","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-219","67877-219-05","67877-219_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Ascend Laboratories, LLC","500","mg/1","","N","20251231"
"5881","CEPHALEXIN","Cephalexin","67877021910","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-219","67877-219-10","67877-219_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Ascend Laboratories, LLC","500","mg/1","","N","20251231"
"5882","CEPHALEXIN","Cephalexin","67877021938","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-219","67877-219-38","67877-219_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Ascend Laboratories, LLC","500","mg/1","","N","20251231"
"5883","CEPHALEXIN","Cephalexin","67877021974","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-219","67877-219-74","67877-219_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Ascend Laboratories, LLC","500","mg/1","","N","20251231"
"5884","CEPHALEXIN","Cephalexin","67877021984","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-219","67877-219-84","67877-219_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Ascend Laboratories, LLC","500","mg/1","","N","20251231"
"5885","CEPHALEXIN","Cephalexin","67877021920","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-219","67877-219-20","67877-219_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Ascend Laboratories, LLC","500","mg/1","","N","20251231"
"5886","CEPHALEXIN","Cephalexin","67877022005","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-220","67877-220-05","67877-220_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Ascend Laboratories, LLC","250","mg/1","","N","20251231"
"5887","CEPHALEXIN","Cephalexin","67877022010","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-220","67877-220-10","67877-220_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Ascend Laboratories, LLC","250","mg/1","","N","20251231"
"5888","CEPHALEXIN","Cephalexin","67877022020","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-220","67877-220-20","67877-220_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Ascend Laboratories, LLC","250","mg/1","","N","20251231"
"5889","CEPHALEXIN","Cephalexin","67877022001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-220","67877-220-01","67877-220_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Ascend Laboratories, LLC","250","mg/1","","N","20251231"
"5890","CEPHALEXIN","Cephalexin","67877022074","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-220","67877-220-74","67877-220_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Ascend Laboratories, LLC","250","mg/1","","N","20251231"
"5891","CEPHALEXIN","Cephalexin","67877022084","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-220","67877-220-84","67877-220_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Ascend Laboratories, LLC","250","mg/1","","N","20251231"
"5892","CEPHALEXIN","Cephalexin","67877022038","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-220","67877-220-38","67877-220_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Ascend Laboratories, LLC","250","mg/1","","N","20251231"
"5893","CEPHALEXIN","Cephalexin","67877025401","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-254","67877-254-01","67877-254_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Ascend Laboratories, LLC","333","mg/1","","N","20251231"
"5894","CEPHALEXIN","Cephalexin","67877025410","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-254","67877-254-10","67877-254_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Ascend Laboratories, LLC","333","mg/1","","N","20251231"
"5895","CEPHALEXIN","Cephalexin","67877025420","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-254","67877-254-20","67877-254_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Ascend Laboratories, LLC","333","mg/1","","N","20251231"
"5896","CEPHALEXIN","Cephalexin","67877025438","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-254","67877-254-38","67877-254_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Ascend Laboratories, LLC","333","mg/1","","N","20251231"
"5897","CEPHALEXIN","Cephalexin","67877025405","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-254","67877-254-05","67877-254_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Ascend Laboratories, LLC","333","mg/1","","N","20251231"
"5898","CEPHALEXIN","Cephalexin","67877025505","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-255","67877-255-05","67877-255_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Ascend Laboratories, LLC","750","mg/1","","N","20251231"
"5899","CEPHALEXIN","Cephalexin","67877025510","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-255","67877-255-10","67877-255_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Ascend Laboratories, LLC","750","mg/1","","N","20251231"
"5900","CEPHALEXIN","Cephalexin","67877025520","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-255","67877-255-20","67877-255_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Ascend Laboratories, LLC","750","mg/1","","N","20251231"
"5901","CEPHALEXIN","Cephalexin","67877025501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-255","67877-255-01","67877-255_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Ascend Laboratories, LLC","750","mg/1","","N","20251231"
"5902","CEPHALEXIN","Cephalexin","67877025523","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-255","67877-255-23","67877-255_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Ascend Laboratories, LLC","750","mg/1","","N","20251231"
"5903","LINEZOLID","Linezolid","67877041901","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","67877-419","67877-419-01","67877-419_1dd1fb9c-98f4-4e25-8246-fb8462ff381c","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151221","","ANDA","ANDA205517","Ascend Laboratories, LLC","600","mg/1","","N","20261231"
"5904","LINEZOLID","Linezolid","67877041905","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","67877-419","67877-419-05","67877-419_1dd1fb9c-98f4-4e25-8246-fb8462ff381c","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151221","","ANDA","ANDA205517","Ascend Laboratories, LLC","600","mg/1","","N","20261231"
"5905","LINEZOLID","Linezolid","67877041910","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","67877-419","67877-419-10","67877-419_1dd1fb9c-98f4-4e25-8246-fb8462ff381c","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151221","","ANDA","ANDA205517","Ascend Laboratories, LLC","600","mg/1","","N","20261231"
"5906","LINEZOLID","Linezolid","67877041933","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","67877-419","67877-419-33","67877-419_1dd1fb9c-98f4-4e25-8246-fb8462ff381c","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151221","","ANDA","ANDA205517","Ascend Laboratories, LLC","600","mg/1","","N","20261231"
"5907","LINEZOLID","Linezolid","67877041938","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","67877-419","67877-419-38","67877-419_1dd1fb9c-98f4-4e25-8246-fb8462ff381c","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151221","","ANDA","ANDA205517","Ascend Laboratories, LLC","600","mg/1","","N","20261231"
"5908","LINEZOLID","Linezolid","67877041984","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","67877-419","67877-419-84","67877-419_1dd1fb9c-98f4-4e25-8246-fb8462ff381c","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151221","","ANDA","ANDA205517","Ascend Laboratories, LLC","600","mg/1","","N","20261231"
"5909","LINEZOLID","Linezolid","67877041920","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","67877-419","67877-419-20","67877-419_1dd1fb9c-98f4-4e25-8246-fb8462ff381c","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151221","","ANDA","ANDA205517","Ascend Laboratories, LLC","600","mg/1","","N","20261231"
"5910","LINEZOLID","Linezolid","67877041985","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","67877-419","67877-419-85","67877-419_1dd1fb9c-98f4-4e25-8246-fb8462ff381c","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151221","","ANDA","ANDA205517","Ascend Laboratories, LLC","600","mg/1","","N","20261231"
"5911","ITRACONAZOLE","Itraconazole","67877045430","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","67877-454","67877-454-30","67877-454_44d1c5d0-d3a3-4665-b00f-21cf0d2720ec","HUMAN PRESCRIPTION DRUG","Itraconazole","","CAPSULE, COATED PELLETS","ORAL","20170612","","ANDA","ANDA208591","Ascend Laboratories, LLC","100","mg/1","","N","20251231"
"5912","ITRACONAZOLE","Itraconazole","67877045484","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","67877-454","67877-454-84","67877-454_44d1c5d0-d3a3-4665-b00f-21cf0d2720ec","HUMAN PRESCRIPTION DRUG","Itraconazole","","CAPSULE, COATED PELLETS","ORAL","20170612","","ANDA","ANDA208591","Ascend Laboratories, LLC","100","mg/1","","N","20251231"
"5913","ITRACONAZOLE","Itraconazole","67877045490","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","67877-454","67877-454-90","67877-454_44d1c5d0-d3a3-4665-b00f-21cf0d2720ec","HUMAN PRESCRIPTION DRUG","Itraconazole","","CAPSULE, COATED PELLETS","ORAL","20170612","","ANDA","ANDA208591","Ascend Laboratories, LLC","100","mg/1","","N","20251231"
"5914","ITRACONAZOLE","Itraconazole","67877045405","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","67877-454","67877-454-05","67877-454_44d1c5d0-d3a3-4665-b00f-21cf0d2720ec","HUMAN PRESCRIPTION DRUG","Itraconazole","","CAPSULE, COATED PELLETS","ORAL","20170612","","ANDA","ANDA208591","Ascend Laboratories, LLC","100","mg/1","","N","20251231"
"5915","CEFDINIR","Cefdinir","67877054338","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-543","67877-543-38","67877-543_254d4dd1-0c63-4cdc-9a4e-98a777372204","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","Ascend Laboratories, LLC","300","mg/1","","N","20251231"
"5916","CEFDINIR","Cefdinir","67877054360","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-543","67877-543-60","67877-543_254d4dd1-0c63-4cdc-9a4e-98a777372204","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","Ascend Laboratories, LLC","300","mg/1","","N","20251231"
"5917","CEFDINIR","Cefdinir","67877054301","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-543","67877-543-01","67877-543_254d4dd1-0c63-4cdc-9a4e-98a777372204","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","Ascend Laboratories, LLC","300","mg/1","","N","20251231"
"5918","CEPHALEXIN","Cephalexin","67877054468","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-544","67877-544-68","67877-544_84f07b4a-a15e-41cb-af85-e110c5cf342e","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Ascend Laboratories, LLC","125","mg/5mL","","N","20251231"
"5919","CEPHALEXIN","Cephalexin","67877054488","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-544","67877-544-88","67877-544_84f07b4a-a15e-41cb-af85-e110c5cf342e","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Ascend Laboratories, LLC","125","mg/5mL","","N","20251231"
"5920","CEPHALEXIN","Cephalexin","67877054588","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-545","67877-545-88","67877-545_84f07b4a-a15e-41cb-af85-e110c5cf342e","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Ascend Laboratories, LLC","250","mg/5mL","","N","20251231"
"5921","CEPHALEXIN","Cephalexin","67877054568","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-545","67877-545-68","67877-545_84f07b4a-a15e-41cb-af85-e110c5cf342e","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Ascend Laboratories, LLC","250","mg/5mL","","N","20251231"
"5922","CEFDINIR","cefdinir","67877054788","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-547","67877-547-88","67877-547_662007e2-462e-4513-b5b0-efd5dcdc2421","HUMAN PRESCRIPTION DRUG","cefdinir","","POWDER, FOR SUSPENSION","ORAL","20210220","","ANDA","ANDA210534","Ascend Laboratories, LLC","125","mg/5mL","","N","20251231"
"5923","CEFDINIR","cefdinir","67877054798","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-547","67877-547-98","67877-547_662007e2-462e-4513-b5b0-efd5dcdc2421","HUMAN PRESCRIPTION DRUG","cefdinir","","POWDER, FOR SUSPENSION","ORAL","20210220","","ANDA","ANDA210534","Ascend Laboratories, LLC","125","mg/5mL","","N","20251231"
"5924","CEFDINIR","cefdinir","67877054898","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-548","67877-548-98","67877-548_662007e2-462e-4513-b5b0-efd5dcdc2421","HUMAN PRESCRIPTION DRUG","cefdinir","","POWDER, FOR SUSPENSION","ORAL","20210220","","ANDA","ANDA210534","Ascend Laboratories, LLC","250","mg/5mL","","N","20251231"
"5925","CEFDINIR","cefdinir","67877054888","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-548","67877-548-88","67877-548_662007e2-462e-4513-b5b0-efd5dcdc2421","HUMAN PRESCRIPTION DRUG","cefdinir","","POWDER, FOR SUSPENSION","ORAL","20210220","","ANDA","ANDA210534","Ascend Laboratories, LLC","250","mg/5mL","","N","20251231"
"5926","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","67877055905","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-559","67877-559-05","67877-559_553fe90f-8d78-4b49-94d2-8c7f7dde9461","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20220519","","ANDA","ANDA210568","Ascend Laboratories, LLC","100","mg/1","","N","20251231"
"5927","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","67877055920","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-559","67877-559-20","67877-559_553fe90f-8d78-4b49-94d2-8c7f7dde9461","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20220519","","ANDA","ANDA210568","Ascend Laboratories, LLC","100","mg/1","","N","20251231"
"5928","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","67877055901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-559","67877-559-01","67877-559_553fe90f-8d78-4b49-94d2-8c7f7dde9461","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20220519","","ANDA","ANDA210568","Ascend Laboratories, LLC","100","mg/1","","N","20251231"
"5929","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","67877056001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-560","67877-560-01","67877-560_553fe90f-8d78-4b49-94d2-8c7f7dde9461","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20220519","","ANDA","ANDA210568","Ascend Laboratories, LLC","200","mg/1","","N","20251231"
"5930","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","67877056020","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-560","67877-560-20","67877-560_553fe90f-8d78-4b49-94d2-8c7f7dde9461","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20220519","","ANDA","ANDA210568","Ascend Laboratories, LLC","200","mg/1","","N","20251231"
"5931","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","67877056005","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-560","67877-560-05","67877-560_553fe90f-8d78-4b49-94d2-8c7f7dde9461","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20220519","","ANDA","ANDA210568","Ascend Laboratories, LLC","200","mg/1","","N","20251231"
"5932","CEFIXIME","CEFIXIME","67877058401","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-584","67877-584-01","67877-584_30690cba-b831-45c1-b799-a013d6cfc2db","HUMAN PRESCRIPTION DRUG","CEFIXIME","","CAPSULE","ORAL","20181012","","ANDA","ANDA210574","Ascend Laboratories, LLC","400","mg/1","","N","20251231"
"5933","CEFIXIME","CEFIXIME","67877058405","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-584","67877-584-05","67877-584_30690cba-b831-45c1-b799-a013d6cfc2db","HUMAN PRESCRIPTION DRUG","CEFIXIME","","CAPSULE","ORAL","20181012","","ANDA","ANDA210574","Ascend Laboratories, LLC","400","mg/1","","N","20251231"
"5934","CEFIXIME","CEFIXIME","67877058433","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-584","67877-584-33","67877-584_30690cba-b831-45c1-b799-a013d6cfc2db","HUMAN PRESCRIPTION DRUG","CEFIXIME","","CAPSULE","ORAL","20181012","","ANDA","ANDA210574","Ascend Laboratories, LLC","400","mg/1","","N","20251231"
"5935","CEFIXIME","CEFIXIME","67877058450","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-584","67877-584-50","67877-584_30690cba-b831-45c1-b799-a013d6cfc2db","HUMAN PRESCRIPTION DRUG","CEFIXIME","","CAPSULE","ORAL","20181012","","ANDA","ANDA210574","Ascend Laboratories, LLC","400","mg/1","","N","20251231"
"5936","TOBRAMYCIN","Tobramycin","67877067870","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","67877-678","67877-678-70","67877-678_25c12569-0ae1-4117-a945-edfc5457e525","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","RESPIRATORY (INHALATION)","20210402","","ANDA","ANDA212848","Ascend Laboratories, LLC","300","mg/5mL","","N","20251231"
"5937","ERYTHROMYCIN","ERYTHROMYCIN","67877076201","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","67877-762","67877-762-01","67877-762_5e004c89-c7dd-4c52-856b-ca3c85a95f8a","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, FILM COATED","ORAL","20220714","","ANDA","ANDA216066","Ascend Laboratories, LLC","250","mg/1","","N","20251231"
"5938","ERYTHROMYCIN","ERYTHROMYCIN","67877076205","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","67877-762","67877-762-05","67877-762_5e004c89-c7dd-4c52-856b-ca3c85a95f8a","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, FILM COATED","ORAL","20220714","","ANDA","ANDA216066","Ascend Laboratories, LLC","250","mg/1","","N","20251231"
"5939","ERYTHROMYCIN","ERYTHROMYCIN","67877076233","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","67877-762","67877-762-33","67877-762_5e004c89-c7dd-4c52-856b-ca3c85a95f8a","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, FILM COATED","ORAL","20220714","","ANDA","ANDA216066","Ascend Laboratories, LLC","250","mg/1","","N","20251231"
"5940","ERYTHROMYCIN","ERYTHROMYCIN","67877076230","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","67877-762","67877-762-30","67877-762_5e004c89-c7dd-4c52-856b-ca3c85a95f8a","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, FILM COATED","ORAL","20220714","","ANDA","ANDA216066","Ascend Laboratories, LLC","250","mg/1","","N","20251231"
"5941","ERYTHROMYCIN","ERYTHROMYCIN","67877076301","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","67877-763","67877-763-01","67877-763_5e004c89-c7dd-4c52-856b-ca3c85a95f8a","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, FILM COATED","ORAL","20220714","","ANDA","ANDA216066","Ascend Laboratories, LLC","500","mg/1","","N","20251231"
"5942","ERYTHROMYCIN","ERYTHROMYCIN","67877076305","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","67877-763","67877-763-05","67877-763_5e004c89-c7dd-4c52-856b-ca3c85a95f8a","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, FILM COATED","ORAL","20220714","","ANDA","ANDA216066","Ascend Laboratories, LLC","500","mg/1","","N","20251231"
"5943","ERYTHROMYCIN","ERYTHROMYCIN","67877076330","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","67877-763","67877-763-30","67877-763_5e004c89-c7dd-4c52-856b-ca3c85a95f8a","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, FILM COATED","ORAL","20220714","","ANDA","ANDA216066","Ascend Laboratories, LLC","500","mg/1","","N","20251231"
"5944","ERYTHROMYCIN","ERYTHROMYCIN","67877076333","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","67877-763","67877-763-33","67877-763_5e004c89-c7dd-4c52-856b-ca3c85a95f8a","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, FILM COATED","ORAL","20220714","","ANDA","ANDA216066","Ascend Laboratories, LLC","500","mg/1","","N","20251231"
"5945","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","67877087801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-878","67877-878-01","67877-878_1a9e47ee-3f6f-4be0-9b06-9430d2a5f1bd","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20230301","","ANDA","ANDA210568","Ascend Laboratories, LLC","100","mg/1","","N","20251231"
"5946","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","67877087805","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-878","67877-878-05","67877-878_1a9e47ee-3f6f-4be0-9b06-9430d2a5f1bd","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20230301","","ANDA","ANDA210568","Ascend Laboratories, LLC","100","mg/1","","N","20251231"
"5947","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","67877087820","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-878","67877-878-20","67877-878_1a9e47ee-3f6f-4be0-9b06-9430d2a5f1bd","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20230301","","ANDA","ANDA210568","Ascend Laboratories, LLC","100","mg/1","","N","20251231"
"5948","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","67877087905","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-879","67877-879-05","67877-879_1a9e47ee-3f6f-4be0-9b06-9430d2a5f1bd","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20230213","","ANDA","ANDA210568","Ascend Laboratories, LLC","200","mg/1","","N","20251231"
"5949","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","67877087920","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-879","67877-879-20","67877-879_1a9e47ee-3f6f-4be0-9b06-9430d2a5f1bd","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20230213","","ANDA","ANDA210568","Ascend Laboratories, LLC","200","mg/1","","N","20251231"
"5950","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","67877087901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-879","67877-879-01","67877-879_1a9e47ee-3f6f-4be0-9b06-9430d2a5f1bd","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20230213","","ANDA","ANDA210568","Ascend Laboratories, LLC","200","mg/1","","N","20251231"
"5951","CEPHALEXIN","Cephalexin","67877089101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-891","67877-891-01","67877-891_779b70b9-d16c-4421-9e45-7800e947690d","HUMAN PRESCRIPTION DRUG","Cephalexin","","TABLET","ORAL","20241021","","ANDA","ANDA218947","Ascend Laboratories, LLC","250","mg/1","","N","20251231"
"5952","CEPHALEXIN","Cephalexin","67877089201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","67877-892","67877-892-01","67877-892_779b70b9-d16c-4421-9e45-7800e947690d","HUMAN PRESCRIPTION DRUG","Cephalexin","","TABLET","ORAL","20241021","","ANDA","ANDA218947","Ascend Laboratories, LLC","500","mg/1","","N","20251231"
"5953","CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM","ceftolozane and tazobactam","67919003001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","67919-030","67919-030-01","67919-030_206062a2-1895-47d9-b37c-51ac1d043d6b","HUMAN PRESCRIPTION DRUG","ZERBAXA","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20141219","","NDA","NDA206829","Merck Sharp & Dohme LLC","1; .5","g/10mL; g/10mL","","N","20251231"
"5954","TEDIZOLID PHOSPHATE","tedizolid phosphate","67919004002","Breast Cancer Resistance Protein Inhibitors [MoA], Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","67919-040","67919-040-02","67919-040_3132b965-d332-43a4-a156-d29b7d0fab8d","HUMAN PRESCRIPTION DRUG","SIVEXTRO","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20140620","","NDA","NDA205436","Merck Sharp & Dohme LLC","200","mg/4mL","","N","20261231"
"5955","TEDIZOLID PHOSPHATE","tedizolid phosphate","67919004104","Breast Cancer Resistance Protein Inhibitors [MoA], Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","67919-041","67919-041-04","67919-041_3132b965-d332-43a4-a156-d29b7d0fab8d","HUMAN PRESCRIPTION DRUG","SIVEXTRO","","TABLET, FILM COATED","ORAL","20140620","","NDA","NDA205435","Merck Sharp & Dohme LLC","200","mg/1","","N","20261231"
"5956","TEDIZOLID PHOSPHATE","tedizolid phosphate","67919004105","Breast Cancer Resistance Protein Inhibitors [MoA], Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","67919-041","67919-041-05","67919-041_3132b965-d332-43a4-a156-d29b7d0fab8d","HUMAN PRESCRIPTION DRUG","SIVEXTRO","","TABLET, FILM COATED","ORAL","20140620","","NDA","NDA205435","Merck Sharp & Dohme LLC","200","mg/1","","N","20261231"
"5957","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","Atovaquone and Proguanil Hydrochloride","68001024500","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","68001-245","68001-245-00","68001-245_eff0fdfe-695c-4e62-e053-2a95a90ab50f","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil Hydrochloride","","TABLET, FILM COATED","ORAL","20140313","","ANDA","ANDA091211","BluePoint Laboratories","250; 100","mg/1; mg/1","","N","20251231"
"5958","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","Atovaquone and Proguanil Hydrochloride","68001024515","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","68001-245","68001-245-15","68001-245_eff0fdfe-695c-4e62-e053-2a95a90ab50f","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil Hydrochloride","","TABLET, FILM COATED","ORAL","20140313","","ANDA","ANDA091211","BluePoint Laboratories","250; 100","mg/1; mg/1","","N","20251231"
"5959","FLUCONAZOLE","Fluconazole","68001025104","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68001-251","68001-251-04","68001-251_1b411437-0986-647f-e063-6294a90a1207","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140313","","ANDA","ANDA077253","BluePoint Laboratories","50","mg/1","","N","20251231"
"5960","FLUCONAZOLE","Fluconazole","68001025204","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68001-252","68001-252-04","68001-252_1b411437-0986-647f-e063-6294a90a1207","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140313","","ANDA","ANDA077253","BluePoint Laboratories","100","mg/1","","N","20251231"
"5961","FLUCONAZOLE","Fluconazole","68001025317","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68001-253","68001-253-17","68001-253_1b411437-0986-647f-e063-6294a90a1207","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140313","","ANDA","ANDA077253","BluePoint Laboratories","150","mg/1","","N","20251231"
"5962","FLUCONAZOLE","Fluconazole","68001025404","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68001-254","68001-254-04","68001-254_1b411437-0986-647f-e063-6294a90a1207","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140313","","ANDA","ANDA077253","BluePoint Laboratories","200","mg/1","","N","20251231"
"5963","MEROPENEM","Meropenem","68001032331","Carbapenems [CS], Penem Antibacterial [EPC]","68001-323","68001-323-31","68001-323_f28d2a00-0213-4467-91b9-a55164bb0a5f","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20170430","","ANDA","ANDA205883","BluePoint Laboratories","500","mg/20mL","","N","20251231"
"5964","MEROPENEM","Meropenem","68001032457","Carbapenems [CS], Penem Antibacterial [EPC]","68001-324","68001-324-57","68001-324_f28d2a00-0213-4467-91b9-a55164bb0a5f","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20170430","","ANDA","ANDA205883","BluePoint Laboratories","1","g/30mL","","N","20251231"
"5965","CEFDINIR","Cefdinir","68001036206","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68001-362","68001-362-06","68001-362_f80ad981-4642-03d3-e053-6394a90ab137","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20180801","","ANDA","ANDA065434","BluePoint Laboratories","300","mg/1","","N","20251231"
"5966","METRONIDAZOLE","Metronidazole","68001036400","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68001-364","68001-364-00","68001-364_2008a35e-f300-a6ef-e063-6394a90a7dcc","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20180801","","ANDA","ANDA203458","BluePoint Laboratories","250","mg/1","","N","20251231"
"5967","METRONIDAZOLE","Metronidazole","68001036500","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68001-365","68001-365-00","68001-365_2008a35e-f300-a6ef-e063-6394a90a7dcc","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20180801","","ANDA","ANDA203458","BluePoint Laboratories","500","mg/1","","N","20251231"
"5968","METRONIDAZOLE","Metronidazole","68001036503","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68001-365","68001-365-03","68001-365_2008a35e-f300-a6ef-e063-6394a90a7dcc","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20180801","","ANDA","ANDA203458","BluePoint Laboratories","500","mg/1","","N","20251231"
"5969","DAPTOMYCIN","Daptomycin","68001037668","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","68001-376","68001-376-68","68001-376_275acfd2-1a25-c0c5-e063-6394a90a15f7","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190501","","ANDA","ANDA208375","BluePoint Laboratories","500","mg/10mL","","N","20251231"
"5970","NITROFURANTOIN","Nitrofurantion","68001038400","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","68001-384","68001-384-00","68001-384_ad020393-1c97-49da-b0f3-d6a9359fb73d","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20190514","","ANDA","ANDA201722","BluePoint Labortories","25","mg/1","","N","20251231"
"5971","NITROFURANTOIN","Nitrofurantion","68001038500","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","68001-385","68001-385-00","68001-385_ad020393-1c97-49da-b0f3-d6a9359fb73d","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20190514","","ANDA","ANDA201722","BluePoint Labortories","50","mg/1","","N","20251231"
"5972","NITROFURANTOIN","Nitrofurantion","68001038600","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","68001-386","68001-386-00","68001-386_ad020393-1c97-49da-b0f3-d6a9359fb73d","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20190514","","ANDA","ANDA201722","BluePoint Labortories","100","mg/1","","N","20251231"
"5973","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","68001040673","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","68001-406","68001-406-73","68001-406_e94323bb-8135-b34a-e053-2995a90a7ab8","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190823","","ANDA","ANDA204125","BluePoint Laboratories","5","g/1","","N","20251231"
"5974","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","68001040775","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","68001-407","68001-407-75","68001-407_e94323bb-8135-b34a-e053-2995a90a7ab8","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190823","","ANDA","ANDA204125","BluePoint Laboratories","10","g/1","","N","20251231"
"5975","ERTAPENEM SODIUM","Ertapenem Sodium","68001040831","Carbapenems [CS], Penem Antibacterial [EPC]","68001-408","68001-408-31","68001-408_12e7c27b-9d21-bf94-e063-6294a90aedcf","HUMAN PRESCRIPTION DRUG","Ertapenem","","INJECTION","INTRAMUSCULAR; INTRAVENOUS","20190829","","ANDA","ANDA207647","BluePoint Laboratories","1","g/20mL","","N","20251231"
"5976","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","68001042300","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","68001-423","68001-423-00","68001-423_304c4688-464f-1655-e063-6294a90af938","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20191113","20260131","ANDA","ANDA208516","BluePoint Laboratories","25; 75","mg/1; mg/1","","N",""
"5977","CLOTRIMAZOLE","antifungal","68001047545","Azole Antifungal [EPC], Azoles [CS]","68001-475","68001-475-45","68001-475_097d120f-44a3-3b38-e063-6294a90a8e70","HUMAN OTC DRUG","Antifungal Cream","","CREAM","TOPICAL","20201125","","OTC MONOGRAPH DRUG","M005","BluePoint Laboratories","1","g/100g","","N","20251231"
"5978","CLOTRIMAZOLE","antifungal","68001047547","Azole Antifungal [EPC], Azoles [CS]","68001-475","68001-475-47","68001-475_097d120f-44a3-3b38-e063-6294a90a8e70","HUMAN OTC DRUG","Antifungal Cream","","CREAM","TOPICAL","20201125","","OTC MONOGRAPH DRUG","M005","BluePoint Laboratories","1","g/100g","","N","20251231"
"5979","MICONAZOLE NITRATE","antifungal","68001048145","Azole Antifungal [EPC], Azoles [CS]","68001-481","68001-481-45","68001-481_097d4e93-7f8b-53f8-e063-6294a90a4e40","HUMAN OTC DRUG","Antifungal Cream","","CREAM","TOPICAL","20201201","","OTC MONOGRAPH DRUG","M005","BluePoint Laboratories","2","g/100g","","N","20251231"
"5980","MICONAZOLE NITRATE","antifungal","68001048147","Azole Antifungal [EPC], Azoles [CS]","68001-481","68001-481-47","68001-481_097d4e93-7f8b-53f8-e063-6294a90a4e40","HUMAN OTC DRUG","Antifungal Cream","","CREAM","TOPICAL","20201201","","OTC MONOGRAPH DRUG","M005","BluePoint Laboratories","2","g/100g","","N","20251231"
"5981","MICONAZOLE NITRATE","antifungal","68001048148","Azole Antifungal [EPC], Azoles [CS]","68001-481","68001-481-48","68001-481_097d4e93-7f8b-53f8-e063-6294a90a4e40","HUMAN OTC DRUG","Antifungal Cream","","CREAM","TOPICAL","20201201","","OTC MONOGRAPH DRUG","M005","BluePoint Laboratories","2","g/100g","","N","20251231"
"5982","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","First Aid Antibiotic","68001048346","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68001-483","68001-483-46","68001-483_0b26450d-312b-fef1-e063-6394a90a7f6f","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20210615","","OTC MONOGRAPH DRUG","M004","BluePoint Laboratories","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"5983","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","First Aid Antibiotic","68001048345","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68001-483","68001-483-45","68001-483_0b26450d-312b-fef1-e063-6394a90a7f6f","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20210615","","OTC MONOGRAPH DRUG","M004","BluePoint Laboratories","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"5984","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN and TAZOBACTAM","68001050630","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68001-506","68001-506-30","68001-506_3774b148-777d-9de2-e063-6394a90a5245","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210811","","ANDA","ANDA204959","BluePoint Laboratories","2; .25","g/10mL; g/10mL","","N","20261231"
"5985","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN and TAZOBACTAM","68001050782","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68001-507","68001-507-82","68001-507_3774b148-777d-9de2-e063-6394a90a5245","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210811","","ANDA","ANDA204959","BluePoint Laboratories","3; .375","g/15mL; g/15mL","","N","20261231"
"5986","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN and TAZOBACTAM","68001050831","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68001-508","68001-508-31","68001-508_3774b148-777d-9de2-e063-6394a90a5245","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210811","","ANDA","ANDA204959","BluePoint Laboratories","4; .5","g/20mL; g/20mL","","N","20261231"
"5987","NITROFURANTOIN","nitrofurantoin macrocrystals","68001060300","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","68001-603","68001-603-00","68001-603_097a3e7d-7d8f-7408-e063-6394a90afa2e","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20231011","","ANDA","ANDA217272","BluePoint Laboratories","25","mg/1","","N","20251231"
"5988","NITROFURANTOIN","nitrofurantoin macrocrystals","68001060400","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","68001-604","68001-604-00","68001-604_097a3e7d-7d8f-7408-e063-6394a90afa2e","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20231011","","ANDA","ANDA217272","BluePoint Laboratories","50","mg/1","","N","20251231"
"5989","NITROFURANTOIN","nitrofurantoin macrocrystals","68001060500","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","68001-605","68001-605-00","68001-605_097a3e7d-7d8f-7408-e063-6394a90afa2e","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20231009","","ANDA","ANDA217272","BluePoint Laboratories","100","mg/1","","N","20251231"
"5990","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","68001060600","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","68001-606","68001-606-00","68001-606_10b8da9b-f0bf-f05e-e063-6394a90af058","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20231015","","ANDA","ANDA217357","BluePoint Laboratories","25; 75","mg/1; mg/1","","N","20251231"
"5991","MICONAZOLE NITRATE","Miconazole Nitrate","68016007009","Azole Antifungal [EPC], Azoles [CS]","68016-070","68016-070-09","68016-070_b4cb8843-8811-4d06-989c-8aceeff009b7","HUMAN OTC DRUG","Premier Value","Miconazole 3","CREAM","VAGINAL","20050302","","ANDA","ANDA076773","Pharmacy Value Alliance LLC","40","mg/g","","N","20251231"
"5992","MICONAZOLE NITRATE","Miconazole Nitrate","68016007301","Azole Antifungal [EPC], Azoles [CS]","68016-073","68016-073-01","68016-073_40fa7a7f-aec8-4b4d-bcbf-2f1ea7e935f0","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20030911","","ANDA","ANDA074164","Chain Drug Consortium, LLC","20","mg/g","","N","20251231"
"5993","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","68016007601","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68016-076","68016-076-01","68016-076_d827202d-4e5a-4444-b8dd-fbacfc15d041","HUMAN OTC DRUG","Premier Value","Antibiotic Plus Pain Relief","CREAM","TOPICAL","20120321","","OTC MONOGRAPH FINAL","part333B","Pharmacy Value Alliance LLC","3.5; 10000; 10","mg/g; [iU]/g; mg/g","","N","20251231"
"5994","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","68016008002","Allylamine Antifungal [EPC], Allylamine [CS]","68016-080","68016-080-02","68016-080_1cc3144f-5f7f-42cb-92c4-b6d026a0cc20","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20070702","","ANDA","ANDA077511","Pharmacy Value Alliance LLC","1","g/100g","","N","20251231"
"5995","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","68016012001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68016-120","68016-120-01","68016-120_3f7907ca-b762-4f4c-94d5-40612028858e","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","","OTC MONOGRAPH FINAL","part333B","Pharmacy Value Alliance LLC","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"5996","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","68016012002","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68016-120","68016-120-02","68016-120_3f7907ca-b762-4f4c-94d5-40612028858e","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","","OTC MONOGRAPH FINAL","part333B","Pharmacy Value Alliance LLC","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"5997","MICONAZOLE NITRATE","Miconazole Nitrate","68016029101","Azole Antifungal [EPC], Azoles [CS]","68016-291","68016-291-01","68016-291_99e74a98-14b2-4487-80aa-6ff6dcee1a4f","HUMAN OTC DRUG","Miconazole","","CREAM","TOPICAL","20090515","","OTC MONOGRAPH DRUG","M005","Chain Drug Consortium, LLC","20","mg/g","","N","20251231"
"5998","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Premier Value Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine HCL","68016029605","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68016-296","68016-296-05","68016-296_29b70a0d-e3fe-db95-e063-6394a90adfb2","HUMAN OTC DRUG","Premier Value Max Strength Antibiotic plus pain relief","","CREAM","TOPICAL","20190922","","OTC MONOGRAPH DRUG","M004","Pharmacy Value Alliance LLC","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"5999","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin Sulfate, Polymyxin B Sulfate","68016031901","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68016-319","68016-319-01","68016-319_29b77541-1fc0-b441-e063-6294a90a6486","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20190110","","OTC MONOGRAPH DRUG","M004","Premier Value Alliance LLC.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"6000","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin Sulfate, Polymyxin B Sulfate","68016032005","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68016-320","68016-320-05","68016-320_29b70f22-a6e4-4c0b-e063-6294a90a8d1d","HUMAN OTC DRUG","Premier Value Triple Antibiotic","","OINTMENT","TOPICAL","20190110","","OTC MONOGRAPH DRUG","M004","Premier Value Alliance LLC.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"6001","MICONAZOLE NITRATE","Antifungal Liquid Continuous Spray","68016051600","Azole Antifungal [EPC], Azoles [CS]","68016-516","68016-516-00","68016-516_29036a14-97cd-4882-e063-6294a90a8155","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, SPRAY","TOPICAL","20100105","","OTC MONOGRAPH DRUG","M005","Chain Drug Consortium, LLC","3","g/150g","","N","20251231"
"6002","MICONAZOLE NITRATE","Miconazorb Antifungal Powder Talc Free","68016067325","Azole Antifungal [EPC], Azoles [CS]","68016-673","68016-673-25","68016-673_29bae726-ff80-4163-e063-6394a90a87a8","HUMAN OTC DRUG","Miconazole Nitrate","","POWDER","TOPICAL","20171022","20260130","OTC MONOGRAPH DRUG","M005","Chain Drug Consortium, LLC","1.42","g/71g","","N",""
"6003","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate and pramoxine hydrochloride","68016071501","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68016-715","68016-715-01","68016-715_8bb154b7-deeb-4949-89e1-93527f864d5d","HUMAN OTC DRUG","Triple Antibiotic plus Pain Relief","Maximum Strength","OINTMENT","TOPICAL","20150710","","OTC MONOGRAPH DRUG","M004","Chain Drug Consortium, LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"6004","CHLOROQUINE PHOSPHATE","Chloroquine Phosphate","68022026401","Antimalarial [EPC]","68022-0264","68022-0264-1","68022-0264_29ca40f3-10ea-6941-e063-6294a90a978b","HUMAN PRESCRIPTION DRUG","Chloroquine Phosphate","","TABLET, COATED","ORAL","20220301","","ANDA","ANDA214756","Suven Pharmaceuticals Limited","500","mg/1","","N","20251231"
"6005","CHLOROQUINE PHOSPHATE","Chloroquine Phosphate","68022026501","Antimalarial [EPC]","68022-0265","68022-0265-1","68022-0265_29ca40f3-10ea-6941-e063-6294a90a978b","HUMAN PRESCRIPTION DRUG","Chloroquine Phosphate","","TABLET, COATED","ORAL","20220301","","ANDA","ANDA214756","Suven Pharmaceuticals Limited","500","mg/1","","N","20251231"
"6006","AZITHROMYCIN MONOHYDRATE","Azithromycin","68071152705","Macrolide Antimicrobial [EPC], Macrolides [CS]","68071-1527","68071-1527-5","68071-1527_1d79fd41-f696-3620-e063-6394a90a7bbb","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20101228","","ANDA","ANDA065246","NuCare Pharmaceuticals,Inc.","100","mg/5mL","","N","20251231"
"6007","OFLOXACIN","Ofloxacin","68071158805","Quinolone Antimicrobial [EPC], Quinolones [CS]","68071-1588","68071-1588-5","68071-1588_1d7a24e6-549c-9297-e063-6394a90a8372","HUMAN PRESCRIPTION DRUG","Ofloxacin Otic","","SOLUTION","AURICULAR (OTIC)","20040514","","ANDA","ANDA076527","NuCare Pharmaceuticals,Inc.","3","mg/mL","","N","20251231"
"6008","OFLOXACIN","Ofloxacin","68071160705","Quinolone Antimicrobial [EPC], Quinolones [CS]","68071-1607","68071-1607-5","68071-1607_2a07b00e-964b-c66b-e063-6394a90a4822","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20080701","","ANDA","ANDA076407","NuCare Pharmaceuticals, Inc.","3","mg/mL","","N","20251231"
"6009","AMOXICILLIN; CLAVULANIC ACID","Amoxicillin and Clavulanate Potassium","68071161901","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-1619","68071-1619-1","68071-1619_1d4c3bbf-43f9-8590-e063-6294a90adebb","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20071201","","ANDA","ANDA065191","NuCare Pharmaceuticals,Inc.","400; 57","mg/5mL; mg/5mL","","N","20251231"
"6010","TERCONAZOLE","Terconazole","68071162602","Azole Antifungal [EPC], Azoles [CS]","68071-1626","68071-1626-2","68071-1626_2a0a39a9-3e19-1ddb-e063-6394a90a9d78","HUMAN PRESCRIPTION DRUG","Terconazole","","CREAM","VAGINAL","20040406","","ANDA","ANDA075953","NuCare Pharmaceuticals,Inc.","8","mg/g","","N","20251231"
"6011","OFLOXACIN","Ofloxacin","68071163003","Quinolone Antimicrobial [EPC], Quinolones [CS]","68071-1630","68071-1630-3","68071-1630_2a2f62dc-8ba6-7ca9-e063-6294a90aca76","HUMAN PRESCRIPTION DRUG","Ofloxacin Otic","","SOLUTION","AURICULAR (OTIC)","20040514","","ANDA","ANDA076527","NuCare Pharmaceuticals,Inc.","3","mg/mL","","N","20251231"
"6012","CEFUROXIME AXETIL","Cefuroxime axetil","68071163702","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-1637","68071-1637-2","68071-1637_1d4dd896-0f51-9c23-e063-6294a90a6f83","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6013","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","68071164003","Allylamine Antifungal [EPC], Allylamine [CS]","68071-1640","68071-1640-3","68071-1640_1d4de36f-4f9b-4e7a-e063-6294a90a4b3a","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20140813","","ANDA","ANDA077137","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6014","PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM","Sulfacetamide Sodium and Prednisolone Sodium Phosphate","68071165005","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","68071-1650","68071-1650-5","68071-1650_1d4de4f7-e86f-d269-e063-6294a90ab688","HUMAN PRESCRIPTION DRUG","Sulfacetamide Sodium and Prednisolone Sodium Phosphate","","SOLUTION/ DROPS","OPHTHALMIC","19951229","","ANDA","ANDA074449","NuCare Pharmaceuticals,Inc.","2.3; 100","mg/mL; mg/mL","","N","20251231"
"6015","POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","Polymyxin B Sulfate and Trimethoprim Sulfate","68071165105","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68071-1651","68071-1651-5","68071-1651_2d82d1c4-efa7-d76d-e063-6294a90af11d","HUMAN PRESCRIPTION DRUG","Polymyxin B Sulfate and Trimethoprim","","SOLUTION/ DROPS","OPHTHALMIC","19970214","","ANDA","ANDA064120","NuCare Pharmaceuticals,Inc.","10000; 1","[USP'U]/mL; mg/mL","","N","20261231"
"6016","AMOXICILLIN","Amoxicillin","68071167501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-1675","68071-1675-1","68071-1675_2a31a975-72fc-2a16-e063-6394a90a8149","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065325","NuCare Pharmaceuticals,Inc.","400","mg/5mL","","N","20251231"
"6017","KETOCONAZOLE","Ketoconazole","68071170903","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","68071-1709","68071-1709-3","68071-1709_2a321ff6-d67f-0fca-e063-6394a90a8644","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20021218","","ANDA","ANDA075638","NuCare Pharmaceuticals,Inc.","20","mg/g","","N","20251231"
"6018","AMOXICILLIN","Amoxicillin","68071176001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-1760","68071-1760-1","68071-1760_2a482e61-0d43-b6a3-e063-6394a90ad94e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","NuCare Pharmaceuticals,Inc.","125","mg/5mL","","N","20251231"
"6019","AMOXICILLIN","Amoxicillin","68071176105","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-1761","68071-1761-5","68071-1761_2a488ba2-1b76-9dd8-e063-6394a90aa946","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","NuCare Pharmaceuticals,Inc.","125","mg/5mL","","N","20251231"
"6020","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071182002","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-1820","68071-1820-2","68071-1820_2a96446e-66cc-0625-e063-6294a90acd03","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","POWDER, FOR SOLUTION","ORAL","19900930","","ANDA","ANDA060456","NuCare Pharmaceuticals,Inc.","250","mg/5mL","","N","20251231"
"6021","DEXAMETHASONE; TOBRAMYCIN","Tobramycin and Dexamethasone","68071182102","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","68071-1821","68071-1821-2","68071-1821_2d96b39b-7f36-79c4-e063-6294a90acfbe","HUMAN PRESCRIPTION DRUG","Tobramycin and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","19991027","","ANDA","ANDA064134","NuCare Pharmaceuticals,Inc.","1; 3","mg/mL; mg/mL","","N","20261231"
"6022","METRONIDAZOLE","Metronidazole","68071187602","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-1876","68071-1876-2","68071-1876_2abcd3a2-5471-3165-e063-6294a90a66ac","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6023","METRONIDAZOLE","Metronidazole","68071187603","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-1876","68071-1876-3","68071-1876_2abcd3a2-5471-3165-e063-6294a90a66ac","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6024","METRONIDAZOLE","Metronidazole","68071187604","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-1876","68071-1876-4","68071-1876_2abcd3a2-5471-3165-e063-6294a90a66ac","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6025","METRONIDAZOLE","Metronidazole","68071187601","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-1876","68071-1876-1","68071-1876_2abcd3a2-5471-3165-e063-6294a90a66ac","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6026","METRONIDAZOLE","Metronidazole","68071187608","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-1876","68071-1876-8","68071-1876_2abcd3a2-5471-3165-e063-6294a90a66ac","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6027","METRONIDAZOLE","Metronidazole","68071187605","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-1876","68071-1876-5","68071-1876_2abcd3a2-5471-3165-e063-6294a90a66ac","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6028","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Polymyxin B Sulfate, Bacitracin Zinc and Neomycin Sulfate","68071221101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68071-2211","68071-2211-1","68071-2211_0dfe5faa-4197-6c4b-e063-6294a90a75e7","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","19950111","","OTC MONOGRAPH DRUG","M004","NuCare Pharmaceuticals,Inc.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"6029","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071222701","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-2227","68071-2227-1","68071-2227_2abf8f97-dbdd-887c-e063-6394a90a0691","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","NuCare Pharmaceuticals,Inc.","400; 57","mg/5mL; mg/5mL","","N","20261231"
"6030","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071224406","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-2244","68071-2244-6","68071-2244_1d7676bc-ea2e-5cb2-e063-6394a90ac2ca","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET","ORAL","19900930","","ANDA","ANDA060711","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6031","CEPHALEXIN","Cephalexin","68071224600","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-2246","68071-2246-0","68071-2246_1d76786e-4b8b-9489-e063-6294a90a2a17","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","NuCare Pharmaceuticals,Inc.","125","mg/5mL","","N","20251231"
"6032","CEPHALEXIN","Cephalexin","68071224903","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-2249","68071-2249-3","68071-2249_1d76830d-a699-9442-e063-6294a90a51b8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6033","CEPHALEXIN","Cephalexin","68071224904","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-2249","68071-2249-4","68071-2249_1d76830d-a699-9442-e063-6294a90a51b8","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6034","METRONIDAZOLE","METRONIDAZOLE","68071225106","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-2251","68071-2251-6","68071-2251_1d7687fa-f16c-943e-e063-6294a90a010b","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20171129","","ANDA","ANDA205245","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6035","OFLOXACIN","Ofloxacin","68071225405","Quinolone Antimicrobial [EPC], Quinolones [CS]","68071-2254","68071-2254-5","68071-2254_1d768ffb-3dbf-944f-e063-6294a90ae733","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20040514","","ANDA","ANDA076622","NuCare Pharmaceuticals,Inc.","3","mg/mL","","N","20251231"
"6036","OFLOXACIN","Ofloxacin","68071226501","Quinolone Antimicrobial [EPC], Quinolones [CS]","68071-2265","68071-2265-1","68071-2265_1d76541f-80dc-2a55-e063-6294a90aa5f9","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20040514","","ANDA","ANDA076622","NuCare Pharmaceuticals,Inc.","3","mg/mL","","N","20251231"
"6037","AZITHROMYCIN DIHYDRATE","Azithromycin","68071226604","Macrolide Antimicrobial [EPC], Macrolides [CS]","68071-2266","68071-2266-4","68071-2266_1d765adb-1f8f-1537-e063-6394a90a3ae0","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210000","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6038","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68071226701","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-2267","68071-2267-1","68071-2267_1d76786e-4b8e-9489-e063-6294a90a2a17","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20061101","","ANDA","ANDA076794","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6039","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68071226904","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-2269","68071-2269-4","68071-2269_1d768e94-f620-944b-e063-6294a90a9549","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20061101","","ANDA","ANDA076794","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6040","TOBRAMYCIN","Tobramycin","68071227205","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","68071-2272","68071-2272-5","68071-2272_1d76957a-bafc-0eb0-e063-6294a90aaadd","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION/ DROPS","OPHTHALMIC","20170628","","ANDA","ANDA207444","NuCare Pharmaceuticals,Inc.","3","mg/mL","","N","20251231"
"6041","METRONIDAZOLE","Metronidazole","68071228004","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-2280","68071-2280-4","68071-2280_36375f83-7e83-afcf-e063-6394a90aa789","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6042","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071228604","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-2286","68071-2286-4","68071-2286_1d784249-8439-ebc0-e063-6294a90ae128","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20251231"
"6043","METRONIDAZOLE","Metronidazole","68071228804","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-2288","68071-2288-4","68071-2288_1d782d6d-d3bd-b7fb-e063-6294a90a4ff3","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6044","AZITHROMYCIN DIHYDRATE","Azithromycin","68071229702","Macrolide Antimicrobial [EPC], Macrolides [CS]","68071-2297","68071-2297-2","68071-2297_1d784ba4-83f4-0a32-e063-6294a90a63a9","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210001","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6045","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071234609","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-2346","68071-2346-9","68071-2346_2b4f6721-ed88-e5d9-e063-6394a90a1160","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20261231"
"6046","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071235505","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-2355","68071-2355-5","68071-2355_2b4f67e8-6790-c22e-e063-6394a90ac9ac","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201091","NuCare Pharmaceuticals,Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"6047","NITROFURANTOIN","Nitrofurantion","68071236307","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","68071-2363","68071-2363-7","68071-2363_2b5c6715-9dd6-70be-e063-6394a90a918a","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","NuCare Pharmaceuticals,Inc.","100","mg/1","","N","20261231"
"6048","NITROFURANTOIN","Nitrofurantion","68071236308","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","68071-2363","68071-2363-8","68071-2363_2b5c6715-9dd6-70be-e063-6394a90a918a","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","NuCare Pharmaceuticals,Inc.","100","mg/1","","N","20261231"
"6049","AMOXICILLIN","Amoxicillin","68071236408","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-2364","68071-2364-8","68071-2364_2b5cbf3b-392b-85c1-e063-6394a90a420b","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","NuCare Pharmaceuticals,Inc.","250","mg/5mL","","N","20261231"
"6050","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071237201","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-2372","68071-2372-1","68071-2372_2bb40925-9bac-1392-e063-6394a90a6429","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20261231"
"6051","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68071237402","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-2374","68071-2374-2","68071-2374_2bb43ca6-01ac-b3e2-e063-6294a90a1a04","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6052","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68071237404","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-2374","68071-2374-4","68071-2374_2bb43ca6-01ac-b3e2-e063-6294a90a1a04","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6053","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68071237406","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-2374","68071-2374-6","68071-2374_2bb43ca6-01ac-b3e2-e063-6294a90a1a04","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6054","METRONIDAZOLE","metronidazole","68071240901","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-2409","68071-2409-1","68071-2409_10f6b5cd-3cf8-e2fe-e063-6394a90a690c","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6055","METRONIDAZOLE","metronidazole","68071240902","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-2409","68071-2409-2","68071-2409_10f6b5cd-3cf8-e2fe-e063-6394a90a690c","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6056","METRONIDAZOLE","metronidazole","68071240904","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-2409","68071-2409-4","68071-2409_10f6b5cd-3cf8-e2fe-e063-6394a90a690c","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6057","METRONIDAZOLE","metronidazole","68071240905","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-2409","68071-2409-5","68071-2409_10f6b5cd-3cf8-e2fe-e063-6394a90a690c","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6058","METRONIDAZOLE","metronidazole","68071240907","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-2409","68071-2409-7","68071-2409_10f6b5cd-3cf8-e2fe-e063-6394a90a690c","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6059","METRONIDAZOLE","metronidazole","68071240903","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-2409","68071-2409-3","68071-2409_10f6b5cd-3cf8-e2fe-e063-6394a90a690c","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6060","METRONIDAZOLE","metronidazole","68071240909","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-2409","68071-2409-9","68071-2409_10f6b5cd-3cf8-e2fe-e063-6394a90a690c","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6061","METRONIDAZOLE","metronidazole","68071240908","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-2409","68071-2409-8","68071-2409_10f6b5cd-3cf8-e2fe-e063-6394a90a690c","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6062","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin, triamcinolone acetonide","68071249103","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","68071-2491","68071-2491-3","68071-2491_239ad172-5ff6-b95f-e063-6394a90aa1d9","HUMAN PRESCRIPTION DRUG","NYSTATIN AND TRIAMCINOLONE ACETONIDE","","CREAM","TOPICAL","20171127","","ANDA","ANDA208479","NuCare Pharmaceuticals,Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"6063","CEFDINIR","Cefdinir","68071250303","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-2503","68071-2503-3","68071-2503_2badf51d-00cc-a56f-e063-6394a90a004d","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20261231"
"6064","CEFDINIR","Cefdinir","68071250302","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-2503","68071-2503-2","68071-2503_2badf51d-00cc-a56f-e063-6394a90a004d","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20261231"
"6065","NYSTATIN","Nystatin","68071255605","Polyene Antifungal [EPC], Polyenes [CS]","68071-2556","68071-2556-5","68071-2556_2dcc540d-ce8e-d0a7-e063-6294a90a646c","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","19930128","","ANDA","ANDA064022","NuCare Pharmaceuticals,Inc.","100000","[USP'U]/g","","N","20261231"
"6066","FLUCONAZOLE","Fluconazole","68071255701","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68071-2557","68071-2557-1","68071-2557_2dcc5468-9b13-b6d5-e063-6294a90a4139","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20201120","","ANDA","ANDA077253","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20261231"
"6067","AMOXICILLIN","Amoxicillin","68071255805","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-2558","68071-2558-5","68071-2558_2dcc5889-6ad9-d3dc-e063-6294a90a50f7","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA061931","NuCare Pharmaceuticals,Inc.","250","mg/5mL","","N","20261231"
"6068","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071263002","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-2630","68071-2630-2","68071-2630_2a083b1e-0baa-b987-e063-6294a90a22c6","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20020315","","ANDA","ANDA065064","NuCare Pharmaceuticals,Inc.","500; 125","mg/1; mg/1","","N","20251231"
"6069","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and hydrocortisone","68071273501","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68071-2735","68071-2735-1","68071-2735_2a7fb18d-ef2a-2218-e063-6394a90af89f","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SOLUTION","AURICULAR (OTIC)","20030318","","ANDA","ANDA062423","NuCare Pharmaceuticals,Inc.","10; 3.5; 10000","mg/mL; mg/mL; [iU]/mL","","N","20251231"
"6070","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071298202","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-2982","68071-2982-2","68071-2982_2dcdd24b-09f3-0b76-e063-6394a90a7775","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20261231"
"6071","METRONIDAZOLE","Metronidazole","68071303901","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-3039","68071-3039-1","68071-3039_2d53f6ea-c356-0993-e063-6294a90aa9a9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","NuCare Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"6072","METRONIDAZOLE","Metronidazole","68071303904","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-3039","68071-3039-4","68071-3039_2d53f6ea-c356-0993-e063-6294a90aa9a9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","NuCare Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"6073","METRONIDAZOLE","Metronidazole","68071303906","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-3039","68071-3039-6","68071-3039_2d53f6ea-c356-0993-e063-6294a90aa9a9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","NuCare Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"6074","METRONIDAZOLE","Metronidazole","68071303908","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-3039","68071-3039-8","68071-3039_2d53f6ea-c356-0993-e063-6294a90aa9a9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","NuCare Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"6075","CLARITHROMYCIN","Clarithromycin","68071311603","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","68071-3116","68071-3116-3","68071-3116_2abbae2e-2b8b-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20151204","","ANDA","ANDA203584","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6076","CLARITHROMYCIN","Clarithromycin","68071311604","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","68071-3116","68071-3116-4","68071-3116_2abbae2e-2b8b-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20151204","","ANDA","ANDA203584","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6077","CLARITHROMYCIN","Clarithromycin","68071311608","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","68071-3116","68071-3116-8","68071-3116_2abbae2e-2b8b-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20151204","","ANDA","ANDA203584","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6078","CLARITHROMYCIN","Clarithromycin","68071311602","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","68071-3116","68071-3116-2","68071-3116_2abbae2e-2b8b-62d9-e063-6394a90a39b0","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20151204","","ANDA","ANDA203584","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6079","AMOXICILLIN","Amoxicillin","68071311900","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3119","68071-3119-0","68071-3119_1d9ea3b9-a766-e967-e063-6294a90a375e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6080","AMOXICILLIN","Amoxicillin","68071311902","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3119","68071-3119-2","68071-3119_1d9ea3b9-a766-e967-e063-6294a90a375e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6081","AMOXICILLIN","Amoxicillin","68071311903","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3119","68071-3119-3","68071-3119_1d9ea3b9-a766-e967-e063-6294a90a375e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6082","AMOXICILLIN","Amoxicillin","68071311904","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3119","68071-3119-4","68071-3119_1d9ea3b9-a766-e967-e063-6294a90a375e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6083","AMOXICILLIN","Amoxicillin","68071311901","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3119","68071-3119-1","68071-3119_1d9ea3b9-a766-e967-e063-6294a90a375e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6084","AMOXICILLIN","Amoxicillin","68071311906","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3119","68071-3119-6","68071-3119_1d9ea3b9-a766-e967-e063-6294a90a375e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6085","AMOXICILLIN","Amoxicillin","68071311908","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3119","68071-3119-8","68071-3119_1d9ea3b9-a766-e967-e063-6294a90a375e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6086","AMOXICILLIN","Amoxicillin","68071311909","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3119","68071-3119-9","68071-3119_1d9ea3b9-a766-e967-e063-6294a90a375e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6087","AMOXICILLIN","Amoxicillin","68071311905","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3119","68071-3119-5","68071-3119_1d9ea3b9-a766-e967-e063-6294a90a375e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6088","CEFDINIR MONOHYDRATE","Cefdinir","68071315606","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3156","68071-3156-6","68071-3156_2d53fd8c-5f3f-8b3f-e063-6394a90a3ea0","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070508","","ANDA","ANDA065332","NuCare Pharmaceuticals, Inc.","125","mg/5mL","","N","20261231"
"6089","AMOXICILLIN","Amoxicillin","68071323503","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3235","68071-3235-3","68071-3235_2d540469-0ca7-fc90-e063-6394a90a701e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"6090","AMOXICILLIN","Amoxicillin","68071323504","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3235","68071-3235-4","68071-3235_2d540469-0ca7-fc90-e063-6394a90a701e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"6091","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071329906","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3299","68071-3299-6","68071-3299_1cd5adb6-a902-f543-e063-6394a90aff13","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6092","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071329909","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3299","68071-3299-9","68071-3299_1cd5adb6-a902-f543-e063-6394a90aff13","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6093","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071329904","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3299","68071-3299-4","68071-3299_1cd5adb6-a902-f543-e063-6394a90aff13","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6094","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68071335103","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-3351","68071-3351-3","68071-3351_1ce8f03a-6915-908c-e063-6394a90a270c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20040507","","NDA AUTHORIZED GENERIC","NDA019992","NuCare Pharmaceuticals,Inc.","3","mg/mL","","N","20251231"
"6095","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and dexamethasone","68071335905","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68071-3359","68071-3359-5","68071-3359_1ce915c3-50fd-c89b-e063-6294a90a1d0e","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Dexamethasone","","SUSPENSION","OPHTHALMIC","19960221","","ANDA","ANDA062341","NuCare Pharmaceuticals,Inc.","1; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"6096","CLOTRIMAZOLE","Clotrimazole","68071339503","Azole Antifungal [EPC], Azoles [CS]","68071-3395","68071-3395-3","68071-3395_1d79b80a-e64c-7d7d-e063-6294a90a82bd","HUMAN OTC DRUG","clotrimazole","","CREAM","TOPICAL","20110603","","OTC MONOGRAPH DRUG","M014","NuCare Pharmaceuticals, Inc.","1","g/100g","","N","20251231"
"6097","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071340104","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3401","68071-3401-4","68071-3401_2d5411e0-ddfc-10a1-e063-6394a90aebe4","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20261231"
"6098","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071340203","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-3402","68071-3402-3","68071-3402_0f3c200e-eb4c-5c2d-e063-6294a90a8342","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6099","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071340204","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-3402","68071-3402-4","68071-3402_0f3c200e-eb4c-5c2d-e063-6294a90a8342","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6100","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071340208","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-3402","68071-3402-8","68071-3402_0f3c200e-eb4c-5c2d-e063-6294a90a8342","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6101","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071340201","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-3402","68071-3402-1","68071-3402_0f3c200e-eb4c-5c2d-e063-6294a90a8342","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6102","CEFDINIR","Cefdinir","68071340301","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3403","68071-3403-1","68071-3403_2d540607-1806-4063-e063-6294a90a7159","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070507","","ANDA","ANDA065259","NuCare Pharmaceuticals,Inc.","250","mg/5mL","","N","20261231"
"6103","CLOTRIMAZOLE","Clotrimazole","68071341603","Azole Antifungal [EPC], Azoles [CS]","68071-3416","68071-3416-3","68071-3416_2d584e7b-d293-0750-e063-6394a90a1985","HUMAN OTC DRUG","Clotrimazole Cream 1%","","CREAM","TOPICAL","20210819","20250701","OTC MONOGRAPH DRUG","M005","NuCare Pharmaceuticals,Inc.","10","mg/g","","N",""
"6104","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071342706","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3427","68071-3427-6","68071-3427_2d586d7e-b398-aee9-e063-6294a90a0230","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20261231"
"6105","FLUCONAZOLE","Fluconazole","68071342802","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68071-3428","68071-3428-2","68071-3428_2d586d7e-b399-aee9-e063-6294a90a0230","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","NuCare Pharmaceuticals,Inc.","200","mg/1","","N","20261231"
"6106","MICONAZOLE NITRATE","MICONAZOLE NITRATE","68071342903","Azole Antifungal [EPC], Azoles [CS]","68071-3429","68071-3429-3","68071-3429_2d587184-fc1e-2fda-e063-6394a90a32fa","HUMAN OTC DRUG","MICONAZOLE Nitrate","","CREAM","TOPICAL","20160322","","OTC MONOGRAPH DRUG","M005","NuCare Pharmaceuticals,Inc.","2","g/100g","","N","20261231"
"6107","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","68071344102","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3441","68071-3441-2","68071-3441_2d80b340-7ddc-adf0-e063-6294a90af485","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20230213","","ANDA","ANDA210568","NuCare Pharmaceuticals,Inc.","200","mg/1","","N","20261231"
"6108","OFLOXACIN","ofloxacin","68071344805","Quinolone Antimicrobial [EPC], Quinolones [CS]","68071-3448","68071-3448-5","68071-3448_1ef20a94-8557-bb67-e063-6394a90afc6c","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20221207","","ANDA","ANDA215886","NuCare Pharmaceuticals,Inc.","3","mg/mL","","N","20251231"
"6109","FLUCONAZOLE","Fluconazole","68071347401","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68071-3474","68071-3474-1","68071-3474_26b9a3a9-56e6-00b4-e063-6394a90a7d3e","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20251231"
"6110","KETOCONAZOLE","Ketoconazole Cream, 2%","68071351205","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","68071-3512","68071-3512-5","68071-3512_2d04d27d-6b6d-e729-e063-6394a90ab60b","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20210527","","ANDA","ANDA212443","NuCare Pharmaceuticals,Inc.","20","mg/g","","N","20261231"
"6111","FLUCONAZOLE","Fluconazole","68071351502","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68071-3515","68071-3515-2","68071-3515_2bae5641-9af8-96cd-e063-6394a90ae348","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20261231"
"6112","FLUCONAZOLE","Fluconazole","68071351504","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68071-3515","68071-3515-4","68071-3515_2bae5641-9af8-96cd-e063-6394a90ae348","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20261231"
"6113","AMOXICILLIN","Amoxicillin","68071351700","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3517","68071-3517-0","68071-3517_1a3c49be-c438-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6114","AMOXICILLIN","Amoxicillin","68071351701","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3517","68071-3517-1","68071-3517_1a3c49be-c438-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6115","AMOXICILLIN","Amoxicillin","68071351702","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3517","68071-3517-2","68071-3517_1a3c49be-c438-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6116","AMOXICILLIN","Amoxicillin","68071351704","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3517","68071-3517-4","68071-3517_1a3c49be-c438-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6117","AMOXICILLIN","Amoxicillin","68071351705","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3517","68071-3517-5","68071-3517_1a3c49be-c438-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6118","AMOXICILLIN","Amoxicillin","68071351703","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3517","68071-3517-3","68071-3517_1a3c49be-c438-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6119","CEPHALEXIN","Cephalexin","68071353201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3532","68071-3532-1","68071-3532_18595b1c-ff31-7aec-e063-6394a90ade9b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6120","CEPHALEXIN","Cephalexin","68071353202","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3532","68071-3532-2","68071-3532_18595b1c-ff31-7aec-e063-6394a90ade9b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6121","CEPHALEXIN","Cephalexin","68071353203","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3532","68071-3532-3","68071-3532_18595b1c-ff31-7aec-e063-6394a90ade9b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6122","CEPHALEXIN","Cephalexin","68071353207","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3532","68071-3532-7","68071-3532_18595b1c-ff31-7aec-e063-6394a90ade9b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6123","CEPHALEXIN","Cephalexin","68071353208","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3532","68071-3532-8","68071-3532_18595b1c-ff31-7aec-e063-6394a90ade9b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6124","CEPHALEXIN","Cephalexin","68071353204","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3532","68071-3532-4","68071-3532_18595b1c-ff31-7aec-e063-6394a90ade9b","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6125","CEPHALEXIN","Cephalexin","68071353803","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3538","68071-3538-3","68071-3538_200c9009-4e15-b147-e063-6294a90a851d","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6126","CEPHALEXIN","Cephalexin","68071353806","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3538","68071-3538-6","68071-3538_200c9009-4e15-b147-e063-6294a90a851d","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6127","CEPHALEXIN","Cephalexin","68071353808","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3538","68071-3538-8","68071-3538_200c9009-4e15-b147-e063-6294a90a851d","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6128","CEPHALEXIN","Cephalexin","68071353804","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3538","68071-3538-4","68071-3538_200c9009-4e15-b147-e063-6294a90a851d","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6129","NYSTATIN","NYSTATIN","68071354306","Polyene Antifungal [EPC], Polyenes [CS]","68071-3543","68071-3543-6","68071-3543_2ad1d4c2-cbc9-0304-e063-6394a90aae6e","HUMAN PRESCRIPTION DRUG","NYSTATIN","","SUSPENSION","ORAL","20221205","","ANDA","ANDA214346","NuCare Pharmaceuticals,Inc.","100000","[USP'U]/mL","","N","20261231"
"6130","MICONAZOLE NITRATE","Miconazole Nitrate","68071354407","Azole Antifungal [EPC], Azoles [CS]","68071-3544","68071-3544-7","68071-3544_2d3fbb35-987f-7d36-e063-6394a90a1acd","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20210315","","ANDA","ANDA074164","NuCare Pharmaceuticals,Inc.","20","mg/g","","N","20261231"
"6131","FLUCONAZOLE","Fluconazole","68071354703","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68071-3547","68071-3547-3","68071-3547_2d3fb96f-feec-5b60-e063-6394a90a46e8","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","NuCare Pharmaceuticals,Inc.","200","mg/1","","N","20261231"
"6132","GENTAMICIN SULFATE","Gentamicin Sulfate","68071355405","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","68071-3554","68071-3554-5","68071-3554_2d3fc60b-5a42-6abc-e063-6394a90af2a0","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","SOLUTION/ DROPS","OPHTHALMIC","19940511","","ANDA","ANDA064048","NuCare Pharmaceuticals,Inc.","3","mg/mL","","N","20261231"
"6133","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071356204","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3562","68071-3562-4","68071-3562_0fb8ab8a-5aa8-e6f4-e063-6294a90a1af6","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6134","OFLOXACIN","ofloxacin","68071356601","Quinolone Antimicrobial [EPC], Quinolones [CS]","68071-3566","68071-3566-1","68071-3566_102c825b-af5d-42e7-e063-6394a90a81a1","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20190301","","ANDA","ANDA076513","NuCare Pharmceuticals,Inc.","3","mg/mL","","N","20251231"
"6135","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","68071356902","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","68071-3569","68071-3569-2","68071-3569_127807d8-587d-49c7-e063-6294a90a0e43","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","NuCare Pharmaceuticals,Inc.","25; 75","mg/1; mg/1","","N","20251231"
"6136","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","68071356904","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","68071-3569","68071-3569-4","68071-3569_127807d8-587d-49c7-e063-6294a90a0e43","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","NuCare Pharmaceuticals,Inc.","25; 75","mg/1; mg/1","","N","20251231"
"6137","AMOXICILLIN","Amoxicillin","68071357401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3574","68071-3574-1","68071-3574_116f655e-e330-5030-e063-6394a90a64e5","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6138","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68071357701","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-3577","68071-3577-1","68071-3577_213b41ae-ec9b-8154-e063-6394a90a080f","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6139","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68071357702","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-3577","68071-3577-2","68071-3577_213b41ae-ec9b-8154-e063-6394a90a080f","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6140","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68071357703","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-3577","68071-3577-3","68071-3577_213b41ae-ec9b-8154-e063-6394a90a080f","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6141","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68071357707","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-3577","68071-3577-7","68071-3577_213b41ae-ec9b-8154-e063-6394a90a080f","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6142","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68071357704","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-3577","68071-3577-4","68071-3577_213b41ae-ec9b-8154-e063-6394a90a080f","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6143","FLUCONAZOLE","Fluconazole","68071357801","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68071-3578","68071-3578-1","68071-3578_3542dd8d-831d-80be-e063-6394a90aa966","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20261231"
"6144","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68071357901","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68071-3579","68071-3579-1","68071-3579_1274d0c6-d3ca-e566-e063-6394a90a402f","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals,Inc.","400; 80","mg/1; mg/1","","N","20251231"
"6145","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68071358201","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-3582","68071-3582-1","68071-3582_33a14d92-da84-996c-e063-6394a90ae3b8","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20261231"
"6146","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68071358203","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-3582","68071-3582-3","68071-3582_33a14d92-da84-996c-e063-6394a90ae3b8","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20261231"
"6147","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68071358204","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-3582","68071-3582-4","68071-3582_33a14d92-da84-996c-e063-6394a90ae3b8","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20261231"
"6148","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68071358207","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-3582","68071-3582-7","68071-3582_33a14d92-da84-996c-e063-6394a90ae3b8","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20261231"
"6149","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68071358206","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-3582","68071-3582-6","68071-3582_33a14d92-da84-996c-e063-6394a90ae3b8","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20261231"
"6150","CEPHALEXIN","Cephalexin","68071358702","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3587","68071-3587-2","68071-3587_141bc1c6-156c-65ca-e063-6394a90a5d9b","HUMAN PRESCRIPTION DRUG","cephalexin","","FOR SUSPENSION","ORAL","20170906","","ANDA","ANDA065234","NuCare Pharmaceuticals,Inc.","250","mg/5mL","","N","20251231"
"6151","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","68071359306","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","68071-3593","68071-3593-6","68071-3593_155c7549-b7db-0c06-e063-6294a90ac65c","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","NuCare Pharmaceuticals,Inc.","25; 75","mg/1; mg/1","","N","20251231"
"6152","CEFADROXIL","Cefadroxil","68071359706","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3597","68071-3597-6","68071-3597_16f40c49-83be-29c3-e063-6394a90a791f","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6153","OFLOXACIN","ofloxacin otic","68071360403","Quinolone Antimicrobial [EPC], Quinolones [CS]","68071-3604","68071-3604-3","68071-3604_1e91730c-0a19-c6d7-e063-6394a90a8395","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION","AURICULAR (OTIC)","20231201","","ANDA","ANDA216130","NuCare Pharmaceuticals,Inc.","3","mg/mL","","N","20251231"
"6154","CEFDINIR","Cefdinir","68071360906","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3609","68071-3609-6","68071-3609_1bbd6db9-8af5-6047-e063-6294a90ab109","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20060531","","ANDA","ANDA065259","NuCare Pharmaceuticals,Inc.","125","mg/5mL","","N","20251231"
"6155","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68071361002","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-3610","68071-3610-2","68071-3610_1dda5ee8-c26a-9a79-e063-6394a90ad408","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6156","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68071361004","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-3610","68071-3610-4","68071-3610_1dda5ee8-c26a-9a79-e063-6394a90ad408","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6157","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68071361001","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-3610","68071-3610-1","68071-3610_1dda5ee8-c26a-9a79-e063-6394a90ad408","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6158","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","68071361604","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3616","68071-3616-4","68071-3616_1b40454e-994c-39d8-e063-6394a90a97cb","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20230301","","ANDA","ANDA210568","NuCare Pharmaceuticals,Inc.","100","mg/1","","N","20251231"
"6159","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071364003","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3640","68071-3640-3","68071-3640_337a4a2b-491a-2698-e063-6294a90aab3b","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6160","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071364008","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3640","68071-3640-8","68071-3640_337a4a2b-491a-2698-e063-6294a90aab3b","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6161","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071364004","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3640","68071-3640-4","68071-3640_337a4a2b-491a-2698-e063-6294a90aab3b","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6162","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68071365701","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-3657","68071-3657-1","68071-3657_22901bcf-7f34-e2d6-e063-6394a90ae0f0","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","NuCare Pharmaceuticals, Inc.","150","mg/1","","N","20251231"
"6163","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","68071366106","Macrolide Antimicrobial [EPC], Macrolides [CS]","68071-3661","68071-3661-6","68071-3661_21c64584-eb85-869f-e063-6394a90a2a30","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6164","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","68071366102","Macrolide Antimicrobial [EPC], Macrolides [CS]","68071-3661","68071-3661-2","68071-3661_21c64584-eb85-869f-e063-6394a90a2a30","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6165","AMOXICILLIN","Amoxicillin","68071366203","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3662","68071-3662-3","68071-3662_3638dae5-153c-4f8e-e063-6394a90ae07e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceutials,Inc.","500","mg/1","","N","20261231"
"6166","AMOXICILLIN","Amoxicillin","68071366204","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3662","68071-3662-4","68071-3662_3638dae5-153c-4f8e-e063-6394a90ae07e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceutials,Inc.","500","mg/1","","N","20261231"
"6167","AMOXICILLIN","Amoxicillin","68071366209","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3662","68071-3662-9","68071-3662_3638dae5-153c-4f8e-e063-6394a90ae07e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceutials,Inc.","500","mg/1","","N","20261231"
"6168","AMOXICILLIN","Amoxicillin","68071366206","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3662","68071-3662-6","68071-3662_3638dae5-153c-4f8e-e063-6394a90ae07e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceutials,Inc.","500","mg/1","","N","20261231"
"6169","AMOXICILLIN","Amoxicillin","68071367502","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3675","68071-3675-2","68071-3675_20eb1df7-535e-a7bd-e063-6394a90ad98c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","NuCare Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6170","AMOXICILLIN","Amoxicillin","68071367801","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3678","68071-3678-1","68071-3678_2177c2a1-7295-5971-e063-6394a90a9282","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065322","NuCare Pharmaceuticals Inc.","250","mg/5mL","","N","20251231"
"6171","CEPHALEXIN","Cephalexin","68071368004","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3680","68071-3680-4","68071-3680_216658a7-d670-a8be-e063-6394a90a0a4d","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","NuCare Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"6172","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68071368106","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-3681","68071-3681-6","68071-3681_2a313eb4-4c20-16d2-e063-6394a90ab025","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","NuCare Pharmaceuticals, Inc.","150","mg/1","","N","20251231"
"6173","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68071368104","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-3681","68071-3681-4","68071-3681_2a313eb4-4c20-16d2-e063-6394a90ab025","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","NuCare Pharmaceuticals, Inc.","150","mg/1","","N","20251231"
"6174","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68071369306","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-3693","68071-3693-6","68071-3693_238284a8-b38f-82af-e063-6394a90a79e1","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","NuCare Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"6175","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68071369906","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-3699","68071-3699-6","68071-3699_290392cc-dcbf-83b4-e063-6294a90a3cb4","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","NuCare Pharmaceutical, Inc.","250","mg/1","","N","20251231"
"6176","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68071369903","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-3699","68071-3699-3","68071-3699_290392cc-dcbf-83b4-e063-6294a90a3cb4","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","NuCare Pharmaceutical, Inc.","250","mg/1","","N","20251231"
"6177","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","68071371504","Macrolide Antimicrobial [EPC], Macrolides [CS]","68071-3715","68071-3715-4","68071-3715_2a32433c-0956-9672-e063-6394a90a1ac3","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208250","NuCare Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"6178","AMOXICILLIN","Amoxicillin","68071371602","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-3716","68071-3716-2","68071-3716_2646715c-d336-9b32-e063-6394a90a120c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, COATED","ORAL","20060329","","ANDA","ANDA065255","NuCare Pharmaceuticals, Inc.","875","mg/1","","N","20251231"
"6179","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68071373702","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-3737","68071-3737-2","68071-3737_36c17958-0221-9987-e063-6294a90ac4f7","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","NuCare Pharmaceutical, Inc.","500","mg/1","","N","20261231"
"6180","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68071373706","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-3737","68071-3737-6","68071-3737_36c17958-0221-9987-e063-6294a90ac4f7","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","NuCare Pharmaceutical, Inc.","500","mg/1","","N","20261231"
"6181","CEPHALEXIN","Cephalexin","68071374003","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3740","68071-3740-3","68071-3740_30ba1cee-116f-089d-e063-6394a90a426f","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","NuCare Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"6182","CEPHALEXIN","Cephalexin","68071374009","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3740","68071-3740-9","68071-3740_30ba1cee-116f-089d-e063-6394a90a426f","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","NuCare Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"6183","FLUCONAZOLE","Fluconazole","68071376803","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68071-3768","68071-3768-3","68071-3768_2b9b049f-8ed3-0535-e063-6394a90afc7a","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","NuCare Pharmaceuticals, Inc.","100","mg/1","","N","20261231"
"6184","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","68071377405","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-3774","68071-3774-5","68071-3774_2bb03d3b-5d45-bc4a-e063-6394a90a656a","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","FOR SUSPENSION","ORAL","20220919","","NDA AUTHORIZED GENERIC","NDA050755","NuCare Pharmaceuticals, Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"6185","CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE","Ciprofloxacin and Dexamethasone","68071380407","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-3804","68071-3804-7","68071-3804_2f780394-c54f-9d92-e063-6294a90ab37b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin and Dexamethasone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","20200810","","ANDA","ANDA205548","NuCare Pharmaceuticals, Inc.","3; 1","mg/mL; mg/mL","","N","20261231"
"6186","CEFDINIR","Cefdinir","68071380601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-3806","68071-3806-1","68071-3806_2fb43adf-3e71-176f-e063-6394a90a29e0","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20060531","","ANDA","ANDA065259","NuCare Pharmaceuticals, Inc.","125","mg/5mL","","N","20261231"
"6187","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071380701","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-3807","68071-3807-1","68071-3807_30144cfc-0fb1-8d62-e063-6394a90acba4","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","NuCare Pharmaceuticals, Inc.","200; 28.5","mg/5mL; mg/5mL","","N","20261231"
"6188","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071382203","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-3822","68071-3822-3","68071-3822_31d00834-4ab4-d764-e063-6294a90ab395","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20220801","","ANDA","ANDA065063","NuCare Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20261231"
"6189","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071384202","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-3842","68071-3842-2","68071-3842_348f7f87-48ae-4cb4-e063-6394a90aa5fe","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20220801","","ANDA","ANDA065063","NuCare Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20261231"
"6190","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071386002","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-3860","68071-3860-2","68071-3860_36d60283-482e-9449-e063-6394a90ae216","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","NuCare Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20261231"
"6191","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071386404","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-3864","68071-3864-4","68071-3864_36efc48d-f5d0-fdb4-e063-6294a90a720b","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20261231"
"6192","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071386603","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-3866","68071-3866-3","68071-3866_377abca8-7077-9ad0-e063-6294a90aa5dc","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20220801","","ANDA","ANDA065063","NuCare Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20261231"
"6193","CEFDINIR","Cefdinir","68071400703","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4007","68071-4007-3","68071-4007_1d7a3d9e-4558-eb2e-e063-6294a90a8f78","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6194","CEFDINIR","Cefdinir","68071400707","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4007","68071-4007-7","68071-4007_1d7a3d9e-4558-eb2e-e063-6294a90a8f78","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6195","CEFDINIR","Cefdinir","68071400702","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4007","68071-4007-2","68071-4007_1d7a3d9e-4558-eb2e-e063-6294a90a8f78","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6196","CLOTRIMAZOLE","Clotrimazole","68071402604","Azole Antifungal [EPC], Azoles [CS]","68071-4026","68071-4026-4","68071-4026_1d7a4d76-63d1-8f28-e063-6394a90aa165","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","19951204","","ANDA","ANDA072641","NuCare Pharmaceuticals,Inc.","1","g/100g","","N","20251231"
"6197","POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","Polymyxin B Sulfate and Trimethoprim","68071410305","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68071-4103","68071-4103-5","68071-4103_1d8e3ec4-a0b3-e6d9-e063-6294a90aeab8","HUMAN PRESCRIPTION DRUG","Polymyxin B Sulfate and Trimethoprim","","SOLUTION","OPHTHALMIC","19980416","","ANDA","ANDA064211","NuCare Pharmaceuticals,Inc.","10000; 1","[USP'U]/mL; mg/mL","","N","20251231"
"6198","MUPIROCIN","Mupirocin","68071411102","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","68071-4111","68071-4111-2","68071-4111_2ac06ba0-af93-d9bf-e063-6294a90aa585","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20110608","","ANDA","ANDA090480","NuCare Pharmaceuticals,Inc.","20","mg/g","","N","20261231"
"6199","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","68071412202","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4122","68071-4122-2","68071-4122_1a13ecfc-3490-4377-e063-6394a90ad455","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6200","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","68071412203","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4122","68071-4122-3","68071-4122_1a13ecfc-3490-4377-e063-6394a90ad455","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6201","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","68071412204","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4122","68071-4122-4","68071-4122_1a13ecfc-3490-4377-e063-6394a90ad455","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6202","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","68071412201","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4122","68071-4122-1","68071-4122_1a13ecfc-3490-4377-e063-6394a90ad455","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6203","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","68071412207","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4122","68071-4122-7","68071-4122_1a13ecfc-3490-4377-e063-6394a90ad455","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6204","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","68071412206","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4122","68071-4122-6","68071-4122_1a13ecfc-3490-4377-e063-6394a90ad455","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6205","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","68071413404","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","68071-4134","68071-4134-4","68071-4134_1a145449-0f8b-a78e-e063-6394a90ad576","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20151106","","ANDA","ANDA202894","NuCare Pharmaceuticals,Inc.",".5; 10","mg/g; mg/g","","N","20251231"
"6206","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68071413905","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4139","68071-4139-5","68071-4139_2d3feef9-74ea-c651-e063-6394a90a2ca3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20040507","","NDA AUTHORIZED GENERIC","NDA019992","NuCare Pharmaceuticals,Inc.","3","mg/mL","","N","20261231"
"6207","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone","68071417401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68071-4174","68071-4174-1","68071-4174_1a3b96b0-10ac-9bb1-e063-6294a90ab279","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SOLUTION/ DROPS","AURICULAR (OTIC)","19951229","","ANDA","ANDA064053","NuCare Pharmaceuticals,Inc.","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"6208","DEXAMETHASONE; TOBRAMYCIN","Tobramycin and Dexamethasone","68071420305","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","68071-4203","68071-4203-5","68071-4203_1a3b96b0-10ad-9bb1-e063-6294a90ab279","HUMAN PRESCRIPTION DRUG","Tobramycin and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","19991027","","ANDA","ANDA064134","NuCare Pharmaceuticals,Inc.","1; 3","mg/mL; mg/mL","","N","20251231"
"6209","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071422402","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-4224","68071-4224-2","68071-4224_1a3c5aaf-d029-1494-e063-6394a90aabc6","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6210","CLOTRIMAZOLE","Clotrimazole","68071422505","Azole Antifungal [EPC], Azoles [CS]","68071-4225","68071-4225-5","68071-4225_1a3c5c49-b373-1318-e063-6394a90a47b6","HUMAN OTC DRUG","clotrimazole","","CREAM","TOPICAL","20110603","","OTC MONOGRAPH DRUG","M005","NuCare Pharmaceuticals,Inc.","1","g/100g","","N","20251231"
"6211","ERYTHROMYCIN","Erythromycin","68071422803","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","68071-4228","68071-4228-3","68071-4228_1a3c49be-c437-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","19940729","","ANDA","ANDA064067","NuCare Pharmaceuticals,Inc.","5","mg/g","","N","20251231"
"6212","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone","68071422901","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68071-4229","68071-4229-1","68071-4229_27d87c0b-26a3-1aa2-e063-6394a90a027b","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","19960828","","ANDA","ANDA064065","NuCare Pharmaceuticals,Inc.","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"6213","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68071423503","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4235","68071-4235-3","68071-4235_2d3ff27f-de04-c79c-e063-6294a90a05c3","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20040507","","NDA AUTHORIZED GENERIC","NDA019992","NuCare Pharmaceuticals,Inc.","3","mg/mL","","N","20261231"
"6214","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071425702","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-4257","68071-4257-2","68071-4257_1a3c49be-c439-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6215","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071425703","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-4257","68071-4257-3","68071-4257_1a3c49be-c439-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6216","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071425704","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-4257","68071-4257-4","68071-4257_1a3c49be-c439-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6217","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071425707","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-4257","68071-4257-7","68071-4257_1a3c49be-c439-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6218","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071425708","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-4257","68071-4257-8","68071-4257_1a3c49be-c439-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6219","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071425709","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-4257","68071-4257-9","68071-4257_1a3c49be-c439-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6220","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071425701","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-4257","68071-4257-1","68071-4257_1a3c49be-c439-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6221","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","68071426002","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4260","68071-4260-2","68071-4260_1a3c49be-c43a-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6222","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","68071426003","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4260","68071-4260-3","68071-4260_1a3c49be-c43a-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6223","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","68071426005","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4260","68071-4260-5","68071-4260_1a3c49be-c43a-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6224","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","68071426006","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4260","68071-4260-6","68071-4260_1a3c49be-c43a-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6225","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","68071426007","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4260","68071-4260-7","68071-4260_1a3c49be-c43a-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6226","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","68071426004","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4260","68071-4260-4","68071-4260_1a3c49be-c43a-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6227","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","68071426009","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4260","68071-4260-9","68071-4260_1a3c49be-c43a-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6228","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","68071426008","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4260","68071-4260-8","68071-4260_1a3c49be-c43a-da6c-e063-6394a90a39bf","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6229","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071427502","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-4275","68071-4275-2","68071-4275_1a3dc0d3-89e5-ab47-e063-6394a90a1952","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","NuCare Pharmaceuticals,Inc.","500; 125","mg/1; mg/1","","N","20251231"
"6230","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071428403","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-4284","68071-4284-3","68071-4284_1a3dcabb-3683-ad32-e063-6394a90a6731","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","NuCare Pharmaceuticals,Inc.","500; 125","mg/1; mg/1","","N","20251231"
"6231","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071428404","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-4284","68071-4284-4","68071-4284_1a3dcabb-3683-ad32-e063-6394a90a6731","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","NuCare Pharmaceuticals,Inc.","500; 125","mg/1; mg/1","","N","20251231"
"6232","NYSTATIN","Nystatin","68071429303","Polyene Antifungal [EPC], Polyenes [CS]","68071-4293","68071-4293-3","68071-4293_275d40f9-dd81-6741-e063-6294a90aece1","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20060921","","ANDA","ANDA062225","NuCare Pharmaceuticals,Inc.","100000","[USP'U]/g","","N","20251231"
"6233","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071429803","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4298","68071-4298-3","68071-4298_289df21b-c70f-57f6-e063-6394a90adab5","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6234","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071429804","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4298","68071-4298-4","68071-4298_289df21b-c70f-57f6-e063-6394a90adab5","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6235","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071429808","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4298","68071-4298-8","68071-4298_289df21b-c70f-57f6-e063-6394a90adab5","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6236","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071429809","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4298","68071-4298-9","68071-4298_289df21b-c70f-57f6-e063-6394a90adab5","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6237","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071429806","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4298","68071-4298-6","68071-4298_289df21b-c70f-57f6-e063-6394a90adab5","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6238","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071430001","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-4300","68071-4300-1","68071-4300_1a3dd3bd-fa17-4035-e063-6294a90a1708","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","NuCare Pharmaceuticals,Inc.","500; 125","mg/1; mg/1","","N","20251231"
"6239","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071430004","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-4300","68071-4300-4","68071-4300_1a3dd3bd-fa17-4035-e063-6294a90a1708","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","NuCare Pharmaceuticals,Inc.","500; 125","mg/1; mg/1","","N","20251231"
"6240","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071430006","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-4300","68071-4300-6","68071-4300_1a3dd3bd-fa17-4035-e063-6294a90a1708","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","NuCare Pharmaceuticals,Inc.","500; 125","mg/1; mg/1","","N","20251231"
"6241","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071430003","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-4300","68071-4300-3","68071-4300_1a3dd3bd-fa17-4035-e063-6294a90a1708","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","NuCare Pharmaceuticals,Inc.","500; 125","mg/1; mg/1","","N","20251231"
"6242","MUPIROCIN","Mupirocin","68071432102","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","68071-4321","68071-4321-2","68071-4321_1a3dc88f-20df-241c-e063-6294a90aa423","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20050923","","ANDA","ANDA065170","NuCare Pharmaceuticals,Inc.","20","mg/g","","N","20251231"
"6243","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071433500","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-4335","68071-4335-0","68071-4335_1a551f3b-f4a5-63c5-e063-6394a90a6eb0","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20251231"
"6244","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071433501","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-4335","68071-4335-1","68071-4335_1a551f3b-f4a5-63c5-e063-6394a90a6eb0","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20251231"
"6245","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071433503","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-4335","68071-4335-3","68071-4335_1a551f3b-f4a5-63c5-e063-6394a90a6eb0","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20251231"
"6246","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071433504","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-4335","68071-4335-4","68071-4335_1a551f3b-f4a5-63c5-e063-6394a90a6eb0","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20251231"
"6247","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071433506","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-4335","68071-4335-6","68071-4335_1a551f3b-f4a5-63c5-e063-6394a90a6eb0","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20251231"
"6248","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071433502","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-4335","68071-4335-2","68071-4335_1a551f3b-f4a5-63c5-e063-6394a90a6eb0","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20251231"
"6249","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071433508","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-4335","68071-4335-8","68071-4335_1a551f3b-f4a5-63c5-e063-6394a90a6eb0","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20251231"
"6250","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071433507","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-4335","68071-4335-7","68071-4335_1a551f3b-f4a5-63c5-e063-6394a90a6eb0","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20251231"
"6251","CEPHALEXIN","Cephalexin","68071435501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4355","68071-4355-1","68071-4355_1a55498c-d3ae-b7f7-e063-6394a90adb13","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6252","CEPHALEXIN","Cephalexin","68071435503","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4355","68071-4355-3","68071-4355_1a55498c-d3ae-b7f7-e063-6394a90adb13","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6253","CEPHALEXIN","Cephalexin","68071435507","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4355","68071-4355-7","68071-4355_1a55498c-d3ae-b7f7-e063-6394a90adb13","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6254","CEPHALEXIN","Cephalexin","68071435508","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4355","68071-4355-8","68071-4355_1a55498c-d3ae-b7f7-e063-6394a90adb13","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6255","CEPHALEXIN","Cephalexin","68071435509","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4355","68071-4355-9","68071-4355_1a55498c-d3ae-b7f7-e063-6394a90adb13","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6256","CEPHALEXIN","Cephalexin","68071435504","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4355","68071-4355-4","68071-4355_1a55498c-d3ae-b7f7-e063-6394a90adb13","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6257","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","68071436701","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","68071-4367","68071-4367-1","68071-4367_2a81d529-e3bd-721c-e063-6394a90a0222","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","NuCare Pharmaceuticals,Inc.","25; 75","mg/1; mg/1","","N","20251231"
"6258","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","68071436704","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","68071-4367","68071-4367-4","68071-4367_2a81d529-e3bd-721c-e063-6394a90a0222","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","NuCare Pharmaceuticals,Inc.","25; 75","mg/1; mg/1","","N","20251231"
"6259","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","68071436702","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","68071-4367","68071-4367-2","68071-4367_2a81d529-e3bd-721c-e063-6394a90a0222","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","NuCare Pharmaceuticals,Inc.","25; 75","mg/1; mg/1","","N","20251231"
"6260","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone","68071437505","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68071-4375","68071-4375-5","68071-4375_1a555d03-b3db-da48-e063-6394a90a7576","HUMAN PRESCRIPTION DRUG","Neomycin Polymyxin B Sulfates and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","19950913","","ANDA","ANDA064135","NuCare Pharmaceuticals,Inc.","1; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"6261","CEPHALEXIN","Cephalexin","68071440604","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4406","68071-4406-4","68071-4406_1a8b85ac-ef99-e207-e063-6394a90a80f1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6262","CEPHALEXIN","Cephalexin","68071440607","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4406","68071-4406-7","68071-4406_1a8b85ac-ef99-e207-e063-6394a90a80f1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6263","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","68071442802","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","68071-4428","68071-4428-2","68071-4428_1a8c366e-d568-fc06-e063-6394a90abec9","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","20270318","ANDA","ANDA077066","NuCare Pharmaceuticals,Inc.","25; 75","mg/1; mg/1","","N",""
"6264","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","68071442806","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","68071-4428","68071-4428-6","68071-4428_1a8c366e-d568-fc06-e063-6394a90abec9","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","20270318","ANDA","ANDA077066","NuCare Pharmaceuticals,Inc.","25; 75","mg/1; mg/1","","N",""
"6265","CEPHALEXIN","Cephalexin","68071442903","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4429","68071-4429-3","68071-4429_1a8c402e-e2e2-a27c-e063-6294a90a9113","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6266","CEPHALEXIN","Cephalexin","68071442904","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4429","68071-4429-4","68071-4429_1a8c402e-e2e2-a27c-e063-6294a90a9113","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6267","CEPHALEXIN","Cephalexin","68071442906","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4429","68071-4429-6","68071-4429_1a8c402e-e2e2-a27c-e063-6294a90a9113","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6268","CEPHALEXIN","Cephalexin","68071442909","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4429","68071-4429-9","68071-4429_1a8c402e-e2e2-a27c-e063-6294a90a9113","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6269","CEPHALEXIN","Cephalexin","68071442908","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4429","68071-4429-8","68071-4429_1a8c402e-e2e2-a27c-e063-6294a90a9113","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6270","CEPHALEXIN","Cephalexin","68071443404","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4434","68071-4434-4","68071-4434_1a8c365e-c71a-3926-e063-6394a90ad642","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6271","CEPHALEXIN","Cephalexin","68071443408","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4434","68071-4434-8","68071-4434_1a8c365e-c71a-3926-e063-6394a90ad642","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6272","AMOXICILLIN","Amoxicillin","68071445500","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4455","68071-4455-0","68071-4455_2b37005a-55d9-d329-e063-6294a90af0da","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6273","AMOXICILLIN","Amoxicillin","68071445502","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4455","68071-4455-2","68071-4455_2b37005a-55d9-d329-e063-6294a90af0da","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6274","AMOXICILLIN","Amoxicillin","68071445503","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4455","68071-4455-3","68071-4455_2b37005a-55d9-d329-e063-6294a90af0da","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6275","AMOXICILLIN","Amoxicillin","68071445504","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4455","68071-4455-4","68071-4455_2b37005a-55d9-d329-e063-6294a90af0da","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6276","AMOXICILLIN","Amoxicillin","68071445501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4455","68071-4455-1","68071-4455_2b37005a-55d9-d329-e063-6294a90af0da","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6277","AMOXICILLIN","Amoxicillin","68071445506","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4455","68071-4455-6","68071-4455_2b37005a-55d9-d329-e063-6294a90af0da","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6278","AMOXICILLIN","Amoxicillin","68071445507","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4455","68071-4455-7","68071-4455_2b37005a-55d9-d329-e063-6294a90af0da","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6279","AMOXICILLIN","Amoxicillin","68071445508","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4455","68071-4455-8","68071-4455_2b37005a-55d9-d329-e063-6294a90af0da","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6280","AMOXICILLIN","Amoxicillin","68071445505","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4455","68071-4455-5","68071-4455_2b37005a-55d9-d329-e063-6294a90af0da","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6281","CEPHALEXIN","Cephalexin","68071446503","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4465","68071-4465-3","68071-4465_1d8a8c99-f547-f912-e063-6394a90a9f39","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6282","CEPHALEXIN","Cephalexin","68071446506","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4465","68071-4465-6","68071-4465_1d8a8c99-f547-f912-e063-6394a90a9f39","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6283","AMOXICILLIN","Amoxicillin","68071446802","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4468","68071-4468-2","68071-4468_1a8d6ebc-8df1-3329-e063-6394a90a06e5","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6284","AMOXICILLIN","Amoxicillin","68071446803","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4468","68071-4468-3","68071-4468_1a8d6ebc-8df1-3329-e063-6394a90a06e5","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6285","AMOXICILLIN","Amoxicillin","68071446804","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4468","68071-4468-4","68071-4468_1a8d6ebc-8df1-3329-e063-6394a90a06e5","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6286","AMOXICILLIN","Amoxicillin","68071446801","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4468","68071-4468-1","68071-4468_1a8d6ebc-8df1-3329-e063-6394a90a06e5","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6287","AMOXICILLIN","Amoxicillin","68071446807","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4468","68071-4468-7","68071-4468_1a8d6ebc-8df1-3329-e063-6394a90a06e5","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6288","AMOXICILLIN","Amoxicillin","68071446808","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4468","68071-4468-8","68071-4468_1a8d6ebc-8df1-3329-e063-6394a90a06e5","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6289","AMOXICILLIN","Amoxicillin","68071446805","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4468","68071-4468-5","68071-4468_1a8d6ebc-8df1-3329-e063-6394a90a06e5","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6290","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","68071450001","Allylamine Antifungal [EPC], Allylamine [CS]","68071-4500","68071-4500-1","68071-4500_1a8daeb9-2c25-ccc0-e063-6394a90a9cae","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6291","FLUCONAZOLE","fluconazole","68071450103","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68071-4501","68071-4501-3","68071-4501_1a8db552-50ac-ade6-e063-6394a90a086e","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","NuCare Pharmaceuticals,Inc.","100","mg/1","","N","20251231"
"6292","CEFADROXIL","Cefadroxil","68071451501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4515","68071-4515-1","68071-4515_1a906cf7-b91d-849f-e063-6294a90a0776","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6293","CEFADROXIL","Cefadroxil","68071451502","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4515","68071-4515-2","68071-4515_1a906cf7-b91d-849f-e063-6294a90a0776","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6294","CEPHALEXIN","Cephalexin","68071451608","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4516","68071-4516-8","68071-4516_1a907bf9-f5a7-c98f-e063-6394a90a81b2","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6295","AMOXICILLIN","Amoxicillin","68071454804","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4548","68071-4548-4","68071-4548_1a91478a-32b8-622d-e063-6294a90a7e51","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6296","AMOXICILLIN","Amoxicillin","68071454806","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4548","68071-4548-6","68071-4548_1a91478a-32b8-622d-e063-6294a90a7e51","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6297","AMOXICILLIN","Amoxicillin","68071454808","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4548","68071-4548-8","68071-4548_1a91478a-32b8-622d-e063-6294a90a7e51","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6298","AMOXICILLIN","Amoxicillin","68071454803","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4548","68071-4548-3","68071-4548_1a91478a-32b8-622d-e063-6294a90a7e51","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6299","AMOXICILLIN","Amoxicillin","68071454809","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4548","68071-4548-9","68071-4548_1a91478a-32b8-622d-e063-6294a90a7e51","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6300","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071454903","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-4549","68071-4549-3","68071-4549_1a9142f9-92c7-38a6-e063-6394a90af05c","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6301","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071454906","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-4549","68071-4549-6","68071-4549_1a9142f9-92c7-38a6-e063-6394a90af05c","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6302","AMOXICILLIN","Amoxicillin","68071457403","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4574","68071-4574-3","68071-4574_1ab537cf-02a7-f8a8-e063-6394a90ab52c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6303","AMOXICILLIN","Amoxicillin","68071457406","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4574","68071-4574-6","68071-4574_1ab537cf-02a7-f8a8-e063-6394a90ab52c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6304","AMOXICILLIN","Amoxicillin","68071457408","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4574","68071-4574-8","68071-4574_1ab537cf-02a7-f8a8-e063-6394a90ab52c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6305","AMOXICILLIN","Amoxicillin","68071457404","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4574","68071-4574-4","68071-4574_1ab537cf-02a7-f8a8-e063-6394a90ab52c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6306","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68071457601","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4576","68071-4576-1","68071-4576_1ab541b5-e90a-a1f7-e063-6294a90a0f25","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6307","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68071457603","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4576","68071-4576-3","68071-4576_1ab541b5-e90a-a1f7-e063-6294a90a0f25","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6308","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68071457604","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4576","68071-4576-4","68071-4576_1ab541b5-e90a-a1f7-e063-6294a90a0f25","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6309","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68071457606","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4576","68071-4576-6","68071-4576_1ab541b5-e90a-a1f7-e063-6294a90a0f25","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6310","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68071457602","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4576","68071-4576-2","68071-4576_1ab541b5-e90a-a1f7-e063-6294a90a0f25","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6311","AMOXICILLIN","Amoxicillin","68071458105","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4581","68071-4581-5","68071-4581_1ab533b4-6f4a-58fa-e063-6294a90a5c25","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065387","NuCare Pharmaceuticals,Inc.","250","mg/5mL","","N","20251231"
"6312","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071458603","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-4586","68071-4586-3","68071-4586_1ab54462-cdcc-f8ea-e063-6394a90ae4d5","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6313","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071458604","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-4586","68071-4586-4","68071-4586_1ab54462-cdcc-f8ea-e063-6394a90ae4d5","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6314","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071458606","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-4586","68071-4586-6","68071-4586_1ab54462-cdcc-f8ea-e063-6394a90ae4d5","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6315","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68071462702","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4627","68071-4627-2","68071-4627_1ab7a9ce-463a-cd78-e063-6394a90a33dd","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6316","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68071462704","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4627","68071-4627-4","68071-4627_1ab7a9ce-463a-cd78-e063-6394a90a33dd","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6317","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68071462706","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4627","68071-4627-6","68071-4627_1ab7a9ce-463a-cd78-e063-6394a90a33dd","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6318","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68071467203","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4672","68071-4672-3","68071-4672_1ab88258-a402-2353-e063-6394a90a5eca","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","SOLUTION","OPHTHALMIC","20181101","","ANDA","ANDA077568","NuCare Pharmaceuticals,Inc.","3","mg/mL","","N","20251231"
"6319","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68071467905","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68071-4679","68071-4679-5","68071-4679_1ab8822b-544e-2350-e063-6394a90ac9a9","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","SOLUTION","OPHTHALMIC","20181101","","ANDA","ANDA077568","NuCare Pharmaceuticals,Inc.","3","mg/mL","","N","20251231"
"6320","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071469708","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4697","68071-4697-8","68071-4697_1ab98051-fe88-bfac-e063-6294a90a883f","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6321","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071469704","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4697","68071-4697-4","68071-4697_1ab98051-fe88-bfac-e063-6294a90a883f","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6322","AMOXICILLIN","Amoxicillin","68071469803","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4698","68071-4698-3","68071-4698_1bfa1d8c-066e-48dc-e063-6394a90af862","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6323","AMOXICILLIN","Amoxicillin","68071469804","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4698","68071-4698-4","68071-4698_1bfa1d8c-066e-48dc-e063-6394a90af862","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6324","AMOXICILLIN","Amoxicillin","68071469809","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4698","68071-4698-9","68071-4698_1bfa1d8c-066e-48dc-e063-6394a90af862","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6325","AMOXICILLIN","Amoxicillin","68071469806","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4698","68071-4698-6","68071-4698_1bfa1d8c-066e-48dc-e063-6394a90af862","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6326","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68071471001","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68071-4710","68071-4710-1","68071-4710_1ab9d4fd-7585-0e8d-e063-6294a90ac0b0","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals,Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6327","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68071471002","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68071-4710","68071-4710-2","68071-4710_1ab9d4fd-7585-0e8d-e063-6294a90ac0b0","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals,Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6328","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68071471004","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68071-4710","68071-4710-4","68071-4710_1ab9d4fd-7585-0e8d-e063-6294a90ac0b0","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals,Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6329","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68071471005","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68071-4710","68071-4710-5","68071-4710_1ab9d4fd-7585-0e8d-e063-6294a90ac0b0","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals,Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6330","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68071471006","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68071-4710","68071-4710-6","68071-4710_1ab9d4fd-7585-0e8d-e063-6294a90ac0b0","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals,Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6331","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68071471003","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68071-4710","68071-4710-3","68071-4710_1ab9d4fd-7585-0e8d-e063-6294a90ac0b0","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals,Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6332","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68071471008","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68071-4710","68071-4710-8","68071-4710_1ab9d4fd-7585-0e8d-e063-6294a90ac0b0","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals,Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6333","AMOXICILLIN","Amoxicillin","68071474103","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4741","68071-4741-3","68071-4741_2d7cf900-c6dd-6484-e063-6294a90a21b4","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20261231"
"6334","AMOXICILLIN","Amoxicillin","68071474104","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4741","68071-4741-4","68071-4741_2d7cf900-c6dd-6484-e063-6294a90a21b4","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20261231"
"6335","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071475308","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4753","68071-4753-8","68071-4753_1adb3623-ebcc-c05a-e063-6294a90acb6e","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6336","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071475306","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4753","68071-4753-6","68071-4753_1adb3623-ebcc-c05a-e063-6294a90acb6e","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6337","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN","68071477305","Macrolide Antimicrobial [EPC], Macrolides [CS]","68071-4773","68071-4773-5","68071-4773_1adbfa42-59d2-ee83-e063-6394a90ab827","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","POWDER, FOR SUSPENSION","ORAL","20180410","","ANDA","ANDA207531","NuCare Pharmaceuticals,Inc.","200","mg/5mL","","N","20251231"
"6338","GENTAMICIN SULFATE","Gentamicin Sulfate","68071477505","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","68071-4775","68071-4775-5","68071-4775_1adbfbb6-92b8-3288-e063-6394a90a6f29","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","SOLUTION","OPHTHALMIC","19960405","","ANDA","ANDA062196","NuCare Pharmaceuticals,Inc.","3","mg/mL","","N","20251231"
"6339","AZITHROMYCIN DIHYDRATE","Azithromycin","68071477903","Macrolide Antimicrobial [EPC], Macrolides [CS]","68071-4779","68071-4779-3","68071-4779_1adc1010-cc6d-31f2-e063-6394a90a64c6","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20180806","","ANDA","ANDA211147","NuCare Pharmaceuticals,Inc.","200","mg/5mL","","N","20251231"
"6340","MUPIROCIN","Mupirocin","68071478902","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","68071-4789","68071-4789-2","68071-4789_1adc263e-eb1e-53b8-e063-6394a90a9fbb","HUMAN PRESCRIPTION DRUG","mupirocin","","OINTMENT","TOPICAL","20091030","","ANDA","ANDA065123","NuCare Pharmaceuticals,Inc.","20","mg/g","","N","20251231"
"6341","ERYTHROMYCIN","erythromycin","68071479106","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","68071-4791","68071-4791-6","68071-4791_1adc3829-e999-21e1-e063-6294a90a7632","HUMAN PRESCRIPTION DRUG","erythromycin","","SOLUTION","TOPICAL","20111219","","ANDA","ANDA063038","NuCare Pharmaceuticals,Inc.","20","mg/mL","","N","20251231"
"6342","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN","68071479503","Macrolide Antimicrobial [EPC], Macrolides [CS]","68071-4795","68071-4795-3","68071-4795_1adc57cf-712e-75b9-e063-6294a90a0de0","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","POWDER, FOR SUSPENSION","ORAL","20180410","","ANDA","ANDA207531","NuCare Pharmaceuticals,Inc.","200","mg/5mL","","N","20251231"
"6343","AMOXICILLIN","Amoxicillin","68071479605","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4796","68071-4796-5","68071-4796_1adc3d94-f2ef-29ec-e063-6294a90af29a","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065325","NuCare Pharmaceuticals,Inc.","400","mg/5mL","","N","20251231"
"6344","ERYTHROMYCIN","erythromycin","68071480303","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","68071-4803","68071-4803-3","68071-4803_1adc6bbc-3f85-b36b-e063-6294a90a6c27","HUMAN PRESCRIPTION DRUG","erythromycin","","OINTMENT","OPHTHALMIC","20140508","","ANDA","ANDA062447","NuCare Pharmaceuticals,Inc.","5","mg/g","","N","20251231"
"6345","AZITHROMYCIN DIHYDRATE","Azithromycin","68071481202","Macrolide Antimicrobial [EPC], Macrolides [CS]","68071-4812","68071-4812-2","68071-4812_2d0644a1-e698-e6a7-e063-6394a90a3623","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207370","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20261231"
"6346","GENTAMICIN SULFATE","gentamicin sulfate","68071482705","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","68071-4827","68071-4827-5","68071-4827_1ade255c-bb1d-b03f-e063-6294a90a6d78","HUMAN PRESCRIPTION DRUG","GENTAMICIN SULFATE","","SOLUTION/ DROPS","OPHTHALMIC","19980105","","ANDA","ANDA062452","NuCare Pharmaceuticals,Inc.","3","mg/mL","","N","20251231"
"6347","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071483803","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4838","68071-4838-3","68071-4838_1ae17471-a0b0-8691-e063-6394a90aa28a","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6348","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071483808","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4838","68071-4838-8","68071-4838_1ae17471-a0b0-8691-e063-6394a90aa28a","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6349","CEFDINIR","Cefdinir","68071485602","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4856","68071-4856-2","68071-4856_36adba7e-e70b-3b86-e063-6394a90aeefc","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20070501","","ANDA","ANDA065264","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20261231"
"6350","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","68071487303","Allylamine Antifungal [EPC], Allylamine [CS]","68071-4873","68071-4873-3","68071-4873_1ae1cc9d-0253-361f-e063-6394a90a966b","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6351","AZITHROMYCIN DIHYDRATE","Azithromycin","68071490206","Macrolide Antimicrobial [EPC], Macrolides [CS]","68071-4902","68071-4902-6","68071-4902_1ae23c57-f5a4-d9ca-e063-6394a90a3ba5","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207370","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6352","AMOXICILLIN","Amoxicillin","68071490701","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4907","68071-4907-1","68071-4907_1ae23083-9120-b5c6-e063-6394a90abe0d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6353","AMOXICILLIN","Amoxicillin","68071490704","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4907","68071-4907-4","68071-4907_1ae23083-9120-b5c6-e063-6394a90abe0d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6354","AMOXICILLIN","Amoxicillin","68071490708","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4907","68071-4907-8","68071-4907_1ae23083-9120-b5c6-e063-6394a90abe0d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6355","AMOXICILLIN","Amoxicillin","68071490707","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4907","68071-4907-7","68071-4907_1ae23083-9120-b5c6-e063-6394a90abe0d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6356","AMOXICILLIN","Amoxicillin","68071492001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4920","68071-4920-1","68071-4920_1ae25a15-b357-3a10-e063-6394a90a74a3","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6357","CEFADROXIL","Cefadroxil","68071493801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4938","68071-4938-1","68071-4938_1b2d4fbf-82bf-1e70-e063-6294a90a1132","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6358","AMOXICILLIN","Amoxicillin","68071494403","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4944","68071-4944-3","68071-4944_1b2e2026-ae73-e31c-e063-6294a90ab36d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6359","CEFDINIR","Cefdinir","68071494602","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4946","68071-4946-2","68071-4946_1b2e2e40-6135-401a-e063-6294a90a8c8f","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6360","CEFUROXIME AXETIL","Cefuroxime axetil","68071494702","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4947","68071-4947-2","68071-4947_1b2e322e-13be-c58d-e063-6394a90a2829","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6361","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68071494802","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68071-4948","68071-4948-2","68071-4948_1b2e33e8-26b2-e5a0-e063-6294a90ae585","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals,Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6362","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68071494804","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68071-4948","68071-4948-4","68071-4948_1b2e33e8-26b2-e5a0-e063-6294a90ae585","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","NuCare Pharmaceuticals,Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6363","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071496702","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-4967","68071-4967-2","68071-4967_1b2e6c45-a8c8-2f47-e063-6394a90a84f7","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6364","AMOXICILLIN","Amoxicillin","68071496905","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4969","68071-4969-5","68071-4969_1b2e7542-5098-c693-e063-6294a90af74b","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065387","NuCare Pharmaceuticals,Inc.","125","mg/5mL","","N","20251231"
"6365","CEFDINIR","Cefdinir","68071497006","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-4970","68071-4970-6","68071-4970_1b2e8147-7c01-7d0a-e063-6394a90aeea1","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20071214","","ANDA","ANDA065473","NuCare Pharmaceuticals,Inc.","125","mg/5mL","","N","20251231"
"6366","AZITHROMYCIN DIHYDRATE","Azithromycin","68071497603","Macrolide Antimicrobial [EPC], Macrolides [CS]","68071-4976","68071-4976-3","68071-4976_1b2e96de-5ed6-c9e9-e063-6394a90a472e","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207398","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6367","AMOXICILLIN","Amoxicillin","68071498202","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-4982","68071-4982-2","68071-4982_1b2ea185-b22f-d708-e063-6394a90a087e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","NuCare Pharmaceuticals,Inc.","875","mg/1","","N","20251231"
"6368","AMOXICILLIN","Amoxicillin","68071501904","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-5019","68071-5019-4","68071-5019_1ceb908d-da9a-515a-e063-6394a90ad07c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6369","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN","68071503505","Macrolide Antimicrobial [EPC], Macrolides [CS]","68071-5035","68071-5035-5","68071-5035_1b411fb5-14de-2e1d-e063-6294a90a3ec9","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","POWDER, FOR SUSPENSION","ORAL","20180410","","ANDA","ANDA207531","NuCare Pharmaceuticals,Inc.","100","mg/5mL","","N","20251231"
"6370","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","68071503703","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","68071-5037","68071-5037-3","68071-5037_1b4117fd-e008-682d-e063-6394a90a89a8","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","19871222","","ANDA","ANDA062364","NuCare Pharmaceuticals,Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"6371","CEPHALEXIN","Cephalexin","68071503800","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-5038","68071-5038-0","68071-5038_1b410dbc-8ddc-344b-e063-6294a90a840b","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","NuCare Pharmaceuticals,Inc.","250","mg/5mL","","N","20251231"
"6372","CLARITHROMYCIN","Clarithromycin","68071504502","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","68071-5045","68071-5045-2","68071-5045_2d53c7c3-4281-47ac-e063-6394a90a5e8c","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6373","CLARITHROMYCIN","Clarithromycin","68071504503","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","68071-5045","68071-5045-3","68071-5045_2d53c7c3-4281-47ac-e063-6394a90a5e8c","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6374","CLARITHROMYCIN","Clarithromycin","68071504508","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","68071-5045","68071-5045-8","68071-5045_2d53c7c3-4281-47ac-e063-6394a90a5e8c","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6375","CLARITHROMYCIN","Clarithromycin","68071504504","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","68071-5045","68071-5045-4","68071-5045_2d53c7c3-4281-47ac-e063-6394a90a5e8c","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6376","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071505703","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-5057","68071-5057-3","68071-5057_1b43176e-f84c-c448-e063-6394a90a6b0e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6377","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071505704","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-5057","68071-5057-4","68071-5057_1b43176e-f84c-c448-e063-6394a90a6b0e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6378","AZITHROMYCIN DIHYDRATE","Azithromycin","68071505803","Macrolide Antimicrobial [EPC], Macrolides [CS]","68071-5058","68071-5058-3","68071-5058_1b4318a7-a74c-c7bc-e063-6394a90aeafb","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207398","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6379","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071506503","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-5065","68071-5065-3","68071-5065_1b4353b9-db65-9ef4-e063-6394a90a4d30","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091569","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6380","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071506504","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-5065","68071-5065-4","68071-5065_1b4353b9-db65-9ef4-e063-6394a90a4d30","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091569","NuCare Pharmaceuticals,Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6381","METRONIDAZOLE","Metronidazole","68071507302","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-5073","68071-5073-2","68071-5073_1b4558f7-9faa-d895-e063-6294a90a6da8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6382","PENICILLIN V POTASSIUM","Penicillin V Potassium","68071508106","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-5081","68071-5081-6","68071-5081_2f9bc6b4-3bad-7b29-e063-6294a90a3085","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20261231"
"6383","AZITHROMYCIN DIHYDRATE","Azithromycin","68071508206","Macrolide Antimicrobial [EPC], Macrolides [CS]","68071-5082","68071-5082-6","68071-5082_2788b460-063c-0b09-e063-6394a90a5b2f","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207398","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6384","AMOXICILLIN","Amoxicillin","68071509602","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-5096","68071-5096-2","68071-5096_2425badb-e194-e9f8-e063-6294a90a7bf4","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","NuCare Pharmaceuticals,Inc.","875","mg/1","","N","20251231"
"6385","AMOXICILLIN","Amoxicillin","68071509603","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-5096","68071-5096-3","68071-5096_2425badb-e194-e9f8-e063-6294a90a7bf4","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","NuCare Pharmaceuticals,Inc.","875","mg/1","","N","20251231"
"6386","AMOXICILLIN","Amoxicillin","68071509607","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-5096","68071-5096-7","68071-5096_2425badb-e194-e9f8-e063-6294a90a7bf4","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","NuCare Pharmaceuticals,Inc.","875","mg/1","","N","20251231"
"6387","CEFDINIR","Cefdinir","68071510606","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-5106","68071-5106-6","68071-5106_1b46ce4d-fa1c-4ce1-e063-6394a90a15f3","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20071214","","ANDA","ANDA065473","NuCare Pharmaceuticals,Inc.","250","mg/5mL","","N","20251231"
"6388","AMOXICILLIN","Amoxicillin","68071510901","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-5109","68071-5109-1","68071-5109_1b46d42b-ffdd-5da2-e063-6394a90afe28","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","NuCare Pharmaceuticals,Inc.","400","mg/5mL","","N","20251231"
"6389","SULFACETAMIDE SODIUM","sulfacetamide sodium","68071512305","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","68071-5123","68071-5123-5","68071-5123_1b54998d-88e0-357a-e063-6394a90a5948","HUMAN PRESCRIPTION DRUG","Sulfacetamide Sodium","","SOLUTION/ DROPS","OPHTHALMIC","19941228","","ANDA","ANDA040066","NuCare Pharmaceuticals,Inc.","100","mg/mL","","N","20251231"
"6390","AMOXICILLIN","Amoxicillin","68071512705","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68071-5127","68071-5127-5","68071-5127_1b548daa-2423-fc2f-e063-6394a90a8cc9","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065378","NuCare Pharmaceuticals,Inc.","400","mg/5mL","","N","20251231"
"6391","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071514405","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-5144","68071-5144-5","68071-5144_2abe2972-43e8-8faf-e063-6294a90abffa","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201091","NuCare Pharmaceuticals,Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"6392","CEFDINIR","Cefdinir","68071514502","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-5145","68071-5145-2","68071-5145_1b54d269-f317-3436-e063-6394a90a629e","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6393","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071517402","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-5174","68071-5174-2","68071-5174_1b5697d6-6d6e-ef26-e063-6394a90ae8d3","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","NuCare Pharmaceuticals,Inc.","300","mg/1","","N","20251231"
"6394","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071518901","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-5189","68071-5189-1","68071-5189_1b56d0c0-b8b2-3250-e063-6394a90ae67b","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20251231"
"6395","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071518903","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-5189","68071-5189-3","68071-5189_1b56d0c0-b8b2-3250-e063-6394a90ae67b","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20251231"
"6396","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071518904","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-5189","68071-5189-4","68071-5189_1b56d0c0-b8b2-3250-e063-6394a90ae67b","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20251231"
"6397","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68071518908","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68071-5189","68071-5189-8","68071-5189_1b56d0c0-b8b2-3250-e063-6394a90ae67b","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","NuCare Pharmaceuticals,Inc.","150","mg/1","","N","20251231"
"6398","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68071520705","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68071-5207","68071-5207-5","68071-5207_1b56f5ec-520c-8185-e063-6294a90a6eda","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201091","NuCare Pharmaceuticals,Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"6399","CEFADROXIL","Cefadroxil","68071523406","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-5234","68071-5234-6","68071-5234_1b592b2d-916c-154d-e063-6294a90a7ccd","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20070125","","ANDA","ANDA065352","NuCare Pharmaceuticals,Inc.","500","mg/1","","N","20251231"
"6400","CEPHALEXIN","Cephalexin","68071524104","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68071-5241","68071-5241-4","68071-5241_1d78c026-b1a3-0461-e063-6294a90ab4e5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6401","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc and Polymyxin B Sulfate","68071526703","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68071-5267","68071-5267-3","68071-5267_2a849ae9-3395-4642-e063-6394a90a1ca4","HUMAN PRESCRIPTION DRUG","Bacitracin Zinc and Polymyxin B Sulfate","","OINTMENT","OPHTHALMIC","20080425","","ANDA","ANDA064046","NuCare Pharmaceuticals,Inc.","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"6402","ERYTHROMYCIN","Erythromycin","68071527903","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","68071-5279","68071-5279-3","68071-5279_2c78e5f1-ab67-d25f-e063-6394a90acb06","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","19960718","20251231","ANDA","ANDA064030","NuCare Pharmaceuticals,Inc.","5","mg/g","","N",""
"6403","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin and Polymyxin B Sulfates and Dexamethasone","68071528103","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68071-5281","68071-5281-3","68071-5281_2a80353b-e221-492b-e063-6294a90a3a7a","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Dexamethasone","","OINTMENT","OPHTHALMIC","19960221","","NDA AUTHORIZED GENERIC","NDA050065","NuCare Pharmaceuticals,Inc.","1; 3.5; 10000","mg/g; mg/g; [iU]/g","","N","20251231"
"6404","METRONIDAZOLE","METRONIDAZOLE","68071528308","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68071-5283","68071-5283-8","68071-5283_2a307d1e-9ca1-c34a-e063-6294a90af55c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20171129","","ANDA","ANDA205245","NuCare Pharmaceuticals,Inc.","250","mg/1","","N","20251231"
"6405","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","68083014325","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","68083-143","68083-143-25","68083-143_8db1f95e-ef2b-4796-9b88-b3c481d47fcc","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20160223","","ANDA","ANDA205694","Gland Pharma Limited","500","mg/10mL","","N","20251231"
"6406","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","68083014410","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","68083-144","68083-144-10","68083-144_8db1f95e-ef2b-4796-9b88-b3c481d47fcc","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20160223","","ANDA","ANDA205694","Gland Pharma Limited","1","g/20mL","","N","20251231"
"6407","MEROPENEM","Meropenem","68083014610","Carbapenems [CS], Penem Antibacterial [EPC]","68083-146","68083-146-10","68083-146_d82a434d-60a4-4f1f-beb3-131a1f60c512","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20170428","","ANDA","ANDA206141","Gland Pharma Limited","500","mg/20mL","","N","20261231"
"6408","MEROPENEM","Meropenem","68083014710","Carbapenems [CS], Penem Antibacterial [EPC]","68083-147","68083-147-10","68083-147_d82a434d-60a4-4f1f-beb3-131a1f60c512","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20170428","","ANDA","ANDA206141","Gland Pharma Limited","1","g/30mL","","N","20261231"
"6409","CASPOFUNGIN ACETATE","Caspofungin Acetate","68083015801","Echinocandin Antifungal [EPC], Lipopeptides [CS]","68083-158","68083-158-01","68083-158_0ebc13ad-ba33-408f-8af3-cf995efc4df2","HUMAN PRESCRIPTION DRUG","Caspofungin Acetate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20171029","","ANDA","ANDA207092","Gland Pharma Limited","5","mg/mL","","N","20251231"
"6410","CASPOFUNGIN ACETATE","Caspofungin Acetate","68083015901","Echinocandin Antifungal [EPC], Lipopeptides [CS]","68083-159","68083-159-01","68083-159_0ebc13ad-ba33-408f-8af3-cf995efc4df2","HUMAN PRESCRIPTION DRUG","Caspofungin Acetate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20171029","","ANDA","ANDA207092","Gland Pharma Limited","7","mg/mL","","N","20251231"
"6411","POLYMYXIN B SULFATE","POLYMYXIN B SULFATE","68083017410","Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68083-174","68083-174-10","68083-174_0f89d7be-ad20-46d1-8cce-0cee8ee572cf","HUMAN PRESCRIPTION DRUG","POLYMYXIN B","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC","20160601","","ANDA","ANDA207322","Gland Pharma Limited","500000","[USP'U]/1","","N","20261231"
"6412","AZITHROMYCIN MONOHYDRATE","Azithromycin monohydrate","68083019910","Macrolide Antimicrobial [EPC], Macrolides [CS]","68083-199","68083-199-10","68083-199_d0a507c6-cb4b-4295-bf17-48bb8e4b03f3","HUMAN PRESCRIPTION DRUG","Azithromycin monohydrate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20091109","","ANDA","ANDA065501","Gland Pharma Limited","500","mg/10mL","","N","20251231"
"6413","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin Ophthalmic","68083021001","Quinolone Antimicrobial [EPC], Quinolones [CS]","68083-210","68083-210-01","68083-210_1762525e-0af9-445f-ab67-00bfa954dc7d","HUMAN PRESCRIPTION DRUG","Moxifloxacin Ophthalmic Solution","","SOLUTION/ DROPS","OPHTHALMIC","20200330","","ANDA","ANDA208778","Gland Pharma Limited","5","mg/mL","","N","20251231"
"6414","TOBRAMYCIN SULFATE","Tobramycin","68083024101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","68083-241","68083-241-01","68083-241_7dec68fc-8f9a-4a26-9578-81bb22a5a1b5","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION","INTRAVENOUS","20210209","","ANDA","ANDA209346","Gland Pharma Limited","40","mg/mL","","N","20251231"
"6415","TOBRAMYCIN SULFATE","Tobramycin","68083025325","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","68083-253","68083-253-25","68083-253_5af7f80d-4d6d-404f-9ff7-1a8315625d8b","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION","INTRAMUSCULAR; INTRAVENOUS","20210211","","ANDA","ANDA209621","Gland Pharma Limited","10","mg/mL","","N","20251231"
"6416","TOBRAMYCIN SULFATE","Tobramycin","68083025425","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","68083-254","68083-254-25","68083-254_5af7f80d-4d6d-404f-9ff7-1a8315625d8b","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION","INTRAMUSCULAR; INTRAVENOUS","20210211","","ANDA","ANDA209621","Gland Pharma Limited","40","mg/mL","","N","20251231"
"6417","TOBRAMYCIN SULFATE","Tobramycin","68083031206","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","68083-312","68083-312-06","68083-312_a13f2109-eb69-4d3a-9203-790cb6520e78","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210518","","ANDA","ANDA211189","Gland Pharma Limited","1.2","g/30mL","","N","20251231"
"6418","VORICONAZOLE","Voriconazole","68083032101","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68083-321","68083-321-01","68083-321_0060b9ef-ec03-4b6f-b525-90741a5fb86f","HUMAN PRESCRIPTION DRUG","Voriconazole","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200331","","ANDA","ANDA211099","Gland Pharma Limited","10","mg/mL","","N","20261231"
"6419","ERTAPENEM SODIUM","Ertapenem Sodium","68083035110","Carbapenems [CS], Penem Antibacterial [EPC]","68083-351","68083-351-10","68083-351_71422270-6a76-40e5-bd89-643b8b2fafd5","HUMAN PRESCRIPTION DRUG","Ertapenem","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20210326","","ANDA","ANDA212040","Gland Pharma Limited","1","g/1","","N","20251231"
"6420","METRONIDAZOLE","Metronidazole","68083037304","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68083-373","68083-373-04","68083-373_156e85a5-b0f3-4f08-84d9-3ec4d6fffa93","HUMAN PRESCRIPTION DRUG","Metronidazole","","INJECTION, SOLUTION","INTRAVENOUS","20200803","","ANDA","ANDA212435","Gland Pharma Limited","500","mg/100mL","","N","20251231"
"6421","TOBRAMYCIN","Tobramycin","68083037401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","68083-374","68083-374-01","68083-374_f43b227e-3e24-428d-bef1-4f32628a786e","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION/ DROPS","OPHTHALMIC","20210309","","ANDA","ANDA212628","Gland Pharma Limited","3","mg/mL","","N","20251231"
"6422","ERYTHROMYCIN LACTOBIONATE","erythromycin lactobionate","68083051310","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","68083-513","68083-513-10","68083-513_62d03a60-5432-4fa9-a4bb-e14276b78b47","HUMAN PRESCRIPTION DRUG","erythromycin lactobionate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20241119","","ANDA","ANDA216761","Gland Pharma Limited","500","mg/10mL","","N","20251231"
"6423","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","68083056901","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","68083-569","68083-569-01","68083-569_c45949e7-eaef-4e97-8a8e-9134855ee6a4","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230606","","ANDA","ANDA205694","Gland Pharma Limited","5","g/100mL","","N","20251231"
"6424","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","68083057001","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","68083-570","68083-570-01","68083-570_c45949e7-eaef-4e97-8a8e-9134855ee6a4","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230606","","ANDA","ANDA205694","Gland Pharma Limited","10","g/100mL","","N","20251231"
"6425","POSACONAZOLE","posaconazole","68083057701","Azole Antifungal [EPC], Azoles [CS]","68083-577","68083-577-01","68083-577_dea5abae-8195-49f7-89bb-2e624208abf0","HUMAN PRESCRIPTION DRUG","posaconazole","","INJECTION, SOLUTION","INTRAVENOUS","20231226","","ANDA","ANDA217553","Gland Pharma Limited","18","mg/mL","","N","20251231"
"6426","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","68083059510","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","68083-595","68083-595-10","68083-595_16f3240c-d1ce-4407-ad09-565915a13805","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20250321","","ANDA","ANDA218140","Gland Pharma Limited","750","mg/1","","N","20261231"
"6427","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","68083059610","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","68083-596","68083-596-10","68083-596_16f3240c-d1ce-4407-ad09-565915a13805","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20250321","","ANDA","ANDA218140","Gland Pharma Limited","1.25","g/1","","N","20261231"
"6428","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","68083059710","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","68083-597","68083-597-10","68083-597_16f3240c-d1ce-4407-ad09-565915a13805","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20250321","","ANDA","ANDA218140","Gland Pharma Limited","1.5","g/1","","N","20261231"
"6429","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68084007001","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68084-070","68084-070-01","68084-070_181bf554-bab9-b287-e063-6294a90ac439","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040818","20250731","ANDA","ANDA076794","American Health Packaging","500","mg/1","","N",""
"6430","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68084024301","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68084-243","68084-243-01","68084-243_261d2129-bd2c-f895-e063-6394a90a8dd2","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20080502","","ANDA","ANDA065061","American Health Packaging","150","mg/1","","N","20251231"
"6431","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68084024401","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68084-244","68084-244-01","68084-244_261d2129-bd2c-f895-e063-6394a90a8dd2","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20080502","","ANDA","ANDA065061","American Health Packaging","300","mg/1","","N","20251231"
"6432","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","68084026901","Antimalarial [EPC], Antirheumatic Agent [EPC]","68084-269","68084-269-01","68084-269_1ea6084a-c32f-e654-e063-6394a90ad851","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20080903","","ANDA","ANDA040657","American Health Packaging","200","mg/1","","N","20251231"
"6433","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin Hydrochloride","68084072265","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68084-722","68084-722-65","68084-722_2b24dadc-fe4e-61dd-e063-6294a90a2a96","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride","","TABLET, FILM COATED","ORAL","20140319","","ANDA","ANDA202632","American Health Packaging","400","mg/1","","N","20261231"
"6434","FLUCONAZOLE","Fluconazole","68084072801","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68084-728","68084-728-01","68084-728_36e9e544-5912-2358-e063-6294a90a1ffb","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20141111","","ANDA","ANDA077731","American Health Packaging","100","mg/1","","N","20261231"
"6435","FLUCONAZOLE","Fluconazole","68084073501","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68084-735","68084-735-01","68084-735_36e9e544-5912-2358-e063-6294a90a1ffb","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140903","","ANDA","ANDA077731","American Health Packaging","200","mg/1","","N","20261231"
"6436","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir","68084096519","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","68084-965","68084-965-19","68084-965_22ca12d3-7404-28f7-e063-6394a90a94bf","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET, FILM COATED","ORAL","20150107","","ANDA","ANDA203511","American Health Packaging","450","mg/1","","N","20251231"
"6437","VALGANCICLOVIR HYDROCHLORIDE","Valganciclovir","68084096525","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","68084-965","68084-965-25","68084-965_22ca12d3-7404-28f7-e063-6394a90a94bf","HUMAN PRESCRIPTION DRUG","Valganciclovir","","TABLET, FILM COATED","ORAL","20150107","","ANDA","ANDA203511","American Health Packaging","450","mg/1","","N","20251231"
"6438","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","68094069030","Macrolide Antimicrobial [EPC], Macrolides [CS]","68094-690","68094-690-30","68094-690_5d373887-5ca3-4911-bd76-0ff51141df5f","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA207566","Precision Dose, Inc.","600","mg/1","","N","20251231"
"6439","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","68094079903","Macrolide Antimicrobial [EPC], Macrolides [CS]","68094-799","68094-799-03","68094-799_80a40f4b-1a43-40a6-9d26-fb41e78249e6","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","Precision Dose, Inc.","500","mg/1","","N","20251231"
"6440","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","68094079909","Macrolide Antimicrobial [EPC], Macrolides [CS]","68094-799","68094-799-09","68094-799_80a40f4b-1a43-40a6-9d26-fb41e78249e6","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","Precision Dose, Inc.","500","mg/1","","N","20251231"
"6441","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","68094079950","Macrolide Antimicrobial [EPC], Macrolides [CS]","68094-799","68094-799-50","68094-799_80a40f4b-1a43-40a6-9d26-fb41e78249e6","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","Precision Dose, Inc.","500","mg/1","","N","20251231"
"6442","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","68094079930","Macrolide Antimicrobial [EPC], Macrolides [CS]","68094-799","68094-799-30","68094-799_80a40f4b-1a43-40a6-9d26-fb41e78249e6","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","Precision Dose, Inc.","500","mg/1","","N","20251231"
"6443","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","68094090018","Macrolide Antimicrobial [EPC], Macrolides [CS]","68094-900","68094-900-18","68094-900_3c497715-9e43-4842-9885-b245a1c72716","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208250","Precision Dose, Inc.","250","mg/1","","N","20251231"
"6444","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","68094090030","Macrolide Antimicrobial [EPC], Macrolides [CS]","68094-900","68094-900-30","68094-900_3c497715-9e43-4842-9885-b245a1c72716","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208250","Precision Dose, Inc.","250","mg/1","","N","20251231"
"6445","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","68094090050","Macrolide Antimicrobial [EPC], Macrolides [CS]","68094-900","68094-900-50","68094-900_3c497715-9e43-4842-9885-b245a1c72716","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208250","Precision Dose, Inc.","250","mg/1","","N","20251231"
"6446","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","68094090006","Macrolide Antimicrobial [EPC], Macrolides [CS]","68094-900","68094-900-06","68094-900_3c497715-9e43-4842-9885-b245a1c72716","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208250","Precision Dose, Inc.","250","mg/1","","N","20251231"
"6447","CEPHALEXIN","Cephalexin","68180012102","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-121","68180-121-02","68180-121_3a2a6351-6463-4947-b0b0-f91e3d12528d","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","Lupin Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"6448","CEPHALEXIN","Cephalexin","68180012101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-121","68180-121-01","68180-121_3a2a6351-6463-4947-b0b0-f91e3d12528d","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","Lupin Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"6449","CEPHALEXIN","Cephalexin","68180012201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-122","68180-122-01","68180-122_3a2a6351-6463-4947-b0b0-f91e3d12528d","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","Lupin Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6450","CEPHALEXIN","Cephalexin","68180012202","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-122","68180-122-02","68180-122_3a2a6351-6463-4947-b0b0-f91e3d12528d","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","Lupin Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6451","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","68180016613","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","68180-166","68180-166-13","68180-166_cf4678a5-2147-44e8-80c2-2a5c699140b6","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20150327","","ANDA","ANDA090439","Lupin Pharmaceuticals, Inc.","125","mg/1","","N","20251231"
"6452","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","68180016713","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","68180-167","68180-167-13","68180-167_cf4678a5-2147-44e8-80c2-2a5c699140b6","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20150327","","ANDA","ANDA090439","Lupin Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"6453","CEFADROXIL","Cefadroxil","68180018008","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-180","68180-180-08","68180-180_32a065b6-b366-4e6d-8905-d6a3d0b3dea3","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20080423","","ANDA","ANDA065392","Lupin Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6454","CEFADROXIL","Cefadroxil","68180018001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-180","68180-180-01","68180-180_32a065b6-b366-4e6d-8905-d6a3d0b3dea3","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20080423","","ANDA","ANDA065392","Lupin Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6455","CEFADROXIL","Cefadroxil","68180018102","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-181","68180-181-02","68180-181_065e9b84-375b-447d-88e8-6cfcd91bb585","HUMAN PRESCRIPTION DRUG","Cefadroxil","","POWDER, FOR SUSPENSION","ORAL","20080423","","ANDA","ANDA065396","Lupin Pharmaceuticals, Inc.","250","mg/5mL","","N","20261231"
"6456","CEFADROXIL","Cefadroxil","68180018202","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-182","68180-182-02","68180-182_065e9b84-375b-447d-88e8-6cfcd91bb585","HUMAN PRESCRIPTION DRUG","Cefadroxil","","POWDER, FOR SUSPENSION","ORAL","20080423","","ANDA","ANDA065396","Lupin Pharmaceuticals, Inc.","500","mg/5mL","","N","20261231"
"6457","CEFADROXIL","Cefadroxil","68180018203","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-182","68180-182-03","68180-182_065e9b84-375b-447d-88e8-6cfcd91bb585","HUMAN PRESCRIPTION DRUG","Cefadroxil","","POWDER, FOR SUSPENSION","ORAL","20080423","","ANDA","ANDA065396","Lupin Pharmaceuticals, Inc.","500","mg/5mL","","N","20261231"
"6458","CEFIXIME","CEFIXIME","68180040501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-405","68180-405-01","68180-405_ca18c22d-8cb9-42fc-8c60-b7515c611a9a","HUMAN PRESCRIPTION DRUG","CEFIXIME","","POWDER, FOR SUSPENSION","ORAL","20150424","","ANDA","ANDA065129","Lupin Pharmaceuticals, Inc.","100","mg/5mL","","N","20261231"
"6459","CEFIXIME","CEFIXIME","68180040703","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-407","68180-407-03","68180-407_ca18c22d-8cb9-42fc-8c60-b7515c611a9a","HUMAN PRESCRIPTION DRUG","CEFIXIME","","POWDER, FOR SUSPENSION","ORAL","20150424","","ANDA","ANDA065355","Lupin Pharmaceuticals, Inc.","200","mg/5mL","","N","20261231"
"6460","CEFIXIME","CEFIXIME","68180040704","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-407","68180-407-04","68180-407_ca18c22d-8cb9-42fc-8c60-b7515c611a9a","HUMAN PRESCRIPTION DRUG","CEFIXIME","","POWDER, FOR SUSPENSION","ORAL","20150424","","ANDA","ANDA065355","Lupin Pharmaceuticals, Inc.","200","mg/5mL","","N","20261231"
"6461","MOXIFLOXACIN HYDROCHLORIDE","MOXIFLOXACIN","68180042101","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68180-421","68180-421-01","68180-421_42db7e00-43ec-4fa6-9405-68cbcca5f79c","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN","","SOLUTION","OPHTHALMIC","20200213","","ANDA","ANDA204079","Lupin Pharmaceuticals, Inc.","5","mg/mL","","N","20261231"
"6462","MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE","Moxifloxacin","68180042201","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68180-422","68180-422-01","68180-422_f3245022-7db4-463a-a87c-550b4dc40201","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20170701","","ANDA","ANDA202867","Lupin Pharmaceuticals, Inc.","5","mg/mL","","N","20261231"
"6463","CEFIXIME","CEFIXIME","68180042308","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-423","68180-423-08","68180-423_ca18c22d-8cb9-42fc-8c60-b7515c611a9a","HUMAN PRESCRIPTION DRUG","CEFIXIME","","CAPSULE","ORAL","20201014","","NDA AUTHORIZED GENERIC","NDA203195","Lupin Pharmaceuticals, Inc.","400","mg/1","","N","20261231"
"6464","CEFIXIME","CEFIXIME","68180042311","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-423","68180-423-11","68180-423_ca18c22d-8cb9-42fc-8c60-b7515c611a9a","HUMAN PRESCRIPTION DRUG","CEFIXIME","","CAPSULE","ORAL","20201014","","NDA AUTHORIZED GENERIC","NDA203195","Lupin Pharmaceuticals, Inc.","400","mg/1","","N","20261231"
"6465","CEPHALEXIN","Cephalexin","68180044001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-440","68180-440-01","68180-440_c1f68e09-52db-4024-ac7b-e2fa4c9bda81","HUMAN PRESCRIPTION DRUG","cephalexin","","FOR SUSPENSION","ORAL","20170821","","ANDA","ANDA065234","Lupin Pharmaceuticals, Inc.","125","mg/5mL","","N","20261231"
"6466","CEPHALEXIN","Cephalexin","68180044002","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-440","68180-440-02","68180-440_c1f68e09-52db-4024-ac7b-e2fa4c9bda81","HUMAN PRESCRIPTION DRUG","cephalexin","","FOR SUSPENSION","ORAL","20170821","","ANDA","ANDA065234","Lupin Pharmaceuticals, Inc.","125","mg/5mL","","N","20261231"
"6467","CEPHALEXIN","Cephalexin","68180044102","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-441","68180-441-02","68180-441_c1f68e09-52db-4024-ac7b-e2fa4c9bda81","HUMAN PRESCRIPTION DRUG","cephalexin","","FOR SUSPENSION","ORAL","20170906","","ANDA","ANDA065234","Lupin Pharmaceuticals, Inc.","250","mg/5mL","","N","20261231"
"6468","CEPHALEXIN","Cephalexin","68180044101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-441","68180-441-01","68180-441_c1f68e09-52db-4024-ac7b-e2fa4c9bda81","HUMAN PRESCRIPTION DRUG","cephalexin","","FOR SUSPENSION","ORAL","20170906","","ANDA","ANDA065234","Lupin Pharmaceuticals, Inc.","250","mg/5mL","","N","20261231"
"6469","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","68180054502","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","68180-545","68180-545-02","68180-545_2477710a-751b-4c38-be9e-fe77a8faed7a","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20181129","","ANDA","ANDA208205","Lupin Pharmaceuticals, Inc.","100000; 1","[USP'U]/g; mg/g","","N","20261231"
"6470","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","68180054503","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","68180-545","68180-545-03","68180-545_2477710a-751b-4c38-be9e-fe77a8faed7a","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20181129","","ANDA","ANDA208205","Lupin Pharmaceuticals, Inc.","100000; 1","[USP'U]/g; mg/g","","N","20261231"
"6471","QUININE SULFATE","QUININE SULFATE","68180056006","Antimalarial [EPC]","68180-560","68180-560-06","68180-560_783df888-cee2-442a-82ba-094261bf657f","HUMAN PRESCRIPTION DRUG","QUININE SULFATE","","CAPSULE","ORAL","20150804","","ANDA","ANDA203112","Lupin Pharmaceuticals, Inc.","324","mg/1","","N","20261231"
"6472","RIFAMPIN","rifampin","68180065806","Rifamycin Antibacterial [EPC], Rifamycins [CS]","68180-658","68180-658-06","68180-658_3cf425be-9523-4985-8b04-642d4301eca0","HUMAN PRESCRIPTION DRUG","rifampin","","CAPSULE","ORAL","20140108","","ANDA","ANDA090034","Lupin Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"6473","RIFAMPIN","rifampin","68180065907","Rifamycin Antibacterial [EPC], Rifamycins [CS]","68180-659","68180-659-07","68180-659_3cf425be-9523-4985-8b04-642d4301eca0","HUMAN PRESCRIPTION DRUG","rifampin","","CAPSULE","ORAL","20140108","","ANDA","ANDA090034","Lupin Pharmaceuticals, Inc.","300","mg/1","","N","20261231"
"6474","RIFAMPIN","rifampin","68180065906","Rifamycin Antibacterial [EPC], Rifamycins [CS]","68180-659","68180-659-06","68180-659_3cf425be-9523-4985-8b04-642d4301eca0","HUMAN PRESCRIPTION DRUG","rifampin","","CAPSULE","ORAL","20140108","","ANDA","ANDA090034","Lupin Pharmaceuticals, Inc.","300","mg/1","","N","20261231"
"6475","CEFDINIR","Cefdinir","68180071160","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-711","68180-711-60","68180-711_c291d40a-1731-44be-8be1-bd6fafc15299","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20060530","","ANDA","ANDA065264","Lupin Pharmaceuticals, Inc.","300","mg/1","","N","20261231"
"6476","CEFDINIR","Cefdinir","68180072204","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-722","68180-722-04","68180-722_aa8c2254-7124-437a-b691-010c18c8c80e","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20060531","","ANDA","ANDA065259","Lupin Pharmaceuticals, Inc.","125","mg/5mL","","N","20261231"
"6477","CEFDINIR","Cefdinir","68180072205","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-722","68180-722-05","68180-722_aa8c2254-7124-437a-b691-010c18c8c80e","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20060531","","ANDA","ANDA065259","Lupin Pharmaceuticals, Inc.","125","mg/5mL","","N","20261231"
"6478","CEFDINIR","Cefdinir","68180072304","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-723","68180-723-04","68180-723_aa8c2254-7124-437a-b691-010c18c8c80e","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070507","","ANDA","ANDA065259","Lupin Pharmaceuticals, Inc.","250","mg/5mL","","N","20261231"
"6479","CEFDINIR","Cefdinir","68180072305","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68180-723","68180-723-05","68180-723_aa8c2254-7124-437a-b691-010c18c8c80e","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070507","","ANDA","ANDA065259","Lupin Pharmaceuticals, Inc.","250","mg/5mL","","N","20261231"
"6480","AZITHROMYCIN DIHYDRATE","azithromycin","68180086106","Macrolide Antimicrobial [EPC], Macrolides [CS]","68180-861","68180-861-06","68180-861_57d21767-d5a3-4c14-a10a-9ecfa5be2aa5","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20221117","","ANDA","ANDA065398","Lupin Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"6481","AZITHROMYCIN DIHYDRATE","azithromycin","68180086111","Macrolide Antimicrobial [EPC], Macrolides [CS]","68180-861","68180-861-11","68180-861_57d21767-d5a3-4c14-a10a-9ecfa5be2aa5","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20221117","","ANDA","ANDA065398","Lupin Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"6482","AZITHROMYCIN DIHYDRATE","azithromycin","68180086206","Macrolide Antimicrobial [EPC], Macrolides [CS]","68180-862","68180-862-06","68180-862_57d21767-d5a3-4c14-a10a-9ecfa5be2aa5","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20150818","","ANDA","ANDA065399","Lupin Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6483","AZITHROMYCIN DIHYDRATE","azithromycin","68180086211","Macrolide Antimicrobial [EPC], Macrolides [CS]","68180-862","68180-862-11","68180-862_57d21767-d5a3-4c14-a10a-9ecfa5be2aa5","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20150818","","ANDA","ANDA065399","Lupin Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6484","AZITHROMYCIN DIHYDRATE","azithromycin","68180086306","Macrolide Antimicrobial [EPC], Macrolides [CS]","68180-863","68180-863-06","68180-863_821a327e-282e-411a-9c3f-0866e90f05af","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20221117","","ANDA","ANDA065400","Lupin Pharmaceuticals, Inc.","600","mg/1","","N","20261231"
"6485","TOBRAMYCIN","Tobramycin","68180096256","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","68180-962","68180-962-56","68180-962_e6e150b5-807d-425e-96f8-345c2a56ee8e","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","RESPIRATORY (INHALATION)","20180612","","ANDA","ANDA208964","Lupin Pharmaceuticals, Inc.","300","mg/5mL","","N","20261231"
"6486","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","68196040021","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68196-400","68196-400-21","68196-400_218dba30-8aa5-4e64-81c5-8a0be537b348","HUMAN OTC DRUG","Members Mark Triple Antibiotic","","OINTMENT","TOPICAL","20240905","","OTC MONOGRAPH DRUG","M004","Sam's West Inc","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"6487","NYSTATIN","Nystatin","68308015215","Polyene Antifungal [EPC], Polyenes [CS]","68308-152","68308-152-15","68308-152_9bd397a3-24b8-4420-9adb-9917a8d6b233","HUMAN PRESCRIPTION DRUG","Nystatin","","POWDER","TOPICAL","20040715","","ANDA","ANDA065203","Mayne Pharma Inc.","100000","[USP'U]/g","","N","20251231"
"6488","NYSTATIN","Nystatin","68308015230","Polyene Antifungal [EPC], Polyenes [CS]","68308-152","68308-152-30","68308-152_9bd397a3-24b8-4420-9adb-9917a8d6b233","HUMAN PRESCRIPTION DRUG","Nystatin","","POWDER","TOPICAL","20040715","","ANDA","ANDA065203","Mayne Pharma Inc.","100000","[USP'U]/g","","N","20251231"
"6489","NYSTATIN","Nystatin","68308015260","Polyene Antifungal [EPC], Polyenes [CS]","68308-152","68308-152-60","68308-152_9bd397a3-24b8-4420-9adb-9917a8d6b233","HUMAN PRESCRIPTION DRUG","Nystatin","","POWDER","TOPICAL","20040715","","ANDA","ANDA065203","Mayne Pharma Inc.","100000","[USP'U]/g","","N","20251231"
"6490","ERYTHROMYCIN","erythromycin","68308025010","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","68308-250","68308-250-10","68308-250_e3b51258-b7cf-4198-b841-72ee6704e8a5","HUMAN PRESCRIPTION DRUG","erythromycin","","CAPSULE, DELAYED RELEASE PELLETS","ORAL","20130729","","NDA AUTHORIZED GENERIC","NDA050536","Mayne Pharma Inc.","250","mg/1","","N","20251231"
"6491","METRONIDAZOLE","metronidazole","68308066360","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68308-663","68308-663-60","68308-663_a5dc0ad6-1b71-45f9-b00b-cac2f5e2a26b","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20231110","","NDA AUTHORIZED GENERIC","NDA021789","Mayne Pharma Inc.","10","mg/g","","N","20261231"
"6492","METRONIDAZOLE","metronidazole","68308066355","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68308-663","68308-663-55","68308-663_a5dc0ad6-1b71-45f9-b00b-cac2f5e2a26b","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20231110","","NDA AUTHORIZED GENERIC","NDA021789","Mayne Pharma Inc.","10","mg/g","","N","20261231"
"6493","METRONIDAZOLE","METRONIDAZOLE","68308071145","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68308-711","68308-711-45","68308-711_944575da-eb42-40dc-9dfe-8ee02bba38f1","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","CREAM","TOPICAL","20250519","","NDA AUTHORIZED GENERIC","NDA020531","Mayne Pharma Inc.","7.5","mg/g","","N","20261231"
"6494","METRONIDAZOLE","metronidazole","68308071259","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68308-712","68308-712-59","68308-712_0860a994-4d9d-4cac-a08c-fecb2ecbbacb","HUMAN PRESCRIPTION DRUG","metronidazole","","LOTION","TOPICAL","20250210","","NDA AUTHORIZED GENERIC","NDA020901","Mayne Pharma Inc.","7.5","mg/g","","N","20261231"
"6495","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","68382009601","Antimalarial [EPC], Antirheumatic Agent [EPC]","68382-096","68382-096-01","68382-096_8b9ea8e4-c27b-4b81-b8d0-2d5eddcec21a","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Zydus Pharmaceuticals USA Inc.","200","mg/1","","N","20251231"
"6496","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","68382009605","Antimalarial [EPC], Antirheumatic Agent [EPC]","68382-096","68382-096-05","68382-096_8b9ea8e4-c27b-4b81-b8d0-2d5eddcec21a","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Zydus Pharmaceuticals USA Inc.","200","mg/1","","N","20251231"
"6497","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","68382009677","Antimalarial [EPC], Antirheumatic Agent [EPC]","68382-096","68382-096-77","68382-096_8b9ea8e4-c27b-4b81-b8d0-2d5eddcec21a","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Zydus Pharmaceuticals USA Inc.","200","mg/1","","N","20251231"
"6498","NYSTATIN","nystatin","68382037002","Polyene Antifungal [EPC], Polyenes [CS]","68382-370","68382-370-02","68382-370_7f7aaf27-0265-40b9-a900-341232347fad","HUMAN PRESCRIPTION DRUG","NYSTATIN","","POWDER","TOPICAL","20211006","","ANDA","ANDA208581","Zydus Pharmaceuticals USA Inc.","100000","[USP'U]/g","","N","20251231"
"6499","NYSTATIN","nystatin","68382037003","Polyene Antifungal [EPC], Polyenes [CS]","68382-370","68382-370-03","68382-370_7f7aaf27-0265-40b9-a900-341232347fad","HUMAN PRESCRIPTION DRUG","NYSTATIN","","POWDER","TOPICAL","20211006","","ANDA","ANDA208581","Zydus Pharmaceuticals USA Inc.","100000","[USP'U]/g","","N","20251231"
"6500","NYSTATIN","nystatin","68382037001","Polyene Antifungal [EPC], Polyenes [CS]","68382-370","68382-370-01","68382-370_7f7aaf27-0265-40b9-a900-341232347fad","HUMAN PRESCRIPTION DRUG","NYSTATIN","","POWDER","TOPICAL","20211006","","ANDA","ANDA208581","Zydus Pharmaceuticals USA Inc.","100000","[USP'U]/g","","N","20251231"
"6501","RIBAVIRIN","ribavirin","68382039504","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","68382-395","68382-395-04","68382-395_5b244567-d037-4fbd-9e2b-ed394e1c07b4","HUMAN PRESCRIPTION DRUG","RIBAVIRIN","","POWDER, FOR SOLUTION","RESPIRATORY (INHALATION)","20161215","","ANDA","ANDA207366","Zydus Pharmaceuticals USA Inc.","6","g/1","","N","20251231"
"6502","NITROFURANTOIN","nitrofurantoin macrocrystals","68382055910","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","68382-559","68382-559-10","68382-559_0d11f48c-867f-471c-a74c-9d50f6a76cfd","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Zydus Pharmaceuticals (USA) Inc.","50","mg/1","","N","20251231"
"6503","NITROFURANTOIN","nitrofurantoin macrocrystals","68382055930","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","68382-559","68382-559-30","68382-559_0d11f48c-867f-471c-a74c-9d50f6a76cfd","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Zydus Pharmaceuticals (USA) Inc.","50","mg/1","","N","20251231"
"6504","NITROFURANTOIN","nitrofurantoin macrocrystals","68382055901","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","68382-559","68382-559-01","68382-559_0d11f48c-867f-471c-a74c-9d50f6a76cfd","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Zydus Pharmaceuticals (USA) Inc.","50","mg/1","","N","20251231"
"6505","NITROFURANTOIN","nitrofurantoin macrocrystals","68382056001","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","68382-560","68382-560-01","68382-560_0d11f48c-867f-471c-a74c-9d50f6a76cfd","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Zydus Pharmaceuticals (USA) Inc.","100","mg/1","","N","20251231"
"6506","NITROFURANTOIN","nitrofurantoin macrocrystals","68382056030","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","68382-560","68382-560-30","68382-560_0d11f48c-867f-471c-a74c-9d50f6a76cfd","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Zydus Pharmaceuticals (USA) Inc.","100","mg/1","","N","20251231"
"6507","NITROFURANTOIN","nitrofurantoin macrocrystals","68382056010","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","68382-560","68382-560-10","68382-560_0d11f48c-867f-471c-a74c-9d50f6a76cfd","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Zydus Pharmaceuticals (USA) Inc.","100","mg/1","","N","20251231"
"6508","ITRACONAZOLE","itraconazole","68382069706","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","68382-697","68382-697-06","68382-697_d4524b32-b45b-4b9c-b709-a197ef0f3851","HUMAN PRESCRIPTION DRUG","itraconazole","","CAPSULE","ORAL","20180306","","ANDA","ANDA204672","Zydus Pharmaceuticals USA Inc.","100","mg/1","","N","20251231"
"6509","ITRACONAZOLE","itraconazole","68382069710","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","68382-697","68382-697-10","68382-697_d4524b32-b45b-4b9c-b709-a197ef0f3851","HUMAN PRESCRIPTION DRUG","itraconazole","","CAPSULE","ORAL","20180306","","ANDA","ANDA204672","Zydus Pharmaceuticals USA Inc.","100","mg/1","","N","20251231"
"6510","ITRACONAZOLE","itraconazole","68382069777","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","68382-697","68382-697-77","68382-697_d4524b32-b45b-4b9c-b709-a197ef0f3851","HUMAN PRESCRIPTION DRUG","itraconazole","","CAPSULE","ORAL","20180306","","ANDA","ANDA204672","Zydus Pharmaceuticals USA Inc.","100","mg/1","","N","20251231"
"6511","ITRACONAZOLE","itraconazole","68382069701","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","68382-697","68382-697-01","68382-697_d4524b32-b45b-4b9c-b709-a197ef0f3851","HUMAN PRESCRIPTION DRUG","itraconazole","","CAPSULE","ORAL","20180306","","ANDA","ANDA204672","Zydus Pharmaceuticals USA Inc.","100","mg/1","","N","20251231"
"6512","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","68382089206","Macrolide Antimicrobial [EPC], Macrolides [CS]","68382-892","68382-892-06","68382-892_0e8b0786-c3c0-4d85-9bd4-43a87084e205","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","TABLET","ORAL","20250612","20250725","ANDA","ANDA213275","Zydus Pharmaceuticals USA Inc.","250","mg/1","","N",""
"6513","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","68382089285","Macrolide Antimicrobial [EPC], Macrolides [CS]","68382-892","68382-892-85","68382-892_0e8b0786-c3c0-4d85-9bd4-43a87084e205","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","TABLET","ORAL","20250612","20250725","ANDA","ANDA213275","Zydus Pharmaceuticals USA Inc.","250","mg/1","","N",""
"6514","AZITHROMYCIN DIHYDRATE","Azithromycin","68382089306","Macrolide Antimicrobial [EPC], Macrolides [CS]","68382-893","68382-893-06","68382-893_f7867e09-5f0f-4a56-b3e5-0c213be514c3","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET","ORAL","20250612","20250725","ANDA","ANDA213056","Zydus Pharmaceuticals USA Inc.","500","mg/1","","N",""
"6515","AZITHROMYCIN DIHYDRATE","Azithromycin","68382089383","Macrolide Antimicrobial [EPC], Macrolides [CS]","68382-893","68382-893-83","68382-893_f7867e09-5f0f-4a56-b3e5-0c213be514c3","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET","ORAL","20250612","20250725","ANDA","ANDA213056","Zydus Pharmaceuticals USA Inc.","500","mg/1","","N",""
"6516","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","68391020716","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68391-207","68391-207-16","68391-207_8408e983-c26a-4fd2-aabb-7d5caa68587b","HUMAN OTC DRUG","berkley and jensen triple antibiotic","","OINTMENT","TOPICAL","20141030","","OTC MONOGRAPH DRUG","M004","BJWC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"6517","FLUCONAZOLE","Fluconazole","68462010110","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68462-101","68462-101-10","68462-101_f73f1503-dd8b-4c95-8013-ed5b5aeab8b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20060125","","ANDA","ANDA077253","Glenmark Pharmaceuticals Inc., USA","50","mg/1","","N","20251231"
"6518","FLUCONAZOLE","Fluconazole","68462010130","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68462-101","68462-101-30","68462-101_f73f1503-dd8b-4c95-8013-ed5b5aeab8b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20060125","","ANDA","ANDA077253","Glenmark Pharmaceuticals Inc., USA","50","mg/1","","N","20251231"
"6519","FLUCONAZOLE","Fluconazole","68462010230","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68462-102","68462-102-30","68462-102_f73f1503-dd8b-4c95-8013-ed5b5aeab8b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20060125","","ANDA","ANDA077253","Glenmark Pharmaceuticals Inc., USA","100","mg/1","","N","20251231"
"6520","FLUCONAZOLE","Fluconazole","68462010210","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68462-102","68462-102-10","68462-102_f73f1503-dd8b-4c95-8013-ed5b5aeab8b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20060125","","ANDA","ANDA077253","Glenmark Pharmaceuticals Inc., USA","100","mg/1","","N","20251231"
"6521","FLUCONAZOLE","Fluconazole","68462010430","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68462-104","68462-104-30","68462-104_f73f1503-dd8b-4c95-8013-ed5b5aeab8b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20060125","","ANDA","ANDA077253","Glenmark Pharmaceuticals Inc., USA","200","mg/1","","N","20251231"
"6522","FLUCONAZOLE","Fluconazole","68462010410","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68462-104","68462-104-10","68462-104_f73f1503-dd8b-4c95-8013-ed5b5aeab8b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20060125","","ANDA","ANDA077253","Glenmark Pharmaceuticals Inc., USA","200","mg/1","","N","20251231"
"6523","FLUCONAZOLE","Fluconazole","68462011940","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68462-119","68462-119-40","68462-119_f73f1503-dd8b-4c95-8013-ed5b5aeab8b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20201120","","ANDA","ANDA077253","Glenmark Pharmaceuticals Inc., USA","150","mg/1","","N","20251231"
"6524","FLUCONAZOLE","Fluconazole","68462011944","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68462-119","68462-119-44","68462-119_f73f1503-dd8b-4c95-8013-ed5b5aeab8b3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20201120","","ANDA","ANDA077253","Glenmark Pharmaceuticals Inc., USA","150","mg/1","","N","20251231"
"6525","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68462014201","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68462-142","68462-142-01","68462-142_b56e38e4-da91-4433-a18c-a35ce9c5c465","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","GLENMARK PHARMACEUTICALS INC., USA","75","mg/1","","N","20251231"
"6526","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68462014301","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68462-143","68462-143-01","68462-143_b56e38e4-da91-4433-a18c-a35ce9c5c465","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","GLENMARK PHARMACEUTICALS INC., USA","150","mg/1","","N","20251231"
"6527","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68462014305","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68462-143","68462-143-05","68462-143_b56e38e4-da91-4433-a18c-a35ce9c5c465","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","GLENMARK PHARMACEUTICALS INC., USA","150","mg/1","","N","20251231"
"6528","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68462014401","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68462-144","68462-144-01","68462-144_b56e38e4-da91-4433-a18c-a35ce9c5c465","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","GLENMARK PHARMACEUTICALS INC., USA","300","mg/1","","N","20251231"
"6529","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68462014481","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68462-144","68462-144-81","68462-144_b56e38e4-da91-4433-a18c-a35ce9c5c465","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","GLENMARK PHARMACEUTICALS INC., USA","300","mg/1","","N","20251231"
"6530","MUPIROCIN","Mupirocin","68462018022","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","68462-180","68462-180-22","68462-180_548852be-c664-4193-8a01-ad60ac6a9460","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20110608","","ANDA","ANDA090480","Glenmark Pharmaceuticals Inc., USA","20","mg/g","","N","20251231"
"6531","CLOTRIMAZOLE","Clotrimazole","68462018117","Azole Antifungal [EPC], Azoles [CS]","68462-181","68462-181-17","68462-181_487b2001-756b-4446-aafa-b9b1e523833e","HUMAN PRESCRIPTION DRUG","Clotrimazole","","CREAM","TOPICAL","20100804","","ANDA","ANDA090219","Glenmark Pharmaceuticals Inc., USA","10","mg/g","","N","20251231"
"6532","CLOTRIMAZOLE","Clotrimazole","68462018135","Azole Antifungal [EPC], Azoles [CS]","68462-181","68462-181-35","68462-181_487b2001-756b-4446-aafa-b9b1e523833e","HUMAN PRESCRIPTION DRUG","Clotrimazole","","CREAM","TOPICAL","20100804","","ANDA","ANDA090219","Glenmark Pharmaceuticals Inc., USA","10","mg/g","","N","20251231"
"6533","CLOTRIMAZOLE","Clotrimazole","68462018147","Azole Antifungal [EPC], Azoles [CS]","68462-181","68462-181-47","68462-181_487b2001-756b-4446-aafa-b9b1e523833e","HUMAN PRESCRIPTION DRUG","Clotrimazole","","CREAM","TOPICAL","20100804","","ANDA","ANDA090219","Glenmark Pharmaceuticals Inc., USA","10","mg/g","","N","20251231"
"6534","CLOTRIMAZOLE","Clotrimazole","68462018148","Azole Antifungal [EPC], Azoles [CS]","68462-181","68462-181-48","68462-181_487b2001-756b-4446-aafa-b9b1e523833e","HUMAN PRESCRIPTION DRUG","Clotrimazole","","CREAM","TOPICAL","20100804","","ANDA","ANDA090219","Glenmark Pharmaceuticals Inc., USA","10","mg/g","","N","20251231"
"6535","METRONIDAZOLE","Metronidazole","68462018449","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68462-184","68462-184-49","68462-184_88fe7a8e-5faa-4065-a56c-775f367742a0","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","VAGINAL","20220127","","ANDA","ANDA215794","GLENMARK PHARMACEUTICALS INC., USA","7.5","mg/g","","N","20251231"
"6536","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","68462029817","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","68462-298","68462-298-17","68462-298_2fc6dcb9-879f-4d6e-8194-4a30af922986","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20151106","","ANDA","ANDA202894","Glenmark Pharmaceuticals Inc. USA",".5; 10","mg/g; mg/g","","N","20251231"
"6537","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","68462029855","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","68462-298","68462-298-55","68462-298_2fc6dcb9-879f-4d6e-8194-4a30af922986","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20151106","","ANDA","ANDA202894","Glenmark Pharmaceuticals Inc. USA",".5; 10","mg/g; mg/g","","N","20251231"
"6538","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","68462031417","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","68462-314","68462-314-17","68462-314_39b52cdc-3387-4aac-9a01-e4c6ae68f282","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20161024","","ANDA","ANDA208136","Glenmark Pharmaceuticals Inc., USA","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"6539","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","68462031435","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","68462-314","68462-314-35","68462-314_39b52cdc-3387-4aac-9a01-e4c6ae68f282","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20161024","","ANDA","ANDA208136","Glenmark Pharmaceuticals Inc., USA","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"6540","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","68462031465","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","68462-314","68462-314-65","68462-314_39b52cdc-3387-4aac-9a01-e4c6ae68f282","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20161024","","ANDA","ANDA208136","Glenmark Pharmaceuticals Inc., USA","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"6541","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","Atovaquone and Proguanil Hydrochloride Pediatric","68462040201","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","68462-402","68462-402-01","68462-402_822b0bad-700b-4e88-8c10-7492bc8b1e1d","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil Hydrochloride Pediatric","","TABLET, FILM COATED","ORAL","20150408","","ANDA","ANDA091211","Glenmark Pharmaceuticals Inc.,USA","62.5; 25","mg/1; mg/1","","N","20251231"
"6542","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","Atovaquone and Proguanil Hydrochloride","68462040467","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","68462-404","68462-404-67","68462-404_822b0bad-700b-4e88-8c10-7492bc8b1e1d","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil Hydrochloride","","TABLET, FILM COATED","ORAL","20110915","","ANDA","ANDA091211","Glenmark Pharmaceuticals Inc.,USA","250; 100","mg/1; mg/1","","N","20251231"
"6543","ATOVAQUONE; PROGUANIL HYDROCHLORIDE","Atovaquone and Proguanil Hydrochloride","68462040401","Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]","68462-404","68462-404-01","68462-404_822b0bad-700b-4e88-8c10-7492bc8b1e1d","HUMAN PRESCRIPTION DRUG","Atovaquone and Proguanil Hydrochloride","","TABLET, FILM COATED","ORAL","20110915","","ANDA","ANDA091211","Glenmark Pharmaceuticals Inc.,USA","250; 100","mg/1; mg/1","","N","20251231"
"6544","ATOVAQUONE","atovaquone","68462042121","Antimalarial [EPC], Antiprotozoal [EPC]","68462-421","68462-421-21","68462-421_9084fbfb-e877-45a3-9126-58a03737adf8","HUMAN PRESCRIPTION DRUG","atovaquone","","SUSPENSION","ORAL","20171231","","ANDA","ANDA209685","Glenmark Pharmaceuticals Inc., USA","750","mg/5mL","","N","20251231"
"6545","ATOVAQUONE","atovaquone","68462042169","Antimalarial [EPC], Antiprotozoal [EPC]","68462-421","68462-421-69","68462-421_9084fbfb-e877-45a3-9126-58a03737adf8","HUMAN PRESCRIPTION DRUG","atovaquone","","SUSPENSION","ORAL","20171231","","ANDA","ANDA209685","Glenmark Pharmaceuticals Inc., USA","750","mg/5mL","","N","20251231"
"6546","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","68462047774","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","68462-477","68462-477-74","68462-477_2e834640-f900-471c-bb72-417ff6853404","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20250321","","ANDA","ANDA218140","GLENMARK PHARMACEUTICALS INC., USA","750","mg/1","","N","20261231"
"6547","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","68462047884","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","68462-478","68462-478-84","68462-478_2e834640-f900-471c-bb72-417ff6853404","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20250321","","ANDA","ANDA218140","GLENMARK PHARMACEUTICALS INC., USA","1.25","g/1","","N","20261231"
"6548","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","68462047984","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","68462-479","68462-479-84","68462-479_2e834640-f900-471c-bb72-417ff6853404","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20250321","","ANDA","ANDA218140","GLENMARK PHARMACEUTICALS INC., USA","1.5","g/1","","N","20261231"
"6549","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","clindamycin and benzoyl peroxide","68462048624","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68462-486","68462-486-24","68462-486_c014804c-8a69-496c-b151-67ccfbeb6aa3","HUMAN PRESCRIPTION DRUG","clindamycin and benzoyl peroxide","","GEL","TOPICAL","20190314","","ANDA","ANDA209252","Glenmark Pharmaceuticals Inc., USA","50; 10","mg/g; mg/g","","N","20251231"
"6550","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","clindamycin and benzoyl peroxide","68462048627","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68462-486","68462-486-27","68462-486_c014804c-8a69-496c-b151-67ccfbeb6aa3","HUMAN PRESCRIPTION DRUG","clindamycin and benzoyl peroxide","","GEL","TOPICAL","20190314","","ANDA","ANDA209252","Glenmark Pharmaceuticals Inc., USA","50; 10","mg/g; mg/g","","N","20251231"
"6551","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","clindamycin and benzoyl peroxide","68462048619","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68462-486","68462-486-19","68462-486_c014804c-8a69-496c-b151-67ccfbeb6aa3","HUMAN PRESCRIPTION DRUG","clindamycin and benzoyl peroxide","","GEL","TOPICAL","20190314","","ANDA","ANDA209252","Glenmark Pharmaceuticals Inc., USA","50; 10","mg/g; mg/g","","N","20251231"
"6552","MUPIROCIN CALCIUM","Mupirocin","68462056047","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","68462-560","68462-560-47","68462-560_dc6f3960-2e28-46f1-8619-de5aee5f97ad","HUMAN PRESCRIPTION DRUG","Pirnuo","","CREAM","TOPICAL","20170729","","ANDA","ANDA201587","Glenmark Pharmaceuticals Inc., USA","2","g/100g","","N","20251231"
"6553","MUPIROCIN CALCIUM","Mupirocin","68462056417","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","68462-564","68462-564-17","68462-564_4d903d30-cc63-4585-bb9c-70fe90da514c","HUMAN PRESCRIPTION DRUG","Mupirocin","","CREAM","TOPICAL","20130124","","ANDA","ANDA201587","Glenmark Pharmaceuticals Inc., USA","2","g/100g","","N","20251231"
"6554","MUPIROCIN CALCIUM","Mupirocin","68462056435","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","68462-564","68462-564-35","68462-564_4d903d30-cc63-4585-bb9c-70fe90da514c","HUMAN PRESCRIPTION DRUG","Mupirocin","","CREAM","TOPICAL","20130124","","ANDA","ANDA201587","Glenmark Pharmaceuticals Inc., USA","2","g/100g","","N","20251231"
"6555","VORICONAZOLE","voriconazole","68462057230","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68462-572","68462-572-30","68462-572_fdf20989-c176-4edb-b5e6-8fbf31a10b08","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20150904","","ANDA","ANDA203503","Glenmark Pharmaceuticals Inc., USA","50","mg/1","","N","20261231"
"6556","VORICONAZOLE","voriconazole","68462057290","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68462-572","68462-572-90","68462-572_fdf20989-c176-4edb-b5e6-8fbf31a10b08","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20150904","","ANDA","ANDA203503","Glenmark Pharmaceuticals Inc., USA","50","mg/1","","N","20261231"
"6557","VORICONAZOLE","voriconazole","68462057213","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68462-572","68462-572-13","68462-572_fdf20989-c176-4edb-b5e6-8fbf31a10b08","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20150904","","ANDA","ANDA203503","Glenmark Pharmaceuticals Inc., USA","50","mg/1","","N","20261231"
"6558","VORICONAZOLE","voriconazole","68462057313","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68462-573","68462-573-13","68462-573_fdf20989-c176-4edb-b5e6-8fbf31a10b08","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20150904","","ANDA","ANDA203503","Glenmark Pharmaceuticals Inc., USA","200","mg/1","","N","20261231"
"6559","VORICONAZOLE","voriconazole","68462057390","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68462-573","68462-573-90","68462-573_fdf20989-c176-4edb-b5e6-8fbf31a10b08","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20150904","","ANDA","ANDA203503","Glenmark Pharmaceuticals Inc., USA","200","mg/1","","N","20261231"
"6560","VORICONAZOLE","voriconazole","68462057330","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68462-573","68462-573-30","68462-573_fdf20989-c176-4edb-b5e6-8fbf31a10b08","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20150904","","ANDA","ANDA203503","Glenmark Pharmaceuticals Inc., USA","200","mg/1","","N","20261231"
"6561","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","68462060527","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68462-605","68462-605-27","68462-605_d0ec3e88-40d9-4919-afc3-cf2e7e863376","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","AEROSOL, FOAM","TOPICAL","20240123","","ANDA","ANDA210778","GLENMARK PHARMACEUTICALS INC., USA","10","mg/g","","N","20251231"
"6562","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","68462060594","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68462-605","68462-605-94","68462-605_d0ec3e88-40d9-4919-afc3-cf2e7e863376","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","AEROSOL, FOAM","TOPICAL","20240123","","ANDA","ANDA210778","GLENMARK PHARMACEUTICALS INC., USA","10","mg/g","","N","20251231"
"6563","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","68462079917","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","68462-799","68462-799-17","68462-799_1b44d0f9-1191-4cbc-aa20-4b66772f030d","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20160623","","ANDA","ANDA208300","Glenmark Pharmaceuticals Inc., USA","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"6564","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","68462079965","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","68462-799","68462-799-65","68462-799_1b44d0f9-1191-4cbc-aa20-4b66772f030d","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20160623","","ANDA","ANDA208300","Glenmark Pharmaceuticals Inc., USA","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"6565","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","68462079935","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","68462-799","68462-799-35","68462-799_1b44d0f9-1191-4cbc-aa20-4b66772f030d","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20160623","","ANDA","ANDA208300","Glenmark Pharmaceuticals Inc., USA","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"6566","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","clindamycin and benzoyl peroxide","68462085927","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68462-859","68462-859-27","68462-859_c014804c-8a69-496c-b151-67ccfbeb6aa3","HUMAN PRESCRIPTION DRUG","clindamycin and benzoyl peroxide","","GEL","TOPICAL","20210924","","ANDA","ANDA209252","Glenmark Pharmaceuticals Inc., USA","50; 10","mg/g; mg/g","","N","20251231"
"6567","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","clindamycin and benzoyl peroxide","68462085924","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68462-859","68462-859-24","68462-859_c014804c-8a69-496c-b151-67ccfbeb6aa3","HUMAN PRESCRIPTION DRUG","clindamycin and benzoyl peroxide","","GEL","TOPICAL","20210924","","ANDA","ANDA209252","Glenmark Pharmaceuticals Inc., USA","50; 10","mg/g; mg/g","","N","20251231"
"6568","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","68462086635","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68462-866","68462-866-35","68462-866_145aa545-3996-4b65-b3f3-8a31d88740af","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20210210","","ANDA","ANDA214251","GLENMARK PHARMACEUTICALS INC., USA","10","mg/g","","N","20251231"
"6569","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","68462086665","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68462-866","68462-866-65","68462-866_145aa545-3996-4b65-b3f3-8a31d88740af","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20210210","","ANDA","ANDA214251","GLENMARK PHARMACEUTICALS INC., USA","10","mg/g","","N","20251231"
"6570","POSACONAZOLE","posaconazole","68462090401","Azole Antifungal [EPC], Azoles [CS]","68462-904","68462-904-01","68462-904_a2ba0343-cd17-4b23-8356-005a1dfd0b35","HUMAN PRESCRIPTION DRUG","posaconazole","","INJECTION, SOLUTION","INTRAVENOUS","20231227","","ANDA","ANDA217553","GLENMARK PHARMACEUTICALS INC., USA","18","mg/mL","","N","20251231"
"6571","POSACONAZOLE","posaconazole","68462091101","Azole Antifungal [EPC], Azoles [CS]","68462-911","68462-911-01","68462-911_91f89a3b-2479-4d05-9997-7b0cfaa496ec","HUMAN PRESCRIPTION DRUG","posaconazole","","INJECTION, SOLUTION","INTRAVENOUS","20240701","","ANDA","ANDA217553","GLENMARK PHARMACEUTICALS INC., USA","18","mg/mL","","N","20251231"
"6572","RIBAVIRIN","ribavirin","68475000304","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","68475-003","68475-003-04","68475-003_76819c30-2ece-43cf-a329-6bc3720ac870","HUMAN PRESCRIPTION DRUG","RIBAVIRIN","","POWDER, FOR SOLUTION","RESPIRATORY (INHALATION)","20200421","","ANDA","ANDA207366","Navinta LLC","6","g/1","","N","20251231"
"6573","CEFTOBIPROLE MEDOCARIL SODIUM","ceftobiprole medocaril sodium","68547057810","Cephalosporin Antibacterial [EPC], Cephalosporins [CS], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]","68547-578","68547-578-10","68547-578_0dc6b4d3-e0fc-43cf-a0b5-afb3d232d70b","HUMAN PRESCRIPTION DRUG","ZEVTERA","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20250401","","NDA","NDA218275","La Jolla Pharmaceutical Company","667","mg/1","","N","20261231"
"6574","MICONAZOLE NITRATE","Miconazole Nitrate","68599020604","Azole Antifungal [EPC], Azoles [CS]","68599-0206","68599-0206-4","68599-0206_1acb3889-ffea-8cd2-e063-6394a90a3ecb","HUMAN OTC DRUG","Antifungal Body","","CREAM","TOPICAL","20170601","","OTC MONOGRAPH DRUG","M005","McKesson","2","mg/100mL","","N","20251231"
"6575","MICONAZOLE NITRATE","Miconazole Nitrate","68599020703","Azole Antifungal [EPC], Azoles [CS]","68599-0207","68599-0207-3","68599-0207_1adaf2c5-f6a7-7cde-e063-6294a90af8d6","HUMAN OTC DRUG","THERA Antifungal Body","","POWDER","TOPICAL","20110901","","OTC MONOGRAPH DRUG","M005","McKesson Medical-Surgical Inc.","20","mg/g","","N","20251231"
"6576","MICONAZOLE NITRATE","Antifungal","68599147104","Azole Antifungal [EPC], Azoles [CS]","68599-1471","68599-1471-4","68599-1471_2424691e-9201-a1b8-e063-6294a90a1cde","HUMAN OTC DRUG","Miconazole Nitrate","","CREAM","TOPICAL","20190725","","OTC MONOGRAPH DRUG","M005","McKesson","2","mg/100mg","","N","20251231"
"6577","SULFACETAMIDE SODIUM","Sodium sulfacetamide","68682001004","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","68682-010","68682-010-04","68682-010_4dcab06b-56fb-4e42-aae0-6e8840ddd80a","HUMAN PRESCRIPTION DRUG","Sodium sulfacetamide","","LOTION","TOPICAL","20151218","","NDA AUTHORIZED GENERIC","NDA019931","Oceanside Pharmaceuticals","100","mg/mL","","N","20251231"
"6578","RIBAVIRIN","Ribavirin","68682001901","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","68682-019","68682-019-01","68682-019_6b3c6edc-c735-46e0-9b31-fac85dda0992","HUMAN PRESCRIPTION DRUG","Ribavirin","","POWDER, FOR SOLUTION","RESPIRATORY (INHALATION)","20170414","","NDA","NDA018859","Oceanside Pharmaceuticals","6","g/1","","N","20251231"
"6579","RIBAVIRIN","Ribavirin","68682001906","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","68682-019","68682-019-06","68682-019_6b3c6edc-c735-46e0-9b31-fac85dda0992","HUMAN PRESCRIPTION DRUG","Ribavirin","","POWDER, FOR SOLUTION","RESPIRATORY (INHALATION)","20170414","","NDA","NDA018859","Oceanside Pharmaceuticals","6","g/1","","N","20251231"
"6580","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate and Benzoyl Peroxide","68682013250","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS]","68682-132","68682-132-50","68682-132_18705773-78c3-4eac-a1a7-f4ac6f667ef2","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Benzoyl Peroxide","","GEL","TOPICAL","20180702","","NDA AUTHORIZED GENERIC","NDA050819","Oceanside Pharmaceuticals","25; 10","mg/g; mg/g","","N","20251231"
"6581","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate and Benzoyl Peroxide","68682013350","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68682-133","68682-133-50","68682-133_c198435e-4173-42de-b599-5d2e24096b70","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Benzoyl Peroxide","","GEL","TOPICAL","20231002","","NDA AUTHORIZED GENERIC","NDA050819","Oceanside Pharmaceuticals","37.5; 10","mg/g; mg/g","","N","20251231"
"6582","METRONIDAZOLE","metronidazole","68682020260","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68682-202","68682-202-60","68682-202_0e74a7e8-92d3-4287-a130-b80624733587","HUMAN PRESCRIPTION DRUG","Metronidazole","","CREAM","TOPICAL","20230801","","NDA","NDA020743","Oceanside Pharmaceuticals","10","mg/60g","","N","20251231"
"6583","CLINDAMYCIN PHOSPHATE; TRETINOIN","clindamycin phosphate and tretinoin","68682030030","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Retinoid [EPC], Retinoids [CS]","68682-300","68682-300-30","68682-300_63b2e85d-8fe5-4f18-9e85-8492c49a7520","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate 1.2% and Tretinoin 0.025%","","GEL","TOPICAL","20200804","","NDA AUTHORIZED GENERIC","NDA050802","Oceanside Pharmaceuticals","12; .25","mg/g; mg/g","","N","20251231"
"6584","CLINDAMYCIN PHOSPHATE; TRETINOIN","clindamycin phosphate and tretinoin","68682030060","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Retinoid [EPC], Retinoids [CS]","68682-300","68682-300-60","68682-300_63b2e85d-8fe5-4f18-9e85-8492c49a7520","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate 1.2% and Tretinoin 0.025%","","GEL","TOPICAL","20200804","","NDA AUTHORIZED GENERIC","NDA050802","Oceanside Pharmaceuticals","12; .25","mg/g; mg/g","","N","20251231"
"6585","METRONIDAZOLE","metronidazole","68682045570","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68682-455","68682-455-70","68682-455_65a9e9bc-c5ac-401a-addf-2d83b0df83a8","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","VAGINAL","20150401","","NDA AUTHORIZED GENERIC","NDA020208","Oceanside Pharmaceuticals","7.5","mg/g","","N","20251231"
"6586","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","68682046275","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68682-462","68682-462-75","68682-462_26a50d53-3f57-a803-e063-6294a90ac355","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20180608","","NDA AUTHORIZED GENERIC","NDA050782","Oceanside Pharmaceuticals","10","mg/mL","","N","20251231"
"6587","LULICONAZOLE","LULICONAZOLE","68682085060","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA]","68682-850","68682-850-60","68682-850_c35b1d80-c764-4bf5-86e0-91ddb5ea4021","HUMAN PRESCRIPTION DRUG","LULICONAZOLE","","CREAM","TOPICAL","20180615","","NDA","NDA204153","Oceanside Pharmaceuticals","10","mg/g","","N","20251231"
"6588","CALCIUM FLUORIDE; CARBON DISULFIDE; MANGANESE; QUININE SULFATE; SALICYLIC ACID","Calc fluor, Carboneum sulph, Chininum sulph, Mang met, Salicylicum ac","68703032202","Antimalarial [EPC]","68703-322","68703-322-02","68703-322_2ab0f66a-fdaf-1f10-e063-6294a90af7bc","HUMAN OTC DRUG","EarStill","","LIQUID","ORAL","20190304","","UNAPPROVED HOMEOPATHIC","","Silver Star Brands","30; 6; 6; 6; 6","[hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL","","N","20261231"
"6589","CLOTRIMAZOLE","Clotrimazole","68747302404","Azole Antifungal [EPC], Azoles [CS]","68747-3024","68747-3024-4","68747-3024_22917ce2-7eec-9049-e063-6394a90a45ff","HUMAN OTC DRUG","Clotrimazole 1%","","CREAM","TOPICAL","20200304","","OTC MONOGRAPH DRUG","M005","Dabur India Limited","10","mg/g","","N","20251231"
"6590","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate","68747302503","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68747-3025","68747-3025-3","68747-3025_229170a3-ef9f-597d-e063-6394a90acf8b","HUMAN OTC DRUG","dabur","First Aid","OINTMENT","TOPICAL","20130517","","OTC MONOGRAPH DRUG","M004","Dabur India Limited","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"6591","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate","68747302504","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68747-3025","68747-3025-4","68747-3025_229170a3-ef9f-597d-e063-6394a90acf8b","HUMAN OTC DRUG","dabur","First Aid","OINTMENT","TOPICAL","20130517","","OTC MONOGRAPH DRUG","M004","Dabur India Limited","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"6592","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate","68747302505","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68747-3025","68747-3025-5","68747-3025_229170a3-ef9f-597d-e063-6394a90acf8b","HUMAN OTC DRUG","dabur","First Aid","OINTMENT","TOPICAL","20130517","","OTC MONOGRAPH DRUG","M004","Dabur India Limited","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"6593","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate","68747302502","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68747-3025","68747-3025-2","68747-3025_229170a3-ef9f-597d-e063-6394a90acf8b","HUMAN OTC DRUG","dabur","First Aid","OINTMENT","TOPICAL","20130517","","OTC MONOGRAPH DRUG","M004","Dabur India Limited","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"6594","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate","68786040028","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68786-400","68786-400-28","68786-400_350833d3-f96d-fbf4-e063-6394a90ae819","HUMAN OTC DRUG","SionBiotext Triple Antibiotic","","OINTMENT","TOPICAL","20250513","","OTC MONOGRAPH DRUG","M004","Sion Biotext Medical Ltd","400; .0035; 500","[USP'U]/g; g/g; [USP'U]/g","","N","20261231"
"6595","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788048301","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-0483","68788-0483-1","68788-0483_dfebfcec-e4d4-4f54-bbc0-ceeea5021742","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111107","","ANDA","ANDA201091","Preferred Pharmaceuticals, Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"6596","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788048307","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-0483","68788-0483-7","68788-0483_dfebfcec-e4d4-4f54-bbc0-ceeea5021742","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111107","","ANDA","ANDA201091","Preferred Pharmaceuticals, Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"6597","NYSTATIN","Nystatin","68788679206","Polyene Antifungal [EPC], Polyenes [CS]","68788-6792","68788-6792-6","68788-6792_a9c727ac-91a4-48cb-bfac-da6d79c241fd","HUMAN PRESCRIPTION DRUG","Nystatin","","SUSPENSION","ORAL","20161102","","ANDA","ANDA062512","Preferred Pharmaceuticals, Inc.","100000","[USP'U]/mL","","N","20251231"
"6598","POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","Polymyxin B Sulfate and Trimethoprim","68788692701","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68788-6927","68788-6927-1","68788-6927_93ef2c28-c068-4e06-ab26-62caabc766de","HUMAN PRESCRIPTION DRUG","Polymyxin B Sulfate and Trimethoprim","","SOLUTION","OPHTHALMIC","20180330","","ANDA","ANDA064211","Preferred Pharmacetucials Inc.","10000; 1","[USP'U]/mL; mg/mL","","N","20251231"
"6599","METRONIDAZOLE","Metronidazole","68788696001","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-6960","68788-6960-1","68788-6960_bc3d96de-11bb-466a-902d-4d690e78033a","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20170509","","ANDA","ANDA203458","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"6600","METRONIDAZOLE","Metronidazole","68788696002","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-6960","68788-6960-2","68788-6960_bc3d96de-11bb-466a-902d-4d690e78033a","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20170509","","ANDA","ANDA203458","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"6601","METRONIDAZOLE","Metronidazole","68788696004","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-6960","68788-6960-4","68788-6960_bc3d96de-11bb-466a-902d-4d690e78033a","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20170509","","ANDA","ANDA203458","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"6602","METRONIDAZOLE","Metronidazole","68788696006","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-6960","68788-6960-6","68788-6960_bc3d96de-11bb-466a-902d-4d690e78033a","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20170509","","ANDA","ANDA203458","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"6603","METRONIDAZOLE","Metronidazole","68788696005","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-6960","68788-6960-5","68788-6960_bc3d96de-11bb-466a-902d-4d690e78033a","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20170509","","ANDA","ANDA203458","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"6604","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68788712201","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68788-7122","68788-7122-1","68788-7122_c41276bf-e569-422f-9357-763190d46ed4","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20190114","","ANDA","ANDA090624","Preferred Pharmaceuticals Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6605","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68788712203","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68788-7122","68788-7122-3","68788-7122_c41276bf-e569-422f-9357-763190d46ed4","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20190114","","ANDA","ANDA090624","Preferred Pharmaceuticals Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6606","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68788712204","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68788-7122","68788-7122-4","68788-7122_c41276bf-e569-422f-9357-763190d46ed4","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20190114","","ANDA","ANDA090624","Preferred Pharmaceuticals Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6607","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68788712206","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68788-7122","68788-7122-6","68788-7122_c41276bf-e569-422f-9357-763190d46ed4","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20190114","","ANDA","ANDA090624","Preferred Pharmaceuticals Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6608","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68788712202","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68788-7122","68788-7122-2","68788-7122_c41276bf-e569-422f-9357-763190d46ed4","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20190114","","ANDA","ANDA090624","Preferred Pharmaceuticals Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6609","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68788712208","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68788-7122","68788-7122-8","68788-7122_c41276bf-e569-422f-9357-763190d46ed4","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20190114","","ANDA","ANDA090624","Preferred Pharmaceuticals Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6610","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68788712207","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68788-7122","68788-7122-7","68788-7122_c41276bf-e569-422f-9357-763190d46ed4","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20190114","","ANDA","ANDA090624","Preferred Pharmaceuticals Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6611","TOBRAMYCIN","Tobramycin","68788725205","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","68788-7252","68788-7252-5","68788-7252_34f50c43-cf2e-43f9-a393-b0a2b87c6b15","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION/ DROPS","OPHTHALMIC","20180829","","ANDA","ANDA207444","Preferred Pharmaceuticals Inc.","3","mg/mL","","N","20251231"
"6612","FLUCONAZOLE","Fluconazole","68788729302","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-7293","68788-7293-2","68788-7293_78c12842-1744-4fe8-a036-9fd858e19bba","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20190104","","ANDA","ANDA077731","Preferred Pharmaceuticals Inc.","150","mg/1","","N","20261231"
"6613","FLUCONAZOLE","Fluconazole","68788729308","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-7293","68788-7293-8","68788-7293_78c12842-1744-4fe8-a036-9fd858e19bba","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20190104","","ANDA","ANDA077731","Preferred Pharmaceuticals Inc.","150","mg/1","","N","20261231"
"6614","FLUCONAZOLE","Fluconazole","68788729301","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-7293","68788-7293-1","68788-7293_78c12842-1744-4fe8-a036-9fd858e19bba","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20190104","","ANDA","ANDA077731","Preferred Pharmaceuticals Inc.","150","mg/1","","N","20261231"
"6615","AMOXICILLIN","Amoxicillin","68788732301","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-7323","68788-7323-1","68788-7323_4308bb1d-c0f8-4047-a5f2-af675ee45ecd","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065325","Preferred Pharmaceuticals Inc.","200","mg/5mL","","N","20261231"
"6616","GENTAMICIN SULFATE","Gentamicin Sulfate","68788733605","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","68788-7336","68788-7336-5","68788-7336_15322965-5759-49e8-95ae-943cbdf2527e","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","SOLUTION","OPHTHALMIC","20190312","","ANDA","ANDA062196","Preferred Pharmaceuticals Inc.","3","mg/mL","","N","20261231"
"6617","CEFDINIR","Cefdinir","68788733902","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-7339","68788-7339-2","68788-7339_0a785239-4b4a-4868-999e-13173b1b5b59","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20190312","","ANDA","ANDA065434","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6618","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68788734504","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68788-7345","68788-7345-4","68788-7345_5b51ac80-49b2-4027-a374-fc78a0e28bbf","HUMAN PRESCRIPTION DRUG","SULFATRIM","","SUSPENSION","ORAL","20200601","","NDA","NDA018615","Preferred Pharmaceuticals, Inc.","200; 40","mg/5mL; mg/5mL","","N","20261231"
"6619","AMOXICILLIN","Amoxicillin","68788741402","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-7414","68788-7414-2","68788-7414_a08574a8-f283-4227-ba63-6aa840389b1e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20200325","","ANDA","ANDA065256","Preferred Pharmaceuticals Inc.","875","mg/1","","N","20261231"
"6620","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","68788745001","Allylamine Antifungal [EPC], Allylamine [CS]","68788-7450","68788-7450-1","68788-7450_9a7440b0-911f-41f9-aa4c-2500181afb80","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Preferred Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"6621","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","68788745003","Allylamine Antifungal [EPC], Allylamine [CS]","68788-7450","68788-7450-3","68788-7450_9a7440b0-911f-41f9-aa4c-2500181afb80","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Preferred Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"6622","CEFADROXIL","Cefadroxil","68788748402","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-7484","68788-7484-2","68788-7484_08918c06-8fad-44f7-b40c-3f17ab5a3f3d","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20200302","","ANDA","ANDA065352","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6623","CEFADROXIL","Cefadroxil","68788748403","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-7484","68788-7484-3","68788-7484_08918c06-8fad-44f7-b40c-3f17ab5a3f3d","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20200302","","ANDA","ANDA065352","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6624","CEFADROXIL","Cefadroxil","68788748404","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-7484","68788-7484-4","68788-7484_08918c06-8fad-44f7-b40c-3f17ab5a3f3d","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20200302","","ANDA","ANDA065352","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6625","CEFADROXIL","Cefadroxil","68788748406","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-7484","68788-7484-6","68788-7484_08918c06-8fad-44f7-b40c-3f17ab5a3f3d","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20200302","","ANDA","ANDA065352","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6626","CEFADROXIL","Cefadroxil","68788748401","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-7484","68788-7484-1","68788-7484_08918c06-8fad-44f7-b40c-3f17ab5a3f3d","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20200302","","ANDA","ANDA065352","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6627","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68788750005","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-7500","68788-7500-5","68788-7500_499527ea-1377-4ebb-969a-aeb7a525c496","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","SOLUTION","OPHTHALMIC","20181101","","ANDA","ANDA077568","Preferred Pharmaceuticals, Inc.","3","mg/mL","","N","20251231"
"6628","CEPHALEXIN","Cephalexin","68788752901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-7529","68788-7529-1","68788-7529_f170357f-5fe8-4ad4-983a-5e46245070cb","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Preferred Pharmaceuticals, Inc.","250","mg/5mL","","N","20261231"
"6629","CEPHALEXIN","Cephalexin","68788752902","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-7529","68788-7529-2","68788-7529_f170357f-5fe8-4ad4-983a-5e46245070cb","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Preferred Pharmaceuticals, Inc.","250","mg/5mL","","N","20261231"
"6630","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788753102","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-7531","68788-7531-2","68788-7531_9aace0de-2aa0-4823-a147-e0f953f0c2f9","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20200311","","ANDA","ANDA204755","Preferred Pharmaceuticals Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6631","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN","68788754903","Macrolide Antimicrobial [EPC], Macrolides [CS]","68788-7549","68788-7549-3","68788-7549_0b972a7e-a2f6-496b-bd00-f7229ec8d73f","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","POWDER, FOR SUSPENSION","PARENTERAL","20180410","","ANDA","ANDA207531","Preferred Pharmaceuticals, Inc.","200","mg/5mL","","N","20261231"
"6632","AZITHROMYCIN DIHYDRATE","Azithromycin","68788759803","Macrolide Antimicrobial [EPC], Macrolides [CS]","68788-7598","68788-7598-3","68788-7598_037b0da7-6b6b-4cce-bb28-05597873a467","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20200213","","ANDA","ANDA207398","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6633","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68788762201","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68788-7622","68788-7622-1","68788-7622_53e0a046-0c56-4f43-a622-04328fb2d507","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200214","","ANDA","ANDA090624","Preferred Pharmaceuticals Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6634","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68788762202","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68788-7622","68788-7622-2","68788-7622_53e0a046-0c56-4f43-a622-04328fb2d507","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200214","","ANDA","ANDA090624","Preferred Pharmaceuticals Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6635","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68788762204","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68788-7622","68788-7622-4","68788-7622_53e0a046-0c56-4f43-a622-04328fb2d507","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200214","","ANDA","ANDA090624","Preferred Pharmaceuticals Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6636","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68788762206","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68788-7622","68788-7622-6","68788-7622_53e0a046-0c56-4f43-a622-04328fb2d507","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200214","","ANDA","ANDA090624","Preferred Pharmaceuticals Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6637","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68788762207","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68788-7622","68788-7622-7","68788-7622_53e0a046-0c56-4f43-a622-04328fb2d507","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200214","","ANDA","ANDA090624","Preferred Pharmaceuticals Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6638","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68788762203","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68788-7622","68788-7622-3","68788-7622_53e0a046-0c56-4f43-a622-04328fb2d507","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200214","","ANDA","ANDA090624","Preferred Pharmaceuticals Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6639","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68788762208","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68788-7622","68788-7622-8","68788-7622_53e0a046-0c56-4f43-a622-04328fb2d507","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200214","","ANDA","ANDA090624","Preferred Pharmaceuticals Inc.","800; 160","mg/1; mg/1","","N","20251231"
"6640","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN","68788763601","Macrolide Antimicrobial [EPC], Macrolides [CS]","68788-7636","68788-7636-1","68788-7636_ced678e9-9718-4181-9f76-592675872e62","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","POWDER, FOR SUSPENSION","ORAL","20200310","","ANDA","ANDA207531","Preferred Pharmaceuticals Inc.","100","mg/5mL","","N","20261231"
"6641","OFLOXACIN","Ofloxacin","68788769305","Quinolone Antimicrobial [EPC], Quinolones [CS]","68788-7693","68788-7693-5","68788-7693_74b6a759-34c3-4751-8f58-40487bd78226","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20200401","","ANDA","ANDA076622","Preferred Pharmaceuticals, Inc.","3","mg/mL","","N","20251231"
"6642","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","68788774703","Antimalarial [EPC], Antirheumatic Agent [EPC]","68788-7747","68788-7747-3","68788-7747_37d496ed-9b82-48cb-b900-64613486835a","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20200701","","ANDA","ANDA040657","Preferred Pharmaceuticals, Inc.","200","mg/1","","N","20251231"
"6643","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","68788774702","Antimalarial [EPC], Antirheumatic Agent [EPC]","68788-7747","68788-7747-2","68788-7747_37d496ed-9b82-48cb-b900-64613486835a","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20200701","","ANDA","ANDA040657","Preferred Pharmaceuticals, Inc.","200","mg/1","","N","20251231"
"6644","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68788775300","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-7753","68788-7753-0","68788-7753_8b1b788b-2099-4578-ac8d-024475caf44d","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20200701","","ANDA","ANDA207402","Preferred Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"6645","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68788775302","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-7753","68788-7753-2","68788-7753_8b1b788b-2099-4578-ac8d-024475caf44d","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20200701","","ANDA","ANDA207402","Preferred Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"6646","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68788775303","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-7753","68788-7753-3","68788-7753_8b1b788b-2099-4578-ac8d-024475caf44d","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20200701","","ANDA","ANDA207402","Preferred Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"6647","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68788775305","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-7753","68788-7753-5","68788-7753_8b1b788b-2099-4578-ac8d-024475caf44d","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20200701","","ANDA","ANDA207402","Preferred Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"6648","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68788775301","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-7753","68788-7753-1","68788-7753_8b1b788b-2099-4578-ac8d-024475caf44d","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20200701","","ANDA","ANDA207402","Preferred Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"6649","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68788775307","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-7753","68788-7753-7","68788-7753_8b1b788b-2099-4578-ac8d-024475caf44d","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20200701","","ANDA","ANDA207402","Preferred Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"6650","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68788775308","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-7753","68788-7753-8","68788-7753_8b1b788b-2099-4578-ac8d-024475caf44d","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20200701","","ANDA","ANDA207402","Preferred Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"6651","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68788775306","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-7753","68788-7753-6","68788-7753_8b1b788b-2099-4578-ac8d-024475caf44d","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20200701","","ANDA","ANDA207402","Preferred Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"6652","KETOCONAZOLE","Ketoconazole","68788775503","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","68788-7755","68788-7755-3","68788-7755_9ba913e0-0e86-44f1-bddc-4c750e1ba9a0","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20200701","","ANDA","ANDA075581","Preferred Pharmaceuticals, Inc.","20","mg/g","","N","20251231"
"6653","KETOCONAZOLE","Ketoconazole","68788775501","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","68788-7755","68788-7755-1","68788-7755_9ba913e0-0e86-44f1-bddc-4c750e1ba9a0","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20200701","","ANDA","ANDA075581","Preferred Pharmaceuticals, Inc.","20","mg/g","","N","20251231"
"6654","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin and polymyxin B sulfates and hydrocortisone otic","68788778701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68788-7787","68788-7787-1","68788-7787_809cb28d-1289-4711-80b4-007d0dc31c36","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension","","SUSPENSION","AURICULAR (OTIC)","20201021","","NDA AUTHORIZED GENERIC","NDA060613","Preferred Pharmaceuticals, Inc.","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"6655","CEPHALEXIN","Cephalexin","68788779602","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-7796","68788-7796-2","68788-7796_f24e71f0-34a4-4e75-a398-e22e633f6413","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20201013","","ANDA","ANDA210221","Preferred Pharmaceuticlas Inc.","125","mg/5mL","","N","20261231"
"6656","CEPHALEXIN","Cephalexin","68788779601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-7796","68788-7796-1","68788-7796_f24e71f0-34a4-4e75-a398-e22e633f6413","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20201013","","ANDA","ANDA210221","Preferred Pharmaceuticlas Inc.","125","mg/5mL","","N","20261231"
"6657","METRONIDAZOLE","metronidazole","68788781501","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-7815","68788-7815-1","68788-7815_cfdea9f8-d6b8-4868-abca-3b3ec21f957d","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20201113","","ANDA","ANDA206560","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"6658","METRONIDAZOLE","metronidazole","68788781502","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-7815","68788-7815-2","68788-7815_cfdea9f8-d6b8-4868-abca-3b3ec21f957d","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20201113","","ANDA","ANDA206560","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"6659","METRONIDAZOLE","metronidazole","68788781503","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-7815","68788-7815-3","68788-7815_cfdea9f8-d6b8-4868-abca-3b3ec21f957d","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20201113","","ANDA","ANDA206560","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"6660","METRONIDAZOLE","metronidazole","68788781505","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-7815","68788-7815-5","68788-7815_cfdea9f8-d6b8-4868-abca-3b3ec21f957d","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20201113","","ANDA","ANDA206560","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"6661","METRONIDAZOLE","metronidazole","68788781507","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-7815","68788-7815-7","68788-7815_cfdea9f8-d6b8-4868-abca-3b3ec21f957d","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20201113","","ANDA","ANDA206560","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"6662","METRONIDAZOLE","metronidazole","68788781504","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-7815","68788-7815-4","68788-7815_cfdea9f8-d6b8-4868-abca-3b3ec21f957d","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20201113","","ANDA","ANDA206560","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"6663","CEFDINIR","Cefdinir","68788784401","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-7844","68788-7844-1","68788-7844_8bee713c-a6b8-40e9-b937-28314868b5c3","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20210120","","ANDA","ANDA065473","Preferred Pharmaceuticals Inc.","250","mg/5mL","","N","20261231"
"6664","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68788786400","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-7864","68788-7864-0","68788-7864_77f966b6-f1ac-4e1d-8937-a10f72241d5a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210208","","ANDA","ANDA076558","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6665","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68788786401","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-7864","68788-7864-1","68788-7864_77f966b6-f1ac-4e1d-8937-a10f72241d5a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210208","","ANDA","ANDA076558","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6666","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68788786403","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-7864","68788-7864-3","68788-7864_77f966b6-f1ac-4e1d-8937-a10f72241d5a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210208","","ANDA","ANDA076558","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6667","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68788786404","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-7864","68788-7864-4","68788-7864_77f966b6-f1ac-4e1d-8937-a10f72241d5a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210208","","ANDA","ANDA076558","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6668","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68788786406","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-7864","68788-7864-6","68788-7864_77f966b6-f1ac-4e1d-8937-a10f72241d5a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210208","","ANDA","ANDA076558","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6669","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68788786402","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-7864","68788-7864-2","68788-7864_77f966b6-f1ac-4e1d-8937-a10f72241d5a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210208","","ANDA","ANDA076558","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6670","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68788786408","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-7864","68788-7864-8","68788-7864_77f966b6-f1ac-4e1d-8937-a10f72241d5a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210208","","ANDA","ANDA076558","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6671","MICONAZOLE NITRATE","Miconazole Nitrate","68788791704","Azole Antifungal [EPC], Azoles [CS]","68788-7917","68788-7917-4","68788-7917_ab8ccb2c-506a-4870-9032-6cb32ca6e61d","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20210527","","ANDA","ANDA074164","Preferred Pharmaceuticals Inc.","20","mg/g","","N","20251231"
"6672","NYSTATIN","Nystatin","68788794901","Polyene Antifungal [EPC], Polyenes [CS]","68788-7949","68788-7949-1","68788-7949_086fdcb2-6bff-45ae-b037-1b5495ef778f","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20210708","","ANDA","ANDA064022","Preferred Pharmaceuticals Inc.","100000","[USP'U]/g","","N","20251231"
"6673","NYSTATIN","Nystatin","68788794903","Polyene Antifungal [EPC], Polyenes [CS]","68788-7949","68788-7949-3","68788-7949_086fdcb2-6bff-45ae-b037-1b5495ef778f","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20210708","","ANDA","ANDA064022","Preferred Pharmaceuticals Inc.","100000","[USP'U]/g","","N","20251231"
"6674","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788795802","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-7958","68788-7958-2","68788-7958_1caccc2d-b217-40ce-826a-a88f9eb5bb0d","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20210719","","ANDA","ANDA065063","Preferred Pharmaceuticals Inc.","875; 125","mg/1; mg/1","","N","20251231"
"6675","FLUCONAZOLE","Fluconazole","68788795901","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-7959","68788-7959-1","68788-7959_ef7750c8-4a8e-46f6-9828-bf0e603dbaa2","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210719","","ANDA","ANDA077253","Preferred Pharmaceuticals Inc., USA","150","mg/1","","N","20261231"
"6676","FLUCONAZOLE","Fluconazole","68788795908","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-7959","68788-7959-8","68788-7959_ef7750c8-4a8e-46f6-9828-bf0e603dbaa2","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210719","","ANDA","ANDA077253","Preferred Pharmaceuticals Inc., USA","150","mg/1","","N","20261231"
"6677","FLUCONAZOLE","Fluconazole","68788795902","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-7959","68788-7959-2","68788-7959_ef7750c8-4a8e-46f6-9828-bf0e603dbaa2","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210719","","ANDA","ANDA077253","Preferred Pharmaceuticals Inc., USA","150","mg/1","","N","20261231"
"6678","CEFDINIR","Cefdinir","68788798702","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-7987","68788-7987-2","68788-7987_c0996ef2-49bb-4951-aa7b-9f96f4a05a87","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210806","","ANDA","ANDA210220","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6679","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","68788799006","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-7990","68788-7990-6","68788-7990_8e751cc7-0c8a-43f7-8a8d-d30980af510c","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20210806","","ANDA","ANDA208767","Preferred Pharmaceuticals Inc","10","mg/mL","","N","20261231"
"6680","MUPIROCIN","Mupirocin","68788799302","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","68788-7993","68788-7993-2","68788-7993_33ea6e78-3c96-474a-b27a-9a6cd9e13b86","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20210809","","ANDA","ANDA065170","Preferred Pharmaceuticals Inc.","20","mg/g","","N","20251231"
"6681","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788799802","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-7998","68788-7998-2","68788-7998_a3831971-3915-4450-ad04-17ab4d1b4922","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20210810","","ANDA","ANDA205707","Preferred Pharmaceuticals Inc.","500; 125","mg/1; mg/1","","N","20251231"
"6682","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788800001","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-8000","68788-8000-1","68788-8000_3ffb94bf-62b9-4eb0-8821-4f29ca02a094","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20210810","","ANDA","ANDA065066","Preferred Pharmaceuticals Inc.","200; 28.5","mg/5mL; mg/5mL","","N","20261231"
"6683","CEFDINIR","cefdinir","68788806201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8062","68788-8062-1","68788-8062_a4846977-d5df-4dc2-aba0-f20b8c94bb85","HUMAN PRESCRIPTION DRUG","cefdinir","","POWDER, FOR SUSPENSION","ORAL","20210813","","ANDA","ANDA210534","Preferred Pharmaceuticals Inc.","250","mg/5mL","","N","20261231"
"6684","SILVER SULFADIAZINE","Silver Sulfadiazine","68788807402","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","68788-8074","68788-8074-2","68788-8074_b6327af5-4bfd-49e3-9a6c-a2171a27ed0d","HUMAN PRESCRIPTION DRUG","SSD Cream","","CREAM","TOPICAL","20210827","","NDA","NDA018578","Preferred Pharmaceuticals Inc.","10","g/1000g","","N","20251231"
"6685","SILVER SULFADIAZINE","Silver Sulfadiazine","68788807405","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","68788-8074","68788-8074-5","68788-8074_b6327af5-4bfd-49e3-9a6c-a2171a27ed0d","HUMAN PRESCRIPTION DRUG","SSD Cream","","CREAM","TOPICAL","20210827","","NDA","NDA018578","Preferred Pharmaceuticals Inc.","10","g/1000g","","N","20251231"
"6686","CLOTRIMAZOLE","CLOTRIMAZOLE","68788809102","Azole Antifungal [EPC], Azoles [CS]","68788-8091","68788-8091-2","68788-8091_6f0e85b4-d5e5-4d75-b34c-27c5bc19ebbf","HUMAN OTC DRUG","RUGBY ANTIFUNGAL CLOTRIMAZOLE","","CREAM","TOPICAL","20211005","","OTC MONOGRAPH DRUG","333C","Preferred Pharmaceuticals Inc.",".01","g/g","","N","20261231"
"6687","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","68788810202","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68788-8102","68788-8102-2","68788-8102_0b9e0b8f-3fda-46e7-99e6-098c0df2584f","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20211014","","OTC MONOGRAPH DRUG","333B","Preferred Pharmaceuticals Inc.","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"6688","MICONAZOLE NITRATE","Miconazole Nitrate","68788810702","Azole Antifungal [EPC], Azoles [CS]","68788-8107","68788-8107-2","68788-8107_d5825362-8e67-429f-86f4-7bc05465319c","HUMAN OTC DRUG","Miconazole Nitrate","","CREAM","TOPICAL","20211103","","OTC MONOGRAPH DRUG","part333c","Preferred Pharmaceuticals Inc.","20","mg/g","","N","20251231"
"6689","CEFDINIR","cefdinir","68788811506","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8115","68788-8115-6","68788-8115_295d2b8d-5383-42a2-904c-4020d2ecf9df","HUMAN PRESCRIPTION DRUG","cefdinir","","POWDER, FOR SUSPENSION","ORAL","20211207","","ANDA","ANDA210534","Preferred Pharmaceuticals Inc.","125","mg/5mL","","N","20261231"
"6690","CEFDINIR","cefdinir","68788811501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8115","68788-8115-1","68788-8115_295d2b8d-5383-42a2-904c-4020d2ecf9df","HUMAN PRESCRIPTION DRUG","cefdinir","","POWDER, FOR SUSPENSION","ORAL","20211207","","ANDA","ANDA210534","Preferred Pharmaceuticals Inc.","125","mg/5mL","","N","20261231"
"6691","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and hydrocortisone","68788813001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68788-8130","68788-8130-1","68788-8130_65408fca-d147-438d-854c-b4b2861c6a4a","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SUSPENSION","AURICULAR (OTIC)","20220203","","ANDA","ANDA062488","Preferred Pharmaceuticals Inc.","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"6692","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68788813600","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8136","68788-8136-0","68788-8136_e6e1419a-65f6-42a7-a4f9-67a2fdf7aa53","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20220203","","ANDA","ANDA077859","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6693","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68788813602","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8136","68788-8136-2","68788-8136_e6e1419a-65f6-42a7-a4f9-67a2fdf7aa53","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20220203","","ANDA","ANDA077859","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6694","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68788813603","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8136","68788-8136-3","68788-8136_e6e1419a-65f6-42a7-a4f9-67a2fdf7aa53","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20220203","","ANDA","ANDA077859","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6695","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68788813608","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8136","68788-8136-8","68788-8136_e6e1419a-65f6-42a7-a4f9-67a2fdf7aa53","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20220203","","ANDA","ANDA077859","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6696","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68788813601","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8136","68788-8136-1","68788-8136_e6e1419a-65f6-42a7-a4f9-67a2fdf7aa53","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20220203","","ANDA","ANDA077859","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6697","POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","Polymyxin B Sulfate and Trimethoprim Sulfate","68788815201","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68788-8152","68788-8152-1","68788-8152_0c72ec67-3a68-4d06-9595-19c0319cf324","HUMAN PRESCRIPTION DRUG","Polymyxin B Sulfate and Trimethoprim","","SOLUTION/ DROPS","OPHTHALMIC","20220314","","ANDA","ANDA064120","Preferred Pharmaceuticals Inc.","10000; 1","[USP'U]/mL; mg/mL","","N","20251231"
"6698","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin, triamcinolone acetonide","68788815603","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","68788-8156","68788-8156-3","68788-8156_8d776fbf-68c8-4973-8f91-60e862c72472","HUMAN PRESCRIPTION DRUG","NYSTATIN AND TRIAMCINOLONE ACETONIDE","","CREAM","TOPICAL","20220317","","ANDA","ANDA208479","Preferred Pharmaceuticals Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"6699","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788815701","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-8157","68788-8157-1","68788-8157_3f50027e-5472-4f64-babd-e9ab1165cf57","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","SUSPENSION","ORAL","20220317","","ANDA","ANDA065358","Preferred Pharmaceuticals Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"6700","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788815707","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-8157","68788-8157-7","68788-8157_3f50027e-5472-4f64-babd-e9ab1165cf57","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","SUSPENSION","ORAL","20220317","","ANDA","ANDA065358","Preferred Pharmaceuticals Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"6701","ECONAZOLE NITRATE","Econazole Nitrate","68788817401","Azole Antifungal [EPC], Azoles [CS]","68788-8174","68788-8174-1","68788-8174_85bf26e9-bc20-4723-b7a9-0aef32723b3a","HUMAN PRESCRIPTION DRUG","Econazole Nitrate","","CREAM","TOPICAL","20220427","","ANDA","ANDA076005","Preferred Pharmaceuticals Inc.","10","mg/g","","N","20261231"
"6702","OFLOXACIN","Ofloxacin","68788819505","Quinolone Antimicrobial [EPC], Quinolones [CS]","68788-8195","68788-8195-5","68788-8195_55b3f11b-5f41-4051-91cb-a44dfd38ed82","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20220526","","ANDA","ANDA076407","Preferred Pharmaceuticals Inc.","3","mg/mL","","N","20251231"
"6703","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","68788819805","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8198","68788-8198-5","68788-8198_8c34fdc0-0963-42e4-b714-f6a3a2407584","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20220523","","NDA AUTHORIZED GENERIC","NDA019992","Preferred Pharmaceuticals Inc.","3","mg/mL","","N","20261231"
"6704","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68788820002","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8200","68788-8200-2","68788-8200_21b1c7cb-edb9-4e64-b04d-e9d27d6efb2b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20220524","","ANDA","ANDA208921","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20261231"
"6705","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68788820003","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8200","68788-8200-3","68788-8200_21b1c7cb-edb9-4e64-b04d-e9d27d6efb2b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20220524","","ANDA","ANDA208921","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20261231"
"6706","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","68788820001","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8200","68788-8200-1","68788-8200_21b1c7cb-edb9-4e64-b04d-e9d27d6efb2b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20220524","","ANDA","ANDA208921","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20261231"
"6707","AMOXICILLIN","Amoxicillin","68788820903","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-8209","68788-8209-3","68788-8209_764e94c8-1fe5-4a9b-ada5-4c26d1a2e94c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20220908","","ANDA","ANDA065271","Preferred Phamraceuticals Inc.","500","mg/1","","N","20261231"
"6708","AMOXICILLIN","Amoxicillin","68788820904","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-8209","68788-8209-4","68788-8209_764e94c8-1fe5-4a9b-ada5-4c26d1a2e94c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20220908","","ANDA","ANDA065271","Preferred Phamraceuticals Inc.","500","mg/1","","N","20261231"
"6709","AMOXICILLIN","Amoxicillin","68788820902","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-8209","68788-8209-2","68788-8209_764e94c8-1fe5-4a9b-ada5-4c26d1a2e94c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20220908","","ANDA","ANDA065271","Preferred Phamraceuticals Inc.","500","mg/1","","N","20261231"
"6710","CLOTRIMAZOLE","Clotrimazole","68788821603","Azole Antifungal [EPC], Azoles [CS]","68788-8216","68788-8216-3","68788-8216_9c721319-a65c-4cdd-b844-ddd264ea7231","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20220908","","OTC MONOGRAPH DRUG","333C","Preferred Pharmaceuticals Inc.","1","g/100g","","N","20251231"
"6711","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68788821902","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8219","68788-8219-2","68788-8219_81a028bc-f36c-47e4-8a2c-3979252edc86","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20220909","","ANDA","ANDA065061","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6712","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68788821903","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8219","68788-8219-3","68788-8219_81a028bc-f36c-47e4-8a2c-3979252edc86","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20220909","","ANDA","ANDA065061","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6713","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68788821904","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8219","68788-8219-4","68788-8219_81a028bc-f36c-47e4-8a2c-3979252edc86","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20220909","","ANDA","ANDA065061","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6714","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68788821905","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8219","68788-8219-5","68788-8219_81a028bc-f36c-47e4-8a2c-3979252edc86","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20220909","","ANDA","ANDA065061","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6715","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68788821906","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8219","68788-8219-6","68788-8219_81a028bc-f36c-47e4-8a2c-3979252edc86","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20220909","","ANDA","ANDA065061","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6716","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68788821908","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8219","68788-8219-8","68788-8219_81a028bc-f36c-47e4-8a2c-3979252edc86","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20220909","","ANDA","ANDA065061","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6717","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","68788821901","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8219","68788-8219-1","68788-8219_81a028bc-f36c-47e4-8a2c-3979252edc86","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20220909","","ANDA","ANDA065061","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6718","FLUCONAZOLE","Fluconazole","68788822000","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-8220","68788-8220-0","68788-8220_6abf4c12-d019-4a7b-af35-ddce6d88a076","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20220909","","ANDA","ANDA077253","Preferred Pharmaceuticals Inc.","200","mg/1","","N","20261231"
"6719","FLUCONAZOLE","Fluconazole","68788822001","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-8220","68788-8220-1","68788-8220_6abf4c12-d019-4a7b-af35-ddce6d88a076","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20220909","","ANDA","ANDA077253","Preferred Pharmaceuticals Inc.","200","mg/1","","N","20261231"
"6720","FLUCONAZOLE","Fluconazole","68788822002","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-8220","68788-8220-2","68788-8220_6abf4c12-d019-4a7b-af35-ddce6d88a076","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20220909","","ANDA","ANDA077253","Preferred Pharmaceuticals Inc.","200","mg/1","","N","20261231"
"6721","FLUCONAZOLE","Fluconazole","68788822006","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-8220","68788-8220-6","68788-8220_6abf4c12-d019-4a7b-af35-ddce6d88a076","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20220909","","ANDA","ANDA077253","Preferred Pharmaceuticals Inc.","200","mg/1","","N","20261231"
"6722","FLUCONAZOLE","Fluconazole","68788822008","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-8220","68788-8220-8","68788-8220_6abf4c12-d019-4a7b-af35-ddce6d88a076","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20220909","","ANDA","ANDA077253","Preferred Pharmaceuticals Inc.","200","mg/1","","N","20261231"
"6723","FLUCONAZOLE","Fluconazole","68788822009","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-8220","68788-8220-9","68788-8220_6abf4c12-d019-4a7b-af35-ddce6d88a076","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20220909","","ANDA","ANDA077253","Preferred Pharmaceuticals Inc.","200","mg/1","","N","20261231"
"6724","FLUCONAZOLE","Fluconazole","68788822003","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-8220","68788-8220-3","68788-8220_6abf4c12-d019-4a7b-af35-ddce6d88a076","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20220909","","ANDA","ANDA077253","Preferred Pharmaceuticals Inc.","200","mg/1","","N","20261231"
"6725","AZITHROMYCIN DIHYDRATE","Azithromycin","68788822901","Macrolide Antimicrobial [EPC], Macrolides [CS]","68788-8229","68788-8229-1","68788-8229_81bad018-7a67-41ab-bb72-3bac1c572738","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20220808","","ANDA","ANDA211147","Preferred Pharmaceuticals Inc.","100","mg/5mL","","N","20251231"
"6726","KETOCONAZOLE","Ketoconazole Cream, 2%","68788823301","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","68788-8233","68788-8233-1","68788-8233_4db602ed-af5e-49a6-b310-acc640c35e84","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20220808","","ANDA","ANDA212443","Preferred Pharmaceuticals Inc.","20","mg/g","","N","20261231"
"6727","KETOCONAZOLE","Ketoconazole Cream, 2%","68788823303","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","68788-8233","68788-8233-3","68788-8233_4db602ed-af5e-49a6-b310-acc640c35e84","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20220808","","ANDA","ANDA212443","Preferred Pharmaceuticals Inc.","20","mg/g","","N","20261231"
"6728","NYSTATIN","Nystatin Cream","68788823401","Polyene Antifungal [EPC], Polyenes [CS]","68788-8234","68788-8234-1","68788-8234_92669947-45d0-47c8-8fea-4369b2b77090","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20220809","","ANDA","ANDA061966","Preferred Pharmaceuticals, Inc.","100000","[USP'U]/g","","N","20251231"
"6729","NYSTATIN","Nystatin Cream","68788823403","Polyene Antifungal [EPC], Polyenes [CS]","68788-8234","68788-8234-3","68788-8234_92669947-45d0-47c8-8fea-4369b2b77090","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20220809","","ANDA","ANDA061966","Preferred Pharmaceuticals, Inc.","100000","[USP'U]/g","","N","20251231"
"6730","AMOXICILLIN","Amoxicillin","68788824003","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-8240","68788-8240-3","68788-8240_df89e863-9f40-45cc-bedb-c2cfea928f09","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20220809","","ANDA","ANDA065271","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20261231"
"6731","AMOXICILLIN","Amoxicillin","68788824002","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-8240","68788-8240-2","68788-8240_df89e863-9f40-45cc-bedb-c2cfea928f09","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20220809","","ANDA","ANDA065271","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20261231"
"6732","PENICILLIN V POTASSIUM","Penicillin V Potassium","68788824204","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-8242","68788-8242-4","68788-8242_2a4b4078-a486-4fcc-8377-aa5e6db1e575","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20220809","","ANDA","ANDA090549","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"6733","PENICILLIN V POTASSIUM","Penicillin V Potassium","68788824202","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-8242","68788-8242-2","68788-8242_2a4b4078-a486-4fcc-8377-aa5e6db1e575","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20220809","","ANDA","ANDA090549","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"6734","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","68788824503","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","68788-8245","68788-8245-3","68788-8245_3aa9f52f-c334-47c2-9c9b-e11769949f60","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20220818","","ANDA","ANDA208136","Preferred Pharmaceuticals Inc., USA","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"6735","TOBRAMYCIN","Tobramycin","68788824805","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","68788-8248","68788-8248-5","68788-8248_a5ad2deb-5f3d-49ae-b916-b6453ed35873","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","OPHTHALMIC","20220819","","ANDA","ANDA064052","Preferred Pharmaceuticals Inc.","3","mg/mL","","N","20251231"
"6736","KETOCONAZOLE","Ketoconazole","68788825701","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","68788-8257","68788-8257-1","68788-8257_a298f5bc-bbe0-4d9a-8496-db45dacc4fbd","HUMAN PRESCRIPTION DRUG","Ketoconazole","","SHAMPOO, SUSPENSION","TOPICAL","20220916","","ANDA","ANDA076942","Preferred Pharmaceuticals Inc.","20","mg/mL","","N","20251231"
"6737","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","68788825800","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","68788-8258","68788-8258-0","68788-8258_63d2a4d1-0cbe-4c8d-abf1-ed8231a85881","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20220916","","ANDA","ANDA208516","Preferred Pharmaceuticals Inc.","25; 75","mg/1; mg/1","","N","20251231"
"6738","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","68788825801","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","68788-8258","68788-8258-1","68788-8258_63d2a4d1-0cbe-4c8d-abf1-ed8231a85881","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20220916","","ANDA","ANDA208516","Preferred Pharmaceuticals Inc.","25; 75","mg/1; mg/1","","N","20251231"
"6739","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","68788825808","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","68788-8258","68788-8258-8","68788-8258_63d2a4d1-0cbe-4c8d-abf1-ed8231a85881","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20220916","","ANDA","ANDA208516","Preferred Pharmaceuticals Inc.","25; 75","mg/1; mg/1","","N","20251231"
"6740","CEFADROXIL","Cefadroxil","68788826102","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8261","68788-8261-2","68788-8261_68d80871-d8f9-40f9-9a59-7037e2943a5c","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20220919","","ANDA","ANDA065392","Preferred Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6741","CEFADROXIL","Cefadroxil","68788826103","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8261","68788-8261-3","68788-8261_68d80871-d8f9-40f9-9a59-7037e2943a5c","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20220919","","ANDA","ANDA065392","Preferred Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"6742","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","68788827002","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68788-8270","68788-8270-2","68788-8270_971bbea1-da0b-4101-b144-54dab4804ebd","HUMAN OTC DRUG","Good Sense First Aid Antibiotic","","OINTMENT","TOPICAL","20221013","","OTC MONOGRAPH DRUG","333B","Preferred Pharmaceuticals Inc.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"6743","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788829901","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-8299","68788-8299-1","68788-8299_beb82e9a-fa07-4ec9-929d-d7a7922300d1","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","SUSPENSION","ORAL","20221129","","ANDA","ANDA065373","Preferred Pharmaceuticals Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"6744","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788829907","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-8299","68788-8299-7","68788-8299_beb82e9a-fa07-4ec9-929d-d7a7922300d1","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","SUSPENSION","ORAL","20221129","","ANDA","ANDA065373","Preferred Pharmaceuticals Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"6745","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788830601","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-8306","68788-8306-1","68788-8306_f71616f5-a4fb-48a7-8f5a-a317564fad7c","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20221220","","ANDA","ANDA201090","Preferred Pharmaceuticals Inc.","200; 28.5","mg/5mL; mg/5mL","","N","20261231"
"6746","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","68788830702","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-8307","68788-8307-2","68788-8307_48d8b38c-7d8d-4260-a251-39d7d6df33f3","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, COATED","ORAL","20221220","","NDA AUTHORIZED GENERIC","NDA050720","Preferred Pharmaceuticals Inc.","875; 125","mg/1; mg/1","","N","20261231"
"6747","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788830802","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-8308","68788-8308-2","68788-8308_855c36d9-68e0-4c19-95d2-3b2aa035d7aa","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20221220","","ANDA","ANDA065101","Preferred Pharmaceuticals Inc.","500; 125","mg/1; mg/1","","N","20261231"
"6748","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","68788831103","Macrolide Antimicrobial [EPC], Macrolides [CS]","68788-8311","68788-8311-3","68788-8311_45da1013-76ad-4087-b408-6526cd79f235","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20221220","","ANDA","ANDA208249","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6749","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788831702","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-8317","68788-8317-2","68788-8317_ec8ace73-aa06-4487-87a7-85e553d61a40","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20221223","","ANDA","ANDA091569","Preferred Pharmaceuticals Inc.","500; 125","mg/1; mg/1","","N","20251231"
"6750","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788831801","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-8318","68788-8318-1","68788-8318_1bed24a2-7beb-4272-81d8-1fb6ae56c15c","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20221223","","ANDA","ANDA201090","Preferred Pharmaceuticals Inc.","400; 57","mg/5mL; mg/5mL","","N","20261231"
"6751","CEFDINIR","Cefdinir","68788832302","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8323","68788-8323-2","68788-8323_93d4eb05-71e8-45e1-8c53-0039b9bcbbbc","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20230123","","ANDA","ANDA065264","Preferred Pharmaceuticals, Inc.","300","mg/1","","N","20261231"
"6752","AMOXICILLIN","Amoxicillin","68788832401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-8324","68788-8324-1","68788-8324_3e3f6dd8-3c25-47d9-ae33-9e71498a1ce1","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20230119","","ANDA","ANDA065334","Preferred Pharmaceuticals Inc.","200","mg/5mL","","N","20261231"
"6753","AMOXICILLIN","Amoxicillin","68788832501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-8325","68788-8325-1","68788-8325_3e3f6dd8-3c25-47d9-ae33-9e71498a1ce1","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20230119","","ANDA","ANDA065334","Preferred Pharmaceuticals Inc.","400","mg/5mL","","N","20261231"
"6754","CLOTRIMAZOLE","Clotrimazole","68788833004","Azole Antifungal [EPC], Azoles [CS]","68788-8330","68788-8330-4","68788-8330_b641049e-308d-4d1e-badf-c92b00826604","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","20230120","","ANDA","ANDA074165","Preferred Pharmaceuticals Inc.","10","mg/g","","N","20261231"
"6755","CEFDINIR","Cefdinir","68788840402","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8404","68788-8404-2","68788-8404_06a3245f-7739-4f4a-b7cc-9c70de6b6859","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20230327","","ANDA","ANDA065434","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6756","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","68788841901","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","68788-8419","68788-8419-1","68788-8419_467ed2fb-c7af-4e32-8b94-8bb7544c21ba","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20230411","","ANDA","ANDA075673","Preferred Pharmaceuticals Inc.",".5; 10","mg/g; mg/g","","N","20261231"
"6757","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate 1%","68788842306","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8423","68788-8423-6","68788-8423_d8e71c8b-2b1c-4b25-be7f-370813ec2207","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20230413","","ANDA","ANDA212438","Preferred Pharmaceuticals Inc.","10","mg/g","","N","20261231"
"6758","NYSTATIN","Nystatin","68788843601","Polyene Antifungal [EPC], Polyenes [CS]","68788-8436","68788-8436-1","68788-8436_540195f8-5c99-4dfb-b258-11903af5aea7","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20230428","","ANDA","ANDA062225","Preferred Pharmaceuticals Inc.","100000","[USP'U]/g","","N","20251231"
"6759","OFLOXACIN","ofloxacin","68788844905","Quinolone Antimicrobial [EPC], Quinolones [CS]","68788-8449","68788-8449-5","68788-8449_11f6a9c7-356c-4fc4-88ee-8093d641e9ad","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20230525","","ANDA","ANDA215886","Preferred Pharmaceuticals Inc.","3","mg/mL","","N","20251231"
"6760","CEFADROXIL","Cefadroxil","68788847902","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8479","68788-8479-2","68788-8479_11ebff6b-9531-4032-a078-0fbf7fa0f997","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20230713","","ANDA","ANDA065352","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6761","CEFADROXIL","Cefadroxil","68788847903","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8479","68788-8479-3","68788-8479_11ebff6b-9531-4032-a078-0fbf7fa0f997","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20230713","","ANDA","ANDA065352","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6762","CLARITHROMYCIN","Clarithromycin","68788848002","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","68788-8480","68788-8480-2","68788-8480_502b3505-5c28-4d75-9d5e-c96d84a19224","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20230713","","ANDA","ANDA065489","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6763","CLARITHROMYCIN","Clarithromycin","68788848008","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","68788-8480","68788-8480-8","68788-8480_502b3505-5c28-4d75-9d5e-c96d84a19224","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20230713","","ANDA","ANDA065489","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6764","CLOTRIMAZOLE","Clotrimazole","68788849104","Azole Antifungal [EPC], Azoles [CS]","68788-8491","68788-8491-4","68788-8491_6a675b34-03f8-4571-8c1c-3a9bb8804df4","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","20230724","","ANDA","ANDA074165","Preferred Pharmaceuticals Inc.","10","mg/g","","N","20261231"
"6765","ERYTHROMYCIN","erythromycin","68788851603","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","68788-8516","68788-8516-3","68788-8516_1b24c00f-4fc9-418a-97ce-9476f0c1d277","HUMAN PRESCRIPTION DRUG","erythromycin","","OINTMENT","OPHTHALMIC","20230901","","ANDA","ANDA062447","Preferred Pharmaceuticals Inc.","5","mg/g","","N","20251231"
"6766","FLUCONAZOLE","Fluconazole","68788852601","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-8526","68788-8526-1","68788-8526_35ab39e4-b393-4125-a88e-cce82611b6ff","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20230920","","ANDA","ANDA077731","Preferred Pharmaceuticals Inc.","200","mg/1","","N","20261231"
"6767","FLUCONAZOLE","Fluconazole","68788852602","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-8526","68788-8526-2","68788-8526_35ab39e4-b393-4125-a88e-cce82611b6ff","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20230920","","ANDA","ANDA077731","Preferred Pharmaceuticals Inc.","200","mg/1","","N","20261231"
"6768","FLUCONAZOLE","Fluconazole","68788852603","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-8526","68788-8526-3","68788-8526_35ab39e4-b393-4125-a88e-cce82611b6ff","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20230920","","ANDA","ANDA077731","Preferred Pharmaceuticals Inc.","200","mg/1","","N","20261231"
"6769","FLUCONAZOLE","Fluconazole","68788852600","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-8526","68788-8526-0","68788-8526_35ab39e4-b393-4125-a88e-cce82611b6ff","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20230920","","ANDA","ANDA077731","Preferred Pharmaceuticals Inc.","200","mg/1","","N","20261231"
"6770","FLUCONAZOLE","Fluconazole","68788852608","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-8526","68788-8526-8","68788-8526_35ab39e4-b393-4125-a88e-cce82611b6ff","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20230920","","ANDA","ANDA077731","Preferred Pharmaceuticals Inc.","200","mg/1","","N","20261231"
"6771","FLUCONAZOLE","Fluconazole","68788852609","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-8526","68788-8526-9","68788-8526_35ab39e4-b393-4125-a88e-cce82611b6ff","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20230920","","ANDA","ANDA077731","Preferred Pharmaceuticals Inc.","200","mg/1","","N","20261231"
"6772","FLUCONAZOLE","Fluconazole","68788852606","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","68788-8526","68788-8526-6","68788-8526_35ab39e4-b393-4125-a88e-cce82611b6ff","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20230920","","ANDA","ANDA077731","Preferred Pharmaceuticals Inc.","200","mg/1","","N","20261231"
"6773","MUPIROCIN","Mupirocin","68788853402","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","68788-8534","68788-8534-2","68788-8534_209dd715-07c5-49ac-8a5c-9eb0e1fd5b76","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20231023","","ANDA","ANDA090480","Preferred Pharmaceuticals Inc.","20","mg/g","","N","20261231"
"6774","CEPHALEXIN","Cephalexin","68788853802","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8538","68788-8538-2","68788-8538_57af31b9-9f8b-4f44-b18d-e59aff4a0bc9","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20231019","","ANDA","ANDA065253","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6775","CEPHALEXIN","Cephalexin","68788853803","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8538","68788-8538-3","68788-8538_57af31b9-9f8b-4f44-b18d-e59aff4a0bc9","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20231019","","ANDA","ANDA065253","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6776","CEPHALEXIN","Cephalexin","68788853804","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8538","68788-8538-4","68788-8538_57af31b9-9f8b-4f44-b18d-e59aff4a0bc9","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20231019","","ANDA","ANDA065253","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6777","CEPHALEXIN","Cephalexin","68788853801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8538","68788-8538-1","68788-8538_57af31b9-9f8b-4f44-b18d-e59aff4a0bc9","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20231019","","ANDA","ANDA065253","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6778","CEPHALEXIN","Cephalexin","68788853806","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8538","68788-8538-6","68788-8538_57af31b9-9f8b-4f44-b18d-e59aff4a0bc9","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20231019","","ANDA","ANDA065253","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6779","CEPHALEXIN","Cephalexin","68788853807","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8538","68788-8538-7","68788-8538_57af31b9-9f8b-4f44-b18d-e59aff4a0bc9","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20231019","","ANDA","ANDA065253","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6780","CEPHALEXIN","Cephalexin","68788853808","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8538","68788-8538-8","68788-8538_57af31b9-9f8b-4f44-b18d-e59aff4a0bc9","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20231019","","ANDA","ANDA065253","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6781","CEPHALEXIN","Cephalexin","68788853809","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8538","68788-8538-9","68788-8538_57af31b9-9f8b-4f44-b18d-e59aff4a0bc9","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20231019","","ANDA","ANDA065253","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6782","CEPHALEXIN","Cephalexin","68788853805","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8538","68788-8538-5","68788-8538_57af31b9-9f8b-4f44-b18d-e59aff4a0bc9","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20231019","","ANDA","ANDA065253","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6783","OFLOXACIN","ofloxacin otic","68788855101","Quinolone Antimicrobial [EPC], Quinolones [CS]","68788-8551","68788-8551-1","68788-8551_f8dd55d7-ba26-401a-aeeb-7c9bb689f123","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION","AURICULAR (OTIC)","20231115","","ANDA","ANDA216130","Preferred Pharmaceuticals Inc.","3","mg/mL","","N","20251231"
"6784","METRONIDAZOLE","Metronidazole","68788855204","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-8552","68788-8552-4","68788-8552_86325864-b6c8-460a-ae9d-3ad7463fd1db","HUMAN PRESCRIPTION DRUG","Metronidazole","","CREAM","TOPICAL","20231120","","ANDA","ANDA217128","Preferred Pharmaceuticals Inc.","7.5","mg/g","","N","20261231"
"6785","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","68788855303","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","68788-8553","68788-8553-3","68788-8553_f33459f4-2241-45fb-af88-202cf634f9cb","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20231120","","ANDA","ANDA062364","Preferred Pharmaceuticals Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"6786","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68788855801","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8558","68788-8558-1","68788-8558_7cfaea7e-b964-4030-bd54-6d8e0c7e730d","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20231221","","ANDA","ANDA216957","Preferred Pharmaceuticals Inc.","150","mg/1","","N","20261231"
"6787","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68788855802","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8558","68788-8558-2","68788-8558_7cfaea7e-b964-4030-bd54-6d8e0c7e730d","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20231221","","ANDA","ANDA216957","Preferred Pharmaceuticals Inc.","150","mg/1","","N","20261231"
"6788","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68788855803","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8558","68788-8558-3","68788-8558_7cfaea7e-b964-4030-bd54-6d8e0c7e730d","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20231221","","ANDA","ANDA216957","Preferred Pharmaceuticals Inc.","150","mg/1","","N","20261231"
"6789","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68788855800","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8558","68788-8558-0","68788-8558_7cfaea7e-b964-4030-bd54-6d8e0c7e730d","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20231221","","ANDA","ANDA216957","Preferred Pharmaceuticals Inc.","150","mg/1","","N","20261231"
"6790","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68788855806","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8558","68788-8558-6","68788-8558_7cfaea7e-b964-4030-bd54-6d8e0c7e730d","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20231221","","ANDA","ANDA216957","Preferred Pharmaceuticals Inc.","150","mg/1","","N","20261231"
"6791","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68788855807","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8558","68788-8558-7","68788-8558_7cfaea7e-b964-4030-bd54-6d8e0c7e730d","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20231221","","ANDA","ANDA216957","Preferred Pharmaceuticals Inc.","150","mg/1","","N","20261231"
"6792","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68788855808","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8558","68788-8558-8","68788-8558_7cfaea7e-b964-4030-bd54-6d8e0c7e730d","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20231221","","ANDA","ANDA216957","Preferred Pharmaceuticals Inc.","150","mg/1","","N","20261231"
"6793","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68788855805","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8558","68788-8558-5","68788-8558_7cfaea7e-b964-4030-bd54-6d8e0c7e730d","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20231221","","ANDA","ANDA216957","Preferred Pharmaceuticals Inc.","150","mg/1","","N","20261231"
"6794","NYSTATIN","NYSTATIN","68788856104","Polyene Antifungal [EPC], Polyenes [CS]","68788-8561","68788-8561-4","68788-8561_8211a0ef-98a8-4136-986c-23c306db1159","HUMAN PRESCRIPTION DRUG","NYSTATIN","","SUSPENSION","ORAL","20240108","","ANDA","ANDA214346","Preferred Pharmaceuticals Inc.","100000","[USP'U]/mL","","N","20251231"
"6795","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","68788857100","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","68788-8571","68788-8571-0","68788-8571_11e8f91c-5712-4267-9956-e619d081d1f4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20240125","","ANDA","ANDA217357","Preferred Pharmaceuticals Inc.","25; 75","mg/1; mg/1","","N","20251231"
"6796","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","68788857101","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","68788-8571","68788-8571-1","68788-8571_11e8f91c-5712-4267-9956-e619d081d1f4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20240125","","ANDA","ANDA217357","Preferred Pharmaceuticals Inc.","25; 75","mg/1; mg/1","","N","20251231"
"6797","GENTAMICIN SULFATE","Gentamicin Sulfate","68788859205","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","68788-8592","68788-8592-5","68788-8592_873de1bc-b4f1-44b7-ba28-01406c298b22","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","SOLUTION/ DROPS","OPHTHALMIC","20240222","","ANDA","ANDA064048","Preferred Pharmaceuticals Inc.","3","mg/mL","","N","20261231"
"6798","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","68788860704","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","68788-8607","68788-8607-4","68788-8607_c6171b62-835c-465e-905e-97f70438186e","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20240314","","ANDA","ANDA214330","Preferred Pharmaceuticals Inc.","200; 40","mg/5mL; mg/5mL","","N","20251231"
"6799","AMOXICILLIN","Amoxicillin","68788861101","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-8611","68788-8611-1","68788-8611_0d540257-d438-43e3-bbea-52b293791002","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20240320","","ANDA","ANDA065119","Preferred Pharmaceuticals Inc.","200","mg/5mL","","N","20261231"
"6800","NYSTATIN","Nystatin","68788863103","Polyene Antifungal [EPC], Polyenes [CS]","68788-8631","68788-8631-3","68788-8631_d92f67a7-dcae-41c0-9a35-dbafa2361170","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20240415","","ANDA","ANDA212557","Preferred Pharmaceuticals Inc.","100000","U/g","","N","20251231"
"6801","NYSTATIN","Nystatin","68788863101","Polyene Antifungal [EPC], Polyenes [CS]","68788-8631","68788-8631-1","68788-8631_d92f67a7-dcae-41c0-9a35-dbafa2361170","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20240415","","ANDA","ANDA212557","Preferred Pharmaceuticals Inc.","100000","U/g","","N","20251231"
"6802","MUPIROCIN","Mupirocin","68788864202","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","68788-8642","68788-8642-2","68788-8642_6c9cd7fc-b72e-406e-b9aa-0f1bc035b832","HUMAN PRESCRIPTION DRUG","mupirocin","","OINTMENT","TOPICAL","20240430","","ANDA","ANDA065123","Preferred Pharmaceuticals Inc.","20","mg/g","","N","20251231"
"6803","MICONAZOLE NITRATE","antifungal","68788864502","Azole Antifungal [EPC], Azoles [CS]","68788-8645","68788-8645-2","68788-8645_c6098653-351a-449f-9b1a-0c617074f2b9","HUMAN OTC DRUG","Antifungal Cream","","CREAM","TOPICAL","20240501","","OTC MONOGRAPH DRUG","M005","Preferred Pharmaceuticals Inc.","2","g/100g","","N","20251231"
"6804","CEFDINIR MONOHYDRATE","Cefdinir","68788865501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8655","68788-8655-1","68788-8655_2e81498d-8e5a-47b9-8b47-8063cf8300a1","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20240509","","ANDA","ANDA065332","Preferred Pharmaceuticals Inc.","250","mg/5mL","","N","20261231"
"6805","MICONAZOLE NITRATE","Miconazole Nitrate","68788866104","Azole Antifungal [EPC], Azoles [CS]","68788-8661","68788-8661-4","68788-8661_85a52081-d9cc-44f0-a8d3-851a45c4eb10","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20090421","","ANDA","ANDA074164","Preferred Pharmaceuticals Inc.","20","mg/g","","N","20251231"
"6806","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and triamcinolone acetonide","68788866203","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","68788-8662","68788-8662-3","68788-8662_c529567b-7061-4389-8c7a-20ef2b22c591","HUMAN PRESCRIPTION DRUG","Nystatin and triamcinolone acetonide","","CREAM","TOPICAL","20240513","","ANDA","ANDA214181","Preferred Pharmaceuticals Inc.","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"6807","METRONIDAZOLE","Metronidazole","68788867402","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-8674","68788-8674-2","68788-8674_cbee69e8-029c-49d2-89cd-f504b8e0ac28","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20240523","","ANDA","ANDA203458","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"6808","METRONIDAZOLE","Metronidazole","68788867403","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-8674","68788-8674-3","68788-8674_cbee69e8-029c-49d2-89cd-f504b8e0ac28","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20240523","","ANDA","ANDA203458","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"6809","METRONIDAZOLE","Metronidazole","68788867404","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-8674","68788-8674-4","68788-8674_cbee69e8-029c-49d2-89cd-f504b8e0ac28","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20240523","","ANDA","ANDA203458","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"6810","METRONIDAZOLE","Metronidazole","68788867401","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-8674","68788-8674-1","68788-8674_cbee69e8-029c-49d2-89cd-f504b8e0ac28","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20240523","","ANDA","ANDA203458","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"6811","METRONIDAZOLE","Metronidazole","68788867407","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-8674","68788-8674-7","68788-8674_cbee69e8-029c-49d2-89cd-f504b8e0ac28","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20240523","","ANDA","ANDA203458","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"6812","METRONIDAZOLE","Metronidazole","68788867405","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","68788-8674","68788-8674-5","68788-8674_cbee69e8-029c-49d2-89cd-f504b8e0ac28","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20240523","","ANDA","ANDA203458","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"6813","AZITHROMYCIN MONOHYDRATE","Azithromycin","68788867501","Macrolide Antimicrobial [EPC], Macrolides [CS]","68788-8675","68788-8675-1","68788-8675_b78393c9-62b3-451c-b926-70f24fa5e60f","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20240523","","ANDA","ANDA065246","Preferred Pharmaceuticals Inc.","100","mg/5mL","","N","20261231"
"6814","AZITHROMYCIN MONOHYDRATE","Azithromycin","68788867603","Macrolide Antimicrobial [EPC], Macrolides [CS]","68788-8676","68788-8676-3","68788-8676_71d3c2cd-65a7-47cf-8b0c-d3d05cc14e55","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20101217","","ANDA","ANDA065246","Preferred Pharmaceuticals Inc.","200","mg/5mL","","N","20261231"
"6815","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68788868501","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8685","68788-8685-1","68788-8685_2ff25679-f340-45df-a9a1-ded74e39f483","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20240601","","ANDA","ANDA216957","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6816","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68788868503","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8685","68788-8685-3","68788-8685_2ff25679-f340-45df-a9a1-ded74e39f483","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20240601","","ANDA","ANDA216957","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6817","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68788868504","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8685","68788-8685-4","68788-8685_2ff25679-f340-45df-a9a1-ded74e39f483","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20240601","","ANDA","ANDA216957","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6818","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68788868505","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8685","68788-8685-5","68788-8685_2ff25679-f340-45df-a9a1-ded74e39f483","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20240601","","ANDA","ANDA216957","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6819","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68788868502","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8685","68788-8685-2","68788-8685_2ff25679-f340-45df-a9a1-ded74e39f483","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20240601","","ANDA","ANDA216957","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6820","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68788868508","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8685","68788-8685-8","68788-8685_2ff25679-f340-45df-a9a1-ded74e39f483","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20240601","","ANDA","ANDA216957","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6821","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","68788868506","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","68788-8685","68788-8685-6","68788-8685_2ff25679-f340-45df-a9a1-ded74e39f483","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20240601","","ANDA","ANDA216957","Preferred Pharmaceuticals Inc.","300","mg/1","","N","20261231"
"6822","CEPHALEXIN","Cephalexin","68788868602","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8686","68788-8686-2","68788-8686_6994016d-9c09-45ad-b869-a8f62f8e0a80","HUMAN PRESCRIPTION DRUG","cephalexin","","FOR SUSPENSION","ORAL","20240603","","ANDA","ANDA065234","Preferred Pharmaceuticals Inc.","250","mg/5mL","","N","20261231"
"6823","NYSTATIN","nystatin","68788869001","Polyene Antifungal [EPC], Polyenes [CS]","68788-8690","68788-8690-1","68788-8690_197e3046-3e58-4246-b260-f3995dce41a1","HUMAN PRESCRIPTION DRUG","nystatin","","TABLET, COATED","ORAL","20240607","","ANDA","ANDA062474","Preferred Pharmaceuticals Inc.","500000","[USP'U]/1","","N","20251231"
"6824","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68788869200","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8692","68788-8692-0","68788-8692_8a3b9bb2-1573-44de-88ea-5310359140ad","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20240610","","ANDA","ANDA208921","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6825","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68788869201","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8692","68788-8692-1","68788-8692_8a3b9bb2-1573-44de-88ea-5310359140ad","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20240610","","ANDA","ANDA208921","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6826","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68788869202","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8692","68788-8692-2","68788-8692_8a3b9bb2-1573-44de-88ea-5310359140ad","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20240610","","ANDA","ANDA208921","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6827","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68788869208","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8692","68788-8692-8","68788-8692_8a3b9bb2-1573-44de-88ea-5310359140ad","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20240610","","ANDA","ANDA208921","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6828","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68788869203","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8692","68788-8692-3","68788-8692_8a3b9bb2-1573-44de-88ea-5310359140ad","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20240610","","ANDA","ANDA208921","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6829","AZITHROMYCIN DIHYDRATE","Azithromycin","68788870206","Macrolide Antimicrobial [EPC], Macrolides [CS]","68788-8702","68788-8702-6","68788-8702_467c8932-77a6-42e9-a9a6-a57f9a021904","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20240627","","ANDA","ANDA207370","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20261231"
"6830","AMOXICILLIN","Amoxicillin","68788873001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-8730","68788-8730-1","68788-8730_d903a717-f9bb-4c52-b32d-7d465c31a128","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20240916","","ANDA","ANDA065325","Preferred Pharmaceuticals Inc.","400","mg/5mL","","N","20261231"
"6831","AMOXICILLIN","Amoxicillin","68788873101","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-8731","68788-8731-1","68788-8731_f265c4ff-e4f3-4654-823a-8180055073f0","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20240916","","ANDA","ANDA065119","Preferred Pharmaceuticals Inc.","400","mg/5mL","","N","20261231"
"6832","CEPHALEXIN","Cephalexin","68788874001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8740","68788-8740-1","68788-8740_e573b8de-1fb4-4ee2-a340-f4a73dfe7bc4","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20240923","","ANDA","ANDA062702","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6833","CEPHALEXIN","Cephalexin","68788874002","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8740","68788-8740-2","68788-8740_e573b8de-1fb4-4ee2-a340-f4a73dfe7bc4","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20240923","","ANDA","ANDA062702","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6834","CEPHALEXIN","Cephalexin","68788874003","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8740","68788-8740-3","68788-8740_e573b8de-1fb4-4ee2-a340-f4a73dfe7bc4","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20240923","","ANDA","ANDA062702","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6835","CEPHALEXIN","Cephalexin","68788874005","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8740","68788-8740-5","68788-8740_e573b8de-1fb4-4ee2-a340-f4a73dfe7bc4","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20240923","","ANDA","ANDA062702","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6836","CEPHALEXIN","Cephalexin","68788874006","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8740","68788-8740-6","68788-8740_e573b8de-1fb4-4ee2-a340-f4a73dfe7bc4","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20240923","","ANDA","ANDA062702","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6837","CEPHALEXIN","Cephalexin","68788874007","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8740","68788-8740-7","68788-8740_e573b8de-1fb4-4ee2-a340-f4a73dfe7bc4","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20240923","","ANDA","ANDA062702","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6838","CEPHALEXIN","Cephalexin","68788874008","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8740","68788-8740-8","68788-8740_e573b8de-1fb4-4ee2-a340-f4a73dfe7bc4","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20240923","","ANDA","ANDA062702","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6839","CEPHALEXIN","Cephalexin","68788874009","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8740","68788-8740-9","68788-8740_e573b8de-1fb4-4ee2-a340-f4a73dfe7bc4","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20240923","","ANDA","ANDA062702","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6840","CEPHALEXIN","Cephalexin","68788874004","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-8740","68788-8740-4","68788-8740_e573b8de-1fb4-4ee2-a340-f4a73dfe7bc4","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20240923","","ANDA","ANDA062702","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6841","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone","68788874803","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68788-8748","68788-8748-3","68788-8748_e42d4837-77c2-40c3-8705-20966a51a822","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Dexamethasone","","OINTMENT","OPHTHALMIC","20241011","","ANDA","ANDA064063","Preferred Pharmaceuticals Inc.","1; 3.5; 10000","mg/g; mg/g; [USP'U]/g","","N","20251231"
"6842","AMOXICILLIN","Amoxicillin","68788875901","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-8759","68788-8759-1","68788-8759_574367fd-da72-4eaf-977a-c3690f64449a","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20241017","","ANDA","ANDA065322","Preferred Pharmaceuticals Inc.","250","mg/5mL","","N","20251231"
"6843","OFLOXACIN","ofloxacin","68788876105","Quinolone Antimicrobial [EPC], Quinolones [CS]","68788-8761","68788-8761-5","68788-8761_f7916bb3-7593-45f8-b9de-98e0f2d57227","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20241111","","ANDA","ANDA076513","Preferred Pharmaceuticals Inc.","3","mg/mL","","N","20251231"
"6844","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788877001","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-8770","68788-8770-1","68788-8770_16915fe9-1ac9-4ebb-afc8-eeb89144f30c","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","SUSPENSION","ORAL","20241120","","ANDA","ANDA065373","Preferred Pharmaceuticals Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"6845","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788877007","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-8770","68788-8770-7","68788-8770_16915fe9-1ac9-4ebb-afc8-eeb89144f30c","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","SUSPENSION","ORAL","20241120","","ANDA","ANDA065373","Preferred Pharmaceuticals Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"6846","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","68788877304","Macrolide Antimicrobial [EPC], Macrolides [CS]","68788-8773","68788-8773-4","68788-8773_3b90572c-cc24-49f0-baaf-09022a2f9a00","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20241120","","ANDA","ANDA208249","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"6847","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","68788877303","Macrolide Antimicrobial [EPC], Macrolides [CS]","68788-8773","68788-8773-3","68788-8773_3b90572c-cc24-49f0-baaf-09022a2f9a00","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20241120","","ANDA","ANDA208249","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20251231"
"6848","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","68788880006","Macrolide Antimicrobial [EPC], Macrolides [CS]","68788-8800","68788-8800-6","68788-8800_b3c84aea-7ba7-4aae-999c-db740a9e53df","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20250101","","ANDA","ANDA208250","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"6849","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","68788880803","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","68788-8808","68788-8808-3","68788-8808_6115a76d-4bad-4829-b2bc-3a077154109d","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20250120","","ANDA","ANDA208205","Preferred Pharmaceuticals Inc.","100000; 1","[USP'U]/g; mg/g","","N","20261231"
"6850","CLOTRIMAZOLE","Clotrimazole","68788883002","Azole Antifungal [EPC], Azoles [CS]","68788-8830","68788-8830-2","68788-8830_0052992a-819c-4c55-bd88-201a09a3573a","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20250221","","OTC MONOGRAPH DRUG","M005","Preferred Pharmaceuticals Inc.","1","g/100g","","N","20261231"
"6851","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","68788883602","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","68788-8836","68788-8836-2","68788-8836_a0822381-ba9a-4f80-bc4f-608301d07fd8","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20250227","","ANDA","ANDA091568","Preferred Pharmaceuticals Inc.","875; 125","mg/1; mg/1","","N","20261231"
"6852","MICONAZOLE NITRATE","MICONAZOLE NITRATE","68788884503","Azole Antifungal [EPC], Azoles [CS]","68788-8845","68788-8845-3","68788-8845_14d2a661-a490-41ca-b84f-f2be3bc271b4","HUMAN OTC DRUG","MICONAZOLE Nitrate 2% Cream ANTIFUNGAL","","CREAM","TOPICAL","20250324","","OTC MONOGRAPH DRUG","M005","Preferred Pharmaceuticals Inc.","2","g/100g","","N","20261231"
"6853","AMOXICILLIN","Amoxicillin","68788885201","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-8852","68788-8852-1","68788-8852_992d7829-34d1-4c88-8a5c-1a92d001d194","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20250324","","ANDA","ANDA065325","Preferred Pharmaceuticals Inc.","200","mg/5mL","","N","20261231"
"6854","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","68788885303","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","68788-8853","68788-8853-3","68788-8853_4202cbfb-52e9-47f2-bd3a-1003319ca3cb","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20250324","","ANDA","ANDA061837","Preferred Pharmaceuticals Inc.","500","mg/1","","N","20261231"
"6855","KETOCONAZOLE","Ketoconazole","68788886801","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","68788-8868","68788-8868-1","68788-8868_39d31bed-9caa-41bb-afdb-25fc18609c14","HUMAN PRESCRIPTION DRUG","Ketoconazole","","SHAMPOO, SUSPENSION","TOPICAL","20250424","","ANDA","ANDA076942","Preferred Pharmaceuticals Inc.","20","mg/mL","","N","20261231"
"6856","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68788887501","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8875","68788-8875-1","68788-8875_15755a35-e29a-47c1-89ab-e6645bb3ade9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20250519","","ANDA","ANDA208921","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20261231"
"6857","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68788887502","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8875","68788-8875-2","68788-8875_15755a35-e29a-47c1-89ab-e6645bb3ade9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20250519","","ANDA","ANDA208921","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20261231"
"6858","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68788887503","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8875","68788-8875-3","68788-8875_15755a35-e29a-47c1-89ab-e6645bb3ade9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20250519","","ANDA","ANDA208921","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20261231"
"6859","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68788887500","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8875","68788-8875-0","68788-8875_15755a35-e29a-47c1-89ab-e6645bb3ade9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20250519","","ANDA","ANDA208921","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20261231"
"6860","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68788887506","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8875","68788-8875-6","68788-8875_15755a35-e29a-47c1-89ab-e6645bb3ade9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20250519","","ANDA","ANDA208921","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20261231"
"6861","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68788887508","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8875","68788-8875-8","68788-8875_15755a35-e29a-47c1-89ab-e6645bb3ade9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20250519","","ANDA","ANDA208921","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20261231"
"6862","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","68788887504","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","68788-8875","68788-8875-4","68788-8875_15755a35-e29a-47c1-89ab-e6645bb3ade9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20250519","","ANDA","ANDA208921","Preferred Pharmaceuticals Inc.","250","mg/1","","N","20261231"
"6863","ECONAZOLE NITRATE","Econazole Nitrate","68788888403","Azole Antifungal [EPC], Azoles [CS]","68788-8884","68788-8884-3","68788-8884_2bd2a48e-cbef-4b14-a02f-9aa693cc4b47","HUMAN PRESCRIPTION DRUG","Econazole Nitrate","","CREAM","TOPICAL","20060808","","ANDA","ANDA076479","Preferred Pharmaceuticals Inc.","10","mg/g","","N","20261231"
"6864","AMOXICILLIN","Amoxicillin","68788901701","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-9017","68788-9017-1","68788-9017_07143486-83e9-4f76-935a-b1897483edaf","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20110615","","ANDA","ANDA065322","Preferred Pharmaceuticals, Inc.","250","mg/5mL","","N","20251231"
"6865","AMOXICILLIN","Amoxicillin","68788901801","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-9018","68788-9018-1","68788-9018_07143486-83e9-4f76-935a-b1897483edaf","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20110615","","ANDA","ANDA065325","Preferred Pharmaceuticals, Inc.","400","mg/5mL","","N","20251231"
"6866","AMOXICILLIN","Amoxicillin","68788901901","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-9019","68788-9019-1","68788-9019_07143486-83e9-4f76-935a-b1897483edaf","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20110615","","ANDA","ANDA065322","Preferred Pharmaceuticals, Inc.","125","mg/5mL","","N","20251231"
"6867","CEPHALEXIN","Cephalexin","68788932602","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9326","68788-9326-2","68788-9326_7a4a5435-29c6-48a8-b0a7-3466d168042a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20150409","","ANDA","ANDA090836","Preferred Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6868","CEPHALEXIN","Cephalexin","68788932603","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9326","68788-9326-3","68788-9326_7a4a5435-29c6-48a8-b0a7-3466d168042a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20150409","","ANDA","ANDA090836","Preferred Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6869","CEPHALEXIN","Cephalexin","68788932606","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9326","68788-9326-6","68788-9326_7a4a5435-29c6-48a8-b0a7-3466d168042a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20150409","","ANDA","ANDA090836","Preferred Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6870","CEPHALEXIN","Cephalexin","68788932607","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9326","68788-9326-7","68788-9326_7a4a5435-29c6-48a8-b0a7-3466d168042a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20150409","","ANDA","ANDA090836","Preferred Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6871","CEPHALEXIN","Cephalexin","68788932608","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9326","68788-9326-8","68788-9326_7a4a5435-29c6-48a8-b0a7-3466d168042a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20150409","","ANDA","ANDA090836","Preferred Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6872","CEPHALEXIN","Cephalexin","68788932604","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9326","68788-9326-4","68788-9326_7a4a5435-29c6-48a8-b0a7-3466d168042a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20150409","","ANDA","ANDA090836","Preferred Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6873","CEPHALEXIN","Cephalexin","68788932609","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9326","68788-9326-9","68788-9326_7a4a5435-29c6-48a8-b0a7-3466d168042a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20150409","","ANDA","ANDA090836","Preferred Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"6874","ERYTHROMYCIN","Erythromycin","68788932803","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","68788-9328","68788-9328-3","68788-9328_0e86b974-a885-43e8-b77c-878f401dd11a","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","20150402","","ANDA","ANDA064067","Preferred Pharmaceuticals, Inc.","5","mg/g","","N","20261231"
"6875","CEPHALEXIN","Cephalexin","68788953801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9538","68788-9538-1","68788-9538_ca2da054-e63c-4dca-9f87-c4a409036430","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","20131203","","ANDA","ANDA062703","Preferred Pharmaceuticals, Inc.","125","mg/5mL","","N","20261231"
"6876","CEPHALEXIN","Cephalexin","68788953802","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9538","68788-9538-2","68788-9538_ca2da054-e63c-4dca-9f87-c4a409036430","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","20131203","","ANDA","ANDA062703","Preferred Pharmaceuticals, Inc.","125","mg/5mL","","N","20261231"
"6877","CEPHALEXIN","Cephalexin","68788953902","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9539","68788-9539-2","68788-9539_ca2da054-e63c-4dca-9f87-c4a409036430","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","20131203","","ANDA","ANDA062703","Preferred Pharmaceuticals, Inc.","250","mg/5mL","","N","20261231"
"6878","CEPHALEXIN","Cephalexin","68788953901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9539","68788-9539-1","68788-9539_ca2da054-e63c-4dca-9f87-c4a409036430","HUMAN PRESCRIPTION DRUG","Cephalexin","","POWDER, FOR SUSPENSION","ORAL","20131203","","ANDA","ANDA062703","Preferred Pharmaceuticals, Inc.","250","mg/5mL","","N","20261231"
"6879","CLOTRIMAZOLE","Clotrimazole","68788966504","Azole Antifungal [EPC], Azoles [CS]","68788-9665","68788-9665-4","68788-9665_f113ae13-2579-4f72-8bb1-8bc551c71df2","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","20130805","","ANDA","ANDA072641","Preferred Pharmaceuticals, Inc.","1","g/100g","","N","20261231"
"6880","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone","68788970205","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68788-9702","68788-9702-5","68788-9702_9a03bf69-b428-47d8-a265-482d1dde5390","HUMAN PRESCRIPTION DRUG","Neomycin Polymyxin B Sulfates and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","20130314","","ANDA","ANDA064135","Preferred Pharmaceuticals, Inc.","1; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"6881","CEPHALEXIN","Cephalexin","68788971302","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9713","68788-9713-2","68788-9713_7a4a5435-29c6-48a8-b0a7-3466d168042a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20130205","","ANDA","ANDA090836","Preferred Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"6882","CEPHALEXIN","Cephalexin","68788971304","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9713","68788-9713-4","68788-9713_7a4a5435-29c6-48a8-b0a7-3466d168042a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20130205","","ANDA","ANDA090836","Preferred Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"6883","CEPHALEXIN","Cephalexin","68788971306","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9713","68788-9713-6","68788-9713_7a4a5435-29c6-48a8-b0a7-3466d168042a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20130205","","ANDA","ANDA090836","Preferred Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"6884","CEPHALEXIN","Cephalexin","68788971307","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9713","68788-9713-7","68788-9713_7a4a5435-29c6-48a8-b0a7-3466d168042a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20130205","","ANDA","ANDA090836","Preferred Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"6885","CEPHALEXIN","Cephalexin","68788971303","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9713","68788-9713-3","68788-9713_7a4a5435-29c6-48a8-b0a7-3466d168042a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20130205","","ANDA","ANDA090836","Preferred Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"6886","CEPHALEXIN","Cephalexin","68788971308","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","68788-9713","68788-9713-8","68788-9713_7a4a5435-29c6-48a8-b0a7-3466d168042a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20130205","","ANDA","ANDA090836","Preferred Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"6887","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","68788981401","Allylamine Antifungal [EPC], Allylamine [CS]","68788-9814","68788-9814-1","68788-9814_31e8568a-8b0a-4aca-bf23-09c5dd76088b","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20120405","","ANDA","ANDA077511","Preferred Pharmaceuticals, Inc","1","g/100g","","N","20251231"
"6888","PENICILLIN V POTASSIUM","Penicillin V Potassium","68788985202","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-9852","68788-9852-2","68788-9852_a7d031ac-55ab-4435-be32-e5cc58e7ca23","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","POWDER, FOR SOLUTION","ORAL","20120314","","ANDA","ANDA060456","Preferred Pharmaceuticals, Inc","250","mg/5mL","","N","20251231"
"6889","PENICILLIN V POTASSIUM","Penicillin V Potassium","68788985201","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-9852","68788-9852-1","68788-9852_a7d031ac-55ab-4435-be32-e5cc58e7ca23","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","POWDER, FOR SOLUTION","ORAL","20120314","","ANDA","ANDA060456","Preferred Pharmaceuticals, Inc","250","mg/5mL","","N","20251231"
"6890","PENICILLIN V POTASSIUM","Penicillin V Potassium","68788985301","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-9853","68788-9853-1","68788-9853_a7d031ac-55ab-4435-be32-e5cc58e7ca23","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","POWDER, FOR SOLUTION","ORAL","20120314","","ANDA","ANDA060456","Preferred Pharmaceuticals, Inc","125","mg/5mL","","N","20251231"
"6891","PENICILLIN V POTASSIUM","Penicillin V Potassium","68788985302","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-9853","68788-9853-2","68788-9853_a7d031ac-55ab-4435-be32-e5cc58e7ca23","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","POWDER, FOR SOLUTION","ORAL","20120314","","ANDA","ANDA060456","Preferred Pharmaceuticals, Inc","125","mg/5mL","","N","20251231"
"6892","SULFACETAMIDE SODIUM","sulfacetamide sodium","68788987101","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","68788-9871","68788-9871-1","68788-9871_f7f5bd6f-2a48-4f0b-b906-69a3b0e5be45","HUMAN PRESCRIPTION DRUG","Sulfacetamide Sodium","","SOLUTION/ DROPS","OPHTHALMIC","20120228","","ANDA","ANDA040066","Preferred Pharmaceuticals, Inc","100","mg/mL","","N","20251231"
"6893","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone","68788992401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","68788-9924","68788-9924-1","68788-9924_a2867d8f-12f4-4dc2-8beb-5cc29277142c","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","20120118","","ANDA","ANDA064065","Preferred Pharmaceuticals, Inc.","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"6894","AMOXICILLIN","Amoxicillin","68788994801","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-9948","68788-9948-1","68788-9948_fed9b192-5bf8-45bc-8422-f426320a4bfd","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20120112","","ANDA","ANDA065387","Preferred Pharmaceuticals, Inc.","250","mg/5mL","","N","20251231"
"6895","AMOXICILLIN","Amoxicillin","68788994901","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68788-9949","68788-9949-1","68788-9949_fed9b192-5bf8-45bc-8422-f426320a4bfd","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20120112","","ANDA","ANDA065387","Preferred Pharmaceuticals, Inc.","125","mg/5mL","","N","20251231"
"6896","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin hydrochloride","68999030928","Quinolone Antimicrobial [EPC], Quinolones [CS]","68999-309","68999-309-28","68999-309_f049eb75-5f01-5caa-e053-2a95a90a804c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","CHARTWELL GOVERNMENTAL & SPECIALTY RX LLC","500","mg/1","","N","20251231"
"6897","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin hydrochloride","68999030920","Quinolone Antimicrobial [EPC], Quinolones [CS]","68999-309","68999-309-20","68999-309_f049eb75-5f01-5caa-e053-2a95a90a804c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","CHARTWELL GOVERNMENTAL & SPECIALTY RX LLC","500","mg/1","","N","20251231"
"6898","AMOXICILLIN","Amoxicillin","68999082401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68999-824","68999-824-01","68999-824_1a03060c-4a9e-4a08-e063-6394a90ad804","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19780803","","ANDA","ANDA062058","Chartwell Governmental & Specialty RX, LLC","250","mg/1","","N","20251231"
"6899","AMOXICILLIN","Amoxicillin","68999082560","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68999-825","68999-825-60","68999-825_1a03060c-4a9e-4a08-e063-6394a90ad804","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19780803","","ANDA","ANDA062058","Chartwell Governmental & Specialty RX, LLC","500","mg/1","","N","20251231"
"6900","AMOXICILLIN","Amoxicillin","68999082501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","68999-825","68999-825-01","68999-825_1a03060c-4a9e-4a08-e063-6394a90ad804","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19780803","","ANDA","ANDA062058","Chartwell Governmental & Specialty RX, LLC","500","mg/1","","N","20251231"
"6901","CEFPODOXIME PROXETIL","CEFPODOXIME PROXETIL","69043000601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69043-006","69043-006-01","69043-006_36f0759f-b50b-4a49-869b-d73f5ad7d8cf","HUMAN PRESCRIPTION DRUG","CEFPODOXIME PROXETIL","","TABLET, FILM COATED","ORAL","20070611","","ANDA","ANDA065370","Cronus Pharma LLC","100","mg/1","","N","20251231"
"6902","CEFPODOXIME PROXETIL","CEFPODOXIME PROXETIL","69043000625","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69043-006","69043-006-25","69043-006_36f0759f-b50b-4a49-869b-d73f5ad7d8cf","HUMAN PRESCRIPTION DRUG","CEFPODOXIME PROXETIL","","TABLET, FILM COATED","ORAL","20070611","","ANDA","ANDA065370","Cronus Pharma LLC","100","mg/1","","N","20251231"
"6903","CEFPODOXIME PROXETIL","CEFPODOXIME PROXETIL","69043000701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69043-007","69043-007-01","69043-007_36f0759f-b50b-4a49-869b-d73f5ad7d8cf","HUMAN PRESCRIPTION DRUG","CEFPODOXIME PROXETIL","","TABLET, FILM COATED","ORAL","20070611","","ANDA","ANDA065370","Cronus Pharma LLC","200","mg/1","","N","20251231"
"6904","CEFPODOXIME PROXETIL","CEFPODOXIME PROXETIL","69043000725","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69043-007","69043-007-25","69043-007_36f0759f-b50b-4a49-869b-d73f5ad7d8cf","HUMAN PRESCRIPTION DRUG","CEFPODOXIME PROXETIL","","TABLET, FILM COATED","ORAL","20070611","","ANDA","ANDA065370","Cronus Pharma LLC","200","mg/1","","N","20251231"
"6905","CEPHALEXIN","Cephalexin","69043000801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69043-008","69043-008-01","69043-008_c71c6d65-8fdd-496e-9338-c70276699886","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Cronus Pharma LLC","250","mg/1","","N","20261231"
"6906","CEPHALEXIN","Cephalexin","69043000805","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69043-008","69043-008-05","69043-008_c71c6d65-8fdd-496e-9338-c70276699886","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Cronus Pharma LLC","250","mg/1","","N","20261231"
"6907","CEPHALEXIN","Cephalexin","69043000901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69043-009","69043-009-01","69043-009_c71c6d65-8fdd-496e-9338-c70276699886","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Cronus Pharma LLC","500","mg/1","","N","20261231"
"6908","CEPHALEXIN","Cephalexin","69043000905","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69043-009","69043-009-05","69043-009_c71c6d65-8fdd-496e-9338-c70276699886","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Cronus Pharma LLC","500","mg/1","","N","20261231"
"6909","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","69043001001","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","69043-010","69043-010-01","69043-010_17de019d-ffdf-436a-bcae-2941f844123a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Cronus Pharma LLC","400; 80","mg/1; mg/1","","N","20261231"
"6910","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","69043001005","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","69043-010","69043-010-05","69043-010_17de019d-ffdf-436a-bcae-2941f844123a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Cronus Pharma LLC","400; 80","mg/1; mg/1","","N","20261231"
"6911","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","69043001101","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","69043-011","69043-011-01","69043-011_17de019d-ffdf-436a-bcae-2941f844123a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Cronus Pharma LLC","800; 160","mg/1; mg/1","","N","20261231"
"6912","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","69043001105","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","69043-011","69043-011-05","69043-011_17de019d-ffdf-436a-bcae-2941f844123a","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Cronus Pharma LLC","800; 160","mg/1; mg/1","","N","20261231"
"6913","CLOTRIMAZOLE","Clotrimazole","69070030301","Azole Antifungal [EPC], Azoles [CS]","69070-303","69070-303-01","69070-303_8244693a-e7b2-45f7-8b3a-f19022ae3d8c","HUMAN OTC DRUG","PerfectHeal Antifungal","","CREAM","TOPICAL","20181206","","OTC MONOGRAPH DRUG","part333C","Zhejiang Dingtai Pharmaceutical Co., Ltd","1","g/100g","","N","20251231"
"6914","MICONAZOLE NITRATE","Miconazole Nitrate","69070030401","Azole Antifungal [EPC], Azoles [CS]","69070-304","69070-304-01","69070-304_6a68e426-11f1-4be8-b0cf-eefd44f5c4aa","HUMAN OTC DRUG","PiYanPing Antifungal","","CREAM","TOPICAL","20181206","","OTC MONOGRAPH DRUG","part333C","Zhejiang Dingtai Pharmaceutical Co., Ltd","2","g/100g","","N","20251231"
"6915","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","69097009843","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","69097-098","69097-098-43","69097-098_07e2bc58-0782-4cba-9e8d-fb9c906ab71e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate potassium","","SUSPENSION","ORAL","20241028","","ANDA","ANDA065431","Cipla USA Inc.","250; 62.5","mg/5mL; mg/5mL","","N","20251231"
"6916","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","69097009844","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","69097-098","69097-098-44","69097-098_07e2bc58-0782-4cba-9e8d-fb9c906ab71e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate potassium","","SUSPENSION","ORAL","20241028","","ANDA","ANDA065431","Cipla USA Inc.","250; 62.5","mg/5mL; mg/5mL","","N","20251231"
"6917","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","69097009808","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","69097-098","69097-098-08","69097-098_07e2bc58-0782-4cba-9e8d-fb9c906ab71e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate potassium","","SUSPENSION","ORAL","20241028","","ANDA","ANDA065431","Cipla USA Inc.","250; 62.5","mg/5mL; mg/5mL","","N","20251231"
"6918","TAVABOROLE","TAVABOROLE","69097068637","Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]","69097-686","69097-686-37","69097-686_5b14d29f-abb3-489c-ab42-74eb7343991f","HUMAN PRESCRIPTION DRUG","TAVABOROLE","","SOLUTION","TOPICAL","20210218","","ANDA","ANDA212224","Cipla USA Inc.","43.5","mg/mL","","N","20251231"
"6919","TAVABOROLE","TAVABOROLE","69097068634","Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]","69097-686","69097-686-34","69097-686_5b14d29f-abb3-489c-ab42-74eb7343991f","HUMAN PRESCRIPTION DRUG","TAVABOROLE","","SOLUTION","TOPICAL","20210218","","ANDA","ANDA212224","Cipla USA Inc.","43.5","mg/mL","","N","20251231"
"6920","TERBINAFINE HYDROCHLORIDE","Terbinafine Tablets 250 mg","69097073107","Allylamine Antifungal [EPC], Allylamine [CS]","69097-731","69097-731-07","69097-731_feb4ee13-5f95-4a62-8395-55bad95c424b","HUMAN PRESCRIPTION DRUG","TERBINAFINE HYDROCHLORIDE","","TABLET","ORAL","20210108","","ANDA","ANDA077137","Cipla USA Inc.","250","mg/1","","N","20251231"
"6921","TERBINAFINE HYDROCHLORIDE","Terbinafine Tablets 250 mg","69097073102","Allylamine Antifungal [EPC], Allylamine [CS]","69097-731","69097-731-02","69097-731_feb4ee13-5f95-4a62-8395-55bad95c424b","HUMAN PRESCRIPTION DRUG","TERBINAFINE HYDROCHLORIDE","","TABLET","ORAL","20210108","","ANDA","ANDA077137","Cipla USA Inc.","250","mg/1","","N","20251231"
"6922","DAPTOMYCIN","Daptomycin","69097080737","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","69097-807","69097-807-37","69097-807_f23eb777-6de7-4b66-8fe9-1f0a70e7f225","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190923","","ANDA","ANDA212513","Cipla USA Inc.","500","mg/10mL","","N","20251231"
"6923","DAPTOMYCIN","daptomycin","69097085067","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","69097-850","69097-850-67","69097-850_219e8987-0f88-4149-80e3-77d97e555791","HUMAN PRESCRIPTION DRUG","daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210326","","ANDA","ANDA213425","Cipla USA Inc.","350","mg/7mL","","N","20251231"
"6924","TERBINAFINE HYDROCHLORIDE","Terbinafine","69097085902","Allylamine Antifungal [EPC], Allylamine [CS]","69097-859","69097-859-02","69097-859_05ca19e5-4fab-490c-ac56-07c8de803e84","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20160627","","ANDA","ANDA077533","Cipla USA Inc.","250","1/1","","N","20251231"
"6925","TERBINAFINE HYDROCHLORIDE","Terbinafine","69097085907","Allylamine Antifungal [EPC], Allylamine [CS]","69097-859","69097-859-07","69097-859_05ca19e5-4fab-490c-ac56-07c8de803e84","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20160627","","ANDA","ANDA077533","Cipla USA Inc.","250","1/1","","N","20251231"
"6926","TERBINAFINE HYDROCHLORIDE","Terbinafine","69097085912","Allylamine Antifungal [EPC], Allylamine [CS]","69097-859","69097-859-12","69097-859_05ca19e5-4fab-490c-ac56-07c8de803e84","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20160627","","ANDA","ANDA077533","Cipla USA Inc.","250","1/1","","N","20251231"
"6927","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","69103560301","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69103-5603","69103-5603-1","69103-5603_1f4591c0-4b50-0625-e063-6394a90afa68","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20220725","","OTC MONOGRAPH DRUG","M004","Provision Medical","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"6928","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","69117000801","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69117-0008","69117-0008-1","69117-0008_2a79eeb6-0438-86f3-e063-6394a90a23a1","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Yiling Pharmaceutical, Inc.","250","mg/1","","N","20251231"
"6929","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","69117000802","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69117-0008","69117-0008-2","69117-0008_2a79eeb6-0438-86f3-e063-6394a90a23a1","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Yiling Pharmaceutical, Inc.","250","mg/1","","N","20251231"
"6930","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","69117000901","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69117-0009","69117-0009-1","69117-0009_2a79eeb6-0438-86f3-e063-6394a90a23a1","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Yiling Pharmaceutical, Inc.","500","mg/1","","N","20251231"
"6931","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","69117000902","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69117-0009","69117-0009-2","69117-0009_2a79eeb6-0438-86f3-e063-6394a90a23a1","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Yiling Pharmaceutical, Inc.","500","mg/1","","N","20251231"
"6932","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","69238137302","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","69238-1373","69238-1373-2","69238-1373_85f526f7-6a3c-4a7b-80e6-229a08811eca","HUMAN PRESCRIPTION DRUG","tobramycin and dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","20210717","","ANDA","ANDA212991","Amneal Pharmaceuticals NY LLC","1; 3","mg/mL; mg/mL","","N","20251231"
"6933","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","69238137403","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","69238-1374","69238-1374-3","69238-1374_85f526f7-6a3c-4a7b-80e6-229a08811eca","HUMAN PRESCRIPTION DRUG","tobramycin and dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","20210717","","ANDA","ANDA212991","Amneal Pharmaceuticals NY LLC","1; 3","mg/mL; mg/mL","","N","20251231"
"6934","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","69238137506","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","69238-1375","69238-1375-6","69238-1375_85f526f7-6a3c-4a7b-80e6-229a08811eca","HUMAN PRESCRIPTION DRUG","tobramycin and dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","20210717","","ANDA","ANDA212991","Amneal Pharmaceuticals NY LLC","1; 3","mg/mL; mg/mL","","N","20251231"
"6935","ERYTHROMYCIN","Erythromycin","69238147101","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","69238-1471","69238-1471-1","69238-1471_ecd62575-1fd6-4ed0-ba18-048be51a607c","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, DELAYED RELEASE","ORAL","20190707","","ANDA","ANDA210954","Amneal Pharmaceuticals NY LLC","250","mg/1","","N","20251231"
"6936","ERYTHROMYCIN","Erythromycin","69238147103","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","69238-1471","69238-1471-3","69238-1471_ecd62575-1fd6-4ed0-ba18-048be51a607c","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, DELAYED RELEASE","ORAL","20190707","","ANDA","ANDA210954","Amneal Pharmaceuticals NY LLC","250","mg/1","","N","20251231"
"6937","ERYTHROMYCIN","Erythromycin","69238147201","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","69238-1472","69238-1472-1","69238-1472_ecd62575-1fd6-4ed0-ba18-048be51a607c","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, DELAYED RELEASE","ORAL","20190707","","ANDA","ANDA210954","Amneal Pharmaceuticals NY LLC","333","mg/1","","N","20251231"
"6938","ERYTHROMYCIN","Erythromycin","69238147203","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","69238-1472","69238-1472-3","69238-1472_ecd62575-1fd6-4ed0-ba18-048be51a607c","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, DELAYED RELEASE","ORAL","20190707","","ANDA","ANDA210954","Amneal Pharmaceuticals NY LLC","333","mg/1","","N","20251231"
"6939","ERYTHROMYCIN","Erythromycin","69238147301","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","69238-1473","69238-1473-1","69238-1473_ecd62575-1fd6-4ed0-ba18-048be51a607c","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, DELAYED RELEASE","ORAL","20190707","","ANDA","ANDA210954","Amneal Pharmaceuticals NY LLC","500","mg/1","","N","20251231"
"6940","ERYTHROMYCIN","Erythromycin","69238147303","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","69238-1473","69238-1473-3","69238-1473_ecd62575-1fd6-4ed0-ba18-048be51a607c","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, DELAYED RELEASE","ORAL","20190707","","ANDA","ANDA210954","Amneal Pharmaceuticals NY LLC","500","mg/1","","N","20251231"
"6941","POSACONAZOLE","Posaconazole","69238147603","Azole Antifungal [EPC], Azoles [CS]","69238-1476","69238-1476-3","69238-1476_e5dd752f-8c59-429e-94ef-b94708120a73","HUMAN PRESCRIPTION DRUG","Posaconazole","","TABLET, DELAYED RELEASE","ORAL","20221230","","ANDA","ANDA216626","Amneal Pharmaceuticals NY LLC","100","mg/1","","N","20251231"
"6942","POSACONAZOLE","Posaconazole","69238147606","Azole Antifungal [EPC], Azoles [CS]","69238-1476","69238-1476-6","69238-1476_e5dd752f-8c59-429e-94ef-b94708120a73","HUMAN PRESCRIPTION DRUG","Posaconazole","","TABLET, DELAYED RELEASE","ORAL","20221230","","ANDA","ANDA216626","Amneal Pharmaceuticals NY LLC","100","mg/1","","N","20251231"
"6943","ERYTHROMYCIN","Erythromycin","69238148403","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","69238-1484","69238-1484-3","69238-1484_61ae864e-1e74-40c1-b67f-22ea1e6f9f21","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20180311","","ANDA","ANDA209720","Amneal Pharmaceuticals NY LLC","250","mg/1","","N","20251231"
"6944","ERYTHROMYCIN","Erythromycin","69238148401","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","69238-1484","69238-1484-1","69238-1484_61ae864e-1e74-40c1-b67f-22ea1e6f9f21","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20180311","","ANDA","ANDA209720","Amneal Pharmaceuticals NY LLC","250","mg/1","","N","20251231"
"6945","ERYTHROMYCIN","Erythromycin","69238148501","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","69238-1485","69238-1485-1","69238-1485_61ae864e-1e74-40c1-b67f-22ea1e6f9f21","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20180311","","ANDA","ANDA209720","Amneal Pharmaceuticals NY LLC","500","mg/1","","N","20251231"
"6946","ERYTHROMYCIN","Erythromycin","69238148503","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","69238-1485","69238-1485-3","69238-1485_61ae864e-1e74-40c1-b67f-22ea1e6f9f21","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20180311","","ANDA","ANDA209720","Amneal Pharmaceuticals NY LLC","500","mg/1","","N","20251231"
"6947","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin","69238150301","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","69238-1503","69238-1503-1","69238-1503_85c41da0-5783-4194-8bb5-7b14ad975d25","HUMAN PRESCRIPTION DRUG","Erythromycin Ethylsuccinate","","SUSPENSION","ORAL","20191104","","ANDA","ANDA211204","Amneal Pharmaceuticals NY LLC","200","mg/5mL","","N","20251231"
"6948","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin","69238150402","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","69238-1504","69238-1504-2","69238-1504_85c41da0-5783-4194-8bb5-7b14ad975d25","HUMAN PRESCRIPTION DRUG","Erythromycin Ethylsuccinate","","SUSPENSION","ORAL","20191104","","ANDA","ANDA211204","Amneal Pharmaceuticals NY LLC","400","mg/5mL","","N","20251231"
"6949","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","69238152201","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","69238-1522","69238-1522-1","69238-1522_15697aca-7bc8-4a3a-a935-1b79790a919e","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20180921","","ANDA","ANDA210674","Amneal Pharmaceuticals NY LLC","250","mg/1","","N","20261231"
"6950","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","69238152301","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","69238-1523","69238-1523-1","69238-1523_15697aca-7bc8-4a3a-a935-1b79790a919e","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20180921","","ANDA","ANDA210674","Amneal Pharmaceuticals NY LLC","500","mg/1","","N","20261231"
"6951","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","69238154405","Antimalarial [EPC], Antirheumatic Agent [EPC]","69238-1544","69238-1544-5","69238-1544_a9b15cd5-6f44-4de8-b6d9-6a90e50b356b","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20180517","","ANDA","ANDA210577","Amneal Pharmaceuticals NY LLC","200","mg/1","","N","20261231"
"6952","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","69238154401","Antimalarial [EPC], Antirheumatic Agent [EPC]","69238-1544","69238-1544-1","69238-1544_a9b15cd5-6f44-4de8-b6d9-6a90e50b356b","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20180517","","ANDA","ANDA210577","Amneal Pharmaceuticals NY LLC","200","mg/1","","N","20261231"
"6953","OFLOXACIN","Ofloxacin Otic","69238161503","Quinolone Antimicrobial [EPC], Quinolones [CS]","69238-1615","69238-1615-3","69238-1615_d15f384c-ca53-4e8c-8d50-bfa1eef73abb","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","AURICULAR (OTIC)","20200317","","ANDA","ANDA211525","Amneal Pharmaceuticals NY LLC","3","mg/mL","","N","20251231"
"6954","OFLOXACIN","Ofloxacin Otic","69238161606","Quinolone Antimicrobial [EPC], Quinolones [CS]","69238-1616","69238-1616-6","69238-1616_d15f384c-ca53-4e8c-8d50-bfa1eef73abb","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","AURICULAR (OTIC)","20190830","","ANDA","ANDA211525","Amneal Pharmaceuticals NY LLC","3","mg/mL","","N","20251231"
"6955","TAVABOROLE","Tavaborole","69238165704","Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]","69238-1657","69238-1657-4","69238-1657_84f7f3e4-e52f-4054-ad9c-d57fc99f52ce","HUMAN PRESCRIPTION DRUG","Tavaborole","","SOLUTION","TOPICAL","20201128","","ANDA","ANDA212256","Amneal Pharmaceuticals NY LLC","43.5","mg/mL","","N","20251231"
"6956","TAVABOROLE","Tavaborole","69238165706","Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]","69238-1657","69238-1657-6","69238-1657_84f7f3e4-e52f-4054-ad9c-d57fc99f52ce","HUMAN PRESCRIPTION DRUG","Tavaborole","","SOLUTION","TOPICAL","20201128","","ANDA","ANDA212256","Amneal Pharmaceuticals NY LLC","43.5","mg/mL","","N","20251231"
"6957","OFLOXACIN","Ofloxacin","69238166506","Quinolone Antimicrobial [EPC], Quinolones [CS]","69238-1665","69238-1665-6","69238-1665_caf6e600-0ca4-4d42-aff9-5dbb0ba662da","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20240304","","ANDA","ANDA211524","Amneal Pharmaceuticals NY LLC","3","mg/mL","","N","20251231"
"6958","MUPIROCIN CALCIUM","Mupirocin","69238202903","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","69238-2029","69238-2029-3","69238-2029_e5ab6651-9d45-4c0d-9c8c-6845054f4991","HUMAN PRESCRIPTION DRUG","Mupirocin","","CREAM","TOPICAL","20221117","","ANDA","ANDA214811","Amneal Pharmaceuticals NY LLC","2","g/100g","","N","20251231"
"6959","MUPIROCIN CALCIUM","Mupirocin","69238202905","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","69238-2029","69238-2029-5","69238-2029_e5ab6651-9d45-4c0d-9c8c-6845054f4991","HUMAN PRESCRIPTION DRUG","Mupirocin","","CREAM","TOPICAL","20221117","","ANDA","ANDA214811","Amneal Pharmaceuticals NY LLC","2","g/100g","","N","20251231"
"6960","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","69238203006","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","69238-2030","69238-2030-6","69238-2030_577561cd-5f28-4b41-9037-0bbc3b6a20df","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20221107","","ANDA","ANDA215219","Amneal Pharmaceuticals NY LLC","10","mg/g","","N","20251231"
"6961","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","69238203003","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","69238-2030","69238-2030-3","69238-2030_577561cd-5f28-4b41-9037-0bbc3b6a20df","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20221107","","ANDA","ANDA215219","Amneal Pharmaceuticals NY LLC","10","mg/g","","N","20251231"
"6962","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","69238203107","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","69238-2031","69238-2031-7","69238-2031_e3ac80f9-e1cc-4e37-bc97-f3ee4cd928e4","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20220808","","ANDA","ANDA214668","Amneal Pharmaceuticals NY LLC","1","g/100mL","","N","20251231"
"6963","CLINDAMYCIN HYDROCHLORIDE","clindamycin hydrochloride","69238212103","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","69238-2121","69238-2121-3","69238-2121_f118e287-5acc-4a8b-bcf0-01436de5bdf9","HUMAN PRESCRIPTION DRUG","clindamycin hydrochloride","","CAPSULE, GELATIN COATED","ORAL","20220425","","ANDA","ANDA065194","Amneal Pharmaceuticals NY LLC","300","mg/1","","N","20251231"
"6964","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","69238226105","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","69238-2261","69238-2261-5","69238-2261_4709fe67-0ab3-4727-950f-b926a7bb21df","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","SOLUTION","ORAL","20230626","","ANDA","ANDA215338","Amneal Pharmaceuticals NY LLC","250","mg/5mL","","N","20251231"
"6965","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","69238226107","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","69238-2261","69238-2261-7","69238-2261_4709fe67-0ab3-4727-950f-b926a7bb21df","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","SOLUTION","ORAL","20230626","","ANDA","ANDA215338","Amneal Pharmaceuticals NY LLC","250","mg/5mL","","N","20251231"
"6966","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","69238226103","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","69238-2261","69238-2261-3","69238-2261_4709fe67-0ab3-4727-950f-b926a7bb21df","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","SOLUTION","ORAL","20230626","","ANDA","ANDA215338","Amneal Pharmaceuticals NY LLC","250","mg/5mL","","N","20251231"
"6967","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","69238243201","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69238-2432","69238-2432-1","69238-2432_d44c6eb1-e419-4bee-977a-b1b46444595f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240229","","ANDA","ANDA075939","Amneal Pharmaceuticals NY LLC","250","mg/1","","N","20251231"
"6968","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","69238243301","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69238-2433","69238-2433-1","69238-2433_d44c6eb1-e419-4bee-977a-b1b46444595f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240229","","ANDA","ANDA075939","Amneal Pharmaceuticals NY LLC","500","mg/1","","N","20251231"
"6969","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","69238243401","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69238-2434","69238-2434-1","69238-2434_d44c6eb1-e419-4bee-977a-b1b46444595f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240229","","ANDA","ANDA075939","Amneal Pharmaceuticals NY LLC","750","mg/1","","N","20251231"
"6970","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","69238243405","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69238-2434","69238-2434-5","69238-2434_d44c6eb1-e419-4bee-977a-b1b46444595f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240229","","ANDA","ANDA075939","Amneal Pharmaceuticals NY LLC","750","mg/1","","N","20251231"
"6971","NITROFURANTOIN","Nitrofurantoin","69238251209","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","69238-2512","69238-2512-9","69238-2512_87af7ed1-6ae7-4eaf-ab35-d46d07549450","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","SUSPENSION","ORAL","20210531","","ANDA","ANDA201679","Amneal Pharmaceuticals NY LLC","25","mg/5mL","","N","20251231"
"6972","MICONAZOLE NITRATE","Jock Itch Spray","69256003846","Azole Antifungal [EPC], Azoles [CS]","69256-038","69256-038-46","69256-038_28f2a326-e2f3-adf1-e063-6294a90aa7fc","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, SPRAY","TOPICAL","20171221","","OTC MONOGRAPH DRUG","M005","Harris Teeter, LLC","1.3","g/130g","","N","20251231"
"6973","MICONAZOLE NITRATE","Athletes Foot Powder Spray Talc Free","69256003946","Azole Antifungal [EPC], Azoles [CS]","69256-039","69256-039-46","69256-039_28f29de6-ac35-685a-e063-6394a90ad40e","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, POWDER","TOPICAL","20170522","","OTC MONOGRAPH DRUG","M005","Harris Teeter, LLC","2.6","g/130g","","N","20251231"
"6974","METRONIDAZOLE","metronidazole","69292020701","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","69292-207","69292-207-01","69292-207_ea93595d-72b5-4df4-8251-3e66be6db5d9","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190826","","ANDA","ANDA070772","AMICI PHARMA INC","250","mg/1","","N","20261231"
"6975","METRONIDAZOLE","metronidazole","69292020750","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","69292-207","69292-207-50","69292-207_ea93595d-72b5-4df4-8251-3e66be6db5d9","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190826","","ANDA","ANDA070772","AMICI PHARMA INC","250","mg/1","","N","20261231"
"6976","METRONIDAZOLE","metronidazole","69292020850","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","69292-208","69292-208-50","69292-208_7287076f-6345-40c4-8ced-5b3cae45b7a4","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20191122","","ANDA","ANDA070772","AMICI PHARMA INC","500","mg/1","","N","20261231"
"6977","METRONIDAZOLE","metronidazole","69292020801","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","69292-208","69292-208-01","69292-208_7287076f-6345-40c4-8ced-5b3cae45b7a4","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20191122","","ANDA","ANDA070772","AMICI PHARMA INC","500","mg/1","","N","20261231"
"6978","KETOCONAZOLE","Ketoconazole","69292022401","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","69292-224","69292-224-01","69292-224_82cd25ed-53c6-4897-bae0-d986d58f0cc8","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","20250621","","ANDA","ANDA075912","Amici Pharma Inc.","200","mg/1","","N","20261231"
"6979","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","69292051050","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69292-510","69292-510-50","69292-510_849a91fa-6412-4985-a567-528c508e6815","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20220826","","ANDA","ANDA210568","Amici Pharmaceuticals, LLC.","100","mg/1","","N","20251231"
"6980","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","69292051001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69292-510","69292-510-01","69292-510_849a91fa-6412-4985-a567-528c508e6815","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20220826","","ANDA","ANDA210568","Amici Pharmaceuticals, LLC.","100","mg/1","","N","20251231"
"6981","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","69292051201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69292-512","69292-512-01","69292-512_849a91fa-6412-4985-a567-528c508e6815","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20220826","","ANDA","ANDA210568","Amici Pharmaceuticals, LLC.","200","mg/1","","N","20251231"
"6982","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","69292051250","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69292-512","69292-512-50","69292-512_849a91fa-6412-4985-a567-528c508e6815","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20220826","","ANDA","ANDA210568","Amici Pharmaceuticals, LLC.","200","mg/1","","N","20251231"
"6983","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","69292051450","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69292-514","69292-514-50","69292-514_157c18ee-7809-4e05-8caa-0359ef50142e","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20221221","","ANDA","ANDA210568","Amici Pharmaceuticals, LLC.","100","mg/1","","N","20251231"
"6984","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","69292051401","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69292-514","69292-514-01","69292-514_157c18ee-7809-4e05-8caa-0359ef50142e","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20221221","","ANDA","ANDA210568","Amici Pharmaceuticals, LLC.","100","mg/1","","N","20251231"
"6985","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","69292051601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69292-516","69292-516-01","69292-516_157c18ee-7809-4e05-8caa-0359ef50142e","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20221221","","ANDA","ANDA210568","Amici Pharmaceuticals, LLC.","200","mg/1","","N","20251231"
"6986","CEFPODOXIME PROXETIL","Cefpodoxime Proxetil","69292051650","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69292-516","69292-516-50","69292-516_157c18ee-7809-4e05-8caa-0359ef50142e","HUMAN PRESCRIPTION DRUG","Cefpodoxime Proxetil","","TABLET, FILM COATED","ORAL","20221221","","ANDA","ANDA210568","Amici Pharmaceuticals, LLC.","200","mg/1","","N","20251231"
"6987","AZITHROMYCIN DIHYDRATE","Azithromycin","69306025006","Macrolide Antimicrobial [EPC], Macrolides [CS]","69306-250","69306-250-06","69306-250_c479da04-f3f7-fa5f-e053-2995a90a9ef8","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210000","Doc Rx","250","mg/1","","N","20251231"
"6988","NYSTATIN","NYSTATIN","69315030615","Polyene Antifungal [EPC], Polyenes [CS]","69315-306","69315-306-15","69315-306_408ac13e-825a-44b1-b8cd-d52cbb0185d0","HUMAN PRESCRIPTION DRUG","NYSTATIN","","POWDER","TOPICAL","20180423","","ANDA","ANDA208838","Leading Pharma, LLC","100000","[USP'U]/g","","N","20251231"
"6989","NYSTATIN","NYSTATIN","69315030660","Polyene Antifungal [EPC], Polyenes [CS]","69315-306","69315-306-60","69315-306_408ac13e-825a-44b1-b8cd-d52cbb0185d0","HUMAN PRESCRIPTION DRUG","NYSTATIN","","POWDER","TOPICAL","20180423","","ANDA","ANDA208838","Leading Pharma, LLC","100000","[USP'U]/g","","N","20251231"
"6990","NYSTATIN","NYSTATIN","69315030630","Polyene Antifungal [EPC], Polyenes [CS]","69315-306","69315-306-30","69315-306_408ac13e-825a-44b1-b8cd-d52cbb0185d0","HUMAN PRESCRIPTION DRUG","NYSTATIN","","POWDER","TOPICAL","20180423","","ANDA","ANDA208838","Leading Pharma, LLC","100000","[USP'U]/g","","N","20251231"
"6991","NYSTATIN","NYSTATIN","69315030730","Polyene Antifungal [EPC], Polyenes [CS]","69315-307","69315-307-30","69315-307_520822eb-a9f1-4017-9a73-1979ee53f4e9","HUMAN PRESCRIPTION DRUG","NYSTATIN","","OINTMENT","TOPICAL","20190819","","ANDA","ANDA209082","Leading Pharma, LLC","100000","[USP'U]/g","","N","20251231"
"6992","NYSTATIN","NYSTATIN","69315030715","Polyene Antifungal [EPC], Polyenes [CS]","69315-307","69315-307-15","69315-307_520822eb-a9f1-4017-9a73-1979ee53f4e9","HUMAN PRESCRIPTION DRUG","NYSTATIN","","OINTMENT","TOPICAL","20190819","","ANDA","ANDA209082","Leading Pharma, LLC","100000","[USP'U]/g","","N","20251231"
"6993","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","69315030802","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69315-308","69315-308-02","69315-308_8217ec14-6498-4c35-a5a9-511b451b9459","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","SOLUTION","OPHTHALMIC","20181101","","ANDA","ANDA077568","Leading Pharma, LLC","3","mg/mL","","N","20251231"
"6994","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","69315030805","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69315-308","69315-308-05","69315-308_8217ec14-6498-4c35-a5a9-511b451b9459","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","SOLUTION","OPHTHALMIC","20181101","","ANDA","ANDA077568","Leading Pharma, LLC","3","mg/mL","","N","20251231"
"6995","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","69315030810","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69315-308","69315-308-10","69315-308_8217ec14-6498-4c35-a5a9-511b451b9459","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","SOLUTION","OPHTHALMIC","20181101","","ANDA","ANDA077568","Leading Pharma, LLC","3","mg/mL","","N","20251231"
"6996","OFLOXACIN","OFLOXACIN","69315032005","Quinolone Antimicrobial [EPC], Quinolones [CS]","69315-320","69315-320-05","69315-320_88154ff7-fd59-4fd3-a82e-e55d3b6192bd","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","SOLUTION","AURICULAR (OTIC)","20240301","","ANDA","ANDA217903","Leading Pharma, LLC","3","mg/mL","","N","20251231"
"6997","OFLOXACIN","OFLOXACIN","69315032010","Quinolone Antimicrobial [EPC], Quinolones [CS]","69315-320","69315-320-10","69315-320_88154ff7-fd59-4fd3-a82e-e55d3b6192bd","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","SOLUTION","AURICULAR (OTIC)","20240301","","ANDA","ANDA217903","Leading Pharma, LLC","3","mg/mL","","N","20251231"
"6998","OFLOXACIN","OFLOXACIN","69315032705","Quinolone Antimicrobial [EPC], Quinolones [CS]","69315-327","69315-327-05","69315-327_f468adb2-e4c3-4c2d-ba1d-af8e9319d035","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","SOLUTION","OPHTHALMIC","20240715","","ANDA","ANDA217904","Leading Pharma, LLC","3","mg/mL","","N","20251231"
"6999","OFLOXACIN","OFLOXACIN","69315032710","Quinolone Antimicrobial [EPC], Quinolones [CS]","69315-327","69315-327-10","69315-327_f468adb2-e4c3-4c2d-ba1d-af8e9319d035","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","SOLUTION","OPHTHALMIC","20240715","","ANDA","ANDA217904","Leading Pharma, LLC","3","mg/mL","","N","20251231"
"7000","NYSTATIN","NYSTATIN","69315050447","Polyene Antifungal [EPC], Polyenes [CS]","69315-504","69315-504-47","69315-504_eb4efca9-e5e8-4509-9437-6ad7c593a9ef","HUMAN PRESCRIPTION DRUG","NYSTATIN","","SUSPENSION","ORAL","20221205","","ANDA","ANDA214346","Leading Pharma, LLC","100000","[USP'U]/mL","","N","20251231"
"7001","NYSTATIN","NYSTATIN","69315050460","Polyene Antifungal [EPC], Polyenes [CS]","69315-504","69315-504-60","69315-504_eb4efca9-e5e8-4509-9437-6ad7c593a9ef","HUMAN PRESCRIPTION DRUG","NYSTATIN","","SUSPENSION","ORAL","20221205","","ANDA","ANDA214346","Leading Pharma, LLC","100000","[USP'U]/mL","","N","20251231"
"7002","ITRACONAZOLE","Itraconazole","69339015917","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","69339-159","69339-159-17","69339-159_2af07b39-fe93-4961-90cb-ed9c5e2f424d","HUMAN PRESCRIPTION DRUG","Itraconazole Oral","","SOLUTION","ORAL","20220425","","ANDA","ANDA212239","Natco Pharma USA LLC","10","mg/mL","","N","20251231"
"7003","SULFACETAMIDE SODIUM; SULFUR","sulfacetamide sodium and sulfur","69367024410","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","69367-244","69367-244-10","69367-244_4fe0b59c-b850-44db-9670-a7499c724fea","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE, SULFUR","","LIQUID","TOPICAL","20200505","","UNAPPROVED DRUG OTHER","","Westminster Pharmaceuticals, LLC","98; 48","mg/g; mg/g","","N","20261231"
"7004","SULFACETAMIDE SODIUM; SULFUR","Sodium Sulfacetamide and Sulfur","69367024516","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","69367-245","69367-245-16","69367-245_b4e89e57-397a-4578-bc59-709cb46db033","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide and Sulfur","","SUSPENSION","TOPICAL","20210618","","UNAPPROVED DRUG OTHER","","Westminster Pharmaceuticals, LLC","80; 40","mg/mL; mg/mL","","N","20261231"
"7005","SULFACETAMIDE SODIUM; SULFUR","sulfacetamide sodium and sulfur","69367024706","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","69367-247","69367-247-06","69367-247_d7d79dc1-75c8-4e7e-ab2d-e71fd138385a","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE, SULFUR","","LIQUID","TOPICAL","20200505","","UNAPPROVED DRUG OTHER","","Westminster Pharmaceuticals, LLC","100; 50","mg/g; mg/g","","N","20251231"
"7006","SULFACETAMIDE SODIUM; SULFUR","sulfacetamide sodium and sulfur","69367024712","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","69367-247","69367-247-12","69367-247_d7d79dc1-75c8-4e7e-ab2d-e71fd138385a","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE, SULFUR","","LIQUID","TOPICAL","20200505","","UNAPPROVED DRUG OTHER","","Westminster Pharmaceuticals, LLC","100; 50","mg/g; mg/g","","N","20251231"
"7007","POSACONAZOLE","Posaconazole","69367024806","Azole Antifungal [EPC], Azoles [CS]","69367-248","69367-248-06","69367-248_c0a5ee9f-92ab-449a-9a5d-0d4449587880","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","TABLET, DELAYED RELEASE","ORAL","20230719","","ANDA","ANDA216326","Westminster Pharmaceuticals, LLC","100","mg/1","","N","20261231"
"7008","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","69367038501","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69367-385","69367-385-01","69367-385_e679760f-b4d3-4a21-9d47-40c2355bc2c0","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","TABLET, FILM COATED","ORAL","20240523","","ANDA","ANDA076593","Westminster Pharmaceuticals, LLC","250","mg/1","","N","20251231"
"7009","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","69367038605","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69367-386","69367-386-05","69367-386_e679760f-b4d3-4a21-9d47-40c2355bc2c0","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","TABLET, FILM COATED","ORAL","20240523","","ANDA","ANDA076593","Westminster Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"7010","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","69367038601","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69367-386","69367-386-01","69367-386_e679760f-b4d3-4a21-9d47-40c2355bc2c0","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","TABLET, FILM COATED","ORAL","20240523","","ANDA","ANDA076593","Westminster Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"7011","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","69367038750","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69367-387","69367-387-50","69367-387_e679760f-b4d3-4a21-9d47-40c2355bc2c0","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","TABLET, FILM COATED","ORAL","20240523","","ANDA","ANDA076593","Westminster Pharmaceuticals, LLC","750","mg/1","","N","20251231"
"7012","MICONAZOLE NITRATE","Miconazole Nitrate","69367039985","Azole Antifungal [EPC], Azoles [CS]","69367-399","69367-399-85","69367-399_e43341a7-731e-4e6c-9b9d-877f4e264478","HUMAN OTC DRUG","Miconazole Nitrate","","POWDER","TOPICAL","20240516","","OTC MONOGRAPH DRUG","M005","Westminster Pharmaceuticals, LLC","2","g/100g","","N","20251231"
"7013","CLOTRIMAZOLE","Clotrimazole","69396000104","Azole Antifungal [EPC], Azoles [CS]","69396-001","69396-001-04","69396-001_2d9524f7-168a-742c-e063-6294a90a4f6d","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M005","TRIFECTA PHARMACEUTICALS USA LLC","1","g/100g","","N","20261231"
"7014","CLOTRIMAZOLE","Clotrimazole","69396000105","Azole Antifungal [EPC], Azoles [CS]","69396-001","69396-001-05","69396-001_2d9524f7-168a-742c-e063-6294a90a4f6d","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M005","TRIFECTA PHARMACEUTICALS USA LLC","1","g/100g","","N","20261231"
"7015","CLOTRIMAZOLE","Clotrimazole","69396000110","Azole Antifungal [EPC], Azoles [CS]","69396-001","69396-001-10","69396-001_2d9524f7-168a-742c-e063-6294a90a4f6d","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M005","TRIFECTA PHARMACEUTICALS USA LLC","1","g/100g","","N","20261231"
"7016","CLOTRIMAZOLE","Clotrimazole","69396000120","Azole Antifungal [EPC], Azoles [CS]","69396-001","69396-001-20","69396-001_2d9524f7-168a-742c-e063-6294a90a4f6d","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M005","TRIFECTA PHARMACEUTICALS USA LLC","1","g/100g","","N","20261231"
"7017","CLOTRIMAZOLE","Clotrimazole","69396000133","Azole Antifungal [EPC], Azoles [CS]","69396-001","69396-001-33","69396-001_2d9524f7-168a-742c-e063-6294a90a4f6d","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M005","TRIFECTA PHARMACEUTICALS USA LLC","1","g/100g","","N","20261231"
"7018","CLOTRIMAZOLE","Clotrimazole","69396000109","Azole Antifungal [EPC], Azoles [CS]","69396-001","69396-001-09","69396-001_2d9524f7-168a-742c-e063-6294a90a4f6d","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M005","TRIFECTA PHARMACEUTICALS USA LLC","1","g/100g","","N","20261231"
"7019","CLOTRIMAZOLE","Clotrimazole","69396000155","Azole Antifungal [EPC], Azoles [CS]","69396-001","69396-001-55","69396-001_2d9524f7-168a-742c-e063-6294a90a4f6d","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M005","TRIFECTA PHARMACEUTICALS USA LLC","1","g/100g","","N","20261231"
"7020","CLOTRIMAZOLE","Clotrimazole","69396000166","Azole Antifungal [EPC], Azoles [CS]","69396-001","69396-001-66","69396-001_2d9524f7-168a-742c-e063-6294a90a4f6d","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M005","TRIFECTA PHARMACEUTICALS USA LLC","1","g/100g","","N","20261231"
"7021","CLOTRIMAZOLE","Clotrimazole","69396000144","Azole Antifungal [EPC], Azoles [CS]","69396-001","69396-001-44","69396-001_2d9524f7-168a-742c-e063-6294a90a4f6d","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M005","TRIFECTA PHARMACEUTICALS USA LLC","1","g/100g","","N","20261231"
"7022","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.","69396000205","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-002","69396-002-05","69396-002_34a32c6e-a475-a1c1-e063-6394a90a3dd2","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M004","TRIFECTA PHARMACEUTICALS USA LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"7023","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.","69396000220","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-002","69396-002-20","69396-002_34a32c6e-a475-a1c1-e063-6394a90a3dd2","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M004","TRIFECTA PHARMACEUTICALS USA LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"7024","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.","69396000222","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-002","69396-002-22","69396-002_34a32c6e-a475-a1c1-e063-6394a90a3dd2","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M004","TRIFECTA PHARMACEUTICALS USA LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"7025","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.","69396000223","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-002","69396-002-23","69396-002_34a32c6e-a475-a1c1-e063-6394a90a3dd2","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M004","TRIFECTA PHARMACEUTICALS USA LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"7026","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.","69396000225","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-002","69396-002-25","69396-002_34a32c6e-a475-a1c1-e063-6394a90a3dd2","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M004","TRIFECTA PHARMACEUTICALS USA LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"7027","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.","69396000233","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-002","69396-002-33","69396-002_34a32c6e-a475-a1c1-e063-6394a90a3dd2","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M004","TRIFECTA PHARMACEUTICALS USA LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"7028","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.","69396000244","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-002","69396-002-44","69396-002_34a32c6e-a475-a1c1-e063-6394a90a3dd2","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M004","TRIFECTA PHARMACEUTICALS USA LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"7029","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.","69396000209","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-002","69396-002-09","69396-002_34a32c6e-a475-a1c1-e063-6394a90a3dd2","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M004","TRIFECTA PHARMACEUTICALS USA LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"7030","MICONAZOLE NITRATE","MICONAZOLE NITRATE","69396001404","Azole Antifungal [EPC], Azoles [CS]","69396-014","69396-014-04","69396-014_2d6792ee-43e9-f011-e063-6394a90accd1","HUMAN OTC DRUG","MICONAZOLE Nitrate 2% Cream ANTIFUNGAL","","CREAM","TOPICAL","20160322","","OTC MONOGRAPH DRUG","M005","Trifecta Pharmaceuticals Usa Llc","2","g/100g","","N","20261231"
"7031","MICONAZOLE NITRATE","MICONAZOLE NITRATE","69396001405","Azole Antifungal [EPC], Azoles [CS]","69396-014","69396-014-05","69396-014_2d6792ee-43e9-f011-e063-6394a90accd1","HUMAN OTC DRUG","MICONAZOLE Nitrate 2% Cream ANTIFUNGAL","","CREAM","TOPICAL","20160322","","OTC MONOGRAPH DRUG","M005","Trifecta Pharmaceuticals Usa Llc","2","g/100g","","N","20261231"
"7032","MICONAZOLE NITRATE","MICONAZOLE NITRATE","69396001420","Azole Antifungal [EPC], Azoles [CS]","69396-014","69396-014-20","69396-014_2d6792ee-43e9-f011-e063-6394a90accd1","HUMAN OTC DRUG","MICONAZOLE Nitrate 2% Cream ANTIFUNGAL","","CREAM","TOPICAL","20160322","","OTC MONOGRAPH DRUG","M005","Trifecta Pharmaceuticals Usa Llc","2","g/100g","","N","20261231"
"7033","MICONAZOLE NITRATE","MICONAZOLE NITRATE","69396001444","Azole Antifungal [EPC], Azoles [CS]","69396-014","69396-014-44","69396-014_2d6792ee-43e9-f011-e063-6394a90accd1","HUMAN OTC DRUG","MICONAZOLE Nitrate 2% Cream ANTIFUNGAL","","CREAM","TOPICAL","20160322","","OTC MONOGRAPH DRUG","M005","Trifecta Pharmaceuticals Usa Llc","2","g/100g","","N","20261231"
"7034","MICONAZOLE NITRATE","MICONAZOLE NITRATE","69396001466","Azole Antifungal [EPC], Azoles [CS]","69396-014","69396-014-66","69396-014_2d6792ee-43e9-f011-e063-6394a90accd1","HUMAN OTC DRUG","MICONAZOLE Nitrate 2% Cream ANTIFUNGAL","","CREAM","TOPICAL","20160322","","OTC MONOGRAPH DRUG","M005","Trifecta Pharmaceuticals Usa Llc","2","g/100g","","N","20261231"
"7035","MICONAZOLE NITRATE","MICONAZOLE NITRATE","69396001433","Azole Antifungal [EPC], Azoles [CS]","69396-014","69396-014-33","69396-014_2d6792ee-43e9-f011-e063-6394a90accd1","HUMAN OTC DRUG","MICONAZOLE Nitrate 2% Cream ANTIFUNGAL","","CREAM","TOPICAL","20160322","","OTC MONOGRAPH DRUG","M005","Trifecta Pharmaceuticals Usa Llc","2","g/100g","","N","20261231"
"7036","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate","69396001505","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-015","69396-015-05","69396-015_29b3cf7a-7949-6a29-e063-6294a90ac3d7","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20160318","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceuticals Usa Llc","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"7037","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate","69396001520","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-015","69396-015-20","69396-015_29b3cf7a-7949-6a29-e063-6294a90ac3d7","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20160318","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceuticals Usa Llc","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"7038","BACITRACIN ZINC; POLYMYXIN B SULFATE","bacitracin zinc, polymyxin B sulfate","69396002930","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-029","69396-029-30","69396-029_292a513a-420d-4ed2-e063-6294a90acae3","HUMAN OTC DRUG","doubleantibioticointment","","OINTMENT","TOPICAL","20170504","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceuticals USA LLC","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"7039","BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin,Neomycin,Polymxin, Pramoxine","69396003044","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-030","69396-030-44","69396-030_3040a066-a4d6-ae1e-e063-6394a90a266e","HUMAN OTC DRUG","Tripleantibioticointmentandpainrelief","","OINTMENT","TOPICAL","20170720","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceuticals USA","500; 3.5; 10000; 10","[USP'U]/100g; mg/100g; [USP'U]/100g; mg/100g","","N","20261231"
"7040","BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin,Neomycin,Polymxin, Pramoxine","69396003001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-030","69396-030-01","69396-030_3040a066-a4d6-ae1e-e063-6394a90a266e","HUMAN OTC DRUG","Tripleantibioticointmentandpainrelief","","OINTMENT","TOPICAL","20170720","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceuticals USA","500; 3.5; 10000; 10","[USP'U]/100g; mg/100g; [USP'U]/100g; mg/100g","","N","20261231"
"7041","BACITRACIN ZINC; POLYMYXIN B SULFATE","Family Wellness bacitracin zinc, polymyxin B sulfate","69396003704","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-037","69396-037-04","69396-037_298d8c06-7975-7cc0-e063-6394a90a3e43","HUMAN OTC DRUG","Family Wellness First Aid Antibiotic","","OINTMENT","TOPICAL","20190829","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceuticals USA, LLC","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"7042","BACITRACIN ZINC; POLYMYXIN B SULFATE","Family Wellness bacitracin zinc, polymyxin B sulfate","69396003705","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-037","69396-037-05","69396-037_298d8c06-7975-7cc0-e063-6394a90a3e43","HUMAN OTC DRUG","Family Wellness First Aid Antibiotic","","OINTMENT","TOPICAL","20190829","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceuticals USA, LLC","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"7043","CLOTRIMAZOLE","Family Wellness Clotrimazole","69396003805","Azole Antifungal [EPC], Azoles [CS]","69396-038","69396-038-05","69396-038_292a513a-420c-4ed2-e063-6294a90acae3","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20190830","","OTC MONOGRAPH DRUG","M005","Trifecta Pharmaceuticals USA LLC","1","g/100g","","N","20251231"
"7044","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Family Wellness Bacitracin, Neomycin, Polymyxin B","69396004101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-041","69396-041-01","69396-041_298da28b-1665-843f-e063-6294a90a2fd8","HUMAN OTC DRUG","Family Wellness Original","","OINTMENT","TOPICAL","20190830","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceuticals USA LLC.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"7045","BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Family Wellness Bacitracin,Neomycin,PolymyxinB,Pramoxine","69396004401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-044","69396-044-01","69396-044_29b3e33a-544c-40b4-e063-6394a90a1107","HUMAN OTC DRUG","Tripleantibioticointmentandpainrelief","","OINTMENT","TOPICAL","20190830","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceutical USA LLC","500; 3.5; 10000; 10","[USP'U]/100g; mg/100g; [USP'U]/100g; mg/100g","","N","20251231"
"7046","BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Family Wellness Bacitracin,Neomycin,PolymyxinB,PramoxineHCL","69396004501","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-045","69396-045-01","69396-045_29b3ad9e-827e-f9c8-e063-6294a90a598e","HUMAN OTC DRUG","Tripleantibioticapainscaritch","","OINTMENT","TOPICAL","20190830","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceutical USA LLC","500; 3.5; 10000; 10","[USP'U]/100g; mg/100g; [USP'U]/100g; mg/100g","","N","20251231"
"7047","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B, Pramoxine HCL","69396005401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-054","69396-054-01","69396-054_298daa67-7d1e-40a2-e063-6294a90a1933","HUMAN OTC DRUG","Family Wellness Pain Scar Itch","","OINTMENT","TOPICAL","20190830","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceutical USA LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"7048","BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin,Neomycin,Polymxin, Pramoxine","69396006122","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-061","69396-061-22","69396-061_34f1e3dc-a729-f0b7-e063-6294a90a2aae","HUMAN OTC DRUG","Tripleantibioticointmentandpainrelief","","OINTMENT","TOPICAL","20250203","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceuticals USA","500; 3.5; 10000; 10","[USP'U]/100g; mg/100g; [USP'U]/100g; mg/100g","","N","20261231"
"7049","BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin,Neomycin,Polymxin, Pramoxine","69396006144","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-061","69396-061-44","69396-061_34f1e3dc-a729-f0b7-e063-6294a90a2aae","HUMAN OTC DRUG","Tripleantibioticointmentandpainrelief","","OINTMENT","TOPICAL","20250203","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceuticals USA","500; 3.5; 10000; 10","[USP'U]/100g; mg/100g; [USP'U]/100g; mg/100g","","N","20261231"
"7050","BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin,Neomycin,Polymxin, Pramoxine","69396006101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-061","69396-061-01","69396-061_34f1e3dc-a729-f0b7-e063-6294a90a2aae","HUMAN OTC DRUG","Tripleantibioticointmentandpainrelief","","OINTMENT","TOPICAL","20250203","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceuticals USA","500; 3.5; 10000; 10","[USP'U]/100g; mg/100g; [USP'U]/100g; mg/100g","","N","20261231"
"7051","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","NeomycinSulfate,PolymyxinBSulfate,PramoxineHCL","69396007101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-071","69396-071-01","69396-071_37297fa6-59f9-1744-e063-6294a90ae727","HUMAN OTC DRUG","Dual Action Cream","","CREAM","TOPICAL","20210106","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceutical USA LLC","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20261231"
"7052","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","NeomycinSulfate,PolymyxinBSulfate,PramoxineHCL","69396007144","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-071","69396-071-44","69396-071_37297fa6-59f9-1744-e063-6294a90ae727","HUMAN OTC DRUG","Dual Action Cream","","CREAM","TOPICAL","20210106","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceutical USA LLC","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20261231"
"7053","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracinzinc,NeomycinSulfate,PolymyxinBSulfate,PramoxineHCL","69396007201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-072","69396-072-01","69396-072_35085fb0-73b6-00c1-e063-6294a90a10f2","HUMAN OTC DRUG","Multi Action","","OINTMENT","TOPICAL","20210122","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceutical USA LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20261231"
"7054","CLOTRIMAZOLE","Clotrimazole","69396008755","Azole Antifungal [EPC], Azoles [CS]","69396-087","69396-087-55","69396-087_14bfccbd-830b-ddae-e063-6294a90a7b08","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20220408","","OTC MONOGRAPH DRUG","M017","TRIFECTA PHARMACEUTICALS USA LLC","1","g/100g","","N","20251231"
"7055","CLOTRIMAZOLE","Clotrimazole","69396008701","Azole Antifungal [EPC], Azoles [CS]","69396-087","69396-087-01","69396-087_14bfccbd-830b-ddae-e063-6294a90a7b08","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20220408","","OTC MONOGRAPH DRUG","M017","TRIFECTA PHARMACEUTICALS USA LLC","1","g/100g","","N","20251231"
"7056","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.","69396012505","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-125","69396-125-05","69396-125_29b3ceb4-42e3-3a65-e063-6294a90a788c","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20230718","","OTC MONOGRAPH DRUG","M004","TRIFECTA PHARMACEUTICALS USA LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"7057","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate","69396013101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-131","69396-131-01","69396-131_2a9212c8-b14c-b537-e063-6394a90a5119","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20231208","","OTC MONOGRAPH DRUG","M004","TRIFECTA PHARMACEUTICALS USA LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"7058","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin,Neomycin,PolymyxinB,Pramoxine","69396013201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-132","69396-132-01","69396-132_2a921552-0f09-e326-e063-6394a90a422d","HUMAN OTC DRUG","Triple Antibiotic and Pain Relief","","OINTMENT","TOPICAL","20231207","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceutical USA LLC","500; 3.5; 10000; 10","[USP'U]/100g; mg/100g; [USP'U]/100g; mg/100g","","N","20251231"
"7059","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin Sulfate, Polymyxin B Sulfate","69396013510","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-135","69396-135-10","69396-135_2a920704-0306-b340-e063-6394a90ae5dc","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20231023","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceuticals USA LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"7060","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin Sulfate, Polymyxin B Sulfate","69396013525","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-135","69396-135-25","69396-135_2a920704-0306-b340-e063-6394a90ae5dc","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20231023","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceuticals USA LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"7061","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracinzinc,NeomycinSulfate,PolymxinBSulfate,PramoxineHCI","69396013802","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-138","69396-138-02","69396-138_298dae2b-f42d-53a1-e063-6394a90a223b","HUMAN OTC DRUG","First Aid Antibiotic plus Burn Relief","","OINTMENT","TOPICAL","20230904","","OTC MONOGRAPH DRUG","M004","Trifecta Pharmaceuticals USA LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"7062","CLOTRIMAZOLE","Clotrimazole","69396014333","Azole Antifungal [EPC], Azoles [CS]","69396-143","69396-143-33","69396-143_11bf503d-be71-0b75-e063-6394a90aa94e","HUMAN OTC DRUG","Clotrimazole Antifungal","","SOLUTION","TOPICAL","20231113","","OTC MONOGRAPH DRUG","M005","Trifecta Pharmaceuticals USA, LLC.","10","g/L","","N","20251231"
"7063","BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate, Lidocaine","69396015401","Amide Local Anesthetic [EPC], Amides [CS], Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Antiarrhythmic [EPC], Decreased Cell Wall Synthesis & Repair [PE], Local Anesthesia [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-154","69396-154-01","69396-154_338c12c6-f312-fa55-e063-6294a90a7377","HUMAN OTC DRUG","Triple Antibiotic plus Lidocaine","","OINTMENT","TOPICAL","20240331","","OTC MONOGRAPH DRUG","M004","TRIFECTA PHARMACEUTICALS USA LLC","500; 40; 3.5; 10000","[USP'U]/g; mg/g; mg/g; [USP'U]/g","","N","20261231"
"7064","BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate, Lidocaine","69396015444","Amide Local Anesthetic [EPC], Amides [CS], Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Antiarrhythmic [EPC], Decreased Cell Wall Synthesis & Repair [PE], Local Anesthesia [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-154","69396-154-44","69396-154_338c12c6-f312-fa55-e063-6294a90a7377","HUMAN OTC DRUG","Triple Antibiotic plus Lidocaine","","OINTMENT","TOPICAL","20240331","","OTC MONOGRAPH DRUG","M004","TRIFECTA PHARMACEUTICALS USA LLC","500; 40; 3.5; 10000","[USP'U]/g; mg/g; mg/g; [USP'U]/g","","N","20261231"
"7065","BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate, Lidocaine","69396015422","Amide Local Anesthetic [EPC], Amides [CS], Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Antiarrhythmic [EPC], Decreased Cell Wall Synthesis & Repair [PE], Local Anesthesia [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69396-154","69396-154-22","69396-154_338c12c6-f312-fa55-e063-6294a90a7377","HUMAN OTC DRUG","Triple Antibiotic plus Lidocaine","","OINTMENT","TOPICAL","20240331","","OTC MONOGRAPH DRUG","M004","TRIFECTA PHARMACEUTICALS USA LLC","500; 40; 3.5; 10000","[USP'U]/g; mg/g; mg/g; [USP'U]/g","","N","20261231"
"7066","PYRIMETHAMINE","pyrimethamine","69413033010","Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]","69413-330","69413-330-10","69413-330_ca65359c-029c-44f4-ba89-c4058ddd4e30","HUMAN PRESCRIPTION DRUG","Daraprim","","TABLET","ORAL","19530123","","NDA","NDA008578","Vyera Pharmaceuticals LLC","25","mg/1","","N","20251231"
"7067","PYRIMETHAMINE","pyrimethamine","69413033030","Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]","69413-330","69413-330-30","69413-330_ca65359c-029c-44f4-ba89-c4058ddd4e30","HUMAN PRESCRIPTION DRUG","Daraprim","","TABLET","ORAL","19530123","","NDA","NDA008578","Vyera Pharmaceuticals LLC","25","mg/1","","N","20251231"
"7068","AZITHROMYCIN DIHYDRATE","Azithromycin","69452017104","Macrolide Antimicrobial [EPC], Macrolides [CS]","69452-171","69452-171-04","69452-171_289d13f6-5fac-35b6-e063-6294a90a5fec","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210000","Bionpharma Inc.","250","mg/1","","N","20251231"
"7069","AZITHROMYCIN DIHYDRATE","Azithromycin","69452017173","Macrolide Antimicrobial [EPC], Macrolides [CS]","69452-171","69452-171-73","69452-171_289d13f6-5fac-35b6-e063-6294a90a5fec","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210000","Bionpharma Inc.","250","mg/1","","N","20251231"
"7070","AZITHROMYCIN DIHYDRATE","Azithromycin","69452017113","Macrolide Antimicrobial [EPC], Macrolides [CS]","69452-171","69452-171-13","69452-171_289d13f6-5fac-35b6-e063-6294a90a5fec","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210000","Bionpharma Inc.","250","mg/1","","N","20251231"
"7071","AZITHROMYCIN DIHYDRATE","Azithromycin","69452017213","Macrolide Antimicrobial [EPC], Macrolides [CS]","69452-172","69452-172-13","69452-172_289d13f6-5fac-35b6-e063-6294a90a5fec","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210001","Bionpharma Inc.","500","mg/1","","N","20251231"
"7072","AZITHROMYCIN DIHYDRATE","Azithromycin","69452017272","Macrolide Antimicrobial [EPC], Macrolides [CS]","69452-172","69452-172-72","69452-172_289d13f6-5fac-35b6-e063-6294a90a5fec","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210001","Bionpharma Inc.","500","mg/1","","N","20251231"
"7073","AZITHROMYCIN DIHYDRATE","Azithromycin","69452017274","Macrolide Antimicrobial [EPC], Macrolides [CS]","69452-172","69452-172-74","69452-172_289d13f6-5fac-35b6-e063-6294a90a5fec","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210001","Bionpharma Inc.","500","mg/1","","N","20251231"
"7074","AZITHROMYCIN DIHYDRATE","Azithromycin","69452017313","Macrolide Antimicrobial [EPC], Macrolides [CS]","69452-173","69452-173-13","69452-173_0d48a6b6-8e7f-a3ae-e063-6394a90ada0c","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20181226","","ANDA","ANDA209999","Bionpharma Inc.","600","mg/1","","N","20251231"
"7075","ATOVAQUONE","Atovaquone","69452025287","Antimalarial [EPC], Antiprotozoal [EPC]","69452-252","69452-252-87","69452-252_0d5fc0ab-9cfa-0a79-e063-6394a90a2b61","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20210601","","ANDA","ANDA212918","Bionpharma Inc.","750","mg/5mL","","N","20251231"
"7076","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","69452033443","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","69452-334","69452-334-43","69452-334_694315ce-8a89-4b37-9d3f-d636f9d00b3d","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20220801","","ANDA","ANDA065066","Bionpharma Inc.","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"7077","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","69452033543","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","69452-335","69452-335-43","69452-335_694315ce-8a89-4b37-9d3f-d636f9d00b3d","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20220801","","ANDA","ANDA065066","Bionpharma Inc.","400; 57","mg/5mL; mg/5mL","","N","20251231"
"7078","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","69452033611","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","69452-336","69452-336-11","69452-336_694315ce-8a89-4b37-9d3f-d636f9d00b3d","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20220801","","ANDA","ANDA065064","Bionpharma Inc.","500; 125","mg/1; mg/1","","N","20251231"
"7079","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","69452033711","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","69452-337","69452-337-11","69452-337_694315ce-8a89-4b37-9d3f-d636f9d00b3d","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20220801","","ANDA","ANDA065063","Bionpharma Inc.","875; 125","mg/1; mg/1","","N","20251231"
"7080","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","69452035120","Allylamine Antifungal [EPC], Allylamine [CS]","69452-351","69452-351-20","69452-351_233cb04d-09cc-4312-923f-f4666bdf9754","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20220128","","ANDA","ANDA078163","Bionpharma Inc.","250","mg/1","","N","20251231"
"7081","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","69452035113","Allylamine Antifungal [EPC], Allylamine [CS]","69452-351","69452-351-13","69452-351_233cb04d-09cc-4312-923f-f4666bdf9754","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20220128","","ANDA","ANDA078163","Bionpharma Inc.","250","mg/1","","N","20251231"
"7082","SULCONAZOLE NITRATE","Sulconazole Nitrate","69489071160","Azole Antifungal [EPC], Azoles [CS]","69489-711","69489-711-60","69489-711_f03361cb-005c-4d0c-bc27-033484f02624","HUMAN PRESCRIPTION DRUG","Exelderm","","CREAM","TOPICAL","20190607","","NDA","NDA018737","Journey Medical Corporation","10","mg/g","","N","20251231"
"7083","SULCONAZOLE NITRATE","Sulconazole Nitrate","69489072130","Azole Antifungal [EPC], Azoles [CS]","69489-721","69489-721-30","69489-721_af026933-9a3d-4027-90f6-57fe4349d11e","HUMAN PRESCRIPTION DRUG","Exelderm","","SOLUTION","TOPICAL","20190607","","NDA","NDA018738","Journey Medical Corporation","10","mg/mL","","N","20251231"
"7084","SULCONAZOLE NITRATE","Sulconazole Nitrate","69489072105","Azole Antifungal [EPC], Azoles [CS]","69489-721","69489-721-05","69489-721_af026933-9a3d-4027-90f6-57fe4349d11e","HUMAN PRESCRIPTION DRUG","Exelderm","","SOLUTION","TOPICAL","20190607","","NDA","NDA018738","Journey Medical Corporation","10","mg/mL","","N","20251231"
"7085","MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE","Moxifloxacin Hydrochloride Tablets, 400 mg","69539000630","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69539-006","69539-006-30","69539-006_1759540d-3df5-4e2d-b565-c2f017b1f7eb","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride Tablets, 400 mg","","TABLET, FILM COATED","ORAL","20170922","","ANDA","ANDA208682","MSN LABORATORIES PRIVATE LIMITED","400","mg/1","","N","20251231"
"7086","MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE","Moxifloxacin Hydrochloride Tablets, 400 mg","69539000631","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69539-006","69539-006-31","69539-006_1759540d-3df5-4e2d-b565-c2f017b1f7eb","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride Tablets, 400 mg","","TABLET, FILM COATED","ORAL","20170922","","ANDA","ANDA208682","MSN LABORATORIES PRIVATE LIMITED","400","mg/1","","N","20251231"
"7087","MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE","Moxifloxacin Hydrochloride Tablets, 400 mg","69539000605","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69539-006","69539-006-05","69539-006_1759540d-3df5-4e2d-b565-c2f017b1f7eb","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride Tablets, 400 mg","","TABLET, FILM COATED","ORAL","20170922","","ANDA","ANDA208682","MSN LABORATORIES PRIVATE LIMITED","400","mg/1","","N","20251231"
"7088","CIPROFLOXACIN","Ciprofloxacin Otic Solution, 0.2%","69543045714","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","69543-457","69543-457-14","69543-457_1f48efd9-828d-4fda-8889-ae992c2b0d62","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Otic Solution, 0.2%","","SOLUTION/ DROPS","AURICULAR (OTIC)","20241115","","ANDA","ANDA217887","Virtus Pharmaceuticals, LLC",".5","mg/.25mL","","N","20251231"
"7089","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","69571000302","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69571-003","69571-003-02","69571-003_08ad67a5-b3c7-1db5-e063-6294a90a20d3","HUMAN OTC DRUG","Family wellness","","OINTMENT","TOPICAL","20170222","","OTC MONOGRAPH DRUG","M004","FRONT PHARMACEUTICAL PLC",".41; .0035; .52","g/100g; g/100g; g/100g","","N","20251231"
"7090","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE","69571000701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69571-007","69571-007-01","69571-007_08a19db8-4da9-6529-e063-6394a90a1b4d","HUMAN OTC DRUG","Family Wellness Antiseptic and Pain Relief","","OINTMENT","TOPICAL","20170613","","OTC MONOGRAPH DRUG","M004","FRONT PHARMACEUTICAL PLC",".51; .0035; 1; .01","g/100g; g/100g; g/100g; g/100g","","N","20251231"
"7091","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.","69571088805","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69571-888","69571-888-05","69571-888_3244d718-fb68-39db-e063-6394a90aa34e","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20250408","","OTC MONOGRAPH DRUG","M004","Front Pharmaceutical PLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"7092","MICONAZOLE NITRATE","MICONAZOLE NITRATE","69729061205","Azole Antifungal [EPC], Azoles [CS]","69729-612","69729-612-05","69729-612_214e6edc-8028-e8d5-e063-6394a90af7a0","HUMAN OTC DRUG","VAGISTEN-V","7 DAY","CREAM","VAGINAL","20180905","","OTC MONOGRAPH DRUG","M005","OPMX LLC","2","g/100g","","N","20251231"
"7093","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","BACITRACIN, NEOMYCIN SULFATE, POLYMIXIN B SULFATE, PRAMOXINE HYDROCHLORIDE","69729061505","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69729-615","69729-615-05","69729-615_18ae5c8b-2507-fac3-e063-6394a90a6072","HUMAN OTC DRUG","PENIMIXCINA","","OINTMENT","TOPICAL","20180905","","OTC MONOGRAPH DRUG","M004","OPMX LLC","500; 5; 5000; 10","[iU]/g; mg/g; [iU]/g; mg/g","","N","20251231"
"7094","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE","69729061661","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69729-616","69729-616-61","69729-616_18ac00d7-fdc6-65b1-e063-6394a90ac204","HUMAN OTC DRUG","PENTREXCILINA TRIPLE ANTIBIOTIC","PLUS PAIN RELIEF","OINTMENT","TOPICAL","20180905","","OTC MONOGRAPH DRUG","M004","OPMX LLC","500; 5; 5000; 10","[iU]/g; mg/g; [iU]/g; mg/g","","N","20251231"
"7095","MICONAZOLE NITRATE","MICONAZOLE NITRATE","69740032800","Azole Antifungal [EPC], Azoles [CS]","69740-328","69740-328-00","69740-328_32f82800-b312-4875-e063-6394a90ae5e0","HUMAN OTC DRUG","Secura Antifungal","Greaseless","CREAM","TOPICAL","20030801","","OTC MONOGRAPH DRUG","M005","Smith & Nephew Medical Ltd","20","mg/g","","N","20261231"
"7096","MICONAZOLE NITRATE","MICONAZOLE NITRATE","69740032900","Azole Antifungal [EPC], Azoles [CS]","69740-329","69740-329-00","69740-329_32f82800-b312-4875-e063-6394a90ae5e0","HUMAN OTC DRUG","Secura Antifungal","Extra Thick","CREAM","TOPICAL","20030801","","OTC MONOGRAPH DRUG","M005","Smith & Nephew Medical Ltd","20","mg/g","","N","20261231"
"7097","SECNIDAZOLE","secnidazole","69751040001","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","69751-400","69751-400-01","69751-400_4a3aa8e8-bb23-46ce-998d-69dc7c9fb386","HUMAN PRESCRIPTION DRUG","Solosec","","GRANULE","ORAL","20180531","","NDA","NDA209363","Evofem Inc.","2","g/4.8g","","N","20261231"
"7098","CLOTRIMAZOLE","Clotrimazole","69771003223","Azole Antifungal [EPC], Azoles [CS]","69771-032","69771-032-23","69771-032_334f174d-fe88-517d-e063-6394a90a8d4d","HUMAN OTC DRUG","Clotrimazole 1%","Athletes Foot","CREAM","TOPICAL","20220817","","OTC MONOGRAPH DRUG","M005","GERI-GENTLE CORPORATION","10","mg/g","","N","20261231"
"7099","MICONAZOLE NITRATE","MICONAZOLE NITRATE","69771004125","Azole Antifungal [EPC], Azoles [CS]","69771-041","69771-041-25","69771-041_334ee902-e3c8-59f1-e063-6294a90adee6","HUMAN OTC DRUG","MICONAZOLE Nitrate 2% Cream ANTIFUNGAL","","CREAM","TOPICAL","20160322","","OTC MONOGRAPH DRUG","M005","GERI-GENTLE CORPORATION","2","g/100g","","N","20261231"
"7100","MICONAZOLE NITRATE","Antifungal","69771016503","Azole Antifungal [EPC], Azoles [CS]","69771-165","69771-165-03","69771-165_1bba9840-7820-c059-e063-6394a90a9a94","HUMAN OTC DRUG","GeriGentle Miconazole nitrate","","POWDER","TOPICAL","20220819","","OTC MONOGRAPH DRUG","M005","GERI-GENTLE CORPORATION","2","g/100g","","N","20251231"
"7101","CEPHALEXIN","Cephalexin","69778093004","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69778-930","69778-930-04","69778-930_5f2379e6-9041-4de6-83a2-f63fa36db0d9","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20101015","","ANDA","ANDA065152","Pharma-C, Inc.","250","mg/1","","N","20251231"
"7102","CEPHALEXIN","Cephalexin","69778093104","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","69778-931","69778-931-04","69778-931_5f2379e6-9041-4de6-83a2-f63fa36db0d9","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20101015","","ANDA","ANDA065152","Pharma-C, Inc.","500","mg/1","","N","20251231"
"7103","CLOTRIMAZOLE","CLOTRIMAZOLE","69822025405","Azole Antifungal [EPC], Azoles [CS]","69822-254","69822-254-05","69822-254_0b57d8e4-f9ea-2401-e063-6394a90a31dc","HUMAN OTC DRUG","AKIN ANTI-FUNGAL","","SOLUTION","TOPICAL","20170101","","OTC MONOGRAPH DRUG","M005","Southern Sales & Service, Inc.","10","mg/mL","","N","20251231"
"7104","CLOTRIMAZOLE","Clotrimazole","69842006200","Azole Antifungal [EPC], Azoles [CS]","69842-062","69842-062-00","69842-062_27eb1c36-e3df-89ff-e063-6394a90abc73","HUMAN OTC DRUG","CVS Pharmacy","Clotrimazole 3","CREAM","VAGINAL","20000412","","NDA","NDA021143","CVS Pharmacy","2","g/100g","","N","20251231"
"7105","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate and Pramoxine HCL","69842016110","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69842-161","69842-161-10","69842-161_2d620e52-77e7-48cc-a0e8-76a0585d5b29","HUMAN OTC DRUG","CVS Health Triple Antibiotic with Pain Relief","","OINTMENT","TOPICAL","20170428","20251018","OTC MONOGRAPH DRUG","M004","CVS Health","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N",""
"7106","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","69842019916","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69842-199","69842-199-16","69842-199_64a2858c-1581-4d1a-9e48-fd17bcd95dba","HUMAN OTC DRUG","Antibiotic","","OINTMENT","TOPICAL","20160804","","OTC MONOGRAPH DRUG","M004","CVS Pharmacy","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"7107","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","69842019958","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69842-199","69842-199-58","69842-199_64a2858c-1581-4d1a-9e48-fd17bcd95dba","HUMAN OTC DRUG","Antibiotic","","OINTMENT","TOPICAL","20160804","","OTC MONOGRAPH DRUG","M004","CVS Pharmacy","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"7108","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","69842019964","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69842-199","69842-199-64","69842-199_64a2858c-1581-4d1a-9e48-fd17bcd95dba","HUMAN OTC DRUG","Antibiotic","","OINTMENT","TOPICAL","20160804","","OTC MONOGRAPH DRUG","M004","CVS Pharmacy","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"7109","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride","69842043258","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69842-432","69842-432-58","69842-432_737c338d-592e-409e-bc24-35020e656df5","HUMAN OTC DRUG","Triple Antibiotic and Burn Relief","","OINTMENT","TOPICAL","20210305","","OTC MONOGRAPH DRUG","M004","CVS Pharmacy","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"7110","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride","69842043264","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69842-432","69842-432-64","69842-432_737c338d-592e-409e-bc24-35020e656df5","HUMAN OTC DRUG","Triple Antibiotic and Burn Relief","","OINTMENT","TOPICAL","20210305","","OTC MONOGRAPH DRUG","M004","CVS Pharmacy","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"7111","MICONAZOLE NITRATE","Anti-fungal Powder Miconazole Nitrate Talc Free","69842049025","Azole Antifungal [EPC], Azoles [CS]","69842-490","69842-490-25","69842-490_37642513-5b07-8868-e063-6294a90affec","HUMAN OTC DRUG","Miconazole Nitrate","","POWDER","TOPICAL","20170904","20270131","OTC MONOGRAPH DRUG","M005","CVS Pharmacy","1.42","g/71g","","N",""
"7112","MICONAZOLE NITRATE","Jock Itch Spray","69842050246","Azole Antifungal [EPC], Azoles [CS]","69842-502","69842-502-46","69842-502_266b5490-01f0-b211-e063-6394a90aee26","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, SPRAY","TOPICAL","20170610","","OTC MONOGRAPH DRUG","M005","CVS Pharmacy","1.3","g/130g","","N","20251231"
"7113","MICONAZOLE NITRATE","Athletes Foot Powder Spray Talc Free","69842051146","Azole Antifungal [EPC], Azoles [CS]","69842-511","69842-511-46","69842-511_266b5ec9-4158-b073-e063-6394a90aec62","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, POWDER","TOPICAL","20170522","","OTC MONOGRAPH DRUG","M005","CVS Pharmacy","2.6","g/130g","","N","20251231"
"7114","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin, neomycin, polymyxin B, pramoxine hydrochloride","69842056258","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69842-562","69842-562-58","69842-562_5f7a5f93-2b3b-4cf5-8db9-c83f4e2c0428","HUMAN OTC DRUG","triple antibiotic and pain relief","","OINTMENT","TOPICAL","20200909","","OTC MONOGRAPH DRUG","M004","CVS Pharmacy","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"7115","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin, neomycin, polymyxin B, pramoxine hydrochloride","69842056264","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69842-562","69842-562-64","69842-562_5f7a5f93-2b3b-4cf5-8db9-c83f4e2c0428","HUMAN OTC DRUG","triple antibiotic and pain relief","","OINTMENT","TOPICAL","20200909","","OTC MONOGRAPH DRUG","M004","CVS Pharmacy","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"7116","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin, neomycin, polymyxin B, pramoxine hydrochloride","69842056217","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69842-562","69842-562-17","69842-562_5f7a5f93-2b3b-4cf5-8db9-c83f4e2c0428","HUMAN OTC DRUG","triple antibiotic and pain relief","","OINTMENT","TOPICAL","20200909","","OTC MONOGRAPH DRUG","M004","CVS Pharmacy","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"7117","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin, Neomycin, Polymyxin B","69842061071","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69842-610","69842-610-71","69842-610_45d5e475-0982-038e-e054-00144ff88e88","HUMAN OTC DRUG","CVS Triple Antibiotic","","OINTMENT","TOPICAL","20081101","","OTC MONOGRAPH FINAL","part333B","CVS Pharmacy","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"7118","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl","69842066958","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69842-669","69842-669-58","69842-669_8258bbb9-3538-40ef-84bd-5a24f7cbee91","HUMAN OTC DRUG","Antibiotic, Pain and Scar","","OINTMENT","TOPICAL","20170220","","OTC MONOGRAPH DRUG","M004","CVS Pharmacy","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"7119","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl","69842066964","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69842-669","69842-669-64","69842-669_8258bbb9-3538-40ef-84bd-5a24f7cbee91","HUMAN OTC DRUG","Antibiotic, Pain and Scar","","OINTMENT","TOPICAL","20170220","","OTC MONOGRAPH DRUG","M004","CVS Pharmacy","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"7120","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","neomycin, polymyxin B, pramoxine hydrochloride","69842075458","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69842-754","69842-754-58","69842-754_ef82061b-48d1-4a68-9ec4-d9a64aad677e","HUMAN OTC DRUG","Antibiotic and Pain Relief","","CREAM","TOPICAL","20210205","","OTC MONOGRAPH DRUG","M004","CVS Pharmacy","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"7121","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","neomycin, polymyxin B, pramoxine hydrochloride","69842075464","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69842-754","69842-754-64","69842-754_ef82061b-48d1-4a68-9ec4-d9a64aad677e","HUMAN OTC DRUG","Antibiotic and Pain Relief","","CREAM","TOPICAL","20210205","","OTC MONOGRAPH DRUG","M004","CVS Pharmacy","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"7122","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","69842098602","Benzylamine Antifungal [EPC], Benzylamines [CS]","69842-986","69842-986-02","69842-986_4986696d-4576-466f-ad73-22779c63223f","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","CVS Pharmacy","10","mg/g","","N","20251231"
"7123","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","69842098608","Benzylamine Antifungal [EPC], Benzylamines [CS]","69842-986","69842-986-08","69842-986_4986696d-4576-466f-ad73-22779c63223f","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","CVS Pharmacy","10","mg/g","","N","20251231"
"7124","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","69842098603","Benzylamine Antifungal [EPC], Benzylamines [CS]","69842-986","69842-986-03","69842-986_4986696d-4576-466f-ad73-22779c63223f","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20171117","","ANDA","ANDA205181","CVS Pharmacy","10","mg/g","","N","20251231"
"7125","MICONAZOLE NITRATE","Miconazole Nitrate","69842098807","Azole Antifungal [EPC], Azoles [CS]","69842-988","69842-988-07","69842-988_362a5224-f51c-e0fc-e063-6394a90ad176","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","19970113","","ANDA","ANDA074444","CVS Pharmacy","20","mg/100g","","N","20261231"
"7126","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","69842098908","Benzylamine Antifungal [EPC], Benzylamines [CS]","69842-989","69842-989-08","69842-989_f31c11d9-11db-4642-a8d9-609f1861f5a5","HUMAN OTC DRUG","Butenafine Hydrochloride 1%","","CREAM","TOPICAL","20181018","","ANDA","ANDA205181","CVS Pharmacy","10","mg/g","","N","20251231"
"7127","CLOTRIMAZOLE","Clotrimazole","69848000101","Azole Antifungal [EPC], Azoles [CS]","69848-001","69848-001-01","69848-001_0dfda666-4ad4-d1d5-e063-6394a90ad8fc","HUMAN OTC DRUG","Clotrimazole","","SOLUTION","TOPICAL","20180701","","OTC MONOGRAPH DRUG","M005","Granules USA, Inc.","1","g/mL","","N","20251231"
"7128","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and dexamethasone","69918051505","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69918-515","69918-515-05","69918-515_17a0003c-5312-4fd6-b481-76cbfb95c1b9","HUMAN PRESCRIPTION DRUG","neomycin sulfate, polymyxin b sulfate and dexamethasone","","SUSPENSION","OPHTHALMIC","20250331","","NDA AUTHORIZED GENERIC","NDA050023","Nordic Pharma, Inc.","1; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20261231"
"7129","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin Sulfate, Polymyxin B Sulfate, and PRAMOXINE HYDROCHLORIDE","69968005401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0054","69968-0054-1","69968-0054_223acc88-c8b9-6df2-e063-6394a90a99b1","HUMAN OTC DRUG","Neosporin Kids Plus Pain Relief","","CREAM","TOPICAL","20161108","","OTC MONOGRAPH DRUG","M004","Kenvue Brands LLC","3.5; 10000; 10","mg/g; [iU]/g; mg/g","","N","20251231"
"7130","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","69968005501","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0055","69968-0055-1","69968-0055_223ce228-cc0e-5108-e063-6294a90a4aea","HUMAN OTC DRUG","Neosporin Plus Pain Relief","First Aid Antibiotic/Pain Relieving","CREAM","TOPICAL","20091201","","OTC MONOGRAPH DRUG","M017","Kenvue Brands LLC","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"7131","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","69968005502","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0055","69968-0055-2","69968-0055_223ce228-cc0e-5108-e063-6294a90a4aea","HUMAN OTC DRUG","Neosporin Plus Pain Relief","First Aid Antibiotic/Pain Relieving","CREAM","TOPICAL","20091201","","OTC MONOGRAPH DRUG","M017","Kenvue Brands LLC","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"7132","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","69968005602","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0056","69968-0056-2","69968-0056_223d1366-063d-652f-e063-6394a90a66bc","HUMAN OTC DRUG","Neosporin Original","","OINTMENT","TOPICAL","20160903","","OTC MONOGRAPH DRUG","M004","Kenvue Brands LLC","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"7133","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","69968005601","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0056","69968-0056-1","69968-0056_223d1366-063d-652f-e063-6394a90a66bc","HUMAN OTC DRUG","Neosporin Original","","OINTMENT","TOPICAL","20160903","","OTC MONOGRAPH DRUG","M004","Kenvue Brands LLC","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"7134","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","69968005701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0057","69968-0057-1","69968-0057_223d1366-063e-652f-e063-6394a90a66bc","HUMAN OTC DRUG","Neosporin Plus Pain Relief","","OINTMENT","TOPICAL","20091201","","OTC MONOGRAPH DRUG","M004","Kenvue Brands LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"7135","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","69968005702","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0057","69968-0057-2","69968-0057_223d1366-063e-652f-e063-6394a90a66bc","HUMAN OTC DRUG","Neosporin Plus Pain Relief","","OINTMENT","TOPICAL","20091201","","OTC MONOGRAPH DRUG","M004","Kenvue Brands LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"7136","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc and Polymyxin B Sulfate","69968006002","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0060","69968-0060-2","69968-0060_223d985d-1107-7dcc-e063-6394a90a94ab","HUMAN OTC DRUG","Polysporin First Aid Antibiotic","","OINTMENT","TOPICAL","20130709","","OTC MONOGRAPH DRUG","M004","Kenvue Brands LLC","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"7137","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc and Polymyxin B Sulfate","69968006003","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0060","69968-0060-3","69968-0060_223d985d-1107-7dcc-e063-6394a90a94ab","HUMAN OTC DRUG","Polysporin First Aid Antibiotic","","OINTMENT","TOPICAL","20130709","","OTC MONOGRAPH DRUG","M004","Kenvue Brands LLC","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"7138","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc and Polymyxin B Sulfate","69968006009","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0060","69968-0060-9","69968-0060_223d985d-1107-7dcc-e063-6394a90a94ab","HUMAN OTC DRUG","Polysporin First Aid Antibiotic","","OINTMENT","TOPICAL","20130709","","OTC MONOGRAPH DRUG","M004","Kenvue Brands LLC","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"7139","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc and Polymyxin B Sulfate","69968006001","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0060","69968-0060-1","69968-0060_223d985d-1107-7dcc-e063-6394a90a94ab","HUMAN OTC DRUG","Polysporin First Aid Antibiotic","","OINTMENT","TOPICAL","20130709","","OTC MONOGRAPH DRUG","M004","Kenvue Brands LLC","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"7140","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","69968009302","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0093","69968-0093-2","69968-0093_21702506-042e-a902-e063-6294a90acaf9","HUMAN OTC DRUG","Neosporin Pain Itch Scar","","OINTMENT","TOPICAL","20160115","","OTC MONOGRAPH DRUG","M004","Kenvue Brands LLC","500; 3.5; 10000; 10","[iU]/g; mg/g; [iU]/g; mg/g","","N","20251231"
"7141","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","69968009301","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0093","69968-0093-1","69968-0093_21702506-042e-a902-e063-6294a90acaf9","HUMAN OTC DRUG","Neosporin Pain Itch Scar","","OINTMENT","TOPICAL","20160115","","OTC MONOGRAPH DRUG","M004","Kenvue Brands LLC","500; 3.5; 10000; 10","[iU]/g; mg/g; [iU]/g; mg/g","","N","20251231"
"7142","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","69968051801","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0518","69968-0518-1","69968-0518_227889ba-a5e0-4b7c-e063-6294a90a73f6","HUMAN OTC DRUG","NEOSPORIN Plus BURN RELIEF","","OINTMENT","TOPICAL","20190201","","OTC MONOGRAPH DRUG","M004","Kenvue Brands LLC","500; 3.5; 10000; 10","[iU]/g; mg/g; [iU]/g; mg/g","","N","20251231"
"7143","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc and Polymyxin B Sulfate","69968061201","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0612","69968-0612-1","69968-0612_26c98f09-2db4-88dc-e063-6294a90a8c9f","HUMAN OTC DRUG","Simply Neosporin","First Aid Antibiotic","OINTMENT","TOPICAL","20200224","","OTC MONOGRAPH DRUG","M004","Kenvue Brands LLC","500; 10000","[iU]/g; [iU]/g","","N","20261231"
"7144","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","69968063401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0634","69968-0634-1","69968-0634_21fa7843-fca7-30ab-e063-6294a90ad79e","HUMAN OTC DRUG","Neosporin Original","","OINTMENT","TOPICAL","20210104","","OTC MONOGRAPH DRUG","M004","Kenvue Brands LLC","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"7145","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","69968063409","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0634","69968-0634-9","69968-0634_21fa7843-fca7-30ab-e063-6294a90ad79e","HUMAN OTC DRUG","Neosporin Original","","OINTMENT","TOPICAL","20210104","","OTC MONOGRAPH DRUG","M004","Kenvue Brands LLC","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"7146","BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin, Neomycin, Polymyxin B, Lidocaine","69968073101","Amide Local Anesthetic [EPC], Amides [CS], Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Antiarrhythmic [EPC], Decreased Cell Wall Synthesis & Repair [PE], Local Anesthesia [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","69968-0731","69968-0731-1","69968-0731_26ca8aa3-4152-9d57-e063-6294a90a1f3d","HUMAN OTC DRUG","Neosporin Plus Lidocaine","","OINTMENT","TOPICAL","20230130","","OTC MONOGRAPH DRUG","M004","Kenvue Brands LLC","500; 40; 3.5; 10000","[iU]/g; mg/g; mg/g; [iU]/g","","N","20251231"
"7147","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride 1g in 100g","69983002702","Allylamine Antifungal [EPC], Allylamine [CS]","69983-027","69983-027-02","69983-027_25ba24d1-b229-8843-e063-6294a90a15bb","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20241115","20260331","ANDA","ANDA077511","Happy Foot Shop LLC","1","g/100g","","N",""
"7148","MICONAZOLE NITRATE","Miconazole Nitrate","70000000901","Azole Antifungal [EPC], Azoles [CS]","70000-0009","70000-0009-1","70000-0009_3e750b76-007d-470a-8c7d-5c5f4f6cbbc9","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20190701","","ANDA","ANDA074164","Cardinal Health (Leader) 70000","20","mg/g","","N","20251231"
"7149","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate","70000005801","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70000-0058","70000-0058-1","70000-0058_aec537e5-002d-4625-b0b5-74ef3993b09a","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20201231","20251231","OTC MONOGRAPH DRUG","M004","Cardinal Health (Leader) 70000","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N",""
"7150","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc, Polymyxin B Sulfate","70000007001","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70000-0070","70000-0070-1","70000-0070_5ac69c2d-e47d-4330-a7b6-60ba2aabbbd2","HUMAN OTC DRUG","Antibiotic","","OINTMENT","TOPICAL","20201231","20251231","OTC MONOGRAPH DRUG","M004","Cardinal Health (Leader) 70000","500; 10000","[iU]/g; [iU]/g","","N",""
"7151","BACITRACIN ZINC; POLYMYXIN B SULFATE","FIRST AID ANTIBIOTIC","70000009301","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70000-0093","70000-0093-1","70000-0093_b1969426-55b8-4cae-9bb7-f641c971667e","HUMAN OTC DRUG","Leader Poly Bacitracin","","OINTMENT","TOPICAL","20210601","","OTC MONOGRAPH DRUG","M004","Cardinal Health 110, Inc.","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"7152","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","First Aid Triple Antibiotic","70000009401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70000-0094","70000-0094-1","70000-0094_46035546-fc64-4b38-a46d-f169b5828b09","HUMAN OTC DRUG","Leader Triple Antibiotic","","OINTMENT","TOPICAL","20210601","","OTC MONOGRAPH DRUG","M004","Cardinal Health 110,Inc.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"7153","MICONAZOLE NITRATE","Anti-fungal Powder Miconazole Nitrate Talc Free","70000032101","Azole Antifungal [EPC], Azoles [CS]","70000-0321","70000-0321-1","70000-0321_25dbec01-f036-08a1-e063-6294a90aa790","HUMAN OTC DRUG","Miconazole Nitrate","","POWDER","TOPICAL","20171020","","OTC MONOGRAPH DRUG","M005","Cardinal Health","2.6","g/130g","","N","20251231"
"7154","MICONAZOLE NITRATE","Anti-fungal Powder Miconazole Nitrate Talc Free","70000032301","Azole Antifungal [EPC], Azoles [CS]","70000-0323","70000-0323-1","70000-0323_29bae1bd-515b-ee2a-e063-6294a90a27a4","HUMAN OTC DRUG","Miconazole Nitrate","","POWDER","TOPICAL","20171020","20260930","OTC MONOGRAPH DRUG","M005","LEADER/ Cardinal Health 110, Inc.","1.42","g/71g","","N",""
"7155","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","70000033801","Allylamine Antifungal [EPC], Allylamine [CS]","70000-0338","70000-0338-1","70000-0338_2d2e23c4-e450-485f-aa1a-17f160d979e3","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20180730","","ANDA","ANDA077511","Cardinal Health, 110 dba LEADER","1","g/100g","","N","20251231"
"7156","MICONAZOLE NITRATE","Miconazole Nitrate Cream USP, 2%","70000034001","Azole Antifungal [EPC], Azoles [CS]","70000-0340","70000-0340-1","70000-0340_2901e804-5f41-e1ff-e063-6394a90ac344","HUMAN OTC DRUG","Miconazole Nitrate Cream USP, 2%","","CREAM","TOPICAL","20180730","","OTC MONOGRAPH DRUG","M005","Cardinal Health","2","g/100g","","N","20251231"
"7157","TIOCONAZOLE","Tioconazole","70000035701","Azole Antifungal [EPC], Azoles [CS]","70000-0357","70000-0357-1","70000-0357_d5dec365-3936-4367-9df2-57a919a11eb3","HUMAN OTC DRUG","Leader Tioconazole 1","","OINTMENT","VAGINAL","20180420","","ANDA","ANDA075915","Cardinal Health 110, LLC. dba Leader","6.5","g/100g","","N","20261231"
"7158","BACITRACIN ZINC; POLYMYXIN B SULFATE","First Aid Antibiotic Ointment","70000047101","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70000-0471","70000-0471-1","70000-0471_0f3cab4d-e3b2-acbc-e063-6294a90aca5b","HUMAN OTC DRUG","Poly Bacitracin","","OINTMENT","TOPICAL","20181120","","OTC MONOGRAPH DRUG","M004","Cardinal Health","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"7159","CLOTRIMAZOLE","CLOTRIMAZOLE","70000049301","Azole Antifungal [EPC], Azoles [CS]","70000-0493","70000-0493-1","70000-0493_d3eb9657-5109-4373-8603-88670fb23bba","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20190515","","OTC MONOGRAPH DRUG","M005","Cardinal Health 110,Inc.","10","mg/g","","N","20251231"
"7160","CLOTRIMAZOLE","CLOTRIMAZOLE","70000054202","Azole Antifungal [EPC], Azoles [CS]","70000-0542","70000-0542-2","70000-0542_2a0264aa-2f30-44e4-ac9b-04d2522579e9","HUMAN OTC DRUG","LEADER ATHLETES FOOT CLOTRIMAZOLE","","CREAM","TOPICAL","20200117","","OTC MONOGRAPH DRUG","M005","LEADER",".01","g/g","","N","20261231"
"7161","CLOTRIMAZOLE","CLOTRIMAZOLE","70000054201","Azole Antifungal [EPC], Azoles [CS]","70000-0542","70000-0542-1","70000-0542_2a0264aa-2f30-44e4-ac9b-04d2522579e9","HUMAN OTC DRUG","LEADER ATHLETES FOOT CLOTRIMAZOLE","","CREAM","TOPICAL","20200117","","OTC MONOGRAPH DRUG","M005","LEADER",".01","g/g","","N","20261231"
"7162","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin,Neomycin,Polymxin, Pramoxine","70000062501","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70000-0625","70000-0625-1","70000-0625_3509079c-c2b0-5882-e063-6394a90a6a06","HUMAN OTC DRUG","Leader Triple antibiotic and pain relief","","OINTMENT","TOPICAL","20230215","","OTC MONOGRAPH DRUG","M004","Cardinal Health 110 dba LEADER","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20261231"
"7163","CLOTRIMAZOLE","Clotrimazole","70000066702","Azole Antifungal [EPC], Azoles [CS]","70000-0667","70000-0667-2","70000-0667_199df0a2-bc61-3e83-e063-6394a90ac7dc","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20240510","","OTC MONOGRAPH DRUG","M005","Cardinal Health 110 dba LEADER","1","g/100g","","N","20251231"
"7164","CLOTRIMAZOLE","Clotrimazole","70000066701","Azole Antifungal [EPC], Azoles [CS]","70000-0667","70000-0667-1","70000-0667_199df0a2-bc61-3e83-e063-6394a90ac7dc","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20240510","","OTC MONOGRAPH DRUG","M005","Cardinal Health 110 dba LEADER","1","g/100g","","N","20251231"
"7165","MICONAZOLE NITRATE","Miconazole Nitrate","70000067901","Azole Antifungal [EPC], Azoles [CS]","70000-0679","70000-0679-1","70000-0679_25dc558d-8a01-852f-e063-6394a90af2e3","HUMAN OTC DRUG","Antifungal Powder","","POWDER","TOPICAL","20240816","","OTC MONOGRAPH DRUG","M005","LEADER/ Cardinal Health 110, Inc.","20","mg/g","","N","20251231"
"7166","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin,Neomycin,Polymxin","70000068701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70000-0687","70000-0687-1","70000-0687_2175e00a-bf86-3377-e063-6394a90a916f","HUMAN OTC DRUG","Leader Triple antibiotic","","OINTMENT","TOPICAL","20240815","","OTC MONOGRAPH DRUG","M004","Cardinal Health 110 dba LEADER","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"7167","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc Polymixin B Sulfate","70000069401","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70000-0694","70000-0694-1","70000-0694_20d75f8e-2a81-2653-e063-6394a90a88a4","HUMAN OTC DRUG","Leader Poly Bacitracin","","OINTMENT","TOPICAL","20240815","","OTC MONOGRAPH DRUG","M004","Cardinal Health 110 dba LEADER","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"7168","MICONAZOLE NITRATE","MICONAZOLE NITRATE","70000071801","Azole Antifungal [EPC], Azoles [CS]","70000-0718","70000-0718-1","70000-0718_3504ed0b-c60f-7b38-e063-6294a90ad91d","HUMAN OTC DRUG","MICONAZOLE Nitrate 2% Cream ANTIFUNGAL","","CREAM","TOPICAL","20250512","","OTC MONOGRAPH DRUG","M005","Cardinal Health 110 dba LEADER","2","g/100g","","N","20261231"
"7169","CLOTRIMAZOLE","Clotrimazole","70000072901","Azole Antifungal [EPC], Azoles [CS]","70000-0729","70000-0729-1","70000-0729_2bf37309-fa5f-470b-98c2-e0b078c9e2fd","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","20250430","","ANDA","ANDA074165","Cardinal Health (Leader) 70000","10","mg/g","","N","20261231"
"7170","CLOTRIMAZOLE","Clotrimazole","70010022954","Azole Antifungal [EPC], Azoles [CS]","70010-229","70010-229-54","70010-229_16d347aa-6269-a426-e063-6294a90adcb9","HUMAN OTC DRUG","Clotrimazole","","SOLUTION","TOPICAL","20230322","","OTC MONOGRAPH DRUG","M005","Granules Pharmaceuticals Inc.","1","g/mL","","N","20251231"
"7171","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin Hydrochloride","70069008101","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70069-081","70069-081-01","70069-081_1a4f432a-c2b2-46bc-88fc-7379c2bbd0a2","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20241125","","ANDA","ANDA209698","Somerset Therapeutics, LLC","5","mg/mL","","N","20251231"
"7172","TOBRAMYCIN","Tobramycin","70069013101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","70069-131","70069-131-01","70069-131_a45353e5-3631-4a52-9ac6-feac3187a08d","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION/ DROPS","OPHTHALMIC","20200811","","ANDA","ANDA207444","Somerset Therapeutics, LLC","3","mg/mL","","N","20251231"
"7173","POLYMYXIN B SULFATE; TRIMETHOPRIM","polymyxin b sulfate and trimethoprim sulfate","70069031101","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70069-311","70069-311-01","70069-311_80ad4adc-72c3-4398-a639-3d6a6ae9ec17","HUMAN PRESCRIPTION DRUG","polymyxin b sulfate and trimethoprim sulfate","","SOLUTION/ DROPS","OPHTHALMIC","20240806","","ANDA","ANDA211572","Somerset Therapeutics, LLC","10000; 1","[iU]/mL; mg/mL","","N","20251231"
"7174","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70069036110","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70069-361","70069-361-10","70069-361_55953381-5afa-4a77-8ac7-e07b5c35e3dc","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","INJECTION, SOLUTION, CONCENTRATE","INTRAVENOUS","20190829","","ANDA","ANDA212231","Somerset Therapeutics, LLC","80; 16","mg/mL; mg/mL","","N","20251231"
"7175","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70069036210","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70069-362","70069-362-10","70069-362_55953381-5afa-4a77-8ac7-e07b5c35e3dc","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","INJECTION, SOLUTION, CONCENTRATE","INTRAVENOUS","20190829","","ANDA","ANDA212231","Somerset Therapeutics, LLC","80; 16","mg/mL; mg/mL","","N","20251231"
"7176","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70069036301","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70069-363","70069-363-01","70069-363_55953381-5afa-4a77-8ac7-e07b5c35e3dc","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","INJECTION, SOLUTION, CONCENTRATE","INTRAVENOUS","20190829","","ANDA","ANDA212231","Somerset Therapeutics, LLC","80; 16","mg/mL; mg/mL","","N","20251231"
"7177","OFLOXACIN","Ofloxacin","70069041101","Quinolone Antimicrobial [EPC], Quinolones [CS]","70069-411","70069-411-01","70069-411_d83e31c5-0a6d-49d6-afd8-34d0c406a401","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20241010","","ANDA","ANDA213597","Somerset Therapeutics, LLC","3","mg/mL","","N","20251231"
"7178","OFLOXACIN","Ofloxacin","70069068601","Quinolone Antimicrobial [EPC], Quinolones [CS]","70069-686","70069-686-01","70069-686_d0e8409c-4b1e-4d0b-bfa7-7e75e0a540c8","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","AURICULAR (OTIC)","20241031","","ANDA","ANDA216328","Somerset Therapeutics, LLC","3","mg/mL","","N","20251231"
"7179","OFLOXACIN","Ofloxacin","70069068701","Quinolone Antimicrobial [EPC], Quinolones [CS]","70069-687","70069-687-01","70069-687_d0e8409c-4b1e-4d0b-bfa7-7e75e0a540c8","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","AURICULAR (OTIC)","20241031","","ANDA","ANDA216328","Somerset Therapeutics, LLC","3","mg/mL","","N","20251231"
"7180","NITROFURANTOIN","Nitrofurantoin","70069082901","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70069-829","70069-829-01","70069-829_dd99ba40-edff-47c3-9ee4-7e5b7774e5b5","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","FOR SUSPENSION","ORAL","20250226","","ANDA","ANDA208909","Somerset Therapeutics, LLC","25","mg/5mL","","N","20261231"
"7181","AZITHROMYCIN MONOHYDRATE","Azithromycin monohydrate","70095002502","Macrolide Antimicrobial [EPC], Macrolides [CS]","70095-025","70095-025-02","70095-025_dd9fbcb9-f8e5-417f-98b0-6ba9939982c1","HUMAN PRESCRIPTION DRUG","Azithromycin monohydrate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230327","","ANDA","ANDA065501","Sun Pharmaceutical Industries Limited","500","mg/10mL","","N","20251231"
"7182","MEROPENEM","Meropenem","70121145307","Carbapenems [CS], Penem Antibacterial [EPC]","70121-1453","70121-1453-7","70121-1453_c346bc7b-a9e5-4669-bbf0-ea71912fd0fb","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20160509","","ANDA","ANDA205883","Amneal Pharmaceuticals LLC","1","g/30mL","","N","20261231"
"7183","MEROPENEM","Meropenem","70121145407","Carbapenems [CS], Penem Antibacterial [EPC]","70121-1454","70121-1454-7","70121-1454_c346bc7b-a9e5-4669-bbf0-ea71912fd0fb","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20160509","","ANDA","ANDA205883","Amneal Pharmaceuticals LLC","500","mg/20mL","","N","20261231"
"7184","TIGECYCLINE","Tigecycline","70121164707","Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]","70121-1647","70121-1647-7","70121-1647_c21de58f-dcd0-46f7-a6d9-0ff5ba5863a1","HUMAN PRESCRIPTION DRUG","Tigecycline","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180131","","NDA","NDA211158","Amneal Pharmaceuticals LLC","50","mg/5mL","","N","20261231"
"7185","MUPIROCIN","Mupirocin","70166035510","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","70166-355","70166-355-10","70166-355_313090ef-ad58-1103-e063-6394a90a7d75","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20180526","","ANDA","ANDA065170","Lohxa","20","mg/g","","N","20261231"
"7186","MUPIROCIN","Mupirocin","70166035550","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","70166-355","70166-355-50","70166-355_313090ef-ad58-1103-e063-6394a90a7d75","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20180526","","ANDA","ANDA065170","Lohxa","20","mg/g","","N","20261231"
"7187","NITROFURANTOIN","Nitrofurantoin","70199000632","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70199-006","70199-006-32","70199-006_d6a47b0a-6d58-4d67-9f0b-932099913ac8","HUMAN PRESCRIPTION DRUG","Furadantin","","SUSPENSION","ORAL","20201223","","NDA","NDA009175","Casper Pharma LLC","25","mg/5mL","","N","20251231"
"7188","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin and Polymyxin B sulfates, Bacitracin zinc","70199001053","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70199-010","70199-010-53","70199-010_27b51a77-a690-42ca-ad60-6f657202a198","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B sulfates, Bacitracin zinc","","OINTMENT","OPHTHALMIC","20170407","","NDA","NDA050417","Casper Pharma LLC","400; 3.5; 10000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"7189","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin and polymyxin B sulfates and hydrocortisone otic","70199001110","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70199-011","70199-011-10","70199-011_6f9e9158-46a9-4297-b14b-6770bacbe3e7","HUMAN PRESCRIPTION DRUG","CASPORYN HC","","SUSPENSION","AURICULAR (OTIC)","20190315","","NDA","NDA060613","Casper Pharma LLC","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"7190","NITROFURANTOIN","Nitrofurantoin","70199003660","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70199-036","70199-036-60","70199-036_d6a47b0a-6d58-4d67-9f0b-932099913ac8","HUMAN PRESCRIPTION DRUG","Furadantin","","SUSPENSION","ORAL","20240201","","NDA","NDA009175","Casper Pharma LLC","50","mg/5mL","","N","20251231"
"7191","POSACONAZOLE","Posaconazole","70377003811","Azole Antifungal [EPC], Azoles [CS]","70377-038","70377-038-11","70377-038_b7a2fd29-83b5-6ae6-775c-98f91a6c0ea4","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","TABLET, DELAYED RELEASE","ORAL","20220308","","ANDA","ANDA214476","Biocon Phama Inc.","100","mg/1","","N","20251231"
"7192","MICAFUNGIN SODIUM","micafungin","70377007591","Echinocandin Antifungal [EPC], Lipopeptides [CS]","70377-075","70377-075-91","70377-075_b47af7ae-3d7f-817f-a585-317195cc1052","HUMAN PRESCRIPTION DRUG","MICAFUNGIN","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20241101","","ANDA","ANDA216438","Biocon Pharma Inc.","10","mg/mL","","N","20251231"
"7193","MICAFUNGIN SODIUM","micafungin","70377007691","Echinocandin Antifungal [EPC], Lipopeptides [CS]","70377-076","70377-076-91","70377-076_b47af7ae-3d7f-817f-a585-317195cc1052","HUMAN PRESCRIPTION DRUG","MICAFUNGIN","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20241101","","ANDA","ANDA216438","Biocon Pharma Inc.","20","mg/mL","","N","20251231"
"7194","DAPTOMYCIN","Daptomycin","70377009391","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","70377-093","70377-093-91","70377-093_1561d176-3d8d-b8c9-ccfd-b4ad9a48d81e","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20241025","","ANDA","ANDA217215","Biocon Pharma Inc.","500","mg/10mL","","N","20251231"
"7195","NITROFURANTOIN","NITROFURANTOIN","70377011831","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70377-118","70377-118-31","70377-118_3cd77dd5-7b86-a52f-fa61-69afc7b4c6b6","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","SUSPENSION","ORAL","20241115","","ANDA","ANDA218346","Biocon Pharma Inc","25","mg/5mL","","N","20251231"
"7196","NITROFURANTOIN","NITROFURANTOIN","70408023932","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70408-239","70408-239-32","70408-239_686f8b08-4e54-4cb2-abdd-595c3fb3d16e","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","SUSPENSION","ORAL","20120304","","ANDA","ANDA201355","Nostrum Laboratories, Inc.","25","mg/5mL","","N","20251231"
"7197","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","70436001982","Macrolide Antimicrobial [EPC], Macrolides [CS]","70436-019","70436-019-82","70436-019_ebe5ec1e-9891-ae48-e053-2a95a90afff6","HUMAN PRESCRIPTION DRUG","Azithromycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20181219","","ANDA","ANDA203412","Slate Run Pharmaceuticals","500","mg/5mL","","N","20251231"
"7198","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","70436002082","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70436-020","70436-020-82","70436-020_c84f514d-5dae-00ff-e053-2a95a90a6fbb","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190603","","ANDA","ANDA212332","Slate Run Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"7199","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","70436002182","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70436-021","70436-021-82","70436-021_c84f514d-5dae-00ff-e053-2a95a90a6fbb","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190603","","ANDA","ANDA212332","Slate Run Pharmaceuticals, LLC","1","g/1","","N","20251231"
"7200","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","70436002282","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70436-022","70436-022-82","70436-022_d1af3995-ce44-521d-e053-2a95a90ada94","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210206","","ANDA","ANDA215821","Slate Run Pharmaceuticals, LLC","5","g/1","","N","20251231"
"7201","VANCOMYCIN HYDROCHLORIDE","VANCOMYCIN HYDROCHLORIDE","70436002382","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70436-023","70436-023-82","70436-023_d1af3995-ce44-521d-e053-2a95a90ada94","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210206","","ANDA","ANDA215821","Slate Run Pharmaceuticals, LLC","10","g/1","","N","20251231"
"7202","VORICONAZOLE","voriconazole","70436002980","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70436-029","70436-029-80","70436-029_20c90584-08b6-a137-e063-6294a90ae213","HUMAN PRESCRIPTION DRUG","voriconazole","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190128","","ANDA","ANDA211661","Slate Run Pharmaceuticals","200","mg/1","","N","20251231"
"7203","DAPTOMYCIN","daptomycin","70436003380","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","70436-033","70436-033-80","70436-033_e6b9cc81-2724-1ecb-e053-2995a90a13c1","HUMAN PRESCRIPTION DRUG","daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION","INTRAVENOUS","20221001","","ANDA","ANDA215890","Slate Run Pharmaceuticals, LLC","500","mg/20mL","","N","20251231"
"7204","GANCICLOVIR SODIUM","ganciclovir sodium","70436008955","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","70436-089","70436-089-55","70436-089_2c55a80a-e482-1d6b-e063-6394a90a41c4","HUMAN PRESCRIPTION DRUG","ganciclovir","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190101","","ANDA","ANDA204204","Slate Run Pharmaceuticals, LLC","500","mg/10mL","","N","20261231"
"7205","TOBRAMYCIN","tobramycin","70436011056","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","70436-110","70436-110-56","70436-110_09af6337-0c92-4cb7-e063-6294a90a0e4a","HUMAN PRESCRIPTION DRUG","tobramycin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20230201","","ANDA","ANDA217029","Slate Run Pharmaceuticals, LLC","1200","mg/30mL","","N","20251231"
"7206","TOBRAMYCIN","tobramycin","70436011080","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","70436-110","70436-110-80","70436-110_09af6337-0c92-4cb7-e063-6294a90a0e4a","HUMAN PRESCRIPTION DRUG","tobramycin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20230201","","ANDA","ANDA217029","Slate Run Pharmaceuticals, LLC","1200","mg/30mL","","N","20251231"
"7207","TOBRAMYCIN","tobramycin","70436011036","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","70436-110","70436-110-36","70436-110_09af6337-0c92-4cb7-e063-6294a90a0e4a","HUMAN PRESCRIPTION DRUG","tobramycin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20230201","","ANDA","ANDA217029","Slate Run Pharmaceuticals, LLC","1200","mg/30mL","","N","20251231"
"7208","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","70436022034","Macrolide Antimicrobial [EPC], Macrolides [CS]","70436-220","70436-220-34","70436-220_32f66ed6-7a90-559b-e063-6394a90aaf93","HUMAN PRESCRIPTION DRUG","azithromycin dihydrate","","POWDER, FOR SUSPENSION","ORAL","20240101","","ANDA","ANDA217036","Slate Run Pharmaceuticals, LLC","100","mg/5mL","","N","20261231"
"7209","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","70436022134","Macrolide Antimicrobial [EPC], Macrolides [CS]","70436-221","70436-221-34","70436-221_32f66ed6-7a90-559b-e063-6394a90aaf93","HUMAN PRESCRIPTION DRUG","azithromycin dihydrate","","POWDER, FOR SUSPENSION","ORAL","20240101","","ANDA","ANDA217036","Slate Run Pharmaceuticals, LLC","200","mg/5mL","","N","20261231"
"7210","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","70436022236","Macrolide Antimicrobial [EPC], Macrolides [CS]","70436-222","70436-222-36","70436-222_32f66ed6-7a90-559b-e063-6394a90aaf93","HUMAN PRESCRIPTION DRUG","azithromycin dihydrate","","POWDER, FOR SUSPENSION","ORAL","20240101","","ANDA","ANDA217036","Slate Run Pharmaceuticals, LLC","200","mg/5mL","","N","20261231"
"7211","FLUCONAZOLE","Fluconazole","70436022748","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70436-227","70436-227-48","70436-227_2c3342fa-abe7-d6b0-e063-6394a90ad1c0","HUMAN PRESCRIPTION DRUG","Fluconazole","","POWDER, FOR SUSPENSION","ORAL","20240101","","ANDA","ANDA215738","Slate Run Pharmaceuticals","40","mg/mL","","N","20261231"
"7212","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","70436022849","Macrolide Antimicrobial [EPC], Macrolides [CS]","70436-228","70436-228-49","70436-228_32f66ed6-7a90-559b-e063-6394a90aaf93","HUMAN PRESCRIPTION DRUG","azithromycin dihydrate","","POWDER, FOR SUSPENSION","ORAL","20240101","","ANDA","ANDA217036","Slate Run Pharmaceuticals, LLC","200","mg/5mL","","N","20261231"
"7213","VORICONAZOLE","voriconazole","70436023039","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70436-230","70436-230-39","70436-230_31b209f9-0d7d-bf0c-e063-6294a90a7f74","HUMAN PRESCRIPTION DRUG","voriconazole","","POWDER, FOR SUSPENSION","ORAL","20240301","","ANDA","ANDA216805","Slate Run Pharmaceuticals, LLC","40","mg/mL","","N","20261231"
"7214","GANCICLOVIR SODIUM","ganciclovir sodium","70436023155","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","70436-231","70436-231-55","70436-231_2ac6c72f-6f19-825c-e063-6294a90af661","HUMAN PRESCRIPTION DRUG","ganciclovir sodium","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190101","","ANDA","ANDA204204","Slate Run Pharmaceuticals, LLC","500","mg/10mL","","N","20261231"
"7215","DAPTOMYCIN","Daptomycin","70511018184","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","70511-181","70511-181-84","70511-181_2284609b-96e2-49a0-9466-4082bbdcecfd","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20250401","","NDA","NDA217630","MAIA Pharmaceuticals, Inc.","350","mg/1","","N","20251231"
"7216","DAPTOMYCIN","Daptomycin","70511018284","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","70511-182","70511-182-84","70511-182_2284609b-96e2-49a0-9466-4082bbdcecfd","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20250401","","NDA","NDA217630","MAIA Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"7217","OFLOXACIN","Ofloxacin Ophthalmic Solution USP, 0.3%","70512079305","Quinolone Antimicrobial [EPC], Quinolones [CS]","70512-793","70512-793-05","70512-793_17426a89-e694-01f6-e063-6394a90a1a4c","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20240430","","ANDA","ANDA217904","SOLA Pharmaceuticals, LLC","3","mg/mL","","N","20251231"
"7218","OFLOXACIN","Ofloxacin Ophthalmic Solution USP, 0.3%","70512079310","Quinolone Antimicrobial [EPC], Quinolones [CS]","70512-793","70512-793-10","70512-793_17426a89-e694-01f6-e063-6394a90a1a4c","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20240430","","ANDA","ANDA217904","SOLA Pharmaceuticals, LLC","3","mg/mL","","N","20251231"
"7219","METRONIDAZOLE","Metronidazole","70518001300","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-0013","70518-0013-0","70518-0013_35ce9fd0-8eb7-041c-e063-6294a90a8e45","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161123","","ANDA","ANDA070027","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7220","METRONIDAZOLE","Metronidazole","70518005801","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-0058","70518-0058-1","70518-0058_361dd3d0-3627-1559-e063-6394a90a9b98","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20161213","","ANDA","ANDA203458","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7221","METRONIDAZOLE","Metronidazole","70518008800","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-0088","70518-0088-0","70518-0088_37369907-9ebb-189c-e063-6394a90a992c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20161228","","ANDA","ANDA203458","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7222","METRONIDAZOLE","Metronidazole","70518008802","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-0088","70518-0088-2","70518-0088_37369907-9ebb-189c-e063-6394a90a992c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20161228","","ANDA","ANDA203458","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7223","METRONIDAZOLE","Metronidazole","70518008803","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-0088","70518-0088-3","70518-0088_37369907-9ebb-189c-e063-6394a90a992c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20161228","","ANDA","ANDA203458","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7224","METRONIDAZOLE","Metronidazole","70518008805","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-0088","70518-0088-5","70518-0088_37369907-9ebb-189c-e063-6394a90a992c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20161228","","ANDA","ANDA203458","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7225","METRONIDAZOLE","Metronidazole","70518008804","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-0088","70518-0088-4","70518-0088_37369907-9ebb-189c-e063-6394a90a992c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20161228","","ANDA","ANDA203458","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7226","CLARITHROMYCIN","Clarithromycin","70518020400","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","70518-0204","70518-0204-0","70518-0204_363521b9-5a80-c6cc-e063-6394a90aa78b","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20170207","","ANDA","ANDA065489","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7227","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystalline","70518026503","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","70518-0265","70518-0265-3","70518-0265_36369e61-1899-57f0-e063-6294a90aad27","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/ Macrocrystalline","","CAPSULE","ORAL","20170228","","NDA","NDA020064","REMEDYREPACK INC.","25; 75","mg/1; mg/1","","N","20261231"
"7228","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","70518033604","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-0336","70518-0336-4","70518-0336_36371828-2211-efa0-e063-6294a90a7826","HUMAN PRESCRIPTION DRUG","Zithromax","","TABLET, FILM COATED","ORAL","20170320","","NDA","NDA050784","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7229","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","70518033900","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","70518-0339","70518-0339-0","70518-0339_3637220c-5d16-d90a-e063-6294a90a83aa","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20170320","","ANDA","ANDA075502","REMEDYREPACK INC.",".5; 10","mg/g; mg/g","","N","20261231"
"7230","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","70518036801","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-0368","70518-0368-1","70518-0368_36382697-0804-0a8f-e063-6394a90ae02c","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20170329","","ANDA","ANDA076639","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7231","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","70518036804","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-0368","70518-0368-4","70518-0368_36382697-0804-0a8f-e063-6394a90ae02c","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20170329","","ANDA","ANDA076639","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7232","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","70518042400","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70518-0424","70518-0424-0","70518-0424_339b3d8a-ade3-ed22-e063-6294a90a945c","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20170412","","ANDA","ANDA065061","REMEDYREPACK INC.","150","mg/1","","N","20261231"
"7233","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","70518042401","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70518-0424","70518-0424-1","70518-0424_339b3d8a-ade3-ed22-e063-6294a90a945c","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20170412","","ANDA","ANDA065061","REMEDYREPACK INC.","150","mg/1","","N","20261231"
"7234","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","70518042406","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70518-0424","70518-0424-6","70518-0424_339b3d8a-ade3-ed22-e063-6294a90a945c","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20170412","","ANDA","ANDA065061","REMEDYREPACK INC.","150","mg/1","","N","20261231"
"7235","ERYTHROMYCIN","Erythromycin","70518046500","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","70518-0465","70518-0465-0","70518-0465_364b57de-f739-9cee-e063-6294a90a46fd","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","20170426","","ANDA","ANDA064067","REMEDYREPACK INC.","5","mg/g","","N","20261231"
"7236","AZITHROMYCIN MONOHYDRATE","Azithromycin","70518059900","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-0599","70518-0599-0","70518-0599_365d70ff-2257-3210-e063-6294a90a5c4a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20170628","","ANDA","ANDA065223","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7237","AZITHROMYCIN MONOHYDRATE","Azithromycin","70518059903","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-0599","70518-0599-3","70518-0599_365d70ff-2257-3210-e063-6294a90a5c4a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20170628","","ANDA","ANDA065223","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7238","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","70518073202","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70518-0732","70518-0732-2","70518-0732_33daa666-1966-fe31-e063-6394a90a483b","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20170912","","ANDA","ANDA065061","REMEDYREPACK INC.","300","mg/1","","N","20261231"
"7239","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","70518073203","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70518-0732","70518-0732-3","70518-0732_33daa666-1966-fe31-e063-6394a90a483b","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20170912","","ANDA","ANDA065061","REMEDYREPACK INC.","300","mg/1","","N","20261231"
"7240","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","70518073204","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70518-0732","70518-0732-4","70518-0732_33daa666-1966-fe31-e063-6394a90a483b","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20170912","","ANDA","ANDA065061","REMEDYREPACK INC.","300","mg/1","","N","20261231"
"7241","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone","70518076300","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70518-0763","70518-0763-0","70518-0763_369a5cde-ce95-26c0-e063-6294a90a5936","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SOLUTION/ DROPS","AURICULAR (OTIC)","20171006","","ANDA","ANDA064053","REMEDYREPACK INC.","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20261231"
"7242","AZITHROMYCIN MONOHYDRATE","Azithromycin","70518078401","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-0784","70518-0784-1","70518-0784_369aa2cf-a09c-4744-e063-6394a90a604b","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20171012","","ANDA","ANDA065225","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7243","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518086302","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-0863","70518-0863-2","70518-0863_36ac74d9-0940-7004-e063-6394a90a5841","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20171124","","ANDA","ANDA090624","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20261231"
"7244","AMOXICILLIN","Amoxicillin","70518089503","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-0895","70518-0895-3","70518-0895_36bfdc2e-4294-117b-e063-6294a90a5003","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20171212","","ANDA","ANDA065271","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7245","AMOXICILLIN","Amoxicillin","70518089505","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-0895","70518-0895-5","70518-0895_36bfdc2e-4294-117b-e063-6294a90a5003","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20171212","","ANDA","ANDA065271","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7246","AMOXICILLIN","Amoxicillin","70518089509","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-0895","70518-0895-9","70518-0895_36bfdc2e-4294-117b-e063-6294a90a5003","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20171212","","ANDA","ANDA065271","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7247","AMOXICILLIN","Amoxicillin","70518089508","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-0895","70518-0895-8","70518-0895_36bfdc2e-4294-117b-e063-6294a90a5003","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20171212","","ANDA","ANDA065271","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7248","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","70518108701","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","70518-1087","70518-1087-1","70518-1087_36d61f2d-930e-f113-e063-6294a90aaf7a","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20180329","","ANDA","ANDA077066","REMEDYREPACK INC.","25; 75","mg/1; mg/1","","N","20261231"
"7249","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","70518111400","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","70518-1114","70518-1114-0","70518-1114_36d70d52-c435-4903-e063-6394a90ab292","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","20180412","","ANDA","ANDA062364","REMEDYREPACK INC.","100000; 1","[USP'U]/g; mg/g","","N","20261231"
"7250","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","70518117000","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-1170","70518-1170-0","70518-1170_36e8be23-f959-0d00-e063-6294a90ae770","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20180515","","NDA AUTHORIZED GENERIC","NDA019992","REMEDYREPACK INC.","3","mg/mL","","N","20261231"
"7251","METRONIDAZOLE","Metronidazole","70518124000","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-1240","70518-1240-0","70518-1240_36d39b27-6801-9eed-e063-6394a90aa051","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20180601","","ANDA","ANDA070033","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7252","METRONIDAZOLE","Metronidazole","70518124001","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-1240","70518-1240-1","70518-1240_36d39b27-6801-9eed-e063-6394a90aa051","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20180601","","ANDA","ANDA070033","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7253","METRONIDAZOLE","Metronidazole","70518124102","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-1241","70518-1241-2","70518-1241_36ebd72c-edf0-dc41-e063-6394a90ad7ca","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20180601","","ANDA","ANDA070033","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7254","TOBRAMYCIN","Tobramycin","70518137000","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","70518-1370","70518-1370-0","70518-1370_3760e6b2-8fdc-6ac4-e063-6294a90a2173","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION/ DROPS","OPHTHALMIC","20180813","","ANDA","ANDA207444","REMEDYREPACK INC.","3","mg/mL","","N","20261231"
"7255","METRONIDAZOLE","Metronidazole","70518153602","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-1536","70518-1536-2","70518-1536_365aa458-e4e3-4baa-e063-6294a90a0a4b","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20181015","","ANDA","ANDA203458","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7256","METRONIDAZOLE","Metronidazole","70518153603","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-1536","70518-1536-3","70518-1536_365aa458-e4e3-4baa-e063-6294a90a0a4b","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20181015","","ANDA","ANDA203458","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7257","SILVER SULFADIAZINE","Silver Sulfadiazine","70518156201","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","70518-1562","70518-1562-1","70518-1562_3802ec71-2673-659b-e063-6294a90ac258","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","20181019","","NDA","NDA018810","REMEDYREPACK INC.","10","mg/g","","N","20261231"
"7258","KETOCONAZOLE","ketoconazole","70518163700","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","70518-1637","70518-1637-0","70518-1637_2ee843aa-9571-fc2c-e063-6294a90a37a4","HUMAN PRESCRIPTION DRUG","ketoconazole","","CREAM","TOPICAL","20181106","","ANDA","ANDA076294","REMEDYREPACK INC.","20","mg/g","","N","20261231"
"7259","POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE","Polymyxin B Sulfate and Trimethoprim","70518173500","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70518-1735","70518-1735-0","70518-1735_2efcccee-f229-2c69-e063-6394a90aba0d","HUMAN PRESCRIPTION DRUG","Polymyxin B Sulfate and Trimethoprim","","SOLUTION","OPHTHALMIC","20181214","","ANDA","ANDA064211","REMEDYREPACK INC.","10000; 1","[USP'U]/mL; mg/mL","","N","20261231"
"7260","MUPIROCIN","Mupirocin","70518180800","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","70518-1808","70518-1808-0","70518-1808_2f11b3a6-bfa5-87cd-e063-6394a90ac3c9","HUMAN PRESCRIPTION DRUG","mupirocin","","OINTMENT","TOPICAL","20190121","","ANDA","ANDA065123","REMEDYREPACK INC.","20","mg/g","","N","20261231"
"7261","CEFDINIR","Cefdinir","70518188000","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-1880","70518-1880-0","70518-1880_313ed5fe-5d2d-8cf6-e063-6294a90a15c2","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20190219","","ANDA","ANDA065434","REMEDYREPACK INC.","300","mg/1","","N","20261231"
"7262","CEFDINIR","Cefdinir","70518188001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-1880","70518-1880-1","70518-1880_313ed5fe-5d2d-8cf6-e063-6294a90a15c2","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20190219","","ANDA","ANDA065434","REMEDYREPACK INC.","300","mg/1","","N","20261231"
"7263","OFLOXACIN","Ofloxacin","70518203700","Quinolone Antimicrobial [EPC], Quinolones [CS]","70518-2037","70518-2037-0","70518-2037_2f881a90-e00f-314d-e063-6294a90a6f9a","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20190425","","ANDA","ANDA078559","REMEDYREPACK INC.","3","mg/mL","","N","20261231"
"7264","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","70518215307","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70518-2153","70518-2153-7","70518-2153_2d54c9a3-f9f4-8cb7-e063-6294a90ad401","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190626","","ANDA","ANDA207402","REMEDYREPACK INC.","300","mg/1","","N","20261231"
"7265","AMOXICILLIN","Amoxicillin","70518218800","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2188","70518-2188-0","70518-2188_2f9eed08-35aa-d323-e063-6294a90a63a9","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20190709","","ANDA","ANDA064076","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7266","AMOXICILLIN","Amoxicillin","70518219001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2190","70518-2190-1","70518-2190_2facc0a3-0662-a817-e063-6294a90ac040","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20190709","","ANDA","ANDA064076","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7267","AMOXICILLIN","Amoxicillin","70518219002","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2190","70518-2190-2","70518-2190_2facc0a3-0662-a817-e063-6294a90ac040","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20190709","","ANDA","ANDA064076","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7268","AMOXICILLIN","Amoxicillin","70518219003","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2190","70518-2190-3","70518-2190_2facc0a3-0662-a817-e063-6294a90ac040","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20190709","","ANDA","ANDA064076","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7269","AMOXICILLIN","Amoxicillin","70518219000","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2190","70518-2190-0","70518-2190_2facc0a3-0662-a817-e063-6294a90ac040","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20190709","","ANDA","ANDA064076","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7270","AMOXICILLIN","Amoxicillin","70518219005","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2190","70518-2190-5","70518-2190_2facc0a3-0662-a817-e063-6294a90ac040","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20190709","","ANDA","ANDA064076","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7271","AMOXICILLIN","Amoxicillin","70518219007","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2190","70518-2190-7","70518-2190_2facc0a3-0662-a817-e063-6294a90ac040","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20190709","","ANDA","ANDA064076","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7272","AMOXICILLIN","Amoxicillin","70518219004","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2190","70518-2190-4","70518-2190_2facc0a3-0662-a817-e063-6294a90ac040","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20190709","","ANDA","ANDA064076","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7273","AMOXICILLIN","Amoxicillin","70518219101","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2191","70518-2191-1","70518-2191_2facfdb0-461c-a843-e063-6394a90a0d89","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20190709","","ANDA","ANDA065256","REMEDYREPACK INC.","875","mg/1","","N","20261231"
"7274","AMOXICILLIN","Amoxicillin","70518219103","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2191","70518-2191-3","70518-2191_2facfdb0-461c-a843-e063-6394a90a0d89","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20190709","","ANDA","ANDA065256","REMEDYREPACK INC.","875","mg/1","","N","20261231"
"7275","AMOXICILLIN","Amoxicillin","70518219104","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2191","70518-2191-4","70518-2191_2facfdb0-461c-a843-e063-6394a90a0d89","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20190709","","ANDA","ANDA065256","REMEDYREPACK INC.","875","mg/1","","N","20261231"
"7276","AMOXICILLIN","Amoxicillin","70518219102","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2191","70518-2191-2","70518-2191_2facfdb0-461c-a843-e063-6394a90a0d89","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20190709","","ANDA","ANDA065256","REMEDYREPACK INC.","875","mg/1","","N","20261231"
"7277","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518222500","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2225","70518-2225-0","70518-2225_2faee58e-538b-a562-e063-6394a90add2d","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20190719","","ANDA","ANDA091568","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7278","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518222501","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2225","70518-2225-1","70518-2225_2faee58e-538b-a562-e063-6394a90add2d","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20190719","","ANDA","ANDA091568","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7279","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518222505","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2225","70518-2225-5","70518-2225_2faee58e-538b-a562-e063-6394a90add2d","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20190719","","ANDA","ANDA091568","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7280","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518222508","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2225","70518-2225-8","70518-2225_2faee58e-538b-a562-e063-6394a90add2d","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20190719","","ANDA","ANDA091568","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7281","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518222502","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2225","70518-2225-2","70518-2225_2faee58e-538b-a562-e063-6394a90add2d","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20190719","","ANDA","ANDA091568","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7282","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518226300","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2263","70518-2263-0","70518-2263_2d9186a7-2ce2-1d01-e063-6294a90a287a","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20190812","","ANDA","ANDA204755","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7283","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518226303","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2263","70518-2263-3","70518-2263_2d9186a7-2ce2-1d01-e063-6294a90a287a","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20190812","","ANDA","ANDA204755","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7284","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518226306","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2263","70518-2263-6","70518-2263_2d9186a7-2ce2-1d01-e063-6294a90a287a","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20190812","","ANDA","ANDA204755","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7285","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518226307","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2263","70518-2263-7","70518-2263_2d9186a7-2ce2-1d01-e063-6294a90a287a","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20190812","","ANDA","ANDA204755","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7286","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518226308","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2263","70518-2263-8","70518-2263_2d9186a7-2ce2-1d01-e063-6294a90a287a","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20190812","","ANDA","ANDA204755","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7287","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518226309","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2263","70518-2263-9","70518-2263_2d9186a7-2ce2-1d01-e063-6294a90a287a","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20190812","","ANDA","ANDA204755","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7288","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518226305","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2263","70518-2263-5","70518-2263_2d9186a7-2ce2-1d01-e063-6294a90a287a","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20190812","","ANDA","ANDA204755","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7289","CEPHALEXIN","Cephalexin","70518227302","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-2273","70518-2273-2","70518-2273_2ffd668f-69df-6eb8-e063-6394a90a04c3","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20190819","","ANDA","ANDA090836","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7290","CEPHALEXIN","Cephalexin","70518227303","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-2273","70518-2273-3","70518-2273_2ffd668f-69df-6eb8-e063-6394a90a04c3","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20190819","","ANDA","ANDA090836","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7291","CEPHALEXIN","Cephalexin","70518227304","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-2273","70518-2273-4","70518-2273_2ffd668f-69df-6eb8-e063-6394a90a04c3","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20190819","","ANDA","ANDA090836","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7292","CEPHALEXIN","Cephalexin","70518227300","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-2273","70518-2273-0","70518-2273_2ffd668f-69df-6eb8-e063-6394a90a04c3","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20190819","","ANDA","ANDA090836","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7293","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","70518230100","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-2301","70518-2301-0","70518-2301_2ffdb774-b6c7-8df1-e063-6394a90afd03","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20190904","","ANDA","ANDA065169","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7294","METRONIDAZOLE","Metronidazole","70518230501","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-2305","70518-2305-1","70518-2305_2ab96a20-20ce-69e2-e063-6294a90ad98e","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20190909","","ANDA","ANDA203458","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7295","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","70518235200","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","70518-2352","70518-2352-0","70518-2352_30019a30-4b0a-655f-e063-6394a90a30e7","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20191008","","ANDA","ANDA075673","REMEDYREPACK INC.",".5; 10","mg/g; mg/g","","N","20261231"
"7296","SILVER SULFADIAZINE","Silver Sulfadiazine","70518237301","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","70518-2373","70518-2373-1","70518-2373_300249a3-ca20-bb73-e063-6394a90a982b","HUMAN PRESCRIPTION DRUG","SSD Cream","","CREAM","TOPICAL","20191021","","NDA","NDA018578","REMEDYREPACK INC.","10","g/1000g","","N","20261231"
"7297","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","70518239000","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-2390","70518-2390-0","70518-2390_303895a3-5b50-2cbf-e063-6294a90aec03","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","SOLUTION","OPHTHALMIC","20191025","","ANDA","ANDA077568","REMEDYREPACK INC.","3","mg/mL","","N","20261231"
"7298","FLUCONAZOLE","fluconazole","70518241501","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70518-2415","70518-2415-1","70518-2415_3027062c-c30a-bcdb-e063-6394a90afcec","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20191111","","ANDA","ANDA208963","REMEDYREPACK INC.","100","mg/1","","N","20261231"
"7299","FLUCONAZOLE","fluconazole","70518241503","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70518-2415","70518-2415-3","70518-2415_3027062c-c30a-bcdb-e063-6394a90afcec","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20191111","","ANDA","ANDA208963","REMEDYREPACK INC.","100","mg/1","","N","20261231"
"7300","FLUCONAZOLE","fluconazole","70518241502","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70518-2415","70518-2415-2","70518-2415_3027062c-c30a-bcdb-e063-6394a90afcec","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20191111","","ANDA","ANDA208963","REMEDYREPACK INC.","100","mg/1","","N","20261231"
"7301","AZITHROMYCIN DIHYDRATE","Azithromycin","70518243300","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-2433","70518-2433-0","70518-2433_303c9666-2400-c841-e063-6394a90a3c0a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20191119","","ANDA","ANDA207370","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7302","AZITHROMYCIN DIHYDRATE","Azithromycin","70518243302","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-2433","70518-2433-2","70518-2433_303c9666-2400-c841-e063-6394a90a3c0a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20191119","","ANDA","ANDA207370","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7303","AZITHROMYCIN DIHYDRATE","Azithromycin","70518243304","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-2433","70518-2433-4","70518-2433_303c9666-2400-c841-e063-6394a90a3c0a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20191119","","ANDA","ANDA207370","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7304","AZITHROMYCIN DIHYDRATE","Azithromycin","70518243305","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-2433","70518-2433-5","70518-2433_303c9666-2400-c841-e063-6394a90a3c0a","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20191119","","ANDA","ANDA207370","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7305","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystalline","70518253100","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","70518-2531","70518-2531-0","70518-2531_308b2840-a7f2-7061-e063-6394a90ac23c","HUMAN PRESCRIPTION DRUG","Macrobid","","CAPSULE","ORAL","20200108","","NDA","NDA020064","REMEDYREPACK INC.","25; 75","mg/1; mg/1","","N","20261231"
"7306","CEFDINIR","Cefdinir","70518253700","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-2537","70518-2537-0","70518-2537_2b485d49-2714-9647-e063-6394a90af0dd","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20200111","","ANDA","ANDA065434","REMEDYREPACK INC.","300","mg/1","","N","20261231"
"7307","CEFDINIR","Cefdinir","70518253701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-2537","70518-2537-1","70518-2537_2b485d49-2714-9647-e063-6394a90af0dd","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20200111","","ANDA","ANDA065434","REMEDYREPACK INC.","300","mg/1","","N","20261231"
"7308","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518260400","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-2604","70518-2604-0","70518-2604_2d042c22-fc73-0660-e063-6394a90a838c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200228","","ANDA","ANDA090624","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20261231"
"7309","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518260403","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-2604","70518-2604-3","70518-2604_2d042c22-fc73-0660-e063-6394a90a838c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200228","","ANDA","ANDA090624","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20261231"
"7310","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518260404","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-2604","70518-2604-4","70518-2604_2d042c22-fc73-0660-e063-6394a90a838c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200228","","ANDA","ANDA090624","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20261231"
"7311","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518260405","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-2604","70518-2604-5","70518-2604_2d042c22-fc73-0660-e063-6394a90a838c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200228","","ANDA","ANDA090624","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20261231"
"7312","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518260406","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-2604","70518-2604-6","70518-2604_2d042c22-fc73-0660-e063-6394a90a838c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200228","","ANDA","ANDA090624","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20261231"
"7313","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518260407","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-2604","70518-2604-7","70518-2604_2d042c22-fc73-0660-e063-6394a90a838c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200228","","ANDA","ANDA090624","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20261231"
"7314","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518260408","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-2604","70518-2604-8","70518-2604_2d042c22-fc73-0660-e063-6394a90a838c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200228","","ANDA","ANDA090624","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20261231"
"7315","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518260409","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-2604","70518-2604-9","70518-2604_2d042c22-fc73-0660-e063-6394a90a838c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200228","","ANDA","ANDA090624","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20261231"
"7316","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518260402","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-2604","70518-2604-2","70518-2604_2d042c22-fc73-0660-e063-6394a90a838c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200228","","ANDA","ANDA090624","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20261231"
"7317","AMPICILLIN TRIHYDRATE","Ampicillin","70518260700","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2607","70518-2607-0","70518-2607_30c8d75d-0a77-b56d-e063-6394a90a75d2","HUMAN PRESCRIPTION DRUG","Ampicillin","","CAPSULE","ORAL","20200228","","ANDA","ANDA064082","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7318","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518262500","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2625","70518-2625-0","70518-2625_31165a2d-8d36-594f-e063-6394a90a9669","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20200313","","ANDA","ANDA205707","REMEDYREPACK INC.","500; 125","mg/1; mg/1","","N","20261231"
"7319","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518262501","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2625","70518-2625-1","70518-2625_31165a2d-8d36-594f-e063-6394a90a9669","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20200313","","ANDA","ANDA205707","REMEDYREPACK INC.","500; 125","mg/1; mg/1","","N","20261231"
"7320","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518262502","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2625","70518-2625-2","70518-2625_31165a2d-8d36-594f-e063-6394a90a9669","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20200313","","ANDA","ANDA205707","REMEDYREPACK INC.","500; 125","mg/1; mg/1","","N","20261231"
"7321","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518262504","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2625","70518-2625-4","70518-2625_31165a2d-8d36-594f-e063-6394a90a9669","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20200313","","ANDA","ANDA205707","REMEDYREPACK INC.","500; 125","mg/1; mg/1","","N","20261231"
"7322","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518262503","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-2625","70518-2625-3","70518-2625_31165a2d-8d36-594f-e063-6394a90a9669","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20200313","","ANDA","ANDA205707","REMEDYREPACK INC.","500; 125","mg/1; mg/1","","N","20261231"
"7323","METRONIDAZOLE","metronidazole","70518266304","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-2663","70518-2663-4","70518-2663_359366ea-aad3-c046-e063-6394a90aae2e","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20200330","","ANDA","ANDA206560","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7324","METRONIDAZOLE","metronidazole","70518266305","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-2663","70518-2663-5","70518-2663_359366ea-aad3-c046-e063-6394a90aae2e","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20200330","","ANDA","ANDA206560","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7325","METRONIDAZOLE","metronidazole","70518266301","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-2663","70518-2663-1","70518-2663_359366ea-aad3-c046-e063-6394a90aae2e","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20200330","","ANDA","ANDA206560","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7326","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","70518273503","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70518-2735","70518-2735-3","70518-2735_316c2123-8ab5-2f13-e063-6294a90ac6f5","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20200512","","ANDA","ANDA065442","REMEDYREPACK INC.","300","mg/1","","N","20261231"
"7327","CEFIXIME","CEFIXIME","70518274902","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-2749","70518-2749-2","70518-2749_2c76895b-9fca-fc43-e063-6394a90aacc7","HUMAN PRESCRIPTION DRUG","CEFIXIME","","CAPSULE","ORAL","20200521","","ANDA","ANDA210574","REMEDYREPACK INC.","400","mg/1","","N","20261231"
"7328","CEFIXIME","CEFIXIME","70518274905","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-2749","70518-2749-5","70518-2749_2c76895b-9fca-fc43-e063-6394a90aacc7","HUMAN PRESCRIPTION DRUG","CEFIXIME","","CAPSULE","ORAL","20200521","","ANDA","ANDA210574","REMEDYREPACK INC.","400","mg/1","","N","20261231"
"7329","PENICILLIN V POTASSIUM","Penicillin V Potassium","70518275801","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2758","70518-2758-1","70518-2758_304d9af3-2bca-2783-e063-6294a90a5707","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20200528","","ANDA","ANDA065435","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7330","PENICILLIN V POTASSIUM","Penicillin V Potassium","70518275802","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2758","70518-2758-2","70518-2758_304d9af3-2bca-2783-e063-6294a90a5707","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20200528","","ANDA","ANDA065435","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7331","PENICILLIN V POTASSIUM","Penicillin V Potassium","70518275805","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2758","70518-2758-5","70518-2758_304d9af3-2bca-2783-e063-6294a90a5707","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20200528","","ANDA","ANDA065435","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7332","PENICILLIN V POTASSIUM","Penicillin V Potassium","70518275800","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2758","70518-2758-0","70518-2758_304d9af3-2bca-2783-e063-6294a90a5707","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20200528","","ANDA","ANDA065435","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7333","METRONIDAZOLE","metronidazole","70518281400","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-2814","70518-2814-0","70518-2814_31ba4760-4e8f-db59-e063-6394a90a5693","HUMAN PRESCRIPTION DRUG","metronidazole vaginal","","GEL","VAGINAL","20200714","","ANDA","ANDA211786","REMEDYREPACK INC.","7.5","mg/g","","N","20261231"
"7334","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","70518283702","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-2837","70518-2837-2","70518-2837_31ce708c-77fc-af94-e063-6294a90a9f27","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20200818","","ANDA","ANDA076558","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7335","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","70518283704","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-2837","70518-2837-4","70518-2837_31ce708c-77fc-af94-e063-6294a90a9f27","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20200818","","ANDA","ANDA076558","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7336","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","70518283701","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-2837","70518-2837-1","70518-2837_31ce708c-77fc-af94-e063-6294a90a9f27","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20200818","","ANDA","ANDA076558","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7337","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518283803","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-2838","70518-2838-3","70518-2838_304caa5f-2d4c-6a56-e063-6394a90a6024","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200818","","ANDA","ANDA076899","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20261231"
"7338","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518283805","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-2838","70518-2838-5","70518-2838_304caa5f-2d4c-6a56-e063-6394a90a6024","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200818","","ANDA","ANDA076899","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20261231"
"7339","PENICILLIN V POTASSIUM","Penicillin V Potassium","70518287701","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-2877","70518-2877-1","70518-2877_31e3245b-ae36-ce3b-e063-6294a90aa9c5","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20200910","","ANDA","ANDA065435","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7340","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","70518303502","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-3035","70518-3035-2","70518-3035_3234fd0c-4371-7edc-e063-6294a90ab925","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20210301","","ANDA","ANDA208921","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7341","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","70518303503","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-3035","70518-3035-3","70518-3035_3234fd0c-4371-7edc-e063-6294a90ab925","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20210301","","ANDA","ANDA208921","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7342","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","70518303501","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-3035","70518-3035-1","70518-3035_3234fd0c-4371-7edc-e063-6294a90ab925","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20210301","","ANDA","ANDA208921","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7343","METRONIDAZOLE","metronidazole","70518304202","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-3042","70518-3042-2","70518-3042_338c34e8-d7b5-ff46-e063-6394a90a8d26","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20210309","","ANDA","ANDA206560","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7344","METRONIDAZOLE","metronidazole","70518304203","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-3042","70518-3042-3","70518-3042_338c34e8-d7b5-ff46-e063-6394a90a8d26","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20210309","","ANDA","ANDA206560","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7345","CEFAZOLIN SODIUM","Cefazolin","70518304700","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3047","70518-3047-0","70518-3047_32ff4534-d3ae-f257-e063-6394a90aa3a4","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20210312","","ANDA","ANDA203661","REMEDYREPACK INC.","1","g/1","","N","20261231"
"7346","CEPHALEXIN","Cephalexin","70518305901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3059","70518-3059-1","70518-3059_37ebe12d-b57a-25d3-e063-6294a90a57f5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210329","","ANDA","ANDA090836","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7347","CEPHALEXIN","Cephalexin","70518305904","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3059","70518-3059-4","70518-3059_37ebe12d-b57a-25d3-e063-6294a90a57f5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210329","","ANDA","ANDA090836","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7348","CEPHALEXIN","Cephalexin","70518305907","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3059","70518-3059-7","70518-3059_37ebe12d-b57a-25d3-e063-6294a90a57f5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210329","","ANDA","ANDA090836","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7349","CEPHALEXIN","Cephalexin","70518305900","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3059","70518-3059-0","70518-3059_37ebe12d-b57a-25d3-e063-6294a90a57f5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210329","","ANDA","ANDA090836","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7350","CEPHALEXIN","Cephalexin","70518305908","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3059","70518-3059-8","70518-3059_37ebe12d-b57a-25d3-e063-6294a90a57f5","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210329","","ANDA","ANDA090836","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7351","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","70518306302","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-3063","70518-3063-2","70518-3063_22dd45b6-df7e-dd08-e063-6394a90abdb0","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210402","","ANDA","ANDA076558","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7352","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","70518306304","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-3063","70518-3063-4","70518-3063_22dd45b6-df7e-dd08-e063-6394a90abdb0","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210402","","ANDA","ANDA076558","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7353","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","70518306306","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-3063","70518-3063-6","70518-3063_22dd45b6-df7e-dd08-e063-6394a90abdb0","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210402","","ANDA","ANDA076558","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7354","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","70518306305","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-3063","70518-3063-5","70518-3063_22dd45b6-df7e-dd08-e063-6394a90abdb0","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20210402","","ANDA","ANDA076558","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7355","METRONIDAZOLE","METRONIDAZOLE","70518307301","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-3073","70518-3073-1","70518-3073_22de2410-efc7-1100-e063-6394a90a2b2c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20210419","","ANDA","ANDA205245","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7356","METRONIDAZOLE","METRONIDAZOLE","70518307302","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-3073","70518-3073-2","70518-3073_22de2410-efc7-1100-e063-6394a90a2b2c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20210419","","ANDA","ANDA205245","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7357","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN MONOHYDRATE","70518309400","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3094","70518-3094-0","70518-3094_22f783be-22b5-8360-e063-6394a90a838c","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20210513","","ANDA","ANDA209044","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7358","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN MONOHYDRATE","70518309402","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3094","70518-3094-2","70518-3094_22f783be-22b5-8360-e063-6394a90a838c","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20210513","","ANDA","ANDA209044","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7359","METRONIDAZOLE","Metronidazole","70518311004","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-3110","70518-3110-4","70518-3110_2b386f49-b586-76af-e063-6294a90a901c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20210603","","ANDA","ANDA203974","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7360","METRONIDAZOLE","Metronidazole","70518311005","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-3110","70518-3110-5","70518-3110_2b386f49-b586-76af-e063-6294a90a901c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20210603","","ANDA","ANDA203974","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7361","METRONIDAZOLE","Metronidazole","70518311007","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-3110","70518-3110-7","70518-3110_2b386f49-b586-76af-e063-6294a90a901c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20210603","","ANDA","ANDA203974","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7362","METRONIDAZOLE","Metronidazole","70518311006","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-3110","70518-3110-6","70518-3110_2b386f49-b586-76af-e063-6294a90a901c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20210603","","ANDA","ANDA203974","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7363","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","70518316801","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3168","70518-3168-1","70518-3168_22f47cf8-e0b6-326d-e063-6394a90a4d70","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20210722","","ANDA","ANDA208249","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7364","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","70518316803","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3168","70518-3168-3","70518-3168_22f47cf8-e0b6-326d-e063-6394a90a4d70","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20210722","","ANDA","ANDA208249","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7365","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","70518316804","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3168","70518-3168-4","70518-3168_22f47cf8-e0b6-326d-e063-6394a90a4d70","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20210722","","ANDA","ANDA208249","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7366","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","70518316805","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3168","70518-3168-5","70518-3168_22f47cf8-e0b6-326d-e063-6394a90a4d70","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20210722","","ANDA","ANDA208249","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7367","AZITHROMYCIN DIHYDRATE","Azithromycin","70518316901","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3169","70518-3169-1","70518-3169_225333a1-7f07-a7c0-e063-6294a90ad3dd","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20210722","","ANDA","ANDA210001","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7368","AZITHROMYCIN DIHYDRATE","Azithromycin","70518316902","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3169","70518-3169-2","70518-3169_225333a1-7f07-a7c0-e063-6294a90ad3dd","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20210722","","ANDA","ANDA210001","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7369","AZITHROMYCIN DIHYDRATE","Azithromycin","70518316903","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3169","70518-3169-3","70518-3169_225333a1-7f07-a7c0-e063-6294a90ad3dd","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20210722","","ANDA","ANDA210001","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7370","CEFUROXIME AXETIL","Cefuroxime Axetil","70518321503","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3215","70518-3215-3","70518-3215_2c767d9f-41d0-1c80-e063-6394a90ae5f8","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET, FILM COATED","ORAL","20210908","","ANDA","ANDA065308","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7371","CEFUROXIME AXETIL","Cefuroxime Axetil","70518321504","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3215","70518-3215-4","70518-3215_2c767d9f-41d0-1c80-e063-6394a90ae5f8","HUMAN PRESCRIPTION DRUG","Cefuroxime Axetil","","TABLET, FILM COATED","ORAL","20210908","","ANDA","ANDA065308","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7372","AZITHROMYCIN DIHYDRATE","Azithromycin","70518321700","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3217","70518-3217-0","70518-3217_139e54bc-fd30-b1f4-e063-6394a90ae0d5","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20210910","","ANDA","ANDA065211","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7373","CEFIXIME","CEFIXIME","70518322104","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3221","70518-3221-4","70518-3221_230bbad3-0bb4-37f5-e063-6394a90ab3e3","HUMAN PRESCRIPTION DRUG","CEFIXIME","","CAPSULE","ORAL","20210914","","NDA AUTHORIZED GENERIC","NDA203195","REMEDYREPACK INC.","400","mg/1","","N","20251231"
"7374","CEFIXIME","CEFIXIME","70518322102","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3221","70518-3221-2","70518-3221_230bbad3-0bb4-37f5-e063-6394a90ab3e3","HUMAN PRESCRIPTION DRUG","CEFIXIME","","CAPSULE","ORAL","20210914","","NDA AUTHORIZED GENERIC","NDA203195","REMEDYREPACK INC.","400","mg/1","","N","20251231"
"7375","AMOXICILLIN","Amoxicillin","70518323403","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-3234","70518-3234-3","70518-3234_26f44925-5333-8a6e-e063-6394a90a0394","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20211011","","ANDA","ANDA061926","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7376","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","70518324900","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3249","70518-3249-0","70518-3249_13a05257-afa8-43c1-e063-6294a90ac267","HUMAN PRESCRIPTION DRUG","Azithromycin dihydrate","","TABLET, FILM COATED","ORAL","20211018","","ANDA","ANDA207566","REMEDYREPACK INC.","600","mg/1","","N","20251231"
"7377","AZITHROMYCIN DIHYDRATE","Azithromycin","70518325401","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3254","70518-3254-1","70518-3254_30275089-d967-7dd8-e063-6294a90adb10","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20211023","","ANDA","ANDA211792","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7378","AZITHROMYCIN DIHYDRATE","Azithromycin","70518325402","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3254","70518-3254-2","70518-3254_30275089-d967-7dd8-e063-6294a90adb10","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20211023","","ANDA","ANDA211792","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7379","AZITHROMYCIN DIHYDRATE","Azithromycin","70518325404","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3254","70518-3254-4","70518-3254_30275089-d967-7dd8-e063-6294a90adb10","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20211023","","ANDA","ANDA211792","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7380","AZITHROMYCIN DIHYDRATE","Azithromycin","70518325400","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3254","70518-3254-0","70518-3254_30275089-d967-7dd8-e063-6294a90adb10","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20211023","","ANDA","ANDA211792","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7381","METRONIDAZOLE","METRONIDAZOLE","70518326500","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-3265","70518-3265-0","70518-3265_23572d81-eb00-41e9-e063-6394a90a8d9b","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20211108","","ANDA","ANDA205245","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7382","METRONIDAZOLE","METRONIDAZOLE","70518326503","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-3265","70518-3265-3","70518-3265_23572d81-eb00-41e9-e063-6394a90a8d9b","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20211108","","ANDA","ANDA205245","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7383","AMOXICILLIN","Amoxicillin","70518329401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-3294","70518-3294-1","70518-3294_31dfba6a-7fe0-406d-e063-6294a90af41e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20211214","","ANDA","ANDA065271","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7384","AMOXICILLIN","Amoxicillin","70518329405","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-3294","70518-3294-5","70518-3294_31dfba6a-7fe0-406d-e063-6294a90af41e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20211214","","ANDA","ANDA065271","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7385","AMOXICILLIN","Amoxicillin","70518329403","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-3294","70518-3294-3","70518-3294_31dfba6a-7fe0-406d-e063-6294a90af41e","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20211214","","ANDA","ANDA065271","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7386","FLUCONAZOLE","Fluconazole","70518331200","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70518-3312","70518-3312-0","70518-3312_16da0dd0-1c41-5c39-e063-6294a90ad119","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20211227","","ANDA","ANDA077253","REMEDYREPACK INC.","50","mg/1","","N","20251231"
"7387","CEPHALEXIN","Cephalexin","70518336200","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3362","70518-3362-0","70518-3362_0f108413-febc-dfe1-e063-6394a90a6186","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20220208","","ANDA","ANDA062702","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7388","CEPHALEXIN","Cephalexin","70518336201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3362","70518-3362-1","70518-3362_0f108413-febc-dfe1-e063-6394a90a6186","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20220208","","ANDA","ANDA062702","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7389","CEPHALEXIN","Cephalexin","70518336203","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3362","70518-3362-3","70518-3362_0f108413-febc-dfe1-e063-6394a90a6186","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20220208","","ANDA","ANDA062702","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7390","CEPHALEXIN","Cephalexin","70518337803","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3378","70518-3378-3","70518-3378_29f64df4-dfa1-6396-e063-6394a90a0d1f","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20220308","","ANDA","ANDA090836","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7391","CEPHALEXIN","Cephalexin","70518337800","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3378","70518-3378-0","70518-3378_29f64df4-dfa1-6396-e063-6394a90a0d1f","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20220308","","ANDA","ANDA090836","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7392","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518343201","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-3432","70518-3432-1","70518-3432_26fa4a7f-7495-0496-e063-6394a90a2bdc","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20220608","","ANDA","ANDA090624","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20251231"
"7393","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518343203","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-3432","70518-3432-3","70518-3432_26fa4a7f-7495-0496-e063-6394a90a2bdc","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20220608","","ANDA","ANDA090624","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20251231"
"7394","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518343205","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-3432","70518-3432-5","70518-3432_26fa4a7f-7495-0496-e063-6394a90a2bdc","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20220608","","ANDA","ANDA090624","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20251231"
"7395","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518343204","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-3432","70518-3432-4","70518-3432_26fa4a7f-7495-0496-e063-6394a90a2bdc","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20220608","","ANDA","ANDA090624","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20251231"
"7396","PENICILLIN V POTASSIUM","Penicillin V Potassium","70518344105","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-3441","70518-3441-5","70518-3441_37ffeeb6-953b-3e8d-e063-6394a90a56d7","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20220622","","ANDA","ANDA090549","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7397","PENICILLIN V POTASSIUM","Penicillin V Potassium","70518344102","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-3441","70518-3441-2","70518-3441_37ffeeb6-953b-3e8d-e063-6394a90a56d7","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20220622","","ANDA","ANDA090549","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7398","CEPHALEXIN","Cephalexin","70518344802","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3448","70518-3448-2","70518-3448_23a7faf4-8b37-5c08-e063-6394a90a1914","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210721","","ANDA","ANDA065229","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7399","CEPHALEXIN","Cephalexin","70518344803","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3448","70518-3448-3","70518-3448_23a7faf4-8b37-5c08-e063-6394a90a1914","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210721","","ANDA","ANDA065229","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7400","CEPHALEXIN","Cephalexin","70518344804","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3448","70518-3448-4","70518-3448_23a7faf4-8b37-5c08-e063-6394a90a1914","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210721","","ANDA","ANDA065229","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7401","CEPHALEXIN","Cephalexin","70518344806","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3448","70518-3448-6","70518-3448_23a7faf4-8b37-5c08-e063-6394a90a1914","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210721","","ANDA","ANDA065229","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7402","CEPHALEXIN","Cephalexin","70518344807","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3448","70518-3448-7","70518-3448_23a7faf4-8b37-5c08-e063-6394a90a1914","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210721","","ANDA","ANDA065229","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7403","CEPHALEXIN","Cephalexin","70518344805","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3448","70518-3448-5","70518-3448_23a7faf4-8b37-5c08-e063-6394a90a1914","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210721","","ANDA","ANDA065229","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7404","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70518345402","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-3454","70518-3454-2","70518-3454_24fc71ef-43db-a9e2-e063-6394a90a32b6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20220718","","ANDA","ANDA090624","REMEDYREPACK INC.","400; 80","mg/1; mg/1","","N","20251231"
"7405","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","70518350100","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3501","70518-3501-0","70518-3501_23fb508d-af6c-1f44-e063-6394a90a20db","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20220829","","ANDA","ANDA208250","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7406","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","70518350103","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3501","70518-3501-3","70518-3501_23fb508d-af6c-1f44-e063-6394a90a20db","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20220829","","ANDA","ANDA208250","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7407","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","70518350104","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3501","70518-3501-4","70518-3501_23fb508d-af6c-1f44-e063-6394a90a20db","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20220829","","ANDA","ANDA208250","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7408","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","70518350101","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3501","70518-3501-1","70518-3501_23fb508d-af6c-1f44-e063-6394a90a20db","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20220829","","ANDA","ANDA208250","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7409","AZITHROMYCIN DIHYDRATE","Azithromycin","70518350800","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3508","70518-3508-0","70518-3508_2640fd60-03df-fddf-e063-6294a90aa5e5","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20220905","","ANDA","ANDA207398","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7410","OFLOXACIN","Ofloxacin","70518357300","Quinolone Antimicrobial [EPC], Quinolones [CS]","70518-3573","70518-3573-0","70518-3573_0f007c74-9634-e0d5-e063-6294a90a3adc","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20221107","","ANDA","ANDA076622","REMEDYREPACK INC.","3","mg/mL","","N","20251231"
"7411","CEFADROXIL","Cefadroxil","70518358001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3580","70518-3580-1","70518-3580_0f00a62f-949b-ec14-e063-6394a90ac5e7","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20221122","","ANDA","ANDA065392","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7412","CEFADROXIL","Cefadroxil","70518358000","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3580","70518-3580-0","70518-3580_0f00a62f-949b-ec14-e063-6394a90ac5e7","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20221122","","ANDA","ANDA065392","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7413","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518362403","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-3624","70518-3624-3","70518-3624_304db758-37e4-4402-e063-6294a90ad22e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20230127","","ANDA","ANDA065063","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7414","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518362402","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-3624","70518-3624-2","70518-3624_304db758-37e4-4402-e063-6294a90ad22e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20230127","","ANDA","ANDA065063","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7415","GENTAMICIN SULFATE","GENTAMICIN SULFATE","70518362802","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","70518-3628","70518-3628-2","70518-3628_241fff7b-ebec-5b7e-e063-6394a90adacc","HUMAN PRESCRIPTION DRUG","Gentamicin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20230130","","ANDA","ANDA062366","REMEDYREPACK INC.","40","mg/mL","","N","20251231"
"7416","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518367602","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-3676","70518-3676-2","70518-3676_37eef47c-9b7f-9690-e063-6394a90ae1dc","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20230315","","ANDA","ANDA091568","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7417","OFLOXACIN","ofloxacin","70518371000","Quinolone Antimicrobial [EPC], Quinolones [CS]","70518-3710","70518-3710-0","70518-3710_2bd8162d-c80f-6496-e063-6294a90a6312","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20230411","","ANDA","ANDA215886","REMEDYREPACK INC.","3","mg/mL","","N","20261231"
"7418","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","70518371700","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","70518-3717","70518-3717-0","70518-3717_14b8a601-f175-e97f-e063-6394a90ad3a0","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20230418","","ANDA","ANDA208516","REMEDYREPACK INC.","25; 75","mg/1; mg/1","","N","20251231"
"7419","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","70518371701","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","70518-3717","70518-3717-1","70518-3717_14b8a601-f175-e97f-e063-6394a90ad3a0","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20230418","","ANDA","ANDA208516","REMEDYREPACK INC.","25; 75","mg/1; mg/1","","N","20251231"
"7420","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","70518371702","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","70518-3717","70518-3717-2","70518-3717_14b8a601-f175-e97f-e063-6394a90ad3a0","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20230418","","ANDA","ANDA208516","REMEDYREPACK INC.","25; 75","mg/1; mg/1","","N","20251231"
"7421","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","70518371703","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","70518-3717","70518-3717-3","70518-3717_14b8a601-f175-e97f-e063-6394a90ad3a0","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20230418","","ANDA","ANDA208516","REMEDYREPACK INC.","25; 75","mg/1; mg/1","","N","20251231"
"7422","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","70518372302","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3723","70518-3723-2","70518-3723_37c3f70d-0dd3-f2ba-e063-6294a90a301a","HUMAN PRESCRIPTION DRUG","azithromycin dihydrate","","TABLET, FILM COATED","ORAL","20230425","20260630","ANDA","ANDA065399","REMEDYREPACK INC.","500","mg/1","","N",""
"7423","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","70518372300","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-3723","70518-3723-0","70518-3723_37c3f70d-0dd3-f2ba-e063-6294a90a301a","HUMAN PRESCRIPTION DRUG","azithromycin dihydrate","","TABLET, FILM COATED","ORAL","20230425","20260630","ANDA","ANDA065399","REMEDYREPACK INC.","500","mg/1","","N",""
"7424","MOXIFLOXACIN HYDROCHLORIDE","moxifloxacin hydrochloride","70518373800","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-3738","70518-3738-0","70518-3738_2df857ca-ebf3-d2de-e063-6294a90ae295","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN HYDROCHLORIDE","","TABLET, FILM COATED","ORAL","20230530","","ANDA","ANDA202632","REMEDYREPACK INC.","400","mg/1","","N","20261231"
"7425","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","70518377200","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70518-3772","70518-3772-0","70518-3772_27d41098-01e1-cf19-e063-6394a90ac686","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230621","","ANDA","ANDA216957","REMEDYREPACK INC.","300","mg/1","","N","20251231"
"7426","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","70518377201","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70518-3772","70518-3772-1","70518-3772_27d41098-01e1-cf19-e063-6394a90ac686","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230621","","ANDA","ANDA216957","REMEDYREPACK INC.","300","mg/1","","N","20251231"
"7427","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","70518377202","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70518-3772","70518-3772-2","70518-3772_27d41098-01e1-cf19-e063-6394a90ac686","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230621","","ANDA","ANDA216957","REMEDYREPACK INC.","300","mg/1","","N","20251231"
"7428","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","70518377204","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70518-3772","70518-3772-4","70518-3772_27d41098-01e1-cf19-e063-6394a90ac686","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230621","","ANDA","ANDA216957","REMEDYREPACK INC.","300","mg/1","","N","20251231"
"7429","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","70518377203","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70518-3772","70518-3772-3","70518-3772_27d41098-01e1-cf19-e063-6394a90ac686","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230621","","ANDA","ANDA216957","REMEDYREPACK INC.","300","mg/1","","N","20251231"
"7430","MUPIROCIN CALCIUM","Mupirocin Calcium","70518377400","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","70518-3774","70518-3774-0","70518-3774_14cdd807-f7ff-4766-e063-6394a90ac942","HUMAN PRESCRIPTION DRUG","Mupirocin","","CREAM","TOPICAL","20230622","","ANDA","ANDA207116","REMEDYREPACK INC.","20","mg/g","","N","20251231"
"7431","GENTAMICIN SULFATE","Gentamicin Sulfate","70518378500","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","70518-3785","70518-3785-0","70518-3785_27d44d67-3879-649d-e063-6394a90ac64c","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","SOLUTION/ DROPS","OPHTHALMIC","20230711","","ANDA","ANDA064048","REMEDYREPACK INC.","3","mg/mL","","N","20251231"
"7432","NITROFURANTOIN","nitrofurantoin macrocrystals","70518382700","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70518-3827","70518-3827-0","70518-3827_2d68b0e8-32f4-5634-e063-6294a90a3dad","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230812","","ANDA","ANDA217272","REMEDYREPACK INC.","100","mg/1","","N","20261231"
"7433","NITROFURANTOIN","nitrofurantoin macrocrystals","70518382701","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70518-3827","70518-3827-1","70518-3827_2d68b0e8-32f4-5634-e063-6294a90a3dad","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230812","","ANDA","ANDA217272","REMEDYREPACK INC.","100","mg/1","","N","20261231"
"7434","NITROFURANTOIN","nitrofurantoin macrocrystals","70518382702","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70518-3827","70518-3827-2","70518-3827_2d68b0e8-32f4-5634-e063-6294a90a3dad","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230812","","ANDA","ANDA217272","REMEDYREPACK INC.","100","mg/1","","N","20261231"
"7435","AMOXICILLIN","Amoxicillin","70518383201","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-3832","70518-3832-1","70518-3832_2c37a243-d3c8-d88f-e063-6394a90adc58","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20230816","","ANDA","ANDA065271","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7436","CEFADROXIL","Cefadroxil","70518383401","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3834","70518-3834-1","70518-3834_249bcb78-ccc5-0d88-e063-6394a90aa1e2","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20230818","","ANDA","ANDA065352","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7437","OFLOXACIN","ofloxacin","70518384200","Quinolone Antimicrobial [EPC], Quinolones [CS]","70518-3842","70518-3842-0","70518-3842_150e0445-802e-4451-e063-6394a90a65c7","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20230823","","ANDA","ANDA076513","REMEDYREPACK INC.","3","mg/mL","","N","20251231"
"7438","CEPHALEXIN","Cephalexin","70518385700","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3857","70518-3857-0","70518-3857_249bf86a-42a1-7b60-e063-6394a90a678e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20230907","","ANDA","ANDA065229","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7439","CEPHALEXIN","Cephalexin","70518385703","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3857","70518-3857-3","70518-3857_249bf86a-42a1-7b60-e063-6394a90a678e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20230907","","ANDA","ANDA065229","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7440","CEPHALEXIN","Cephalexin","70518385702","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3857","70518-3857-2","70518-3857_249bf86a-42a1-7b60-e063-6394a90a678e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20230907","","ANDA","ANDA065229","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7441","AMOXICILLIN","Amoxicillin","70518388600","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-3886","70518-3886-0","70518-3886_308b0927-910e-fecd-e063-6294a90a4e01","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20231005","","ANDA","ANDA065256","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7442","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","70518388700","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-3887","70518-3887-0","70518-3887_15214774-310b-fcac-e063-6294a90a6850","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20231007","","ANDA","ANDA076558","REMEDYREPACK INC.","750","mg/1","","N","20251231"
"7443","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","clindamycin and benzoyl peroxide","70518389200","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70518-3892","70518-3892-0","70518-3892_1530cf11-a6a8-2bef-e063-6394a90a472e","HUMAN PRESCRIPTION DRUG","clindamycin and benzoyl peroxide","","GEL","TOPICAL","20231011","","ANDA","ANDA209252","REMEDYREPACK INC.","50; 10","mg/g; mg/g","","N","20251231"
"7444","FLUCONAZOLE","Fluconazole","70518390100","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70518-3901","70518-3901-0","70518-3901_28721dcc-6684-22f9-e063-6394a90a4a3f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20231018","","ANDA","ANDA078423","REMEDYREPACK INC.","100","mg/1","","N","20251231"
"7445","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","70518390700","Allylamine Antifungal [EPC], Allylamine [CS]","70518-3907","70518-3907-0","70518-3907_18078ab5-cca7-f47b-e063-6394a90a1c06","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20231103","","ANDA","ANDA078163","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7446","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","70518390702","Allylamine Antifungal [EPC], Allylamine [CS]","70518-3907","70518-3907-2","70518-3907_18078ab5-cca7-f47b-e063-6394a90a1c06","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20231103","","ANDA","ANDA078163","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7447","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","70518390701","Allylamine Antifungal [EPC], Allylamine [CS]","70518-3907","70518-3907-1","70518-3907_18078ab5-cca7-f47b-e063-6394a90a1c06","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20231103","","ANDA","ANDA078163","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7448","AMOXICILLIN","Amoxicillin","70518391403","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-3914","70518-3914-3","70518-3914_36c4ee93-0ce7-97f6-e063-6394a90ab7a5","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20231113","","ANDA","ANDA064076","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7449","AMOXICILLIN","Amoxicillin","70518391404","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-3914","70518-3914-4","70518-3914_36c4ee93-0ce7-97f6-e063-6394a90ab7a5","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20231113","","ANDA","ANDA064076","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7450","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","70518391601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-3916","70518-3916-1","70518-3916_153314f7-4d74-071e-e063-6394a90a347c","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20231117","","ANDA","ANDA203702","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7451","FLUCONAZOLE","Fluconazole","70518391800","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70518-3918","70518-3918-0","70518-3918_28737c50-21b8-5ae0-e063-6294a90ab853","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20231120","","ANDA","ANDA078423","REMEDYREPACK INC.","200","mg/1","","N","20251231"
"7452","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","70518391900","Allylamine Antifungal [EPC], Allylamine [CS]","70518-3919","70518-3919-0","70518-3919_1dd706c7-f618-41b0-e063-6294a90a177a","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20231120","","ANDA","ANDA078297","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7453","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","70518391901","Allylamine Antifungal [EPC], Allylamine [CS]","70518-3919","70518-3919-1","70518-3919_1dd706c7-f618-41b0-e063-6294a90a177a","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20231120","","ANDA","ANDA078297","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7454","FLUCONAZOLE","Fluconazole","70518392400","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70518-3924","70518-3924-0","70518-3924_1dd74521-2a70-a7e3-e063-6394a90a4104","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20231124","","ANDA","ANDA076658","REMEDYREPACK INC.","200","mg/1","","N","20251231"
"7455","OFLOXACIN","ofloxacin otic","70518398400","Quinolone Antimicrobial [EPC], Quinolones [CS]","70518-3984","70518-3984-0","70518-3984_0f1043b7-18c2-cb34-e063-6394a90a7d68","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION","AURICULAR (OTIC)","20240114","","ANDA","ANDA216130","REMEDYREPACK INC.","3","mg/mL","","N","20251231"
"7456","DEXAMETHASONE; TOBRAMYCIN","Tobramycin and Dexamethasone","70518399400","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","70518-3994","70518-3994-0","70518-3994_374b9715-4615-7948-e063-6294a90a40a3","HUMAN PRESCRIPTION DRUG","Tobramycin and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","20240124","","NDA AUTHORIZED GENERIC","NDA050592","REMEDYREPACK INC.","1; 3","mg/mL; mg/mL","","N","20261231"
"7457","FLUCONAZOLE","Fluconazole","70518402000","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70518-4020","70518-4020-0","70518-4020_287620c1-a366-cc5d-e063-6394a90a5db8","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20240212","","ANDA","ANDA077731","REMEDYREPACK INC.","200","mg/1","","N","20251231"
"7458","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","70518402600","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","70518-4026","70518-4026-0","70518-4026_314138f8-3f04-930b-e063-6394a90a37fd","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20240221","","ANDA","ANDA217357","REMEDYREPACK INC.","25; 75","mg/1; mg/1","","N","20261231"
"7459","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","70518402602","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","70518-4026","70518-4026-2","70518-4026_314138f8-3f04-930b-e063-6394a90a37fd","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20240221","","ANDA","ANDA217357","REMEDYREPACK INC.","25; 75","mg/1; mg/1","","N","20261231"
"7460","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","70518402603","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","70518-4026","70518-4026-3","70518-4026_314138f8-3f04-930b-e063-6394a90a37fd","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20240221","","ANDA","ANDA217357","REMEDYREPACK INC.","25; 75","mg/1; mg/1","","N","20261231"
"7461","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","70518402601","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","70518-4026","70518-4026-1","70518-4026_314138f8-3f04-930b-e063-6394a90a37fd","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20240221","","ANDA","ANDA217357","REMEDYREPACK INC.","25; 75","mg/1; mg/1","","N","20261231"
"7462","LINEZOLID","Linezolid","70518403400","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","70518-4034","70518-4034-0","70518-4034_1e02de3c-2784-f835-e063-6294a90a0b5b","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20240508","","ANDA","ANDA205517","REMEDYREPACK INC.","600","mg/1","","N","20251231"
"7463","CLOTRIMAZOLE","Clotrimazole","70518403700","Azole Antifungal [EPC], Azoles [CS]","70518-4037","70518-4037-0","70518-4037_13b4d950-642a-6fb8-e063-6394a90a9b26","HUMAN PRESCRIPTION DRUG","Clotrimazole","","CREAM","TOPICAL","20240315","","ANDA","ANDA072640","REMEDYREPACK INC.","10","mg/g","","N","20251231"
"7464","SULFAMETHOXAZOLE; TRIMETHOPRIM","sulfamethoxazole and Trimethoprim","70518404300","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-4043","70518-4043-0","70518-4043_1e1224e5-fd90-8a2b-e063-6294a90a0972","HUMAN PRESCRIPTION DRUG","Bactrim DS","","TABLET","ORAL","20240402","","NDA","NDA017377","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20251231"
"7465","SULFAMETHOXAZOLE; TRIMETHOPRIM","sulfamethoxazole and Trimethoprim","70518404301","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70518-4043","70518-4043-1","70518-4043_1e1224e5-fd90-8a2b-e063-6294a90a0972","HUMAN PRESCRIPTION DRUG","Bactrim DS","","TABLET","ORAL","20240402","","NDA","NDA017377","REMEDYREPACK INC.","800; 160","mg/1; mg/1","","N","20251231"
"7466","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","70518410500","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-4105","70518-4105-0","70518-4105_1b17a5d5-7aca-a9bd-e063-6394a90a5d57","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240617","","ANDA","ANDA208249","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7467","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","70518413300","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-4133","70518-4133-0","70518-4133_23f69bd2-bee0-fabe-e063-6394a90a0d1a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20240703","","ANDA","ANDA208921","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7468","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","70518413301","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-4133","70518-4133-1","70518-4133_23f69bd2-bee0-fabe-e063-6394a90a0d1a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20240703","","ANDA","ANDA208921","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7469","OFLOXACIN","ofloxacin otic","70518414700","Quinolone Antimicrobial [EPC], Quinolones [CS]","70518-4147","70518-4147-0","70518-4147_1dedb690-d035-3544-e063-6294a90adf7f","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION","AURICULAR (OTIC)","20240722","","ANDA","ANDA216130","REMEDYREPACK INC.","3","mg/mL","","N","20251231"
"7470","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518414802","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-4148","70518-4148-2","70518-4148_348b0d24-a89c-3f4e-e063-6394a90a183d","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20240725","","ANDA","ANDA203824","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7471","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518414803","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-4148","70518-4148-3","70518-4148_348b0d24-a89c-3f4e-e063-6394a90a183d","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20240725","","ANDA","ANDA203824","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7472","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518414804","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-4148","70518-4148-4","70518-4148_348b0d24-a89c-3f4e-e063-6394a90a183d","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20240725","","ANDA","ANDA203824","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7473","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70518414800","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70518-4148","70518-4148-0","70518-4148_348b0d24-a89c-3f4e-e063-6394a90a183d","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20240725","","ANDA","ANDA203824","REMEDYREPACK INC.","875; 125","mg/1; mg/1","","N","20261231"
"7474","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","70518416000","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-4160","70518-4160-0","70518-4160_25899453-4d6d-fe0f-e063-6394a90a279a","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240815","","ANDA","ANDA208250","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7475","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","70518416001","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-4160","70518-4160-1","70518-4160_25899453-4d6d-fe0f-e063-6394a90a279a","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240815","","ANDA","ANDA208250","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7476","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","70518416002","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-4160","70518-4160-2","70518-4160_25899453-4d6d-fe0f-e063-6394a90a279a","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240815","","ANDA","ANDA208250","REMEDYREPACK INC.","250","mg/1","","N","20251231"
"7477","CEFDINIR","Cefdinir","70518416901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-4169","70518-4169-1","70518-4169_30387bb7-762a-175d-e063-6394a90a5ccf","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20240827","","ANDA","ANDA210220","REMEDYREPACK INC.","300","mg/1","","N","20261231"
"7478","CEFDINIR","Cefdinir","70518416902","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-4169","70518-4169-2","70518-4169_30387bb7-762a-175d-e063-6394a90a5ccf","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20240827","","ANDA","ANDA210220","REMEDYREPACK INC.","300","mg/1","","N","20261231"
"7479","CEFDINIR","Cefdinir","70518416900","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-4169","70518-4169-0","70518-4169_30387bb7-762a-175d-e063-6394a90a5ccf","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20240827","","ANDA","ANDA210220","REMEDYREPACK INC.","300","mg/1","","N","20261231"
"7480","TINIDAZOLE","Tinidazole","70518417200","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-4172","70518-4172-0","70518-4172_214c8c23-6187-cc09-e063-6394a90a0293","HUMAN PRESCRIPTION DRUG","Tindazole","","TABLET, FILM COATED","ORAL","20240830","","ANDA","ANDA202489","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7481","TINIDAZOLE","Tinidazole","70518417201","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70518-4172","70518-4172-1","70518-4172_214c8c23-6187-cc09-e063-6394a90a0293","HUMAN PRESCRIPTION DRUG","Tindazole","","TABLET, FILM COATED","ORAL","20240830","","ANDA","ANDA202489","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7482","FLUCONAZOLE","Fluconazole","70518419300","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70518-4193","70518-4193-0","70518-4193_236a71a1-a006-3fab-e063-6394a90a269b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20240930","","ANDA","ANDA077253","REMEDYREPACK INC.","100","mg/1","","N","20251231"
"7483","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","70518420200","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-4202","70518-4202-0","70518-4202_23817c4d-fd8c-c21f-e063-6394a90a2d40","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20241002","","ANDA","ANDA207566","REMEDYREPACK INC.","600","mg/1","","N","20251231"
"7484","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","70518421400","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-4214","70518-4214-0","70518-4214_26cb9ba7-31b0-014f-e063-6394a90addd6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20241015","","ANDA","ANDA077859","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7485","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","70518421401","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-4214","70518-4214-1","70518-4214_26cb9ba7-31b0-014f-e063-6394a90addd6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20241015","","ANDA","ANDA077859","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7486","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","70518421402","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-4214","70518-4214-2","70518-4214_26cb9ba7-31b0-014f-e063-6394a90addd6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20241015","","ANDA","ANDA077859","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7487","DICLOXACILLIN SODIUM","Dicloxacillin Sodium","70518421600","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-4216","70518-4216-0","70518-4216_24afee10-c922-605c-e063-6394a90a2626","HUMAN PRESCRIPTION DRUG","Dicloxacillin Sodium","","CAPSULE","ORAL","20241016","","ANDA","ANDA062286","REMEDYREPACK INC.","500","mg/1","","N","20251231"
"7488","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","70518421700","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","70518-4217","70518-4217-0","70518-4217_25897e93-2519-1f48-e063-6294a90af4ed","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20241021","","ANDA","ANDA075673","REMEDYREPACK INC.",".5; 10","mg/g; mg/g","","N","20251231"
"7489","OFLOXACIN","Ofloxacin","70518422600","Quinolone Antimicrobial [EPC], Quinolones [CS]","70518-4226","70518-4226-0","70518-4226_274646ec-c164-de7d-e063-6394a90a9d26","HUMAN PRESCRIPTION DRUG","Ofloxacin Otic","","SOLUTION","AURICULAR (OTIC)","20241031","","ANDA","ANDA076527","REMEDYREPACK INC.","3","mg/mL","","N","20251231"
"7490","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","70518422900","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-4229","70518-4229-0","70518-4229_35bc0e88-2cf8-2f6f-e063-6394a90a8ea0","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20241111","","ANDA","ANDA208921","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7491","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","70518422902","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-4229","70518-4229-2","70518-4229_35bc0e88-2cf8-2f6f-e063-6394a90a8ea0","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20241111","","ANDA","ANDA208921","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7492","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","70518422903","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-4229","70518-4229-3","70518-4229_35bc0e88-2cf8-2f6f-e063-6394a90a8ea0","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20241111","","ANDA","ANDA208921","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7493","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","70518422904","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-4229","70518-4229-4","70518-4229_35bc0e88-2cf8-2f6f-e063-6394a90a8ea0","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20241111","","ANDA","ANDA208921","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7494","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","70518422901","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-4229","70518-4229-1","70518-4229_35bc0e88-2cf8-2f6f-e063-6394a90a8ea0","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20241111","","ANDA","ANDA208921","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7495","KETOCONAZOLE","Ketoconazole Cream, 2%","70518423600","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","70518-4236","70518-4236-0","70518-4236_29022b89-2b78-2d7a-e063-6394a90a45b2","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20241205","","ANDA","ANDA212443","REMEDYREPACK INC.","20","mg/g","","N","20251231"
"7496","FLUCONAZOLE","Fluconazole","70518424200","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70518-4242","70518-4242-0","70518-4242_29b80fe3-9fd2-df9a-e063-6294a90ac9d2","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20241220","","ANDA","ANDA077731","REMEDYREPACK INC.","100","mg/1","","N","20251231"
"7497","NITROFURANTOIN","NITROFURANTOIN","70518424400","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70518-4244","70518-4244-0","70518-4244_29f43426-6add-fdf7-e063-6294a90adc20","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20241220","","ANDA","ANDA211935","REMEDYREPACK INC.","100","mg/1","","N","20251231"
"7498","CEPHALEXIN","Cephalexin","70518425001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-4250","70518-4250-1","70518-4250_31cc73c6-0d60-3ab3-e063-6294a90acede","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20241231","","ANDA","ANDA065253","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7499","CEPHALEXIN","Cephalexin","70518425002","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-4250","70518-4250-2","70518-4250_31cc73c6-0d60-3ab3-e063-6294a90acede","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20241231","","ANDA","ANDA065253","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7500","CEPHALEXIN","Cephalexin","70518425000","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70518-4250","70518-4250-0","70518-4250_31cc73c6-0d60-3ab3-e063-6294a90acede","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20241231","","ANDA","ANDA065253","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7501","AMOXICILLIN","Amoxicillin","70518427900","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-4279","70518-4279-0","70518-4279_2d800014-7753-ba1a-e063-6294a90ab9cb","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20250206","","ANDA","ANDA065291","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7502","PENICILLIN V POTASSIUM","Penicillin V Potassium","70518431000","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70518-4310","70518-4310-0","70518-4310_308aed94-a9ab-d601-e063-6294a90a42b4","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET","ORAL","20250314","","ANDA","ANDA060711","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7503","MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE","Moxifloxacin Hydrochloride Tablets, 400 mg","70518431200","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70518-4312","70518-4312-0","70518-4312_32e85992-b654-20db-e063-6394a90adcee","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride Tablets, 400 mg","","TABLET, FILM COATED","ORAL","20250318","","ANDA","ANDA208682","REMEDYREPACK INC.","400","mg/1","","N","20261231"
"7504","FLUCONAZOLE","Fluconazole","70518433200","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70518-4332","70518-4332-0","70518-4332_339c83ec-5296-2d93-e063-6394a90af4e6","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20250425","","ANDA","ANDA077253","REMEDYREPACK INC.","150","mg/1","","N","20261231"
"7505","FLUCONAZOLE","Fluconazole","70518433600","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70518-4336","70518-4336-0","70518-4336_3417721f-a8dd-16f4-e063-6394a90a3c27","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20250501","","ANDA","ANDA077731","REMEDYREPACK INC.","150","mg/1","","N","20261231"
"7506","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","70518435300","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70518-4353","70518-4353-0","70518-4353_36d817ce-4ed6-8645-e063-6294a90ae853","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20250605","","ANDA","ANDA216957","REMEDYREPACK INC.","150","mg/1","","N","20261231"
"7507","AZITHROMYCIN DIHYDRATE","azithromycin","70518435600","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-4356","70518-4356-0","70518-4356_3775cbf0-0d9a-dff6-e063-6394a90afc4a","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20250613","","ANDA","ANDA065398","REMEDYREPACK INC.","250","mg/1","","N","20261231"
"7508","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","70518435800","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","70518-4358","70518-4358-0","70518-4358_37c44afb-0143-270f-e063-6294a90a1871","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20250616","","ANDA","ANDA217357","REMEDYREPACK INC.","25; 75","mg/1; mg/1","","N","20261231"
"7509","AZITHROMYCIN DIHYDRATE","azithromycin","70518436700","Macrolide Antimicrobial [EPC], Macrolides [CS]","70518-4367","70518-4367-0","70518-4367_38030a84-49cd-d324-e063-6394a90a22b4","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20250620","","ANDA","ANDA065399","REMEDYREPACK INC.","500","mg/1","","N","20261231"
"7510","ADENOSINE TRIPHOSPHATE DISODIUM; ARTEMISIA CINA PRE-FLOWERING TOP; BACOPA MONNIERI WHOLE; DOPAMINE HYDROCHLORIDE; EQUOL, (+/-)-; GAMBOGE; IODINE; LYCOPODIUM CLAVATUM SPORE; OXYTOCIN; PANTOTHENIC ACID; PHOSPHORUS; QUININE SULFATE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SEDUM ROSEUM ROOT; SEROTONIN HYDROCHLORIDE; SUS SCROFA ADRENAL CORTEX; SUS SCROFA STOMACH; SUS SCROFA THYROID","Adenosinum Triphosphoricum Dinatrum, Adrenal Cortex (Suis), Bacopa Speciosa, Equol, Pantothenic Acid, Rhodiola, Stomach (Suis), Chininum Sulphuricum, Iodium, Lycopodium Clavatum, Phosphorous, Dopamine Hydrochloride, Thyroidinum (Suis), Cina, Serotonin (Hydrochloride), Oxytocin, Gambogia, Morgan Gaertner","70558000701","Antimalarial [EPC], Catecholamine [EPC], Catecholamines [CS], Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [CS]","70558-0007","70558-0007-1","70558-0007_cb6f98f6-6fd9-4868-953f-a5ab6dc2c6a9","HUMAN OTC DRUG","Hunger Control","","LIQUID","ORAL","20201012","","UNAPPROVED HOMEOPATHIC","","Pro Weight Loss Inc.","6; 8; 6; 8; 6; 14; 6; 6; 12; 6; 6; 6; 30; 6; 8; 6; 6; 8","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"7511","COLISTIMETHATE SODIUM","Colistimethate Sodium","70594002309","Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70594-023","70594-023-09","70594-023_ab4cbd6f-da57-4cb8-ae7f-5ae547b04b8a","HUMAN PRESCRIPTION DRUG","Colistimethate","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20181001","","ANDA","ANDA205356","Xellia Pharmaceuticals USA LLC","150","mg/1","","N","20251231"
"7512","COLISTIMETHATE SODIUM","Colistimethate Sodium","70594002304","Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70594-023","70594-023-04","70594-023_ab4cbd6f-da57-4cb8-ae7f-5ae547b04b8a","HUMAN PRESCRIPTION DRUG","Colistimethate","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20181001","","ANDA","ANDA205356","Xellia Pharmaceuticals USA LLC","150","mg/1","","N","20251231"
"7513","COLISTIMETHATE SODIUM","Colistimethate Sodium","70594002301","Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70594-023","70594-023-01","70594-023_ab4cbd6f-da57-4cb8-ae7f-5ae547b04b8a","HUMAN PRESCRIPTION DRUG","Colistimethate","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20181001","","ANDA","ANDA205356","Xellia Pharmaceuticals USA LLC","150","mg/1","","N","20251231"
"7514","DAPTOMYCIN","Daptomycin","70594003401","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","70594-034","70594-034-01","70594-034_32561d31-66ad-4616-970c-2a7f043b0d0e","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20181001","","ANDA","ANDA206005","Xellia Pharmaceuticals USA LLC","500","mg/10mL","","N","20251231"
"7515","DAPTOMYCIN","Daptomycin","70594003402","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","70594-034","70594-034-02","70594-034_32561d31-66ad-4616-970c-2a7f043b0d0e","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20181001","","ANDA","ANDA206005","Xellia Pharmaceuticals USA LLC","500","mg/10mL","","N","20251231"
"7516","MICAFUNGIN SODIUM","Micafungin Sodium","70594003601","Echinocandin Antifungal [EPC], Lipopeptides [CS]","70594-036","70594-036-01","70594-036_e26f3507-cb01-46d6-8fa4-c64588a71574","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210602","20251231","ANDA","ANDA211713","Xellia Pharmaceuticals USA LLC","10","mg/mL","","N",""
"7517","MICAFUNGIN SODIUM","Micafungin Sodium","70594003701","Echinocandin Antifungal [EPC], Lipopeptides [CS]","70594-037","70594-037-01","70594-037_e26f3507-cb01-46d6-8fa4-c64588a71574","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210602","20251231","ANDA","ANDA211713","Xellia Pharmaceuticals USA LLC","20","mg/mL","","N",""
"7518","VANCOMYCIN","Vancomycin","70594004102","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70594-041","70594-041-02","70594-041_e49b6589-caca-4c8f-8c57-55a1ee7774cc","HUMAN PRESCRIPTION DRUG","Vancomycin","","INJECTION, SOLUTION","INTRAVENOUS","20190215","","NDA","NDA211962","Xellia Pharmaceuticals USA LLC","500","mg/100mL","","N","20251231"
"7519","VANCOMYCIN","Vancomycin","70594004103","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70594-041","70594-041-03","70594-041_e49b6589-caca-4c8f-8c57-55a1ee7774cc","HUMAN PRESCRIPTION DRUG","Vancomycin","","INJECTION, SOLUTION","INTRAVENOUS","20190215","","NDA","NDA211962","Xellia Pharmaceuticals USA LLC","500","mg/100mL","","N","20251231"
"7520","VANCOMYCIN","Vancomycin","70594004203","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70594-042","70594-042-03","70594-042_e49b6589-caca-4c8f-8c57-55a1ee7774cc","HUMAN PRESCRIPTION DRUG","Vancomycin","","INJECTION, SOLUTION","INTRAVENOUS","20190215","","NDA","NDA211962","Xellia Pharmaceuticals USA LLC","1","g/200mL","","N","20251231"
"7521","VANCOMYCIN","Vancomycin","70594004202","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70594-042","70594-042-02","70594-042_e49b6589-caca-4c8f-8c57-55a1ee7774cc","HUMAN PRESCRIPTION DRUG","Vancomycin","","INJECTION, SOLUTION","INTRAVENOUS","20190215","","NDA","NDA211962","Xellia Pharmaceuticals USA LLC","1","g/200mL","","N","20251231"
"7522","VANCOMYCIN","Vancomycin","70594004302","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70594-043","70594-043-02","70594-043_e49b6589-caca-4c8f-8c57-55a1ee7774cc","HUMAN PRESCRIPTION DRUG","Vancomycin","","INJECTION, SOLUTION","INTRAVENOUS","20190215","","NDA","NDA211962","Xellia Pharmaceuticals USA LLC","1.5","g/300mL","","N","20251231"
"7523","VANCOMYCIN","Vancomycin","70594004402","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70594-044","70594-044-02","70594-044_e49b6589-caca-4c8f-8c57-55a1ee7774cc","HUMAN PRESCRIPTION DRUG","Vancomycin","","INJECTION, SOLUTION","INTRAVENOUS","20190215","","NDA","NDA211962","Xellia Pharmaceuticals USA LLC","2","g/400mL","","N","20251231"
"7524","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","70594004503","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70594-045","70594-045-03","70594-045_d0999ed3-4357-4df9-998a-6b6a0e9bba52","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20190128","","ANDA","ANDA204107","Xellia Pharmaceuticals USA LLC","500","mg/1","","N","20251231"
"7525","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","70594004602","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70594-046","70594-046-02","70594-046_d0999ed3-4357-4df9-998a-6b6a0e9bba52","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20181001","","ANDA","ANDA204107","Xellia Pharmaceuticals USA LLC","1","g/1","","N","20251231"
"7526","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","70594004701","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70594-047","70594-047-01","70594-047_97ab8feb-99b4-48f0-9cf0-72b81658e7ba","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190402","","ANDA","ANDA204125","Xellia Pharmaceuticals USA LLC","5","g/1","","N","20251231"
"7527","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","70594004801","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70594-048","70594-048-01","70594-048_97ab8feb-99b4-48f0-9cf0-72b81658e7ba","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20181001","","ANDA","ANDA204125","Xellia Pharmaceuticals USA LLC","10","g/1","","N","20251231"
"7528","POLYMYXIN B SULFATE","Polymyxin B Sulfate","70594004901","Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70594-049","70594-049-01","70594-049_28ae30e3-7830-4c3d-b507-de8723c79278","HUMAN PRESCRIPTION DRUG","Polymyxin B","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC","20181001","","ANDA","ANDA202766","Xellia Pharmaceuticals USA LLC","500000","[USP'U]/1","","N","20261231"
"7529","POLYMYXIN B SULFATE","Polymyxin B Sulfate","70594004902","Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70594-049","70594-049-02","70594-049_28ae30e3-7830-4c3d-b507-de8723c79278","HUMAN PRESCRIPTION DRUG","Polymyxin B","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC","20181001","","ANDA","ANDA202766","Xellia Pharmaceuticals USA LLC","500000","[USP'U]/1","","N","20261231"
"7530","DAPTOMYCIN","Daptomycin","70594005301","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","70594-053","70594-053-01","70594-053_08352c0c-9494-4a27-bc09-ec6a378df233","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190315","","NDA","NDA209949","Xellia Pharmaceuticals USA LLC","350","mg/7mL","","N","20251231"
"7531","VANCOMYCIN","Vancomycin","70594005602","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70594-056","70594-056-02","70594-056_e49b6589-caca-4c8f-8c57-55a1ee7774cc","HUMAN PRESCRIPTION DRUG","Vancomycin","","INJECTION, SOLUTION","INTRAVENOUS","20200513","","NDA","NDA211962","Xellia Pharmaceuticals USA LLC","750","mg/150mL","","N","20251231"
"7532","VANCOMYCIN","Vancomycin","70594005603","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70594-056","70594-056-03","70594-056_e49b6589-caca-4c8f-8c57-55a1ee7774cc","HUMAN PRESCRIPTION DRUG","Vancomycin","","INJECTION, SOLUTION","INTRAVENOUS","20200513","","NDA","NDA211962","Xellia Pharmaceuticals USA LLC","750","mg/150mL","","N","20251231"
"7533","VANCOMYCIN","Vancomycin","70594005702","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70594-057","70594-057-02","70594-057_e49b6589-caca-4c8f-8c57-55a1ee7774cc","HUMAN PRESCRIPTION DRUG","Vancomycin","","INJECTION, SOLUTION","INTRAVENOUS","20190223","","NDA","NDA211962","Xellia Pharmaceuticals USA LLC","1.25","g/250mL","","N","20251231"
"7534","VANCOMYCIN","Vancomycin","70594005802","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70594-058","70594-058-02","70594-058_e49b6589-caca-4c8f-8c57-55a1ee7774cc","HUMAN PRESCRIPTION DRUG","Vancomycin","","INJECTION, SOLUTION","INTRAVENOUS","20200513","","NDA","NDA211962","Xellia Pharmaceuticals USA LLC","1.75","g/350mL","","N","20251231"
"7535","DAPTOMYCIN","daptomycin","70594006001","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","70594-060","70594-060-01","70594-060_49c340b4-c825-4e34-adcf-f49be55ec2a6","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20231103","","NDA","NDA217415","Xellia Pharmaceuticals USA LLC","500","mg/10mL","","N","20251231"
"7536","DAPTOMYCIN","daptomycin","70594006601","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","70594-066","70594-066-01","70594-066_49c340b4-c825-4e34-adcf-f49be55ec2a6","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20231103","","NDA","NDA217415","Xellia Pharmaceuticals USA LLC","350","mg/7mL","","N","20251231"
"7537","VORICONAZOLE","Voriconazole","70594006701","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70594-067","70594-067-01","70594-067_794911b6-dd66-445a-b73d-5037552e0b94","HUMAN PRESCRIPTION DRUG","Voriconazole","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230824","","NDA","NDA208562","Xellia Pharmaceuticals USA LLC","10","mg/mL","","N","20251231"
"7538","MEROPENEM","MEROPENEM","70594007502","Carbapenems [CS], Penem Antibacterial [EPC]","70594-075","70594-075-02","70594-075_3ee484ef-4e7f-464a-ac2e-7963d9dc5df6","HUMAN PRESCRIPTION DRUG","MEROPENEM","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210628","","ANDA","ANDA206141","Xellia Pharmaceuticals USA LLC","500","mg/1","","N","20251231"
"7539","MEROPENEM","MEROPENEM","70594007602","Carbapenems [CS], Penem Antibacterial [EPC]","70594-076","70594-076-02","70594-076_3ee484ef-4e7f-464a-ac2e-7963d9dc5df6","HUMAN PRESCRIPTION DRUG","MEROPENEM","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210628","","ANDA","ANDA206141","Xellia Pharmaceuticals USA LLC","1","g/1","","N","20251231"
"7540","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN SODIUM and TAZOBACTAM SODIUM","70594007802","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70594-078","70594-078-02","70594-078_b2fac277-0a3b-47ff-90ca-a0a5c8ad993f","HUMAN PRESCRIPTION DRUG","PIPERACILLIN SODIUM and TAZOBACTAM SODIUM","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210110","20251231","ANDA","ANDA212287","Xellia Pharmaceuticals USA LLC","2; 250","g/50mL; mg/50mL","","N",""
"7541","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN SODIUM and TAZOBACTAM SODIUM","70594007902","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70594-079","70594-079-02","70594-079_b2fac277-0a3b-47ff-90ca-a0a5c8ad993f","HUMAN PRESCRIPTION DRUG","PIPERACILLIN SODIUM and TAZOBACTAM SODIUM","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210110","20251231","ANDA","ANDA212287","Xellia Pharmaceuticals USA LLC","3; 375","g/100mL; mg/100mL","","N",""
"7542","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","PIPERACILLIN SODIUM and TAZOBACTAM SODIUM","70594008002","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70594-080","70594-080-02","70594-080_b2fac277-0a3b-47ff-90ca-a0a5c8ad993f","HUMAN PRESCRIPTION DRUG","PIPERACILLIN SODIUM and TAZOBACTAM SODIUM","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210110","20251231","ANDA","ANDA212287","Xellia Pharmaceuticals USA LLC","4; 500","g/150mL; mg/150mL","","N",""
"7543","AMPICILLIN SODIUM; SULBACTAM SODIUM","AMPICILLIN SODIUM and SULBACTAM SODIUM","70594008102","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70594-081","70594-081-02","70594-081_ec431dfa-fe17-4e43-acf9-60eee408cc6b","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20210110","20251231","ANDA","ANDA090579","Xellia Pharmaceuticals USA LLC","1; .5","g/1; g/1","","N",""
"7544","AMPICILLIN SODIUM; SULBACTAM SODIUM","AMPICILLIN SODIUM and SULBACTAM SODIUM","70594008202","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70594-082","70594-082-02","70594-082_ec431dfa-fe17-4e43-acf9-60eee408cc6b","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20210110","20251231","ANDA","ANDA090579","Xellia Pharmaceuticals USA LLC","2; 1","g/1; g/1","","N",""
"7545","AMPICILLIN SODIUM; SULBACTAM SODIUM","AMPICILLIN SODIUM and SULBACTAM SODIUM","70594008301","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70594-083","70594-083-01","70594-083_a5ceb934-acf0-4be2-849d-473f3b4183d5","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20210110","20251231","ANDA","ANDA090578","Xellia Pharmaceuticals USA LLC","100; 50","mg/mL; mg/mL","","N",""
"7546","AMPICILLIN SODIUM","AMPICILLIN SODIUM","70594008402","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70594-084","70594-084-02","70594-084_03c0f1f1-0132-46ee-a71c-f5e77bd6131e","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210110","20251231","ANDA","ANDA090583","Xellia Pharmaceuticals USA LLC","250","mg/1","","N",""
"7547","AMPICILLIN SODIUM","AMPICILLIN SODIUM","70594008502","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70594-085","70594-085-02","70594-085_03c0f1f1-0132-46ee-a71c-f5e77bd6131e","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210110","20251231","ANDA","ANDA090583","Xellia Pharmaceuticals USA LLC","500","mg/1","","N",""
"7548","AMPICILLIN SODIUM","AMPICILLIN SODIUM","70594008602","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70594-086","70594-086-02","70594-086_03c0f1f1-0132-46ee-a71c-f5e77bd6131e","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210110","20251231","ANDA","ANDA090583","Xellia Pharmaceuticals USA LLC","1","g/1","","N",""
"7549","AMPICILLIN SODIUM","AMPICILLIN SODIUM","70594008702","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70594-087","70594-087-02","70594-087_03c0f1f1-0132-46ee-a71c-f5e77bd6131e","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210110","20251231","ANDA","ANDA090583","Xellia Pharmaceuticals USA LLC","2","g/1","","N",""
"7550","AMPICILLIN SODIUM","AMPICILLIN SODIUM","70594008801","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70594-088","70594-088-01","70594-088_a3afd568-b3ad-466d-b302-8f7470c05a7b","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210110","20251231","ANDA","ANDA090581","Xellia Pharmaceuticals USA LLC","10","g/1","","N",""
"7551","CEFEPIME HYDROCHLORIDE","CEFEPIME HYDROCHLORIDE","70594008902","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70594-089","70594-089-02","70594-089_c95e6247-9ce3-4376-b394-ac8c8009f495","HUMAN PRESCRIPTION DRUG","CEFEPIME HYDROCHLORIDE","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20210110","20251231","ANDA","ANDA212721","Xellia Pharmaceuticals USA LLC","1","g/1","","N",""
"7552","CEFEPIME HYDROCHLORIDE","CEFEPIME HYDROCHLORIDE","70594009002","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70594-090","70594-090-02","70594-090_c95e6247-9ce3-4376-b394-ac8c8009f495","HUMAN PRESCRIPTION DRUG","CEFEPIME HYDROCHLORIDE","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20210110","20251231","ANDA","ANDA212721","Xellia Pharmaceuticals USA LLC","2","g/1","","N",""
"7553","CEFTRIAXONE SODIUM","Ceftriaxone","70594009801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70594-098","70594-098-01","70594-098_6f9223ec-bdaa-40a0-8a27-329aa27a50a7","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20220106","20251231","ANDA","ANDA091117","Xellia Pharmaceuticals USA LLC","10","g/1","","N",""
"7554","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","70594012202","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70594-122","70594-122-02","70594-122_047a47f7-3fc4-4f77-aae1-a895c0f47e32","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20160223","","ANDA","ANDA205694","Xellia Pharmaceuticals USA LLC","500","mg/1","","N","20251231"
"7555","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","70594012302","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","70594-123","70594-123-02","70594-123_047a47f7-3fc4-4f77-aae1-a895c0f47e32","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20160223","","ANDA","ANDA205694","Xellia Pharmaceuticals USA LLC","1","g/1","","N","20251231"
"7556","TOBRAMYCIN","Tobramycin","70644089999","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","70644-899","70644-899-99","70644-899_aeeb7c89-484f-4429-a5d5-0025d19745fd","HUMAN PRESCRIPTION DRUG","Tobramycin","Inhalation Solution Pak","SOLUTION","RESPIRATORY (INHALATION)","20160711","","NDA AUTHORIZED GENERIC","NDA205433","Genericus, Inc.","300","mg/5mL","","N","20261231"
"7557","CLOTRIMAZOLE","CLOTRIMAZOLE","70673074701","Azole Antifungal [EPC], Azoles [CS]","70673-747","70673-747-01","70673-747_09d7805e-6556-5fa8-e063-6294a90ac4bb","HUMAN OTC DRUG","Smooth Gator Fungus Eliminator","","LIQUID","TOPICAL","20160429","","OTC MONOGRAPH DRUG","M005","Smooth Gator, LLC","10","mg/mL","","N","20251231"
"7558","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","70677001301","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70677-0013","70677-0013-1","70677-0013_23ada0bd-6502-5c78-e063-6394a90a641c","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","20251031","OTC MONOGRAPH DRUG","M004","Strategic Sourcing Services LLC","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N",""
"7559","MICONAZOLE NITRATE","Miconazole Nitrate","70677100001","Azole Antifungal [EPC], Azoles [CS]","70677-1000","70677-1000-1","70677-1000_262cc8d7-1e3e-31f0-e063-6294a90a4a58","HUMAN OTC DRUG","Miconazole Nitrate","","CREAM","TOPICAL","20230714","","OTC MONOGRAPH DRUG","M005","STRATEGIC SOURCING SERVICES LLC","20","mg/g","","N","20251231"
"7560","CLOTRIMAZOLE","Clotrimazole","70677100201","Azole Antifungal [EPC], Azoles [CS]","70677-1002","70677-1002-1","70677-1002_26b99a8e-bb1a-f2e8-e063-6394a90a963a","HUMAN OTC DRUG","Clotrimazole 1%","Athletes Foot","CREAM","TOPICAL","20230614","","OTC MONOGRAPH DRUG","M005","STRATEGIC SOURCING SERVICES LLC","10","mg/g","","N","20251231"
"7561","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","70677100301","Allylamine Antifungal [EPC], Allylamine [CS]","70677-1003","70677-1003-1","70677-1003_bc058e1f-e6b9-40d9-a65e-82a2df0d3fb7","HUMAN OTC DRUG","Terbinafine Hydrochloride","","CREAM","TOPICAL","20230630","","ANDA","ANDA077511","STRATEGIC SOURCING SERVICES LLC","1","g/100g","","N","20251231"
"7562","BACITRACIN ZINC; POLYMYXIN B SULFATE","Bacitracin Zinc and Polymyxin B Sulfate","70677121201","Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70677-1212","70677-1212-1","70677-1212_0df67729-d79f-2970-e063-6394a90aaad2","HUMAN OTC DRUG","Double Antibiotic","","OINTMENT","TOPICAL","20231215","","OTC MONOGRAPH DRUG","M004","STRATEGIC SOURCING SERVICES LLC","500; 10000","[USP'U]/g; [USP'U]/g","","N","20251231"
"7563","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, and polymyxin b sulfate","70677121701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70677-1217","70677-1217-1","70677-1217_fcb92f91-76f7-4f1c-9521-b7d99057cf54","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20240111","","OTC MONOGRAPH DRUG","M004","STRATEGIC SOURCING SERVICES LLC","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"7564","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","70677121801","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70677-1218","70677-1218-1","70677-1218_1006d5e8-fcc9-1c68-e063-6394a90a8613","HUMAN OTC DRUG","Antibiotic and Pain Relief","","CREAM","TOPICAL","20240124","","OTC MONOGRAPH DRUG","M017","STRATEGIC SOURCING SERVICES LLC","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"7565","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride","70677121901","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","70677-1219","70677-1219-1","70677-1219_105ce69f-dee7-12ae-e063-6294a90a4ff7","HUMAN OTC DRUG","Triple Antibiotic plus Pain Relief","","OINTMENT","TOPICAL","20240129","","OTC MONOGRAPH DRUG","M004","STRATEGIC SOURCING SERVICES LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"7566","MICONAZOLE NITRATE","Miconazole nitrate","70677122201","Azole Antifungal [EPC], Azoles [CS]","70677-1222","70677-1222-1","70677-1222_09c4f6c9-ba51-47f4-95b4-d236fa45778b","HUMAN OTC DRUG","foster and thrive miconazole","","CREAM","VAGINAL","20231025","","ANDA","ANDA074760","Strategic Sourcing Services LLC","2","g/100g","","N","20251231"
"7567","TIOCONAZOLE","Tioconazole","70677122401","Azole Antifungal [EPC], Azoles [CS]","70677-1224","70677-1224-1","70677-1224_daa1027d-de49-41dc-9d4d-9bbdd7b359c8","HUMAN OTC DRUG","foster and thrive tioconazole","","OINTMENT","VAGINAL","20231025","","ANDA","ANDA075915","Strategic Sourcing Services LLC","6.5","g/100g","","N","20251231"
"7568","MICONAZOLE NITRATE","Miconazole nitrate","70677122501","Azole Antifungal [EPC], Azoles [CS]","70677-1225","70677-1225-1","70677-1225_b06590b5-1dcf-47b7-8e81-5887b1c3893a","HUMAN OTC DRUG","foster and thrive miconazole 7","","CREAM","VAGINAL","20231105","","ANDA","ANDA074760","Strategic Sourcing Services LLC","2","g/100g","","N","20251231"
"7569","CLOTRIMAZOLE","Clotrimazole","70677122801","Azole Antifungal [EPC], Azoles [CS]","70677-1228","70677-1228-1","70677-1228_36c36551-dc1c-4736-b0e6-c53445a4b5fc","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","20230901","","ANDA","ANDA074165","Strategic Sourcing Services LLC","10","mg/g","","N","20251231"
"7570","CLOTRIMAZOLE","Clotrimazole","70677123101","Azole Antifungal [EPC], Azoles [CS]","70677-1231","70677-1231-1","70677-1231_0e7f63f6-45a5-0538-e063-6294a90a6324","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","20231005","","NDA","NDA021143","Foster and Thrive (Mckesson /STRATEGIC SOURCING SERVICES LLC)","2","g/100g","","N","20251231"
"7571","CLOTRIMAZOLE","Clotrimazole","70677126201","Azole Antifungal [EPC], Azoles [CS]","70677-1262","70677-1262-1","70677-1262_26fb17e7-2fc1-c208-e063-6294a90a1b61","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","20241107","","ANDA","ANDA072641","STRATEGIC SOURCING SERVICES LLC","1","g/100g","","N","20251231"
"7572","BUTENAFINE HYDROCHLORIDE","BUTENAFINE HYDROCHLORIDE","70677126901","Benzylamine Antifungal [EPC], Benzylamines [CS]","70677-1269","70677-1269-1","70677-1269_26dd3203-5b17-568e-e063-6394a90a2a50","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20241107","","ANDA","ANDA205181","STRATEGIC SOURCING SERVICES LLC","10","mg/g","","N","20251231"
"7573","KETOCONAZOLE","Ketoconazole Foam","70700016019","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","70700-160","70700-160-19","70700-160_1d2842b4-06d6-8054-d485-cb30f0ed4f69","HUMAN PRESCRIPTION DRUG","Ketoconazole","","AEROSOL, FOAM","TOPICAL","20210521","","ANDA","ANDA213601","Xiromed, LLC","20","mg/g","","N","20251231"
"7574","KETOCONAZOLE","Ketoconazole Foam","70700016020","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","70700-160","70700-160-20","70700-160_1d2842b4-06d6-8054-d485-cb30f0ed4f69","HUMAN PRESCRIPTION DRUG","Ketoconazole","","AEROSOL, FOAM","TOPICAL","20210521","","ANDA","ANDA213601","Xiromed, LLC","20","mg/g","","N","20251231"
"7575","NAFTIFINE HYDROCHLORIDE","Naftifine hydrochloride","70700016117","Allylamine Antifungal [EPC], Allylamine [CS]","70700-161","70700-161-17","70700-161_7ad13433-2f93-1881-5fe6-2e0630ac70fe","HUMAN PRESCRIPTION DRUG","Naftifine hydrochloride","","CREAM","TOPICAL","20210115","","ANDA","ANDA210038","Xiromed, LLC","20","mg/g","","N","20251231"
"7576","NAFTIFINE HYDROCHLORIDE","Naftifine hydrochloride","70700016118","Allylamine Antifungal [EPC], Allylamine [CS]","70700-161","70700-161-18","70700-161_7ad13433-2f93-1881-5fe6-2e0630ac70fe","HUMAN PRESCRIPTION DRUG","Naftifine hydrochloride","","CREAM","TOPICAL","20210115","","ANDA","ANDA210038","Xiromed, LLC","20","mg/g","","N","20251231"
"7577","TOBRAMYCIN SULFATE","Tobramycin","70700017386","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","70700-173","70700-173-86","70700-173_85d94342-3699-d4cb-69f5-391593a54ebe","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210712","","ANDA","ANDA211189","Xiromed LLC","1.2","g/30mL","","N","20251231"
"7578","ERYTHROMYCIN","Erythromycin","70710104701","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","70710-1047","70710-1047-1","70710-1047_98d365a7-fc2c-4602-aef6-a604c82252c7","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230630","","ANDA","ANDA212693","Zydus Pharmaceuticals USA Inc.","250","mg/1","","N","20251231"
"7579","ERYTHROMYCIN","Erythromycin","70710104705","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","70710-1047","70710-1047-5","70710-1047_98d365a7-fc2c-4602-aef6-a604c82252c7","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230630","","ANDA","ANDA212693","Zydus Pharmaceuticals USA Inc.","250","mg/1","","N","20251231"
"7580","ERYTHROMYCIN","Erythromycin","70710104703","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","70710-1047","70710-1047-3","70710-1047_98d365a7-fc2c-4602-aef6-a604c82252c7","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230630","","ANDA","ANDA212693","Zydus Pharmaceuticals USA Inc.","250","mg/1","","N","20251231"
"7581","ERYTHROMYCIN","Erythromycin","70710104801","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","70710-1048","70710-1048-1","70710-1048_98d365a7-fc2c-4602-aef6-a604c82252c7","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230630","","ANDA","ANDA212693","Zydus Pharmaceuticals USA Inc.","500","mg/1","","N","20251231"
"7582","ERYTHROMYCIN","Erythromycin","70710104803","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","70710-1048","70710-1048-3","70710-1048_98d365a7-fc2c-4602-aef6-a604c82252c7","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230630","","ANDA","ANDA212693","Zydus Pharmaceuticals USA Inc.","500","mg/1","","N","20251231"
"7583","ERYTHROMYCIN","Erythromycin","70710104805","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","70710-1048","70710-1048-5","70710-1048_98d365a7-fc2c-4602-aef6-a604c82252c7","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230630","","ANDA","ANDA212693","Zydus Pharmaceuticals USA Inc.","500","mg/1","","N","20251231"
"7584","FLUCONAZOLE","fluconazole","70710113703","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1137","70710-1137-3","70710-1137_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","50","mg/1","","N","20251231"
"7585","FLUCONAZOLE","fluconazole","70710113704","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1137","70710-1137-4","70710-1137_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","50","mg/1","","N","20251231"
"7586","FLUCONAZOLE","fluconazole","70710113705","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1137","70710-1137-5","70710-1137_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","50","mg/1","","N","20251231"
"7587","FLUCONAZOLE","fluconazole","70710113701","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1137","70710-1137-1","70710-1137_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","50","mg/1","","N","20251231"
"7588","FLUCONAZOLE","fluconazole","70710113803","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1138","70710-1138-3","70710-1138_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","100","mg/1","","N","20251231"
"7589","FLUCONAZOLE","fluconazole","70710113804","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1138","70710-1138-4","70710-1138_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","100","mg/1","","N","20251231"
"7590","FLUCONAZOLE","fluconazole","70710113805","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1138","70710-1138-5","70710-1138_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","100","mg/1","","N","20251231"
"7591","FLUCONAZOLE","fluconazole","70710113801","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1138","70710-1138-1","70710-1138_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","100","mg/1","","N","20251231"
"7592","FLUCONAZOLE","fluconazole","70710113901","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1139","70710-1139-1","70710-1139_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","150","mg/1","","N","20251231"
"7593","FLUCONAZOLE","fluconazole","70710113905","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1139","70710-1139-5","70710-1139_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","150","mg/1","","N","20251231"
"7594","FLUCONAZOLE","fluconazole","70710113907","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1139","70710-1139-7","70710-1139_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","150","mg/1","","N","20251231"
"7595","FLUCONAZOLE","fluconazole","70710113908","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1139","70710-1139-8","70710-1139_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","150","mg/1","","N","20251231"
"7596","FLUCONAZOLE","fluconazole","70710113903","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1139","70710-1139-3","70710-1139_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","150","mg/1","","N","20251231"
"7597","FLUCONAZOLE","fluconazole","70710114003","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1140","70710-1140-3","70710-1140_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","200","mg/1","","N","20251231"
"7598","FLUCONAZOLE","fluconazole","70710114004","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1140","70710-1140-4","70710-1140_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","200","mg/1","","N","20251231"
"7599","FLUCONAZOLE","fluconazole","70710114005","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1140","70710-1140-5","70710-1140_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","200","mg/1","","N","20251231"
"7600","FLUCONAZOLE","fluconazole","70710114001","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1140","70710-1140-1","70710-1140_e8f911c2-10c7-4e95-a696-cf5a29b912d6","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Pharmaceuticals (USA) Inc.","200","mg/1","","N","20251231"
"7601","VORICONAZOLE","voriconazole","70710124701","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70710-1247","70710-1247-1","70710-1247_63f99ef1-dd00-4375-8baa-a06c2de48686","HUMAN PRESCRIPTION DRUG","VORICONAZOLE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190103","","ANDA","ANDA208983","Zydus Pharmaceuticals USA Inc.","10","mg/mL","","N","20251231"
"7602","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate and Benzoyl Peroxide","70710144504","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70710-1445","70710-1445-4","70710-1445_96b1eb6c-b99b-4509-a8eb-424123aead6a","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Benzoyl Peroxide","","GEL","TOPICAL","20190307","","ANDA","ANDA210794","Zydus Pharmaceuticals USA Inc.","50; 10","mg/g; mg/g","","N","20251231"
"7603","AZITHROMYCIN DIHYDRATE","Azithromycin","70710145701","Macrolide Antimicrobial [EPC], Macrolides [CS]","70710-1457","70710-1457-1","70710-1457_6cf603d4-b79b-4a0a-906c-f1967a0db9a4","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20180806","","ANDA","ANDA211147","Zydus Pharmaceuticals USA Inc.","100","mg/5mL","","N","20261231"
"7604","AZITHROMYCIN DIHYDRATE","Azithromycin","70710145802","Macrolide Antimicrobial [EPC], Macrolides [CS]","70710-1458","70710-1458-2","70710-1458_6cf603d4-b79b-4a0a-906c-f1967a0db9a4","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20180806","","ANDA","ANDA211147","Zydus Pharmaceuticals USA Inc.","200","mg/5mL","","N","20261231"
"7605","AZITHROMYCIN DIHYDRATE","Azithromycin","70710145902","Macrolide Antimicrobial [EPC], Macrolides [CS]","70710-1459","70710-1459-2","70710-1459_6cf603d4-b79b-4a0a-906c-f1967a0db9a4","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20180806","","ANDA","ANDA211147","Zydus Pharmaceuticals USA Inc.","200","mg/5mL","","N","20261231"
"7606","AZITHROMYCIN DIHYDRATE","Azithromycin","70710146002","Macrolide Antimicrobial [EPC], Macrolides [CS]","70710-1460","70710-1460-2","70710-1460_6cf603d4-b79b-4a0a-906c-f1967a0db9a4","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20180806","","ANDA","ANDA211147","Zydus Pharmaceuticals USA Inc.","200","mg/5mL","","N","20261231"
"7607","MICAFUNGIN SODIUM","Micafungin","70710172401","Echinocandin Antifungal [EPC], Lipopeptides [CS]","70710-1724","70710-1724-1","70710-1724_ae363dc7-b3b5-41e8-8f04-82e30cf3c718","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230410","","ANDA","ANDA215241","Zydus Pharmaceuticals USA Inc.","10","mg/mL","","N","20261231"
"7608","MICAFUNGIN SODIUM","Micafungin","70710172406","Echinocandin Antifungal [EPC], Lipopeptides [CS]","70710-1724","70710-1724-6","70710-1724_ae363dc7-b3b5-41e8-8f04-82e30cf3c718","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230410","","ANDA","ANDA215241","Zydus Pharmaceuticals USA Inc.","10","mg/mL","","N","20261231"
"7609","MICAFUNGIN SODIUM","Micafungin","70710172506","Echinocandin Antifungal [EPC], Lipopeptides [CS]","70710-1725","70710-1725-6","70710-1725_ae363dc7-b3b5-41e8-8f04-82e30cf3c718","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230410","","ANDA","ANDA215241","Zydus Pharmaceuticals USA Inc.","20","mg/mL","","N","20261231"
"7610","MICAFUNGIN SODIUM","Micafungin","70710172501","Echinocandin Antifungal [EPC], Lipopeptides [CS]","70710-1725","70710-1725-1","70710-1725_ae363dc7-b3b5-41e8-8f04-82e30cf3c718","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230410","","ANDA","ANDA215241","Zydus Pharmaceuticals USA Inc.","20","mg/mL","","N","20261231"
"7611","POSACONAZOLE","POSACONAZOLE","70748025807","Azole Antifungal [EPC], Azoles [CS]","70748-258","70748-258-07","70748-258_eaee3d25-1c94-4a4c-b667-f5b2cf64ee33","HUMAN PRESCRIPTION DRUG","POSACONAZOLE","","TABLET, DELAYED RELEASE","ORAL","20210217","","ANDA","ANDA213454","Lupin Pharmaceuticals, Inc.","100","mg/1","","N","20261231"
"7612","ATOVAQUONE","ATOVAQUONE","70748029901","Antimalarial [EPC], Antiprotozoal [EPC]","70748-299","70748-299-01","70748-299_26a9360d-7db4-42fe-b9d2-ecddfe369d2e","HUMAN PRESCRIPTION DRUG","ATOVAQUONE","","SUSPENSION","ORAL","20210601","","ANDA","ANDA210692","Lupin Pharmaceuticals, Inc.","750","mg/5mL","","N","20251231"
"7613","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","70756040411","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","70756-404","70756-404-11","70756-404_98c85803-fdee-41fa-af1a-98f05ef725d4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Lifestar Pharma LLC","25; 75","mg/1; mg/1","","N","20251231"
"7614","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","70756040451","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","70756-404","70756-404-51","70756-404_98c85803-fdee-41fa-af1a-98f05ef725d4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Lifestar Pharma LLC","25; 75","mg/1; mg/1","","N","20251231"
"7615","NITROFURANTOIN","nitrofurantoin macrocrystals","70756041011","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70756-410","70756-410-11","70756-410_9add55a0-f57d-473d-9e83-ceffe099a1b1","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Lifestar Pharma LLC","25","mg/1","","N","20251231"
"7616","NITROFURANTOIN","nitrofurantoin macrocrystals","70756041111","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70756-411","70756-411-11","70756-411_9add55a0-f57d-473d-9e83-ceffe099a1b1","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Lifestar Pharma LLC","50","mg/1","","N","20251231"
"7617","NITROFURANTOIN","nitrofurantoin macrocrystals","70756041211","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70756-412","70756-412-11","70756-412_9add55a0-f57d-473d-9e83-ceffe099a1b1","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Lifestar Pharma LLC","100","mg/1","","N","20251231"
"7618","TOBRAMYCIN","Tobramycin","70756060456","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","70756-604","70756-604-56","70756-604_0d769be2-4528-456f-af6b-2e1d1ad90c13","HUMAN PRESCRIPTION DRUG","TOBRAMYCIN","","SOLUTION","RESPIRATORY (INHALATION)","20230630","","ANDA","ANDA214478","Lifestar Pharma LLC","300","mg/5mL","","N","20251231"
"7619","OFLOXACIN","ofloxacin","70756060730","Quinolone Antimicrobial [EPC], Quinolones [CS]","70756-607","70756-607-30","70756-607_66cf1093-a724-4802-aa04-1c50b8a96c7e","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20221207","","ANDA","ANDA215886","Lifestar Pharma LLC","3","mg/mL","","N","20251231"
"7620","OFLOXACIN","ofloxacin otic","70756060915","Quinolone Antimicrobial [EPC], Quinolones [CS]","70756-609","70756-609-15","70756-609_7556cd96-134e-4aaa-bf2d-7b6f9c8133c9","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION","AURICULAR (OTIC)","20220715","","ANDA","ANDA216130","Lifestar Pharma LLC","3","mg/mL","","N","20251231"
"7621","OFLOXACIN","ofloxacin otic","70756061030","Quinolone Antimicrobial [EPC], Quinolones [CS]","70756-610","70756-610-30","70756-610_7556cd96-134e-4aaa-bf2d-7b6f9c8133c9","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION","AURICULAR (OTIC)","20220715","","ANDA","ANDA216130","Lifestar Pharma LLC","3","mg/mL","","N","20251231"
"7622","TOBRAMYCIN","Tobramycin","70756061756","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","70756-617","70756-617-56","70756-617_e9af1897-30d0-4886-8e50-593b317c6001","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","RESPIRATORY (INHALATION)","20220923","","ANDA","ANDA216725","Lifestar Pharma LLC","300","mg/4mL","","N","20251231"
"7623","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin","70756063825","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70756-638","70756-638-25","70756-638_22d5cd84-26c0-49b0-afbf-1e9155749cf6","HUMAN PRESCRIPTION DRUG","Moxifloxacin ophthalmic solution","","SOLUTION/ DROPS","OPHTHALMIC","20250127","","ANDA","ANDA217988","Lifestar Pharma LLC","5","mg/mL","","N","20261231"
"7624","OFLOXACIN","ofloxacin","70756065030","Quinolone Antimicrobial [EPC], Quinolones [CS]","70756-650","70756-650-30","70756-650_66cf1093-a724-4802-aa04-1c50b8a96c7e","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20230825","","ANDA","ANDA215886","Lifestar Pharma LLC","3","mg/mL","","N","20251231"
"7625","METRONIDAZOLE","METRONIDAZOLE","70771104505","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70771-1045","70771-1045-5","70771-1045_b7d7886c-cdcf-4200-8149-d99b6b135183","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Zydus Lifesciences Limited","250","mg/1","","N","20251231"
"7626","METRONIDAZOLE","METRONIDAZOLE","70771104508","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70771-1045","70771-1045-8","70771-1045_b7d7886c-cdcf-4200-8149-d99b6b135183","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Zydus Lifesciences Limited","250","mg/1","","N","20251231"
"7627","METRONIDAZOLE","METRONIDAZOLE","70771104501","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70771-1045","70771-1045-1","70771-1045_b7d7886c-cdcf-4200-8149-d99b6b135183","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Zydus Lifesciences Limited","250","mg/1","","N","20251231"
"7628","METRONIDAZOLE","METRONIDAZOLE","70771104601","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70771-1046","70771-1046-1","70771-1046_b7d7886c-cdcf-4200-8149-d99b6b135183","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Zydus Lifesciences Limited","500","mg/1","","N","20251231"
"7629","METRONIDAZOLE","METRONIDAZOLE","70771104607","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70771-1046","70771-1046-7","70771-1046_b7d7886c-cdcf-4200-8149-d99b6b135183","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Zydus Lifesciences Limited","500","mg/1","","N","20251231"
"7630","METRONIDAZOLE","METRONIDAZOLE","70771104605","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70771-1046","70771-1046-5","70771-1046_b7d7886c-cdcf-4200-8149-d99b6b135183","HUMAN PRESCRIPTION DRUG","METRONIDAZOLE","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Zydus Lifesciences Limited","500","mg/1","","N","20251231"
"7631","FLUCONAZOLE","fluconazole","70771106303","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1063","70771-1063-3","70771-1063_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","50","mg/1","","N","20251231"
"7632","FLUCONAZOLE","fluconazole","70771106304","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1063","70771-1063-4","70771-1063_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","50","mg/1","","N","20251231"
"7633","FLUCONAZOLE","fluconazole","70771106305","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1063","70771-1063-5","70771-1063_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","50","mg/1","","N","20251231"
"7634","FLUCONAZOLE","fluconazole","70771106301","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1063","70771-1063-1","70771-1063_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","50","mg/1","","N","20251231"
"7635","FLUCONAZOLE","fluconazole","70771106403","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1064","70771-1064-3","70771-1064_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","100","mg/1","","N","20251231"
"7636","FLUCONAZOLE","fluconazole","70771106404","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1064","70771-1064-4","70771-1064_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","100","mg/1","","N","20251231"
"7637","FLUCONAZOLE","fluconazole","70771106405","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1064","70771-1064-5","70771-1064_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","100","mg/1","","N","20251231"
"7638","FLUCONAZOLE","fluconazole","70771106401","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1064","70771-1064-1","70771-1064_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","100","mg/1","","N","20251231"
"7639","FLUCONAZOLE","fluconazole","70771106503","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1065","70771-1065-3","70771-1065_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","150","mg/1","","N","20251231"
"7640","FLUCONAZOLE","fluconazole","70771106505","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1065","70771-1065-5","70771-1065_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","150","mg/1","","N","20251231"
"7641","FLUCONAZOLE","fluconazole","70771106507","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1065","70771-1065-7","70771-1065_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","150","mg/1","","N","20251231"
"7642","FLUCONAZOLE","fluconazole","70771106501","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1065","70771-1065-1","70771-1065_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","150","mg/1","","N","20251231"
"7643","FLUCONAZOLE","fluconazole","70771106508","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1065","70771-1065-8","70771-1065_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","150","mg/1","","N","20251231"
"7644","FLUCONAZOLE","fluconazole","70771106603","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1066","70771-1066-3","70771-1066_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","200","mg/1","","N","20251231"
"7645","FLUCONAZOLE","fluconazole","70771106604","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1066","70771-1066-4","70771-1066_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","200","mg/1","","N","20251231"
"7646","FLUCONAZOLE","fluconazole","70771106605","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1066","70771-1066-5","70771-1066_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","200","mg/1","","N","20251231"
"7647","FLUCONAZOLE","fluconazole","70771106601","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1066","70771-1066-1","70771-1066_4813fe26-a1f0-4782-a210-c669ae1ad899","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Zydus Lifesciences Limited","200","mg/1","","N","20251231"
"7648","NITROFURANTOIN","nitrofurantoin macrocrystals","70771117001","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70771-1170","70771-1170-1","70771-1170_a2deefdc-9b32-44e4-a6bc-4eeae30e5c46","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Zydus Lifesciences Limited","50","mg/1","","N","20251231"
"7649","NITROFURANTOIN","nitrofurantoin macrocrystals","70771117002","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70771-1170","70771-1170-2","70771-1170_a2deefdc-9b32-44e4-a6bc-4eeae30e5c46","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Zydus Lifesciences Limited","50","mg/1","","N","20251231"
"7650","NITROFURANTOIN","nitrofurantoin macrocrystals","70771117000","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70771-1170","70771-1170-0","70771-1170_a2deefdc-9b32-44e4-a6bc-4eeae30e5c46","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Zydus Lifesciences Limited","50","mg/1","","N","20251231"
"7651","NITROFURANTOIN","nitrofurantoin macrocrystals","70771117100","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70771-1171","70771-1171-0","70771-1171_a2deefdc-9b32-44e4-a6bc-4eeae30e5c46","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Zydus Lifesciences Limited","100","mg/1","","N","20251231"
"7652","NITROFURANTOIN","nitrofurantoin macrocrystals","70771117102","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70771-1171","70771-1171-2","70771-1171_a2deefdc-9b32-44e4-a6bc-4eeae30e5c46","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Zydus Lifesciences Limited","100","mg/1","","N","20251231"
"7653","NITROFURANTOIN","nitrofurantoin macrocrystals","70771117101","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70771-1171","70771-1171-1","70771-1171_a2deefdc-9b32-44e4-a6bc-4eeae30e5c46","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Zydus Lifesciences Limited","100","mg/1","","N","20251231"
"7654","ITRACONAZOLE","itraconazole","70771120800","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","70771-1208","70771-1208-0","70771-1208_79dd4097-f8f1-45e5-8f25-9e8b4fc5b8bd","HUMAN PRESCRIPTION DRUG","itraconazole","","CAPSULE","ORAL","20180306","","ANDA","ANDA204672","Zydus Lifesciences Limited","100","mg/1","","N","20251231"
"7655","ITRACONAZOLE","itraconazole","70771120803","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","70771-1208","70771-1208-3","70771-1208_79dd4097-f8f1-45e5-8f25-9e8b4fc5b8bd","HUMAN PRESCRIPTION DRUG","itraconazole","","CAPSULE","ORAL","20180306","","ANDA","ANDA204672","Zydus Lifesciences Limited","100","mg/1","","N","20251231"
"7656","ITRACONAZOLE","itraconazole","70771120804","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","70771-1208","70771-1208-4","70771-1208_79dd4097-f8f1-45e5-8f25-9e8b4fc5b8bd","HUMAN PRESCRIPTION DRUG","itraconazole","","CAPSULE","ORAL","20180306","","ANDA","ANDA204672","Zydus Lifesciences Limited","100","mg/1","","N","20251231"
"7657","ITRACONAZOLE","itraconazole","70771120801","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","70771-1208","70771-1208-1","70771-1208_79dd4097-f8f1-45e5-8f25-9e8b4fc5b8bd","HUMAN PRESCRIPTION DRUG","itraconazole","","CAPSULE","ORAL","20180306","","ANDA","ANDA204672","Zydus Lifesciences Limited","100","mg/1","","N","20251231"
"7658","NYSTATIN","Nystatin","70771135702","Polyene Antifungal [EPC], Polyenes [CS]","70771-1357","70771-1357-2","70771-1357_f94a3196-9f89-4b93-8b26-bf811b9bbc3f","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20180808","","ANDA","ANDA207767","Zydus Lifesciences Limited","100000","U/g","","N","20251231"
"7659","NYSTATIN","Nystatin","70771135701","Polyene Antifungal [EPC], Polyenes [CS]","70771-1357","70771-1357-1","70771-1357_f94a3196-9f89-4b93-8b26-bf811b9bbc3f","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20180808","","ANDA","ANDA207767","Zydus Lifesciences Limited","100000","U/g","","N","20251231"
"7660","VORICONAZOLE","voriconazole","70771141301","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70771-1413","70771-1413-1","70771-1413_4a0dfaa3-a2b7-4a4f-9dda-d8662ac705be","HUMAN PRESCRIPTION DRUG","VORICONAZOLE","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190103","","ANDA","ANDA208983","Zydus Lifesciences Limited","10","mg/mL","","N","20251231"
"7661","CLINDAMYCIN PHOSPHATE","Clindamycin phosphate","70771141402","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70771-1414","70771-1414-2","70771-1414_fed995d0-8469-4af3-af36-5c786e50799a","HUMAN PRESCRIPTION DRUG","Clindamycin phosphate","","SOLUTION","TOPICAL","20190103","","ANDA","ANDA208767","Zydus Lifesciences Limited","10","mg/mL","","N","20251231"
"7662","CLINDAMYCIN PHOSPHATE","Clindamycin phosphate","70771141403","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70771-1414","70771-1414-3","70771-1414_fed995d0-8469-4af3-af36-5c786e50799a","HUMAN PRESCRIPTION DRUG","Clindamycin phosphate","","SOLUTION","TOPICAL","20190103","","ANDA","ANDA208767","Zydus Lifesciences Limited","10","mg/mL","","N","20251231"
"7663","AZITHROMYCIN DIHYDRATE","Azithromycin","70771142201","Macrolide Antimicrobial [EPC], Macrolides [CS]","70771-1422","70771-1422-1","70771-1422_654b77ea-07ad-4747-ac35-5a2eb41f4588","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20180806","","ANDA","ANDA211147","Zydus Lifesciences Limited","100","mg/5mL","","N","20261231"
"7664","AZITHROMYCIN DIHYDRATE","Azithromycin","70771142302","Macrolide Antimicrobial [EPC], Macrolides [CS]","70771-1423","70771-1423-2","70771-1423_654b77ea-07ad-4747-ac35-5a2eb41f4588","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20180806","","ANDA","ANDA211147","Zydus Lifesciences Limited","200","mg/5mL","","N","20261231"
"7665","AZITHROMYCIN DIHYDRATE","Azithromycin","70771142402","Macrolide Antimicrobial [EPC], Macrolides [CS]","70771-1424","70771-1424-2","70771-1424_654b77ea-07ad-4747-ac35-5a2eb41f4588","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20180806","","ANDA","ANDA211147","Zydus Lifesciences Limited","200","mg/5mL","","N","20261231"
"7666","AZITHROMYCIN DIHYDRATE","Azithromycin","70771142502","Macrolide Antimicrobial [EPC], Macrolides [CS]","70771-1425","70771-1425-2","70771-1425_654b77ea-07ad-4747-ac35-5a2eb41f4588","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20180806","","ANDA","ANDA211147","Zydus Lifesciences Limited","200","mg/5mL","","N","20261231"
"7667","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","70771144702","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","70771-1447","70771-1447-2","70771-1447_349e5bb9-e74a-45f6-8d4f-75f0b1ad8d3f","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20181120","","ANDA","ANDA207764","Zydus Lifesciences Limited","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"7668","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","70771144703","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","70771-1447","70771-1447-3","70771-1447_349e5bb9-e74a-45f6-8d4f-75f0b1ad8d3f","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20181120","","ANDA","ANDA207764","Zydus Lifesciences Limited","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"7669","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","70771144701","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","70771-1447","70771-1447-1","70771-1447_349e5bb9-e74a-45f6-8d4f-75f0b1ad8d3f","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20181120","","ANDA","ANDA207764","Zydus Lifesciences Limited","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"7670","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate and Benzoyl Peroxide","70771145004","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70771-1450","70771-1450-4","70771-1450_f53d71f1-24d4-4601-8aa5-d427ecb51e8a","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Benzoyl Peroxide","","GEL","TOPICAL","20190307","","ANDA","ANDA210794","Zydus Lifesciences Limited","50; 10","mg/g; mg/g","","N","20251231"
"7671","ERYTHROMYCIN","Erythromycin","70771154801","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","70771-1548","70771-1548-1","70771-1548_35a32479-429b-4e71-9c5c-1e8ddbdff5e7","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230630","","ANDA","ANDA212693","Zydus Lifesciences Limited","250","mg/1","","N","20251231"
"7672","ERYTHROMYCIN","Erythromycin","70771154803","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","70771-1548","70771-1548-3","70771-1548_35a32479-429b-4e71-9c5c-1e8ddbdff5e7","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230630","","ANDA","ANDA212693","Zydus Lifesciences Limited","250","mg/1","","N","20251231"
"7673","ERYTHROMYCIN","Erythromycin","70771154805","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","70771-1548","70771-1548-5","70771-1548_35a32479-429b-4e71-9c5c-1e8ddbdff5e7","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230630","","ANDA","ANDA212693","Zydus Lifesciences Limited","250","mg/1","","N","20251231"
"7674","ERYTHROMYCIN","Erythromycin","70771154903","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","70771-1549","70771-1549-3","70771-1549_35a32479-429b-4e71-9c5c-1e8ddbdff5e7","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230630","","ANDA","ANDA212693","Zydus Lifesciences Limited","500","mg/1","","N","20251231"
"7675","ERYTHROMYCIN","Erythromycin","70771154905","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","70771-1549","70771-1549-5","70771-1549_35a32479-429b-4e71-9c5c-1e8ddbdff5e7","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230630","","ANDA","ANDA212693","Zydus Lifesciences Limited","500","mg/1","","N","20251231"
"7676","ERYTHROMYCIN","Erythromycin","70771154901","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","70771-1549","70771-1549-1","70771-1549_35a32479-429b-4e71-9c5c-1e8ddbdff5e7","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20230630","","ANDA","ANDA212693","Zydus Lifesciences Limited","500","mg/1","","N","20251231"
"7677","NYSTATIN","nystatin","70771158501","Polyene Antifungal [EPC], Polyenes [CS]","70771-1585","70771-1585-1","70771-1585_ea55d8af-28a2-491e-8aae-aa5102c228aa","HUMAN PRESCRIPTION DRUG","NYSTATIN","","POWDER","TOPICAL","20211006","","ANDA","ANDA208581","Zydus Lifesciences Limited","100000","[USP'U]/g","","N","20251231"
"7678","NYSTATIN","nystatin","70771158503","Polyene Antifungal [EPC], Polyenes [CS]","70771-1585","70771-1585-3","70771-1585_ea55d8af-28a2-491e-8aae-aa5102c228aa","HUMAN PRESCRIPTION DRUG","NYSTATIN","","POWDER","TOPICAL","20211006","","ANDA","ANDA208581","Zydus Lifesciences Limited","100000","[USP'U]/g","","N","20251231"
"7679","NYSTATIN","nystatin","70771158502","Polyene Antifungal [EPC], Polyenes [CS]","70771-1585","70771-1585-2","70771-1585_ea55d8af-28a2-491e-8aae-aa5102c228aa","HUMAN PRESCRIPTION DRUG","NYSTATIN","","POWDER","TOPICAL","20211006","","ANDA","ANDA208581","Zydus Lifesciences Limited","100000","[USP'U]/g","","N","20251231"
"7680","MICAFUNGIN SODIUM","Micafungin","70771168306","Echinocandin Antifungal [EPC], Lipopeptides [CS]","70771-1683","70771-1683-6","70771-1683_52146be3-eeb8-472d-a58a-c70f8c3b7219","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230410","","ANDA","ANDA215241","Zydus Lifesciences Limited","10","mg/mL","","N","20251231"
"7681","MICAFUNGIN SODIUM","Micafungin","70771168301","Echinocandin Antifungal [EPC], Lipopeptides [CS]","70771-1683","70771-1683-1","70771-1683_52146be3-eeb8-472d-a58a-c70f8c3b7219","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230410","","ANDA","ANDA215241","Zydus Lifesciences Limited","10","mg/mL","","N","20251231"
"7682","MICAFUNGIN SODIUM","Micafungin","70771168406","Echinocandin Antifungal [EPC], Lipopeptides [CS]","70771-1684","70771-1684-6","70771-1684_52146be3-eeb8-472d-a58a-c70f8c3b7219","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230410","","ANDA","ANDA215241","Zydus Lifesciences Limited","20","mg/mL","","N","20251231"
"7683","MICAFUNGIN SODIUM","Micafungin","70771168401","Echinocandin Antifungal [EPC], Lipopeptides [CS]","70771-1684","70771-1684-1","70771-1684_52146be3-eeb8-472d-a58a-c70f8c3b7219","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230410","","ANDA","ANDA215241","Zydus Lifesciences Limited","20","mg/mL","","N","20251231"
"7684","TAVABOROLE","Tavaborole","70771182600","Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]","70771-1826","70771-1826-0","70771-1826_b7ea9baf-cd2b-4430-a0cf-85945ce38a17","HUMAN PRESCRIPTION DRUG","Tavaborole","","SOLUTION","TOPICAL","20230424","","ANDA","ANDA212294","Zydus Lifesciences Limited","43.5","mg/mL","","N","20251231"
"7685","AZITHROMYCIN DIHYDRATE","Azithromycin","70771182903","Macrolide Antimicrobial [EPC], Macrolides [CS]","70771-1829","70771-1829-3","70771-1829_840c9c79-1518-4e20-9f09-b5028784aa8f","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET","ORAL","20250612","20250725","ANDA","ANDA213056","Zydus Lifesciences Limited","500","mg/1","","N",""
"7686","AZITHROMYCIN DIHYDRATE","Azithromycin","70771182908","Macrolide Antimicrobial [EPC], Macrolides [CS]","70771-1829","70771-1829-8","70771-1829_840c9c79-1518-4e20-9f09-b5028784aa8f","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET","ORAL","20250612","20250725","ANDA","ANDA213056","Zydus Lifesciences Limited","500","mg/1","","N",""
"7687","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","70771183008","Macrolide Antimicrobial [EPC], Macrolides [CS]","70771-1830","70771-1830-8","70771-1830_d8b0d0f3-9618-4b28-97b8-8917638c53b8","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","TABLET","ORAL","20250612","20250725","ANDA","ANDA213275","Zydus Lifesciences Limited","250","mg/1","","N",""
"7688","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","70771183003","Macrolide Antimicrobial [EPC], Macrolides [CS]","70771-1830","70771-1830-3","70771-1830_d8b0d0f3-9618-4b28-97b8-8917638c53b8","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","TABLET","ORAL","20250612","20250725","ANDA","ANDA213275","Zydus Lifesciences Limited","250","mg/1","","N",""
"7689","METRONIDAZOLE","Metronidazole","70771183404","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70771-1834","70771-1834-4","70771-1834_bac9d2c8-3d87-4ec8-aa22-760d3c66440b","HUMAN PRESCRIPTION DRUG","Metronidazole","","CREAM","TOPICAL","20230531","","ANDA","ANDA217128","Zydus Lifesciences Limited","7.5","mg/g","","N","20251231"
"7690","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","70771185502","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70771-1855","70771-1855-2","70771-1855_63bb3224-d5c6-4756-9e39-c6d82edac14d","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20230920","","ANDA","ANDA216587","Zydus Lifesciences Limited","10","mg/g","","N","20251231"
"7691","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","70771185503","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70771-1855","70771-1855-3","70771-1855_63bb3224-d5c6-4756-9e39-c6d82edac14d","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20230920","","ANDA","ANDA216587","Zydus Lifesciences Limited","10","mg/g","","N","20251231"
"7692","KETOCONAZOLE","Ketoconazole","70771187407","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","70771-1874","70771-1874-7","70771-1874_9795147c-bca9-481c-b910-edee5bdd5f29","HUMAN PRESCRIPTION DRUG","Ketoconazole","","SHAMPOO","TOPICAL","20250308","","ANDA","ANDA218559","Zydus Lifesciences Limited","20","mg/mL","","N","20261231"
"7693","DELAFLOXACIN MEGLUMINE","delafloxacin meglumine","70842010101","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70842-101","70842-101-01","70842-101_6ae4571c-23dc-488a-91ab-523e020691ea","HUMAN PRESCRIPTION DRUG","Baxdela","","TABLET","ORAL","20170619","","NDA","NDA208610","Melinta Therapeutics, LLC","450","mg/1","","N","20261231"
"7694","DELAFLOXACIN MEGLUMINE","delafloxacin meglumine","70842010102","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70842-101","70842-101-02","70842-101_6ae4571c-23dc-488a-91ab-523e020691ea","HUMAN PRESCRIPTION DRUG","Baxdela","","TABLET","ORAL","20170619","","NDA","NDA208610","Melinta Therapeutics, LLC","450","mg/1","","N","20261231"
"7695","DELAFLOXACIN MEGLUMINE","delafloxacin meglumine","70842010105","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70842-101","70842-101-05","70842-101_6ae4571c-23dc-488a-91ab-523e020691ea","HUMAN PRESCRIPTION DRUG","Baxdela","","TABLET","ORAL","20170619","","NDA","NDA208610","Melinta Therapeutics, LLC","450","mg/1","","N","20261231"
"7696","DELAFLOXACIN MEGLUMINE","delafloxacin meglumine","70842010203","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70842-102","70842-102-03","70842-102_6ae4571c-23dc-488a-91ab-523e020691ea","HUMAN PRESCRIPTION DRUG","Baxdela","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20170619","","NDA","NDA208611","Melinta Therapeutics, LLC","300","mg/10.5mL","","N","20261231"
"7697","MEROPENEM; VABORBACTAM","Meropenem-Vaborbactam","70842012006","Carbapenems [CS], Penem Antibacterial [EPC], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70842-120","70842-120-06","70842-120_28b97a01-452c-4eed-b59e-1fc920ab9536","HUMAN PRESCRIPTION DRUG","VABOMERE","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20171002","","NDA","NDA209776","Melinta Therapeutics, LLC","1; 1","g/2g; g/2g","","N","20261231"
"7698","ORITAVANCIN","oritavancin","70842014003","Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]","70842-140","70842-140-03","70842-140_5a48771c-f9a5-4181-8029-6000722ce92f","HUMAN PRESCRIPTION DRUG","Orbactiv","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20140901","","NDA","NDA206334","Melinta Therapeutics, LLC","400","mg/1","","N","20251231"
"7699","ORITAVANCIN DIPHOSPHATE","oritavancin diphosphate","70842022501","Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]","70842-225","70842-225-01","70842-225_1908b5d2-6795-4a9b-b04b-1443ac2a7aa7","HUMAN PRESCRIPTION DRUG","Kimyrsa","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210323","","NDA","NDA214155","Melinta Therapeutics, LLC","1200","mg/40mL","","N","20261231"
"7700","REZAFUNGIN","rezafungin","70842024001","Echinocandin Antifungal [EPC], Lipopeptides [CS]","70842-240","70842-240-01","70842-240_4714cf42-4658-4261-b828-828c5c254ac8","HUMAN PRESCRIPTION DRUG","REZZAYO","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230609","","NDA","NDA217417","Melinta Therapeutics, LLC","200","mg/1","","N","20251231"
"7701","CLOTRIMAZOLE","Antifungal 1% Clotrimazole Cream","70856358501","Azole Antifungal [EPC], Azoles [CS]","70856-3585","70856-3585-1","70856-3585_2969fbeb-2eb1-77ce-e063-6394a90a20b6","HUMAN OTC DRUG","Antifungal 1% Clotrimazole Cream","","CREAM","TOPICAL","20241001","","OTC MONOGRAPH DRUG","M005","Defense Soap LLC","1","g/100mL","","N","20251231"
"7702","AZITHROMYCIN MONOHYDRATE","azithromycin monohydrate","70860010010","Macrolide Antimicrobial [EPC], Macrolides [CS]","70860-100","70860-100-10","70860-100_2cc930e3-dd57-6e2f-e063-6294a90a3111","HUMAN PRESCRIPTION DRUG","Azithromycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20170101","20270331","ANDA","ANDA065501","Athenex Pharmaceutical Division, LLC.","500","mg/5mL","","N",""
"7703","NAFCILLIN SODIUM","nafcillin sodium","70860011726","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70860-117","70860-117-26","70860-117_12dde6de-9680-cb5e-e063-6294a90acede","HUMAN PRESCRIPTION DRUG","Nafcillin","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20180801","20251130","ANDA","ANDA090560","Athenex Pharmaceutical Division, LLC.","2","g/1","","N",""
"7704","AMPICILLIN SODIUM","ampicillin sodium","70860011899","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70860-118","70860-118-99","70860-118_2cc9237d-bad7-3781-e063-6394a90a81c4","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20180531","20260930","ANDA","ANDA201404","Athenex Pharmaceutical Division, LLC.","10","g/100mL","","N",""
"7705","NAFCILLIN SODIUM","nafcillin sodium","70860011999","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70860-119","70860-119-99","70860-119_2cc9cc61-54ac-9a94-e063-6394a90a2376","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20180815","20260630","ANDA","ANDA090005","Athenex Pharmaceutical Division, LLC.","10","g/100mL","","N",""
"7706","AZITHROMYCIN MONOHYDRATE","azithromycin monohydrate","70860012566","Macrolide Antimicrobial [EPC], Macrolides [CS]","70860-125","70860-125-66","70860-125_2cc927cf-6a15-6851-e063-6394a90a0b8c","HUMAN PRESCRIPTION DRUG","Azithromycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190830","20270331","ANDA","ANDA065501","Athenex Pharmaceutical Division, LLC.","500","mg/5mL","","N",""
"7707","PENICILLIN G POTASSIUM","penicillin g potassium","70860012620","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70860-126","70860-126-20","70860-126_2cc9e113-4939-08d2-e063-6294a90ad0e9","HUMAN PRESCRIPTION DRUG","Penicillin G Potassium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20190521","20251130","ANDA","ANDA065448","Athenex Pharmaceutical Division, LLC.","5000000","[iU]/1","","N",""
"7708","PENICILLIN G POTASSIUM","penicillin g potassium","70860012751","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70860-127","70860-127-51","70860-127_2cc9e113-4939-08d2-e063-6294a90ad0e9","HUMAN PRESCRIPTION DRUG","Penicillin G Potassium","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20190521","20270531","ANDA","ANDA065448","Athenex Pharmaceutical Division, LLC.","20000000","[iU]/1","","N",""
"7709","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","70882011120","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","70882-111","70882-111-20","70882-111_f0063b1e-af9e-474d-96b9-0b3aa1a37ea2","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20050823","","ANDA","ANDA065189","Cambridge Therapeutics Technologies, LLC","250; 125","mg/1; mg/1","","N","20251231"
"7710","AMOXICILLIN","Amoxicillin","70882011330","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70882-113","70882-113-30","70882-113_af0ae6a3-1435-40dd-a62a-ce533791a28c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Cambridge Therapeutics Technologies, LLC","250","mg/1","","N","20251231"
"7711","AMOXICILLIN","Amoxicillin","70882011420","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70882-114","70882-114-20","70882-114_af0ae6a3-1435-40dd-a62a-ce533791a28c","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Cambridge Therapeutics Technologies, LLC","500","mg/1","","N","20251231"
"7712","METRONIDAZOLE","Metronidazole","70882013021","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70882-130","70882-130-21","70882-130_0aa5cb55-934d-4eb1-9c3c-b986053a97da","HUMAN PRESCRIPTION DRUG","Metronidazole250 mg","250 mg","TABLET, FILM COATED","ORAL","20160613","","ANDA","ANDA070040","Cambridge Therapeutics Technologies, LLC","250","mg/1","","N","20251231"
"7713","METRONIDAZOLE","Metronidazole","70882013114","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70882-131","70882-131-14","70882-131_1835a76b-e6ee-4e9a-b35d-9c39c6cfcbf3","HUMAN PRESCRIPTION DRUG","Metronidazole500 mg","500 mg","TABLET, FILM COATED","ORAL","20160613","","ANDA","ANDA070039","Cambridge Therapeutics Technologies, LLC","500","mg/1","","N","20251231"
"7714","AMOXICILLIN","Amoxicillin","70934003820","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70934-038","70934-038-20","70934-038_ff48f0bd-7144-d34a-e053-6294a90a3c1d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20171031","20250731","ANDA","ANDA065256","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","875","mg/1","","N",""
"7715","AMOXICILLIN","Amoxicillin","70934003891","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70934-038","70934-038-91","70934-038_ff48f0bd-7144-d34a-e053-6294a90a3c1d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20171031","20250731","ANDA","ANDA065256","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","875","mg/1","","N",""
"7716","AMOXICILLIN","Amoxicillin","70934003894","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70934-038","70934-038-94","70934-038_ff48f0bd-7144-d34a-e053-6294a90a3c1d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20171031","20250731","ANDA","ANDA065256","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","875","mg/1","","N",""
"7717","AMOXICILLIN","Amoxicillin","70934003814","Penicillin-class Antibacterial [EPC], Penicillins [CS]","70934-038","70934-038-14","70934-038_ff48f0bd-7144-d34a-e053-6294a90a3c1d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20171031","20250731","ANDA","ANDA065256","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","875","mg/1","","N",""
"7718","CEPHALEXIN","Cephalexin","70934004014","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70934-040","70934-040-14","70934-040_ff49699c-cf19-13d2-e053-6394a90af079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20171030","20250731","ANDA","ANDA090836","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7719","CEPHALEXIN","Cephalexin","70934004020","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70934-040","70934-040-20","70934-040_ff49699c-cf19-13d2-e053-6394a90af079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20171030","20250731","ANDA","ANDA090836","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7720","CEPHALEXIN","Cephalexin","70934004021","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70934-040","70934-040-21","70934-040_ff49699c-cf19-13d2-e053-6394a90af079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20171030","20250731","ANDA","ANDA090836","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7721","CEPHALEXIN","Cephalexin","70934004028","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70934-040","70934-040-28","70934-040_ff49699c-cf19-13d2-e053-6394a90af079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20171030","20250731","ANDA","ANDA090836","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7722","CEPHALEXIN","Cephalexin","70934004030","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70934-040","70934-040-30","70934-040_ff49699c-cf19-13d2-e053-6394a90af079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20171030","20250731","ANDA","ANDA090836","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7723","CEPHALEXIN","Cephalexin","70934004040","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70934-040","70934-040-40","70934-040_ff49699c-cf19-13d2-e053-6394a90af079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20171030","20250731","ANDA","ANDA090836","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7724","CEPHALEXIN","Cephalexin","70934004056","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70934-040","70934-040-56","70934-040_ff49699c-cf19-13d2-e053-6394a90af079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20171030","20250731","ANDA","ANDA090836","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7725","CEPHALEXIN","Cephalexin","70934004094","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70934-040","70934-040-94","70934-040_ff49699c-cf19-13d2-e053-6394a90af079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20171030","20250731","ANDA","ANDA090836","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7726","CEPHALEXIN","Cephalexin","70934004010","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","70934-040","70934-040-10","70934-040_ff49699c-cf19-13d2-e053-6394a90af079","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20171030","20250731","ANDA","ANDA090836","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7727","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70934054406","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70934-544","70934-544-06","70934-544_d8500916-caf6-2622-e053-2995a90ac5f8","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200212","20261231","ANDA","ANDA090624","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","800; 160","mg/1; mg/1","","N",""
"7728","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70934054410","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70934-544","70934-544-10","70934-544_d8500916-caf6-2622-e053-2995a90ac5f8","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200212","20261231","ANDA","ANDA090624","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","800; 160","mg/1; mg/1","","N",""
"7729","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70934054420","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70934-544","70934-544-20","70934-544_d8500916-caf6-2622-e053-2995a90ac5f8","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200212","20261231","ANDA","ANDA090624","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","800; 160","mg/1; mg/1","","N",""
"7730","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70934054428","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70934-544","70934-544-28","70934-544_d8500916-caf6-2622-e053-2995a90ac5f8","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200212","20261231","ANDA","ANDA090624","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","800; 160","mg/1; mg/1","","N",""
"7731","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70934054414","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70934-544","70934-544-14","70934-544_d8500916-caf6-2622-e053-2995a90ac5f8","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20200212","20261231","ANDA","ANDA090624","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","800; 160","mg/1; mg/1","","N",""
"7732","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","70934086530","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70934-865","70934-865-30","70934-865_c50ba5da-9b83-9236-e053-2a95a90acf90","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20210617","20250731","ANDA","ANDA065442","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","300","mg/1","","N",""
"7733","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","70934086540","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","70934-865","70934-865-40","70934-865_c50ba5da-9b83-9236-e053-2a95a90acf90","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20210617","20250731","ANDA","ANDA065442","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","300","mg/1","","N",""
"7734","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","70934096514","Quinolone Antimicrobial [EPC], Quinolones [CS]","70934-965","70934-965-14","70934-965_e10891a7-9e65-ca14-e053-2995a90afa2f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20220502","20260831","ANDA","ANDA076126","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7735","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","70934096520","Quinolone Antimicrobial [EPC], Quinolones [CS]","70934-965","70934-965-20","70934-965_e10891a7-9e65-ca14-e053-2995a90afa2f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20220502","20260831","ANDA","ANDA076126","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7736","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","70934096530","Quinolone Antimicrobial [EPC], Quinolones [CS]","70934-965","70934-965-30","70934-965_e10891a7-9e65-ca14-e053-2995a90afa2f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20220502","20260831","ANDA","ANDA076126","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7737","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","70934096506","Quinolone Antimicrobial [EPC], Quinolones [CS]","70934-965","70934-965-06","70934-965_e10891a7-9e65-ca14-e053-2995a90afa2f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20220502","20260831","ANDA","ANDA076126","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7738","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","70934096560","Quinolone Antimicrobial [EPC], Quinolones [CS]","70934-965","70934-965-60","70934-965_e10891a7-9e65-ca14-e053-2995a90afa2f","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20220502","20260831","ANDA","ANDA076126","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7739","METRONIDAZOLE","METRONIDAZOLE","70934097014","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70934-970","70934-970-14","70934-970_e295c653-d082-75b0-e053-2995a90a7db9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20220526","20251231","ANDA","ANDA205245","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7740","METRONIDAZOLE","METRONIDAZOLE","70934097020","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70934-970","70934-970-20","70934-970_e295c653-d082-75b0-e053-2995a90a7db9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20220526","20251231","ANDA","ANDA205245","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7741","METRONIDAZOLE","METRONIDAZOLE","70934097021","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70934-970","70934-970-21","70934-970_e295c653-d082-75b0-e053-2995a90a7db9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20220526","20251231","ANDA","ANDA205245","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7742","METRONIDAZOLE","METRONIDAZOLE","70934097030","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","70934-970","70934-970-30","70934-970_e295c653-d082-75b0-e053-2995a90a7db9","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20220526","20251231","ANDA","ANDA205245","Denton Pharma, Inc. DBA Northwind Pharmaceuticals","500","mg/1","","N",""
"7743","CLOTRIMAZOLE","Clotrimazole topical","70954003620","Azole Antifungal [EPC], Azoles [CS]","70954-036","70954-036-20","70954-036_7d0a148e-294d-4975-9937-5244473f665d","HUMAN PRESCRIPTION DRUG","Clotrimazole","","SOLUTION","TOPICAL","20190218","","ANDA","ANDA209815","Novitium Pharma LLC","10","mg/mL","","N","20251231"
"7744","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","70954025810","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","70954-258","70954-258-10","70954-258_59295b39-6beb-49a6-86a7-02013ae2db29","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20220208","","ANDA","ANDA214330","ANI Pharmaceuticals, Inc.","200; 40","mg/5mL; mg/5mL","","N","20261231"
"7745","NITROFURANTOIN","Nitrofurantoin","70954049610","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","70954-496","70954-496-10","70954-496_7e94d701-0d57-4a04-bc74-d07febb8ad7b","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","SUSPENSION","ORAL","20230417","","ANDA","ANDA216385","ANI Pharmaceuticals, Inc.","25","mg/5mL","","N","20251231"
"7746","TRIMETHOPRIM","Trimethoprim","70954054110","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]","70954-541","70954-541-10","70954-541_95a1572c-6109-4d1f-bf92-262015a7654e","HUMAN PRESCRIPTION DRUG","Trimethoprim","","TABLET","ORAL","20221104","","ANDA","ANDA216393","Novitium Pharma LLC","100","mg/1","","N","20251231"
"7747","KETOCONAZOLE","Ketoconazole","70954066210","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","70954-662","70954-662-10","70954-662_00c1cac8-a865-4583-aaba-3a0f21fb31e6","HUMAN PRESCRIPTION DRUG","Ketoconazole","","SUSPENSION","TOPICAL","20240916","","ANDA","ANDA218498","ANI Pharmaceuticals, Inc.","20","mg/mL","","N","20251231"
"7748","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","70954080410","Antimalarial [EPC], Antirheumatic Agent [EPC]","70954-804","70954-804-10","70954-804_f8c163b7-15a0-424d-b53d-05fb400948bf","HUMAN PRESCRIPTION DRUG","SOVUNA","","TABLET, FILM COATED","ORAL","20230915","","NDA","NDA214581","ANI Pharmaceuticals, Inc.","200","mg/1","","N","20261231"
"7749","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","70954080420","Antimalarial [EPC], Antirheumatic Agent [EPC]","70954-804","70954-804-20","70954-804_f8c163b7-15a0-424d-b53d-05fb400948bf","HUMAN PRESCRIPTION DRUG","SOVUNA","","TABLET, FILM COATED","ORAL","20230915","","NDA","NDA214581","ANI Pharmaceuticals, Inc.","200","mg/1","","N","20261231"
"7750","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","70954080430","Antimalarial [EPC], Antirheumatic Agent [EPC]","70954-804","70954-804-30","70954-804_f8c163b7-15a0-424d-b53d-05fb400948bf","HUMAN PRESCRIPTION DRUG","SOVUNA","","TABLET, FILM COATED","ORAL","20230915","","NDA","NDA214581","ANI Pharmaceuticals, Inc.","200","mg/1","","N","20261231"
"7751","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","70954080520","Antimalarial [EPC], Antirheumatic Agent [EPC]","70954-805","70954-805-20","70954-805_f8c163b7-15a0-424d-b53d-05fb400948bf","HUMAN PRESCRIPTION DRUG","SOVUNA","","TABLET, FILM COATED","ORAL","20230915","","NDA","NDA214581","ANI Pharmaceuticals, Inc.","300","mg/1","","N","20261231"
"7752","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","70954080510","Antimalarial [EPC], Antirheumatic Agent [EPC]","70954-805","70954-805-10","70954-805_f8c163b7-15a0-424d-b53d-05fb400948bf","HUMAN PRESCRIPTION DRUG","SOVUNA","","TABLET, FILM COATED","ORAL","20230915","","NDA","NDA214581","ANI Pharmaceuticals, Inc.","300","mg/1","","N","20261231"
"7753","NITAZOXANIDE","Nitazoxanide","70954093410","Antiprotozoal [EPC]","70954-934","70954-934-10","70954-934_cd3652fa-a183-4fb6-9a21-73fbeba6fc4b","HUMAN PRESCRIPTION DRUG","Nitazoxanide","","TABLET","ORAL","20250305","","ANDA","ANDA214844","ANI Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"7754","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","70985000801","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70985-008","70985-008-01","70985-008_0d2e5bb4-3066-32d5-e063-6394a90a0a03","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20210426","","ANDA","ANDA076639","DRUG OCEAN LLC","500","mg/1","","N","20251231"
"7755","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","70985000802","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70985-008","70985-008-02","70985-008_0d2e5bb4-3066-32d5-e063-6394a90a0a03","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20210426","","ANDA","ANDA076639","DRUG OCEAN LLC","500","mg/1","","N","20251231"
"7756","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","70985001101","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70985-011","70985-011-01","70985-011_0d2e5bb4-3066-32d5-e063-6394a90a0a03","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20210426","","ANDA","ANDA076639","DRUG OCEAN LLC","250","mg/1","","N","20251231"
"7757","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","70985001102","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70985-011","70985-011-02","70985-011_0d2e5bb4-3066-32d5-e063-6394a90a0a03","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20210426","","ANDA","ANDA076639","DRUG OCEAN LLC","250","mg/1","","N","20251231"
"7758","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","70985001201","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70985-012","70985-012-01","70985-012_0d2e5bb4-3066-32d5-e063-6394a90a0a03","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","DRUG OCEAN LLC","750","mg/1","","N","20251231"
"7759","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","70985001202","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","70985-012","70985-012-02","70985-012_0d2e5bb4-3066-32d5-e063-6394a90a0a03","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","DRUG OCEAN LLC","750","mg/1","","N","20251231"
"7760","FLUCONAZOLE","Fluconazole","70985001301","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70985-013","70985-013-01","70985-013_26f3e26c-4214-2928-e063-6394a90a47cb","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210626","","ANDA","ANDA076957","Drug Ocean LLC","50","mg/1","","N","20251231"
"7761","FLUCONAZOLE","Fluconazole","70985001303","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70985-013","70985-013-03","70985-013_26f3e26c-4214-2928-e063-6394a90a47cb","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210626","","ANDA","ANDA076957","Drug Ocean LLC","50","mg/1","","N","20251231"
"7762","FLUCONAZOLE","Fluconazole","70985001403","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70985-014","70985-014-03","70985-014_26f3e26c-4214-2928-e063-6394a90a47cb","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210626","","ANDA","ANDA076957","Drug Ocean LLC","100","mg/1","","N","20251231"
"7763","FLUCONAZOLE","Fluconazole","70985001401","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70985-014","70985-014-01","70985-014_26f3e26c-4214-2928-e063-6394a90a47cb","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210626","","ANDA","ANDA076957","Drug Ocean LLC","100","mg/1","","N","20251231"
"7764","FLUCONAZOLE","Fluconazole","70985001506","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70985-015","70985-015-06","70985-015_26f3e26c-4214-2928-e063-6394a90a47cb","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210626","","ANDA","ANDA076957","Drug Ocean LLC","150","mg/1","","N","20251231"
"7765","FLUCONAZOLE","Fluconazole","70985001601","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70985-016","70985-016-01","70985-016_26f3e26c-4214-2928-e063-6394a90a47cb","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210626","","ANDA","ANDA076957","Drug Ocean LLC","200","mg/1","","N","20251231"
"7766","FLUCONAZOLE","Fluconazole","70985001603","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","70985-016","70985-016-03","70985-016_26f3e26c-4214-2928-e063-6394a90a47cb","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210626","","ANDA","ANDA076957","Drug Ocean LLC","200","mg/1","","N","20251231"
"7767","KETOCONAZOLE","Ketoconazole","71085000860","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71085-008","71085-008-60","71085-008_ea618ceb-2b37-4885-a3da-16bbf0fa429a","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20021218","","ANDA","ANDA075638","IPG PHARMACEUTICALS, INC.","20","mg/g","","N","20251231"
"7768","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","71085000930","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","71085-009","71085-009-30","71085-009_b6eaa871-a050-4ee4-99d2-baefe246546f","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","CREAM","TOPICAL","19871222","","ANDA","ANDA062364","IPG PHARMACEUTICALS, INC.","100000; 1","mg/g; mg/g","","N","20251231"
"7769","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","71093017401","Macrolide Antimicrobial [EPC], Macrolides [CS]","71093-174","71093-174-01","71093-174_5df20b25-1932-414b-b028-210e839c1c38","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20221201","","ANDA","ANDA215772","ACI Healthcare USA, Inc.","250","mg/1","","N","20251231"
"7770","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","71093017505","Macrolide Antimicrobial [EPC], Macrolides [CS]","71093-175","71093-175-05","71093-175_77a7e874-29c3-449c-92b3-448023e67197","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20230730","","ANDA","ANDA215773","ACI Healthcare USA, Inc.","500","mg/1","","N","20251231"
"7771","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","71093017501","Macrolide Antimicrobial [EPC], Macrolides [CS]","71093-175","71093-175-01","71093-175_77a7e874-29c3-449c-92b3-448023e67197","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20230730","","ANDA","ANDA215773","ACI Healthcare USA, Inc.","500","mg/1","","N","20251231"
"7772","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","71101021001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","71101-210","71101-210-01","71101-210_299514c6-0462-7bd2-e063-6294a90af9b3","HUMAN OTC DRUG","TheraCare First Aid Triple Antibiotic","","OINTMENT","TOPICAL","20210401","","OTC MONOGRAPH DRUG","M004","Veridian Healthcare","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"7773","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","71101022101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","71101-221","71101-221-01","71101-221_298ef7ed-981f-dca9-e063-6294a90acd8f","HUMAN OTC DRUG","TheraCare Triple Antibiotic","","OINTMENT","TOPICAL","20231201","","OTC MONOGRAPH DRUG","M004","Veridian Healthcare","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"7774","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin,Neomycin,Polymxin, Pramoxine","71101022901","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","71101-229","71101-229-01","71101-229_298eedaa-11c6-e130-e063-6394a90af559","HUMAN OTC DRUG","TheraCare Triple Antibiotic Pain Relief","","OINTMENT","TOPICAL","20230501","","OTC MONOGRAPH DRUG","M004","Veridian Healthcare","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"7775","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","71101080101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","71101-801","71101-801-01","71101-801_2994e64d-69f0-440f-e063-6294a90adbae","HUMAN OTC DRUG","Caring Mills Triple Antibiotic","","OINTMENT","TOPICAL","20230501","","OTC MONOGRAPH DRUG","M004","Veridian Healthcare","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"7776","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Triple Antibiotic First Aid Ointment","71105056012","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","71105-560","71105-560-12","71105-560_2f9d65d6-8755-31a4-e063-6394a90a7b48","HUMAN OTC DRUG","Redicare Triple Antibiotic First Aid","","OINTMENT","TOPICAL","20191008","","OTC MONOGRAPH DRUG","M004","Redicare LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"7777","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate","71141013432","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","71141-134","71141-134-32","71141-134_262f0dbd-b742-541a-e063-6394a90af06c","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20151215","","OTC MONOGRAPH DRUG","M004","Lidl US, LLC","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"7778","VALGANCICLOVIR HYDROCHLORIDE","valganciclovir","71151000301","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","71151-003","71151-003-01","71151-003_d94fb558-d963-5c7a-e053-2a95a90a04b4","HUMAN PRESCRIPTION DRUG","VALGANCICLOVIR","","FOR SOLUTION","ORAL","20220228","","ANDA","ANDA210169","airis PHARMA PVT LTD","50","mg/mL","","N","20251231"
"7779","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate","71205000628","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","71205-006","71205-006-28","71205-006_92996a14-b98c-41d0-8519-2f66b294040d","HUMAN OTC DRUG","TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20110601","","OTC MONOGRAPH DRUG","M004","Proficient Rx LP","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"7780","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205001406","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-014","71205-014-06","71205-014_0ac7c0f7-8f34-45f5-9979-2b1c95b3d63f","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","Proficient Rx LP","500; 125","mg/1; mg/1","","N","20251231"
"7781","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205001421","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-014","71205-014-21","71205-014_0ac7c0f7-8f34-45f5-9979-2b1c95b3d63f","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","Proficient Rx LP","500; 125","mg/1; mg/1","","N","20251231"
"7782","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205001420","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-014","71205-014-20","71205-014_0ac7c0f7-8f34-45f5-9979-2b1c95b3d63f","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","Proficient Rx LP","500; 125","mg/1; mg/1","","N","20251231"
"7783","NITROFURANTOIN","Nitrofurantion Macrocrystals","71205002310","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71205-023","71205-023-10","71205-023_0193ca88-0938-a229-e063-6294a90a4b38","HUMAN PRESCRIPTION DRUG","Nitrofurantion Macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Proficient Rx LP","50","mg/1","","N","20251231"
"7784","NITROFURANTOIN","Nitrofurantion Macrocrystals","71205002314","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71205-023","71205-023-14","71205-023_0193ca88-0938-a229-e063-6294a90a4b38","HUMAN PRESCRIPTION DRUG","Nitrofurantion Macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Proficient Rx LP","50","mg/1","","N","20251231"
"7785","NITROFURANTOIN","Nitrofurantion Macrocrystals","71205002320","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71205-023","71205-023-20","71205-023_0193ca88-0938-a229-e063-6294a90a4b38","HUMAN PRESCRIPTION DRUG","Nitrofurantion Macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Proficient Rx LP","50","mg/1","","N","20251231"
"7786","NITROFURANTOIN","Nitrofurantion Macrocrystals","71205002360","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71205-023","71205-023-60","71205-023_0193ca88-0938-a229-e063-6294a90a4b38","HUMAN PRESCRIPTION DRUG","Nitrofurantion Macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Proficient Rx LP","50","mg/1","","N","20251231"
"7787","NITROFURANTOIN","Nitrofurantion Macrocrystals","71205002390","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71205-023","71205-023-90","71205-023_0193ca88-0938-a229-e063-6294a90a4b38","HUMAN PRESCRIPTION DRUG","Nitrofurantion Macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Proficient Rx LP","50","mg/1","","N","20251231"
"7788","NITROFURANTOIN","Nitrofurantion Macrocrystals","71205002330","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71205-023","71205-023-30","71205-023_0193ca88-0938-a229-e063-6294a90a4b38","HUMAN PRESCRIPTION DRUG","Nitrofurantion Macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Proficient Rx LP","50","mg/1","","N","20251231"
"7789","AMOXICILLIN","Amoxicillin","71205003514","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-035","71205-035-14","71205-035_23c32fbb-0d4d-4830-883f-0967c8586247","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20050713","","ANDA","ANDA065228","Proficient Rx LP","875","mg/1","","N","20251231"
"7790","AMOXICILLIN","Amoxicillin","71205003530","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-035","71205-035-30","71205-035_23c32fbb-0d4d-4830-883f-0967c8586247","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20050713","","ANDA","ANDA065228","Proficient Rx LP","875","mg/1","","N","20251231"
"7791","AMOXICILLIN","Amoxicillin","71205003560","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-035","71205-035-60","71205-035_23c32fbb-0d4d-4830-883f-0967c8586247","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20050713","","ANDA","ANDA065228","Proficient Rx LP","875","mg/1","","N","20251231"
"7792","AMOXICILLIN","Amoxicillin","71205003590","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-035","71205-035-90","71205-035_23c32fbb-0d4d-4830-883f-0967c8586247","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20050713","","ANDA","ANDA065228","Proficient Rx LP","875","mg/1","","N","20251231"
"7793","AMOXICILLIN","Amoxicillin","71205003520","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-035","71205-035-20","71205-035_23c32fbb-0d4d-4830-883f-0967c8586247","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20050713","","ANDA","ANDA065228","Proficient Rx LP","875","mg/1","","N","20251231"
"7794","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205003675","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-036","71205-036-75","71205-036_d8353a21-2ed6-4faa-b0a0-f35aae947ac2","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201091","Proficient Rx LP","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"7795","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205003612","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-036","71205-036-12","71205-036_d8353a21-2ed6-4faa-b0a0-f35aae947ac2","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201091","Proficient Rx LP","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"7796","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71205006130","Allylamine Antifungal [EPC], Allylamine [CS]","71205-061","71205-061-30","71205-061_f2548203-c59d-46a1-bf6f-098e91344380","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Proficient Rx LP","250","mg/1","","N","20251231"
"7797","FLUCONAZOLE","fluconazole","71205008101","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-081","71205-081-01","71205-081_40f55b8c-8674-413a-b58d-f1c8b767d680","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Proficient Rx LP","150","mg/1","","N","20251231"
"7798","FLUCONAZOLE","fluconazole","71205008104","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-081","71205-081-04","71205-081_40f55b8c-8674-413a-b58d-f1c8b767d680","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Proficient Rx LP","150","mg/1","","N","20251231"
"7799","FLUCONAZOLE","fluconazole","71205008102","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-081","71205-081-02","71205-081_40f55b8c-8674-413a-b58d-f1c8b767d680","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Proficient Rx LP","150","mg/1","","N","20251231"
"7800","TOBRAMYCIN","Tobramycin","71205010105","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","71205-101","71205-101-05","71205-101_d8d5861a-e24a-4b45-8c72-196492c27271","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION/ DROPS","OPHTHALMIC","20170705","","ANDA","ANDA207444","Proficient Rx LP","3","mg/mL","","N","20251231"
"7801","KETOCONAZOLE","Ketoconazole","71205010572","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71205-105","71205-105-72","71205-105_c7f1508c-9478-4379-9c50-4d5a6b8cdcef","HUMAN PRESCRIPTION DRUG","Ketoconazole","","SHAMPOO, SUSPENSION","TOPICAL","20161001","","ANDA","ANDA076942","Proficient Rx LP","20","mg/mL","","N","20251231"
"7802","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71205012714","Allylamine Antifungal [EPC], Allylamine [CS]","71205-127","71205-127-14","71205-127_ebcef20e-0991-4cd7-b79c-0d1a29b90fed","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Proficient Rx LP","250","mg/1","","N","20251231"
"7803","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71205012730","Allylamine Antifungal [EPC], Allylamine [CS]","71205-127","71205-127-30","71205-127_ebcef20e-0991-4cd7-b79c-0d1a29b90fed","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Proficient Rx LP","250","mg/1","","N","20251231"
"7804","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71205012735","Allylamine Antifungal [EPC], Allylamine [CS]","71205-127","71205-127-35","71205-127_ebcef20e-0991-4cd7-b79c-0d1a29b90fed","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Proficient Rx LP","250","mg/1","","N","20251231"
"7805","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71205012742","Allylamine Antifungal [EPC], Allylamine [CS]","71205-127","71205-127-42","71205-127_ebcef20e-0991-4cd7-b79c-0d1a29b90fed","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Proficient Rx LP","250","mg/1","","N","20251231"
"7806","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71205012715","Allylamine Antifungal [EPC], Allylamine [CS]","71205-127","71205-127-15","71205-127_ebcef20e-0991-4cd7-b79c-0d1a29b90fed","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Proficient Rx LP","250","mg/1","","N","20251231"
"7807","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71205012760","Allylamine Antifungal [EPC], Allylamine [CS]","71205-127","71205-127-60","71205-127_ebcef20e-0991-4cd7-b79c-0d1a29b90fed","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Proficient Rx LP","250","mg/1","","N","20251231"
"7808","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71205012790","Allylamine Antifungal [EPC], Allylamine [CS]","71205-127","71205-127-90","71205-127_ebcef20e-0991-4cd7-b79c-0d1a29b90fed","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Proficient Rx LP","250","mg/1","","N","20251231"
"7809","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71205012745","Allylamine Antifungal [EPC], Allylamine [CS]","71205-127","71205-127-45","71205-127_ebcef20e-0991-4cd7-b79c-0d1a29b90fed","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Proficient Rx LP","250","mg/1","","N","20251231"
"7810","TERBINAFINE HYDROCHLORIDE","Terbinafine","71205015230","Allylamine Antifungal [EPC], Allylamine [CS]","71205-152","71205-152-30","71205-152_86d7ee5e-ebfd-45ea-a520-b6f65814c3e2","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20160627","","ANDA","ANDA077533","Proficient Rx LP","250","1/1","","N","20251231"
"7811","TERBINAFINE HYDROCHLORIDE","Terbinafine","71205015235","Allylamine Antifungal [EPC], Allylamine [CS]","71205-152","71205-152-35","71205-152_86d7ee5e-ebfd-45ea-a520-b6f65814c3e2","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20160627","","ANDA","ANDA077533","Proficient Rx LP","250","1/1","","N","20251231"
"7812","TERBINAFINE HYDROCHLORIDE","Terbinafine","71205015245","Allylamine Antifungal [EPC], Allylamine [CS]","71205-152","71205-152-45","71205-152_86d7ee5e-ebfd-45ea-a520-b6f65814c3e2","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20160627","","ANDA","ANDA077533","Proficient Rx LP","250","1/1","","N","20251231"
"7813","TERBINAFINE HYDROCHLORIDE","Terbinafine","71205015215","Allylamine Antifungal [EPC], Allylamine [CS]","71205-152","71205-152-15","71205-152_86d7ee5e-ebfd-45ea-a520-b6f65814c3e2","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20160627","","ANDA","ANDA077533","Proficient Rx LP","250","1/1","","N","20251231"
"7814","TERBINAFINE HYDROCHLORIDE","Terbinafine","71205015290","Allylamine Antifungal [EPC], Allylamine [CS]","71205-152","71205-152-90","71205-152_86d7ee5e-ebfd-45ea-a520-b6f65814c3e2","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20160627","","ANDA","ANDA077533","Proficient Rx LP","250","1/1","","N","20251231"
"7815","TERBINAFINE HYDROCHLORIDE","Terbinafine","71205015260","Allylamine Antifungal [EPC], Allylamine [CS]","71205-152","71205-152-60","71205-152_86d7ee5e-ebfd-45ea-a520-b6f65814c3e2","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20160627","","ANDA","ANDA077533","Proficient Rx LP","250","1/1","","N","20251231"
"7816","AZITHROMYCIN DIHYDRATE","Azithromycin","71205015803","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-158","71205-158-03","71205-158_d47fa421-e017-48f1-95a9-c0922cca63d6","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207370","Proficient Rx LP","250","mg/1","","N","20251231"
"7817","AZITHROMYCIN DIHYDRATE","Azithromycin","71205015830","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-158","71205-158-30","71205-158_d47fa421-e017-48f1-95a9-c0922cca63d6","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207370","Proficient Rx LP","250","mg/1","","N","20251231"
"7818","AZITHROMYCIN DIHYDRATE","Azithromycin","71205015866","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-158","71205-158-66","71205-158_d47fa421-e017-48f1-95a9-c0922cca63d6","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207370","Proficient Rx LP","250","mg/1","","N","20251231"
"7819","AZITHROMYCIN DIHYDRATE","Azithromycin","71205015806","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-158","71205-158-06","71205-158_d47fa421-e017-48f1-95a9-c0922cca63d6","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207370","Proficient Rx LP","250","mg/1","","N","20251231"
"7820","NITROFURANTOIN","Nitrofurantion","71205017110","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71205-171","71205-171-10","71205-171_a1447d12-32dc-4e06-960e-d4c2f2880fae","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Proficient Rx LP","100","mg/1","","N","20251231"
"7821","NITROFURANTOIN","Nitrofurantion","71205017120","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71205-171","71205-171-20","71205-171_a1447d12-32dc-4e06-960e-d4c2f2880fae","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Proficient Rx LP","100","mg/1","","N","20251231"
"7822","NITROFURANTOIN","Nitrofurantion","71205017128","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71205-171","71205-171-28","71205-171_a1447d12-32dc-4e06-960e-d4c2f2880fae","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Proficient Rx LP","100","mg/1","","N","20251231"
"7823","NITROFURANTOIN","Nitrofurantion","71205017114","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71205-171","71205-171-14","71205-171_a1447d12-32dc-4e06-960e-d4c2f2880fae","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Proficient Rx LP","100","mg/1","","N","20251231"
"7824","AMOXICILLIN","Amoxicillin","71205017700","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-177","71205-177-00","71205-177_aefe01bd-575f-4718-872e-b5d89f4916b5","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20030226","","ANDA","ANDA065119","Proficient Rx LP","400","mg/5mL","","N","20251231"
"7825","AZITHROMYCIN DIHYDRATE","Azithromycin","71205021630","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-216","71205-216-30","71205-216_476af655-9fb8-4253-a569-fb3295680838","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20180806","","ANDA","ANDA211147","Proficient Rx LP","200","mg/5mL","","N","20251231"
"7826","CEFDINIR","Cefdinir","71205022414","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-224","71205-224-14","71205-224_cca0fc04-974d-49a1-8fc9-4e07684fed0a","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","Proficient Rx LP","300","mg/1","","N","20251231"
"7827","CEFDINIR","Cefdinir","71205022420","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-224","71205-224-20","71205-224_cca0fc04-974d-49a1-8fc9-4e07684fed0a","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","Proficient Rx LP","300","mg/1","","N","20251231"
"7828","CEFDINIR","Cefdinir","71205022430","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-224","71205-224-30","71205-224_cca0fc04-974d-49a1-8fc9-4e07684fed0a","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","Proficient Rx LP","300","mg/1","","N","20251231"
"7829","CEFDINIR","Cefdinir","71205022490","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-224","71205-224-90","71205-224_cca0fc04-974d-49a1-8fc9-4e07684fed0a","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","Proficient Rx LP","300","mg/1","","N","20251231"
"7830","CEFDINIR","Cefdinir","71205022460","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-224","71205-224-60","71205-224_cca0fc04-974d-49a1-8fc9-4e07684fed0a","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","Proficient Rx LP","300","mg/1","","N","20251231"
"7831","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN","71205025330","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-253","71205-253-30","71205-253_55f728b3-b5c9-427f-a09a-2764663d4175","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","POWDER, FOR SUSPENSION","PARENTERAL","20180410","","ANDA","ANDA207531","Proficient Rx LP","200","mg/5mL","","N","20251231"
"7832","ERYTHROMYCIN","erythromycin","71205026535","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","71205-265","71205-265-35","71205-265_e81dd1b8-6a0c-4fc4-afbe-496ed719c048","HUMAN PRESCRIPTION DRUG","erythromycin","","OINTMENT","OPHTHALMIC","20140508","","ANDA","ANDA062447","Proficient Rx LP","5","mg/g","","N","20251231"
"7833","AMOXICILLIN","Amoxicillin","71205026615","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-266","71205-266-15","71205-266_b7495577-9753-41ff-96cf-8122612928de","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065387","Proficient Rx LP","125","mg/5mL","","N","20251231"
"7834","FLUCONAZOLE","fluconazole","71205028330","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-283","71205-283-30","71205-283_1410a251-cc08-49a0-b4aa-dfd217bca85b","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Proficient Rx LP","200","mg/1","","N","20251231"
"7835","FLUCONAZOLE","fluconazole","71205028360","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-283","71205-283-60","71205-283_1410a251-cc08-49a0-b4aa-dfd217bca85b","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Proficient Rx LP","200","mg/1","","N","20251231"
"7836","FLUCONAZOLE","fluconazole","71205028390","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-283","71205-283-90","71205-283_1410a251-cc08-49a0-b4aa-dfd217bca85b","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Proficient Rx LP","200","mg/1","","N","20251231"
"7837","NITROFURANTOIN","Nitrofurantoin Macrocrystals","71205029714","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71205-297","71205-297-14","71205-297_63647c09-e111-4a17-85e7-9f5f1853fad7","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Macrocrystals","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","Proficient Rx LP","100","mg/1","","N","20251231"
"7838","NITROFURANTOIN","Nitrofurantoin Macrocrystals","71205029720","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71205-297","71205-297-20","71205-297_63647c09-e111-4a17-85e7-9f5f1853fad7","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Macrocrystals","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","Proficient Rx LP","100","mg/1","","N","20251231"
"7839","NITROFURANTOIN","Nitrofurantoin Macrocrystals","71205029710","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71205-297","71205-297-10","71205-297_63647c09-e111-4a17-85e7-9f5f1853fad7","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Macrocrystals","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","Proficient Rx LP","100","mg/1","","N","20251231"
"7840","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71205030005","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-300","71205-300-05","71205-300_a797de06-c8be-4417-9bac-137dc4931c8b","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","SOLUTION","OPHTHALMIC","20181101","","ANDA","ANDA077568","Proficient Rx LP","3","mg/mL","","N","20251231"
"7841","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin and Polymyxin B Sulfates and Dexamethasone","71205033035","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","71205-330","71205-330-35","71205-330_d7249352-be32-4361-801a-98b4886615f6","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Dexamethasone","","OINTMENT","OPHTHALMIC","19960221","","NDA AUTHORIZED GENERIC","NDA050065","Proficient Rx LP","1; 3.5; 10000","mg/g; mg/g; [iU]/g","","N","20251231"
"7842","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205033114","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-331","71205-331-14","71205-331_32686b6d-d8ac-4f0a-831e-f1bbbf2cf640","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7843","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205033115","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-331","71205-331-15","71205-331_32686b6d-d8ac-4f0a-831e-f1bbbf2cf640","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7844","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205033120","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-331","71205-331-20","71205-331_32686b6d-d8ac-4f0a-831e-f1bbbf2cf640","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7845","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205033160","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-331","71205-331-60","71205-331_32686b6d-d8ac-4f0a-831e-f1bbbf2cf640","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7846","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205033190","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-331","71205-331-90","71205-331_32686b6d-d8ac-4f0a-831e-f1bbbf2cf640","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7847","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205033130","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-331","71205-331-30","71205-331_32686b6d-d8ac-4f0a-831e-f1bbbf2cf640","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7848","GENTAMICIN SULFATE","Gentamicin Sulfate","71205033305","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","71205-333","71205-333-05","71205-333_f7b2d19f-57fe-4aae-a6be-c9f4525e1438","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","SOLUTION","OPHTHALMIC","19960405","","ANDA","ANDA062196","Proficient Rx LP","3","mg/mL","","N","20261231"
"7849","CEFDINIR","Cefdinir","71205038060","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-380","71205-380-60","71205-380_eb67d441-028c-49e6-93b4-2be3b6bc9acf","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070507","","ANDA","ANDA065259","Proficient Rx LP","250","mg/5mL","","N","20251231"
"7850","CEFDINIR","Cefdinir","71205038000","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-380","71205-380-00","71205-380_eb67d441-028c-49e6-93b4-2be3b6bc9acf","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070507","","ANDA","ANDA065259","Proficient Rx LP","250","mg/5mL","","N","20251231"
"7851","CEFDINIR","Cefdinir","71205040500","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-405","71205-405-00","71205-405_b484ae16-7d8d-4be7-9c9a-2b613592eca3","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20071214","","ANDA","ANDA065473","Proficient Rx LP","250","mg/5mL","","N","20251231"
"7852","CEFDINIR","Cefdinir","71205040560","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-405","71205-405-60","71205-405_b484ae16-7d8d-4be7-9c9a-2b613592eca3","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20071214","","ANDA","ANDA065473","Proficient Rx LP","250","mg/5mL","","N","20251231"
"7853","OFLOXACIN","ofloxacin","71205042005","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-420","71205-420-05","71205-420_e65f9309-c5da-4159-ba09-28754fe12593","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20190301","","ANDA","ANDA076513","Proficient Rx LP","3","mg/mL","","N","20251231"
"7854","AMOXICILLIN","Amoxicillin","71205042200","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-422","71205-422-00","71205-422_ffdf60e8-a414-4675-8e7d-8e90ebab3614","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20060619","","ANDA","ANDA065325","Proficient Rx LP","400","mg/5mL","","N","20251231"
"7855","AZITHROMYCIN DIHYDRATE","Azithromycin","71205042406","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-424","71205-424-06","71205-424_d8e60aa5-76e2-4c27-9f03-f6a188be7079","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210000","Proficient Rx LP","250","mg/1","","N","20251231"
"7856","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","71205043004","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-430","71205-430-04","71205-430_edcedd16-fe45-4edb-a0f8-55d904a59096","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","","ANDA","ANDA208250","Proficient Rx LP","250","mg/1","","N","20251231"
"7857","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","71205043006","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-430","71205-430-06","71205-430_edcedd16-fe45-4edb-a0f8-55d904a59096","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","","ANDA","ANDA208250","Proficient Rx LP","250","mg/1","","N","20251231"
"7858","CLOTRIMAZOLE","Clotrimazole","71205043215","Azole Antifungal [EPC], Azoles [CS]","71205-432","71205-432-15","71205-432_64950943-266b-4fe5-bfc0-643875330c13","HUMAN PRESCRIPTION DRUG","Clotrimazole","","CREAM","TOPICAL","19930831","","ANDA","ANDA072640","Proficient Rx LP","10","mg/g","","N","20251231"
"7859","CLOTRIMAZOLE","Clotrimazole","71205043405","Azole Antifungal [EPC], Azoles [CS]","71205-434","71205-434-05","71205-434_fa8aeb26-bd17-471f-aa37-827321613599","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20150310","","OTC MONOGRAPH DRUG","M005","Proficient Rx LP","1","g/100g","","N","20251231"
"7860","AMOXICILLIN","Amoxicillin","71205043600","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-436","71205-436-00","71205-436_ead1e453-af08-4a3b-8379-aa182dff514b","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065378","Proficient Rx LP","400","mg/5mL","","N","20251231"
"7861","NYSTATIN","Nystatin Ointment","71205043715","Polyene Antifungal [EPC], Polyenes [CS]","71205-437","71205-437-15","71205-437_711950c4-1889-4acd-ab76-9a16176ce1e4","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20171006","","ANDA","ANDA209114","Proficient Rx LP","100000","[USP'U]/g","","N","20251231"
"7862","CLOTRIMAZOLE","CLOTRIMAZOLE","71205043805","Azole Antifungal [EPC], Azoles [CS]","71205-438","71205-438-05","71205-438_6e0da803-8e4f-43a7-a961-930c7dd1794f","HUMAN OTC DRUG","Major Clotrimazole","","CREAM","TOPICAL","20041004","","OTC MONOGRAPH DRUG","M005","Proficient Rx LP","10","mg/g","","N","20251231"
"7863","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71205044420","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71205-444","71205-444-20","71205-444_a19e5779-7d1a-4f35-9ab8-9568a18fbd8e","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Proficient Rx LP","300","mg/1","","N","20251231"
"7864","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71205044428","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71205-444","71205-444-28","71205-444_a19e5779-7d1a-4f35-9ab8-9568a18fbd8e","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Proficient Rx LP","300","mg/1","","N","20251231"
"7865","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71205044430","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71205-444","71205-444-30","71205-444_a19e5779-7d1a-4f35-9ab8-9568a18fbd8e","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Proficient Rx LP","300","mg/1","","N","20251231"
"7866","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71205044440","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71205-444","71205-444-40","71205-444_a19e5779-7d1a-4f35-9ab8-9568a18fbd8e","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Proficient Rx LP","300","mg/1","","N","20251231"
"7867","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71205044421","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71205-444","71205-444-21","71205-444_a19e5779-7d1a-4f35-9ab8-9568a18fbd8e","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Proficient Rx LP","300","mg/1","","N","20251231"
"7868","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71205044490","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71205-444","71205-444-90","71205-444_a19e5779-7d1a-4f35-9ab8-9568a18fbd8e","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Proficient Rx LP","300","mg/1","","N","20251231"
"7869","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71205044460","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71205-444","71205-444-60","71205-444_a19e5779-7d1a-4f35-9ab8-9568a18fbd8e","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Proficient Rx LP","300","mg/1","","N","20251231"
"7870","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71205044812","Antimalarial [EPC], Antirheumatic Agent [EPC]","71205-448","71205-448-12","71205-448_8aec894d-5711-4079-b167-240713bf04f2","HUMAN PRESCRIPTION DRUG","Plaquenil","","TABLET","ORAL","20130628","","NDA","NDA009768","Proficient Rx LP","200","mg/1","","N","20251231"
"7871","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205046200","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-462","71205-462-00","71205-462_ed89149c-e68a-4c7f-9ca0-ae8f4a91c403","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","Proficient Rx LP","400; 57","mg/5mL; mg/5mL","","N","20251231"
"7872","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205046250","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-462","71205-462-50","71205-462_ed89149c-e68a-4c7f-9ca0-ae8f4a91c403","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","Proficient Rx LP","400; 57","mg/5mL; mg/5mL","","N","20251231"
"7873","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","71205049103","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-491","71205-491-03","71205-491_c11b77b5-22be-4867-8752-ffc72a57f768","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","","ANDA","ANDA208249","Proficient Rx LP","500","mg/1","","N","20251231"
"7874","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","71205049104","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-491","71205-491-04","71205-491_c11b77b5-22be-4867-8752-ffc72a57f768","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","","ANDA","ANDA208249","Proficient Rx LP","500","mg/1","","N","20251231"
"7875","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71205049230","Allylamine Antifungal [EPC], Allylamine [CS]","71205-492","71205-492-30","71205-492_bfd48470-04e9-46cb-857b-10d014b5ae1f","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Proficient Rx LP","250","mg/1","","N","20251231"
"7876","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71205049242","Allylamine Antifungal [EPC], Allylamine [CS]","71205-492","71205-492-42","71205-492_bfd48470-04e9-46cb-857b-10d014b5ae1f","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Proficient Rx LP","250","mg/1","","N","20251231"
"7877","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71205049245","Allylamine Antifungal [EPC], Allylamine [CS]","71205-492","71205-492-45","71205-492_bfd48470-04e9-46cb-857b-10d014b5ae1f","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Proficient Rx LP","250","mg/1","","N","20251231"
"7878","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71205049260","Allylamine Antifungal [EPC], Allylamine [CS]","71205-492","71205-492-60","71205-492_bfd48470-04e9-46cb-857b-10d014b5ae1f","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Proficient Rx LP","250","mg/1","","N","20251231"
"7879","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71205049290","Allylamine Antifungal [EPC], Allylamine [CS]","71205-492","71205-492-90","71205-492_bfd48470-04e9-46cb-857b-10d014b5ae1f","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Proficient Rx LP","250","mg/1","","N","20251231"
"7880","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71205049235","Allylamine Antifungal [EPC], Allylamine [CS]","71205-492","71205-492-35","71205-492_bfd48470-04e9-46cb-857b-10d014b5ae1f","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Proficient Rx LP","250","mg/1","","N","20251231"
"7881","AZITHROMYCIN DIHYDRATE","Azithromycin","71205050303","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-503","71205-503-03","71205-503_31df881c-4b9b-4717-8f76-98b6ca8be644","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210001","Proficient Rx LP","500","mg/1","","N","20251231"
"7882","AMOXICILLIN","Amoxicillin","71205050720","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-507","71205-507-20","71205-507_b3e15f9d-bb6f-47c3-b7d9-12742497837f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"7883","AMOXICILLIN","Amoxicillin","71205050721","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-507","71205-507-21","71205-507_b3e15f9d-bb6f-47c3-b7d9-12742497837f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"7884","AMOXICILLIN","Amoxicillin","71205050730","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-507","71205-507-30","71205-507_b3e15f9d-bb6f-47c3-b7d9-12742497837f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"7885","AMOXICILLIN","Amoxicillin","71205050714","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-507","71205-507-14","71205-507_b3e15f9d-bb6f-47c3-b7d9-12742497837f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"7886","AMOXICILLIN","Amoxicillin","71205050760","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-507","71205-507-60","71205-507_b3e15f9d-bb6f-47c3-b7d9-12742497837f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"7887","AMOXICILLIN","Amoxicillin","71205050790","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-507","71205-507-90","71205-507_b3e15f9d-bb6f-47c3-b7d9-12742497837f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"7888","AMOXICILLIN","Amoxicillin","71205050740","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-507","71205-507-40","71205-507_b3e15f9d-bb6f-47c3-b7d9-12742497837f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"7889","AZITHROMYCIN DIHYDRATE","Azithromycin","71205051903","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-519","71205-519-03","71205-519_8a140f7c-4dc7-454d-9ff9-473f4306a649","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207398","Proficient Rx LP","500","mg/1","","N","20251231"
"7890","AZITHROMYCIN DIHYDRATE","Azithromycin","71205051930","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-519","71205-519-30","71205-519_8a140f7c-4dc7-454d-9ff9-473f4306a649","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20180705","","ANDA","ANDA207398","Proficient Rx LP","500","mg/1","","N","20251231"
"7891","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","71205052415","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","71205-524","71205-524-15","71205-524_c6e4bf5f-f6d6-489e-9286-c30568c601b7","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20151106","","ANDA","ANDA202894","Proficient Rx LP",".5; 10","mg/g; mg/g","","N","20251231"
"7892","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","71205054501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-545","71205-545-01","71205-545_5112a092-8be2-47d6-81f5-10e632329781","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170630","","ANDA","ANDA203702","Proficient Rx LP","1","g/1","","N","20251231"
"7893","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","71205054610","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71205-546","71205-546-10","71205-546_ffdcd017-8fc8-4cd2-9319-06e3d2e7f3e9","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20141101","","ANDA","ANDA077066","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"7894","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","71205054620","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71205-546","71205-546-20","71205-546_ffdcd017-8fc8-4cd2-9319-06e3d2e7f3e9","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20141101","","ANDA","ANDA077066","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"7895","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","71205054630","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71205-546","71205-546-30","71205-546_ffdcd017-8fc8-4cd2-9319-06e3d2e7f3e9","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20141101","","ANDA","ANDA077066","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"7896","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","71205054660","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71205-546","71205-546-60","71205-546_ffdcd017-8fc8-4cd2-9319-06e3d2e7f3e9","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20141101","","ANDA","ANDA077066","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"7897","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","71205054690","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71205-546","71205-546-90","71205-546_ffdcd017-8fc8-4cd2-9319-06e3d2e7f3e9","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20141101","","ANDA","ANDA077066","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"7898","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","71205054614","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71205-546","71205-546-14","71205-546_ffdcd017-8fc8-4cd2-9319-06e3d2e7f3e9","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20141101","","ANDA","ANDA077066","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"7899","CEPHALEXIN","Cephalexin","71205055300","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-553","71205-553-00","71205-553_ff4b7d77-f5bf-4286-a4a3-9bb13949ad35","HUMAN PRESCRIPTION DRUG","cephalexin","","FOR SUSPENSION","ORAL","20170906","","ANDA","ANDA065234","Proficient Rx LP","250","mg/5mL","","N","20251231"
"7900","GENTAMICIN SULFATE","Gentamicin Sulfate","71205056015","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","71205-560","71205-560-15","71205-560_cf4386ba-c62a-4ee8-ab59-1bb2e737a5da","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","OINTMENT","TOPICAL","20141128","","ANDA","ANDA064054","Proficient Rx LP","1","mg/g","","N","20251231"
"7901","FLUCONAZOLE","Fluconazole","71205056301","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-563","71205-563-01","71205-563_17807dbb-9edb-488a-b1ee-d2e4ecc7edb3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Proficient Rx LP","150","mg/1","","N","20251231"
"7902","FLUCONAZOLE","Fluconazole","71205056302","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-563","71205-563-02","71205-563_17807dbb-9edb-488a-b1ee-d2e4ecc7edb3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Proficient Rx LP","150","mg/1","","N","20251231"
"7903","FLUCONAZOLE","Fluconazole","71205056304","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-563","71205-563-04","71205-563_17807dbb-9edb-488a-b1ee-d2e4ecc7edb3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Proficient Rx LP","150","mg/1","","N","20251231"
"7904","FLUCONAZOLE","Fluconazole","71205056303","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-563","71205-563-03","71205-563_17807dbb-9edb-488a-b1ee-d2e4ecc7edb3","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Proficient Rx LP","150","mg/1","","N","20251231"
"7905","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN","71205056615","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-566","71205-566-15","71205-566_191f951e-0a52-4ecf-992a-ea1afffffab8","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","POWDER, FOR SUSPENSION","ORAL","20180410","","ANDA","ANDA207531","Proficient Rx LP","200","mg/5mL","","N","20251231"
"7906","NYSTATIN","nystatin","71205057530","Polyene Antifungal [EPC], Polyenes [CS]","71205-575","71205-575-30","71205-575_98364393-50d2-4479-9048-8095cfa7a290","HUMAN PRESCRIPTION DRUG","nystatin","","TABLET, COATED","ORAL","20111031","","ANDA","ANDA062474","Proficient Rx LP","500000","[USP'U]/1","","N","20251231"
"7907","NYSTATIN","nystatin","71205057590","Polyene Antifungal [EPC], Polyenes [CS]","71205-575","71205-575-90","71205-575_98364393-50d2-4479-9048-8095cfa7a290","HUMAN PRESCRIPTION DRUG","nystatin","","TABLET, COATED","ORAL","20111031","","ANDA","ANDA062474","Proficient Rx LP","500000","[USP'U]/1","","N","20251231"
"7908","NYSTATIN","nystatin","71205057560","Polyene Antifungal [EPC], Polyenes [CS]","71205-575","71205-575-60","71205-575_98364393-50d2-4479-9048-8095cfa7a290","HUMAN PRESCRIPTION DRUG","nystatin","","TABLET, COATED","ORAL","20111031","","ANDA","ANDA062474","Proficient Rx LP","500000","[USP'U]/1","","N","20251231"
"7909","CEFDINIR","Cefdinir","71205057606","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-576","71205-576-06","71205-576_e9946b03-ade7-4c74-b94d-78c966bb0c89","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","Proficient Rx LP","300","mg/1","","N","20251231"
"7910","CEFDINIR","Cefdinir","71205057610","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-576","71205-576-10","71205-576_e9946b03-ade7-4c74-b94d-78c966bb0c89","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","Proficient Rx LP","300","mg/1","","N","20251231"
"7911","CEFDINIR","Cefdinir","71205057620","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-576","71205-576-20","71205-576_e9946b03-ade7-4c74-b94d-78c966bb0c89","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","Proficient Rx LP","300","mg/1","","N","20251231"
"7912","CEFDINIR","Cefdinir","71205057630","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-576","71205-576-30","71205-576_e9946b03-ade7-4c74-b94d-78c966bb0c89","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","Proficient Rx LP","300","mg/1","","N","20251231"
"7913","CEFDINIR","Cefdinir","71205057660","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-576","71205-576-60","71205-576_e9946b03-ade7-4c74-b94d-78c966bb0c89","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","Proficient Rx LP","300","mg/1","","N","20251231"
"7914","CEFDINIR","Cefdinir","71205057690","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-576","71205-576-90","71205-576_e9946b03-ade7-4c74-b94d-78c966bb0c89","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","Proficient Rx LP","300","mg/1","","N","20251231"
"7915","CEFDINIR","Cefdinir","71205057614","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-576","71205-576-14","71205-576_e9946b03-ade7-4c74-b94d-78c966bb0c89","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20210220","","ANDA","ANDA210220","Proficient Rx LP","300","mg/1","","N","20251231"
"7916","CEPHALEXIN","Cephalexin","71205059106","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-591","71205-591-06","71205-591_ada7b8a5-98f4-454c-b38f-92192d4db33f","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","Proficient Rx LP","500","mg/1","","N","20251231"
"7917","CEPHALEXIN","Cephalexin","71205059115","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-591","71205-591-15","71205-591_ada7b8a5-98f4-454c-b38f-92192d4db33f","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","Proficient Rx LP","500","mg/1","","N","20251231"
"7918","CEPHALEXIN","Cephalexin","71205059120","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-591","71205-591-20","71205-591_ada7b8a5-98f4-454c-b38f-92192d4db33f","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","Proficient Rx LP","500","mg/1","","N","20251231"
"7919","CEPHALEXIN","Cephalexin","71205059121","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-591","71205-591-21","71205-591_ada7b8a5-98f4-454c-b38f-92192d4db33f","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","Proficient Rx LP","500","mg/1","","N","20251231"
"7920","CEPHALEXIN","Cephalexin","71205059128","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-591","71205-591-28","71205-591_ada7b8a5-98f4-454c-b38f-92192d4db33f","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","Proficient Rx LP","500","mg/1","","N","20251231"
"7921","CEPHALEXIN","Cephalexin","71205059130","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-591","71205-591-30","71205-591_ada7b8a5-98f4-454c-b38f-92192d4db33f","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","Proficient Rx LP","500","mg/1","","N","20251231"
"7922","CEPHALEXIN","Cephalexin","71205059140","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-591","71205-591-40","71205-591_ada7b8a5-98f4-454c-b38f-92192d4db33f","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","Proficient Rx LP","500","mg/1","","N","20251231"
"7923","CEPHALEXIN","Cephalexin","71205059114","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-591","71205-591-14","71205-591_ada7b8a5-98f4-454c-b38f-92192d4db33f","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","Proficient Rx LP","500","mg/1","","N","20251231"
"7924","CEFTRIAXONE SODIUM","Ceftriaxone","71205059301","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-593","71205-593-01","71205-593_5f684b27-197e-45f0-b623-83a5fab20b0f","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20080724","","ANDA","ANDA065329","Proficient Rx LP","2","g/1","","N","20251231"
"7925","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205062075","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-620","71205-620-75","71205-620_6852b72b-bec8-43c3-a1c3-1fea0c6b633f","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","SUSPENSION","ORAL","20070813","","ANDA","ANDA065358","Proficient Rx LP","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"7926","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205063610","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-636","71205-636-10","71205-636_e72981fd-0d15-473b-8e3d-ee84e3d71c03","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Proficient Rx LP","250","mg/1","","N","20251231"
"7927","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205063614","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-636","71205-636-14","71205-636_e72981fd-0d15-473b-8e3d-ee84e3d71c03","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Proficient Rx LP","250","mg/1","","N","20251231"
"7928","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205063620","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-636","71205-636-20","71205-636_e72981fd-0d15-473b-8e3d-ee84e3d71c03","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Proficient Rx LP","250","mg/1","","N","20251231"
"7929","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205063606","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-636","71205-636-06","71205-636_e72981fd-0d15-473b-8e3d-ee84e3d71c03","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Proficient Rx LP","250","mg/1","","N","20251231"
"7930","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205063660","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-636","71205-636-60","71205-636_e72981fd-0d15-473b-8e3d-ee84e3d71c03","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Proficient Rx LP","250","mg/1","","N","20251231"
"7931","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205063690","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-636","71205-636-90","71205-636_e72981fd-0d15-473b-8e3d-ee84e3d71c03","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Proficient Rx LP","250","mg/1","","N","20251231"
"7932","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205063630","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-636","71205-636-30","71205-636_e72981fd-0d15-473b-8e3d-ee84e3d71c03","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Proficient Rx LP","250","mg/1","","N","20251231"
"7933","AZITHROMYCIN DIHYDRATE","Azithromycin","71205064506","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-645","71205-645-06","71205-645_8e6754bd-b54c-41db-ae4b-a69b9f8424d8","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20051114","","ANDA","ANDA065211","Proficient Rx LP","250","mg/1","","N","20251231"
"7934","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205064907","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71205-649","71205-649-07","71205-649_00f44d29-72b5-47a6-a26a-eb1f1c430917","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Proficient Rx LP","500","mg/1","","N","20251231"
"7935","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205064910","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71205-649","71205-649-10","71205-649_00f44d29-72b5-47a6-a26a-eb1f1c430917","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Proficient Rx LP","500","mg/1","","N","20251231"
"7936","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205064914","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71205-649","71205-649-14","71205-649_00f44d29-72b5-47a6-a26a-eb1f1c430917","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Proficient Rx LP","500","mg/1","","N","20251231"
"7937","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205064920","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71205-649","71205-649-20","71205-649_00f44d29-72b5-47a6-a26a-eb1f1c430917","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Proficient Rx LP","500","mg/1","","N","20251231"
"7938","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205064930","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71205-649","71205-649-30","71205-649_00f44d29-72b5-47a6-a26a-eb1f1c430917","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Proficient Rx LP","500","mg/1","","N","20251231"
"7939","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205064960","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71205-649","71205-649-60","71205-649_00f44d29-72b5-47a6-a26a-eb1f1c430917","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Proficient Rx LP","500","mg/1","","N","20251231"
"7940","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205064906","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71205-649","71205-649-06","71205-649_00f44d29-72b5-47a6-a26a-eb1f1c430917","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Proficient Rx LP","500","mg/1","","N","20251231"
"7941","FLUCONAZOLE","Fluconazole","71205065003","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-650","71205-650-03","71205-650_2e7093ee-60d8-4b7f-b28d-f415a36ae086","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Proficient Rx LP","100","mg/1","","N","20251231"
"7942","FLUCONAZOLE","Fluconazole","71205065010","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-650","71205-650-10","71205-650_2e7093ee-60d8-4b7f-b28d-f415a36ae086","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Proficient Rx LP","100","mg/1","","N","20251231"
"7943","FLUCONAZOLE","Fluconazole","71205065030","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-650","71205-650-30","71205-650_2e7093ee-60d8-4b7f-b28d-f415a36ae086","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Proficient Rx LP","100","mg/1","","N","20251231"
"7944","FLUCONAZOLE","Fluconazole","71205065060","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-650","71205-650-60","71205-650_2e7093ee-60d8-4b7f-b28d-f415a36ae086","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Proficient Rx LP","100","mg/1","","N","20251231"
"7945","FLUCONAZOLE","Fluconazole","71205065090","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-650","71205-650-90","71205-650_2e7093ee-60d8-4b7f-b28d-f415a36ae086","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Proficient Rx LP","100","mg/1","","N","20251231"
"7946","FLUCONAZOLE","Fluconazole","71205065020","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-650","71205-650-20","71205-650_2e7093ee-60d8-4b7f-b28d-f415a36ae086","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Proficient Rx LP","100","mg/1","","N","20251231"
"7947","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205065120","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-651","71205-651-20","71205-651_f636413f-82e5-446f-94cc-b4841bdedb33","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7948","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205065130","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-651","71205-651-30","71205-651_f636413f-82e5-446f-94cc-b4841bdedb33","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7949","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205065160","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-651","71205-651-60","71205-651_f636413f-82e5-446f-94cc-b4841bdedb33","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7950","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205065190","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-651","71205-651-90","71205-651_f636413f-82e5-446f-94cc-b4841bdedb33","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7951","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205065110","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-651","71205-651-10","71205-651_f636413f-82e5-446f-94cc-b4841bdedb33","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7952","CEPHALEXIN","Cephalexin","71205067206","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-672","71205-672-06","71205-672_7059a0b2-dd57-4fc1-ac3d-6aead35a4b08","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Proficient Rx LP","500","mg/1","","N","20251231"
"7953","CEPHALEXIN","Cephalexin","71205067215","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-672","71205-672-15","71205-672_7059a0b2-dd57-4fc1-ac3d-6aead35a4b08","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Proficient Rx LP","500","mg/1","","N","20251231"
"7954","CEPHALEXIN","Cephalexin","71205067220","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-672","71205-672-20","71205-672_7059a0b2-dd57-4fc1-ac3d-6aead35a4b08","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Proficient Rx LP","500","mg/1","","N","20251231"
"7955","CEPHALEXIN","Cephalexin","71205067221","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-672","71205-672-21","71205-672_7059a0b2-dd57-4fc1-ac3d-6aead35a4b08","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Proficient Rx LP","500","mg/1","","N","20251231"
"7956","CEPHALEXIN","Cephalexin","71205067214","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-672","71205-672-14","71205-672_7059a0b2-dd57-4fc1-ac3d-6aead35a4b08","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Proficient Rx LP","500","mg/1","","N","20251231"
"7957","CEPHALEXIN","Cephalexin","71205067230","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-672","71205-672-30","71205-672_7059a0b2-dd57-4fc1-ac3d-6aead35a4b08","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Proficient Rx LP","500","mg/1","","N","20251231"
"7958","CEPHALEXIN","Cephalexin","71205067240","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-672","71205-672-40","71205-672_7059a0b2-dd57-4fc1-ac3d-6aead35a4b08","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Proficient Rx LP","500","mg/1","","N","20251231"
"7959","CEPHALEXIN","Cephalexin","71205067228","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-672","71205-672-28","71205-672_7059a0b2-dd57-4fc1-ac3d-6aead35a4b08","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Proficient Rx LP","500","mg/1","","N","20251231"
"7960","AZITHROMYCIN DIHYDRATE","Azithromycin","71205067403","Macrolide Antimicrobial [EPC], Macrolides [CS]","71205-674","71205-674-03","71205-674_69477c94-fdae-4d10-b4e0-2f3c566f2eba","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20051114","","ANDA","ANDA065212","Proficient Rx LP","500","mg/1","","N","20251231"
"7961","CEFAZOLIN SODIUM","Cefazolin","71205067901","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-679","71205-679-01","71205-679_d24529e3-e2b4-46d6-81ba-b7da74501792","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170630","","ANDA","ANDA203661","Proficient Rx LP","1","g/1","","N","20251231"
"7962","OFLOXACIN","Ofloxaxin","71205068205","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-682","71205-682-05","71205-682_e517e70f-da42-4421-98cc-5a31e84f1d45","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","AURICULAR (OTIC)","20080317","","ANDA","ANDA076616","Proficient Rx LP","3","mg/mL","","N","20251231"
"7963","SULFACETAMIDE SODIUM","sulfacetamide sodium","71205068915","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","71205-689","71205-689-15","71205-689_2b4f125c-338e-479f-8feb-b82324230c65","HUMAN PRESCRIPTION DRUG","Sulfacetamide Sodium","","SOLUTION/ DROPS","OPHTHALMIC","19941228","","ANDA","ANDA040066","Proficient Rx LP","100","mg/mL","","N","20251231"
"7964","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","71205071001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71205-710","71205-710-01","71205-710_a25ab5ea-c46d-4562-8f7e-0ccffc2ab069","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050509","","ANDA","ANDA065169","Proficient Rx LP","2","g/1","","N","20251231"
"7965","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205071214","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-712","71205-712-14","71205-712_a0d22635-0e11-448d-b151-6f6168c65723","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7966","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205071220","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-712","71205-712-20","71205-712_a0d22635-0e11-448d-b151-6f6168c65723","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7967","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205071221","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-712","71205-712-21","71205-712_a0d22635-0e11-448d-b151-6f6168c65723","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7968","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205071210","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-712","71205-712-10","71205-712_a0d22635-0e11-448d-b151-6f6168c65723","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7969","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205071230","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-712","71205-712-30","71205-712_a0d22635-0e11-448d-b151-6f6168c65723","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7970","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205071260","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-712","71205-712-60","71205-712_a0d22635-0e11-448d-b151-6f6168c65723","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7971","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205071290","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-712","71205-712-90","71205-712_a0d22635-0e11-448d-b151-6f6168c65723","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7972","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71205071228","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71205-712","71205-712-28","71205-712_a0d22635-0e11-448d-b151-6f6168c65723","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"7973","NYSTATIN","Nystatin Cream","71205072330","Polyene Antifungal [EPC], Polyenes [CS]","71205-723","71205-723-30","71205-723_b1efcc2c-f71a-463d-9a02-fad7550f31ec","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20150401","","ANDA","ANDA061966","Proficient Rx LP","100000","[USP'U]/g","","N","20251231"
"7974","CLOTRIMAZOLE","CLOTRIMAZOLE","71205073815","Azole Antifungal [EPC], Azoles [CS]","71205-738","71205-738-15","71205-738_c923176e-3604-42a2-9820-6b6fbe81d578","HUMAN OTC DRUG","RUGBY ANTIFUNGAL CLOTRIMAZOLE","","CREAM","TOPICAL","20200114","","OTC MONOGRAPH DRUG","M005","Proficient Rx LP",".01","g/g","","N","20251231"
"7975","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71205074906","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-749","71205-749-06","71205-749_6b5fe0aa-c74f-42f3-a84a-1cb16009aa80","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Proficient Rx LP","250","mg/1","","N","20251231"
"7976","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71205074910","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-749","71205-749-10","71205-749_6b5fe0aa-c74f-42f3-a84a-1cb16009aa80","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Proficient Rx LP","250","mg/1","","N","20251231"
"7977","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71205074914","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-749","71205-749-14","71205-749_6b5fe0aa-c74f-42f3-a84a-1cb16009aa80","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Proficient Rx LP","250","mg/1","","N","20251231"
"7978","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71205074920","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-749","71205-749-20","71205-749_6b5fe0aa-c74f-42f3-a84a-1cb16009aa80","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Proficient Rx LP","250","mg/1","","N","20251231"
"7979","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71205074928","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-749","71205-749-28","71205-749_6b5fe0aa-c74f-42f3-a84a-1cb16009aa80","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Proficient Rx LP","250","mg/1","","N","20251231"
"7980","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71205074930","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-749","71205-749-30","71205-749_6b5fe0aa-c74f-42f3-a84a-1cb16009aa80","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Proficient Rx LP","250","mg/1","","N","20251231"
"7981","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71205074960","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-749","71205-749-60","71205-749_6b5fe0aa-c74f-42f3-a84a-1cb16009aa80","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Proficient Rx LP","250","mg/1","","N","20251231"
"7982","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71205074990","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-749","71205-749-90","71205-749_6b5fe0aa-c74f-42f3-a84a-1cb16009aa80","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Proficient Rx LP","250","mg/1","","N","20251231"
"7983","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71205074905","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-749","71205-749-05","71205-749_6b5fe0aa-c74f-42f3-a84a-1cb16009aa80","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Proficient Rx LP","250","mg/1","","N","20251231"
"7984","AMOXICILLIN","Amoxicillin","71205077500","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-775","71205-775-00","71205-775_d5eba477-e255-4d97-9e16-30543c298680","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20061228","","ANDA","ANDA065334","Proficient Rx LP","200","mg/5mL","","N","20251231"
"7985","FLUCONAZOLE","Fluconazole","71205079601","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-796","71205-796-01","71205-796_fa2fa2f8-f3a6-4bc0-943c-03dabd0f1581","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20201120","","ANDA","ANDA077253","Proficient Rx LP","150","mg/1","","N","20251231"
"7986","FLUCONAZOLE","Fluconazole","71205079602","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71205-796","71205-796-02","71205-796_fa2fa2f8-f3a6-4bc0-943c-03dabd0f1581","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20201120","","ANDA","ANDA077253","Proficient Rx LP","150","mg/1","","N","20251231"
"7987","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71205081006","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71205-810","71205-810-06","71205-810_2b902590-982d-43cc-b3a4-52cd9f7edf6f","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"7988","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71205081014","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71205-810","71205-810-14","71205-810_2b902590-982d-43cc-b3a4-52cd9f7edf6f","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"7989","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71205081020","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71205-810","71205-810-20","71205-810_2b902590-982d-43cc-b3a4-52cd9f7edf6f","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"7990","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71205081028","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71205-810","71205-810-28","71205-810_2b902590-982d-43cc-b3a4-52cd9f7edf6f","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"7991","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71205081010","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71205-810","71205-810-10","71205-810_2b902590-982d-43cc-b3a4-52cd9f7edf6f","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"7992","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71205081040","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71205-810","71205-810-40","71205-810_2b902590-982d-43cc-b3a4-52cd9f7edf6f","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"7993","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71205081060","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71205-810","71205-810-60","71205-810_2b902590-982d-43cc-b3a4-52cd9f7edf6f","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"7994","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71205081090","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71205-810","71205-810-90","71205-810_2b902590-982d-43cc-b3a4-52cd9f7edf6f","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"7995","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71205081030","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71205-810","71205-810-30","71205-810_2b902590-982d-43cc-b3a4-52cd9f7edf6f","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Proficient Rx LP","800; 160","mg/1; mg/1","","N","20251231"
"7996","AMOXICILLIN","Amoxicillin","71205081714","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-817","71205-817-14","71205-817_2c395111-c9c1-483e-a542-58b935ede689","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"7997","AMOXICILLIN","Amoxicillin","71205081720","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-817","71205-817-20","71205-817_2c395111-c9c1-483e-a542-58b935ede689","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"7998","AMOXICILLIN","Amoxicillin","71205081721","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-817","71205-817-21","71205-817_2c395111-c9c1-483e-a542-58b935ede689","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"7999","AMOXICILLIN","Amoxicillin","71205081740","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-817","71205-817-40","71205-817_2c395111-c9c1-483e-a542-58b935ede689","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"8000","AMOXICILLIN","Amoxicillin","71205081760","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-817","71205-817-60","71205-817_2c395111-c9c1-483e-a542-58b935ede689","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"8001","AMOXICILLIN","Amoxicillin","71205081790","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-817","71205-817-90","71205-817_2c395111-c9c1-483e-a542-58b935ede689","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"8002","AMOXICILLIN","Amoxicillin","71205081730","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71205-817","71205-817-30","71205-817_2c395111-c9c1-483e-a542-58b935ede689","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Proficient Rx LP","500","mg/1","","N","20251231"
"8003","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71205085210","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71205-852","71205-852-10","71205-852_34d3c103-27b8-454b-9f38-c33157c3b6fc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"8004","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71205085214","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71205-852","71205-852-14","71205-852_34d3c103-27b8-454b-9f38-c33157c3b6fc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"8005","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71205085220","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71205-852","71205-852-20","71205-852_34d3c103-27b8-454b-9f38-c33157c3b6fc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"8006","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71205085200","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71205-852","71205-852-00","71205-852_34d3c103-27b8-454b-9f38-c33157c3b6fc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"8007","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71205085255","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71205-852","71205-852-55","71205-852_34d3c103-27b8-454b-9f38-c33157c3b6fc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"8008","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71205085230","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71205-852","71205-852-30","71205-852_34d3c103-27b8-454b-9f38-c33157c3b6fc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"8009","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205099700","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-997","71205-997-00","71205-997_1c1b4148-3301-4ab7-8955-667658b4c133","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Proficient Rx LP","500","mg/1","","N","20251231"
"8010","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205099710","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-997","71205-997-10","71205-997_1c1b4148-3301-4ab7-8955-667658b4c133","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Proficient Rx LP","500","mg/1","","N","20251231"
"8011","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205099714","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-997","71205-997-14","71205-997_1c1b4148-3301-4ab7-8955-667658b4c133","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Proficient Rx LP","500","mg/1","","N","20251231"
"8012","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205099730","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-997","71205-997-30","71205-997_1c1b4148-3301-4ab7-8955-667658b4c133","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Proficient Rx LP","500","mg/1","","N","20251231"
"8013","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205099755","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-997","71205-997-55","71205-997_1c1b4148-3301-4ab7-8955-667658b4c133","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Proficient Rx LP","500","mg/1","","N","20251231"
"8014","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71205099720","Quinolone Antimicrobial [EPC], Quinolones [CS]","71205-997","71205-997-20","71205-997_1c1b4148-3301-4ab7-8955-667658b4c133","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Proficient Rx LP","500","mg/1","","N","20251231"
"8015","METRONIDAZOLE","Metronidazole","71209006202","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71209-062","71209-062-02","71209-062_476e38a5-95eb-4809-9125-2a36badc6ee2","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20171229","","ANDA","ANDA209794","Cadila Pharmaceuticals Limited","250","mg/1","","N","20251231"
"8016","METRONIDAZOLE","Metronidazole","71209006210","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71209-062","71209-062-10","71209-062_476e38a5-95eb-4809-9125-2a36badc6ee2","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20171229","","ANDA","ANDA209794","Cadila Pharmaceuticals Limited","250","mg/1","","N","20251231"
"8017","METRONIDAZOLE","Metronidazole","71209006310","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71209-063","71209-063-10","71209-063_476e38a5-95eb-4809-9125-2a36badc6ee2","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20171229","","ANDA","ANDA209794","Cadila Pharmaceuticals Limited","500","mg/1","","N","20251231"
"8018","METRONIDAZOLE","Metronidazole","71209006302","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71209-063","71209-063-02","71209-063_476e38a5-95eb-4809-9125-2a36badc6ee2","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20171229","","ANDA","ANDA209794","Cadila Pharmaceuticals Limited","500","mg/1","","N","20251231"
"8019","OFLOXACIN","OFLOXACIN","71209009702","Quinolone Antimicrobial [EPC], Quinolones [CS]","71209-097","71209-097-02","71209-097_85ff09b7-6b73-44bd-a654-11fbab9efdbe","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, FILM COATED","ORAL","20151229","","ANDA","ANDA091656","Cadila Pharmaceuticals Limited","200","mg/1","","N","20251231"
"8020","OFLOXACIN","OFLOXACIN","71209009705","Quinolone Antimicrobial [EPC], Quinolones [CS]","71209-097","71209-097-05","71209-097_85ff09b7-6b73-44bd-a654-11fbab9efdbe","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, FILM COATED","ORAL","20151229","","ANDA","ANDA091656","Cadila Pharmaceuticals Limited","200","mg/1","","N","20251231"
"8021","OFLOXACIN","OFLOXACIN","71209009710","Quinolone Antimicrobial [EPC], Quinolones [CS]","71209-097","71209-097-10","71209-097_85ff09b7-6b73-44bd-a654-11fbab9efdbe","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, FILM COATED","ORAL","20151229","","ANDA","ANDA091656","Cadila Pharmaceuticals Limited","200","mg/1","","N","20251231"
"8022","OFLOXACIN","OFLOXACIN","71209009805","Quinolone Antimicrobial [EPC], Quinolones [CS]","71209-098","71209-098-05","71209-098_85ff09b7-6b73-44bd-a654-11fbab9efdbe","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, FILM COATED","ORAL","20151229","","ANDA","ANDA091656","Cadila Pharmaceuticals Limited","300","mg/1","","N","20251231"
"8023","OFLOXACIN","OFLOXACIN","71209009810","Quinolone Antimicrobial [EPC], Quinolones [CS]","71209-098","71209-098-10","71209-098_85ff09b7-6b73-44bd-a654-11fbab9efdbe","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, FILM COATED","ORAL","20151229","","ANDA","ANDA091656","Cadila Pharmaceuticals Limited","300","mg/1","","N","20251231"
"8024","OFLOXACIN","OFLOXACIN","71209009802","Quinolone Antimicrobial [EPC], Quinolones [CS]","71209-098","71209-098-02","71209-098_85ff09b7-6b73-44bd-a654-11fbab9efdbe","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, FILM COATED","ORAL","20151229","","ANDA","ANDA091656","Cadila Pharmaceuticals Limited","300","mg/1","","N","20251231"
"8025","OFLOXACIN","OFLOXACIN","71209009902","Quinolone Antimicrobial [EPC], Quinolones [CS]","71209-099","71209-099-02","71209-099_85ff09b7-6b73-44bd-a654-11fbab9efdbe","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, FILM COATED","ORAL","20151229","","ANDA","ANDA091656","Cadila Pharmaceuticals Limited","400","mg/1","","N","20251231"
"8026","OFLOXACIN","OFLOXACIN","71209009905","Quinolone Antimicrobial [EPC], Quinolones [CS]","71209-099","71209-099-05","71209-099_85ff09b7-6b73-44bd-a654-11fbab9efdbe","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, FILM COATED","ORAL","20151229","","ANDA","ANDA091656","Cadila Pharmaceuticals Limited","400","mg/1","","N","20251231"
"8027","OFLOXACIN","OFLOXACIN","71209009910","Quinolone Antimicrobial [EPC], Quinolones [CS]","71209-099","71209-099-10","71209-099_85ff09b7-6b73-44bd-a654-11fbab9efdbe","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, FILM COATED","ORAL","20151229","","ANDA","ANDA091656","Cadila Pharmaceuticals Limited","400","mg/1","","N","20251231"
"8028","ERYTHROMYCIN","Erythromycin","71209010001","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","71209-100","71209-100-01","71209-100_feeef834-a0cb-482c-b5bc-078be4f94e38","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20211006","","ANDA","ANDA213628","Cadila Pharmaceuticals Limited","250","mg/1","","N","20251231"
"8029","ERYTHROMYCIN","Erythromycin","71209010005","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","71209-100","71209-100-05","71209-100_feeef834-a0cb-482c-b5bc-078be4f94e38","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20211006","","ANDA","ANDA213628","Cadila Pharmaceuticals Limited","250","mg/1","","N","20251231"
"8030","ERYTHROMYCIN","Erythromycin","71209010101","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","71209-101","71209-101-01","71209-101_feeef834-a0cb-482c-b5bc-078be4f94e38","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20211006","","ANDA","ANDA213628","Cadila Pharmaceuticals Limited","500","mg/1","","N","20251231"
"8031","ERYTHROMYCIN","Erythromycin","71209010105","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","71209-101","71209-101-05","71209-101_feeef834-a0cb-482c-b5bc-078be4f94e38","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20211006","","ANDA","ANDA213628","Cadila Pharmaceuticals Limited","500","mg/1","","N","20251231"
"8032","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin ethylsuccinate","71209010221","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","71209-102","71209-102-21","71209-102_f9139eef-80df-428d-a326-a70cc827f9c9","HUMAN PRESCRIPTION DRUG","Erythromycin ethylsuccinate","","FOR SUSPENSION","ORAL","20221121","","ANDA","ANDA216212","Cadila Pharmaceuticals Limited","200","mg/5mL","","N","20251231"
"8033","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin ethylsuccinate","71209010321","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","71209-103","71209-103-21","71209-103_f9139eef-80df-428d-a326-a70cc827f9c9","HUMAN PRESCRIPTION DRUG","Erythromycin ethylsuccinate","","FOR SUSPENSION","ORAL","20221121","","ANDA","ANDA216212","Cadila Pharmaceuticals Limited","400","mg/5mL","","N","20251231"
"8034","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71262000215","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71262-002","71262-002-15","71262-002_2e71c67f-12a1-3588-e063-6394a90af7cf","HUMAN OTC DRUG","Vitastem","","OINTMENT","TOPICAL","20161108","","OTC MONOGRAPH DRUG","M004","ViaDerma Distribution, Inc.","30","mg/mL","","N","20261231"
"8035","TETRACYCLINE HYDROCHLORIDE","TETRACYCLINE HYDROCHLORIDE","71262000300","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71262-003","71262-003-00","71262-003_2c66c8a8-c66a-08f4-e063-6294a90a5bd7","HUMAN OTC DRUG","Vitastem-tetracycline hydrochloride","","SPRAY","TOPICAL","20190801","","OTC MONOGRAPH DRUG","M004","ViaDerma Distribution, Inc.","30","mg/mL","","N","20261231"
"8036","TETRACYCLINE HYDROCHLORIDE","TETRACYCLINE HYDROCHLORIDE","71262000901","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71262-009","71262-009-01","71262-009_1ea3306d-037f-cb46-e063-6294a90abc20","HUMAN OTC DRUG","Tetracyte Topical Tetracycline Hydrochloride","","OINTMENT","TOPICAL","20240501","","OTC MONOGRAPH DRUG","M004","VIADERMA DISTRIBUTION INC","30","mg/mL","","N","20251231"
"8037","TETRACYCLINE HYDROCHLORIDE","TETRACYCLINE HYDROCHLORIDE","71262001001","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71262-010","71262-010-01","71262-010_2cf03094-91a1-1f6d-e063-6394a90aa65c","HUMAN OTC DRUG","Tetracyte Topical Tetracycline Hydrochloride","","SPRAY","TOPICAL","20240501","","OTC MONOGRAPH DRUG","M004","VIADERMA DISTRIBUTION INC","30","mg/mL","","N","20261231"
"8038","TETRACYCLINE HYDROCHLORIDE","TETRACYCLINE HYDROCHLORIDE","71262001101","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71262-011","71262-011-01","71262-011_25028ec9-8930-3bb7-e063-6394a90a441c","HUMAN OTC DRUG","Tetracyte First Aid and Antibiotic Topical","","OINTMENT","TOPICAL","20241010","","OTC MONOGRAPH DRUG","M004","VIADERMA DISTRIBUTION INC","30","mg/g","","N","20251231"
"8039","TETRACYCLINE HYDROCHLORIDE","TETRACYCLINE HYDROCHLORIDE","71262001201","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71262-012","71262-012-01","71262-012_3016c65c-a150-7c00-e063-6294a90a60ca","HUMAN OTC DRUG","Vitastem First Aid Antibiotic","","OINTMENT","TOPICAL","20250310","","OTC MONOGRAPH DRUG","M004","VIADERMA DISTRIBUTION INC","30","mg/g","","N","20261231"
"8040","DAPTOMYCIN","DAPTOMYCIN","71288001615","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","71288-016","71288-016-15","71288-016_5d017d3b-63c6-49a0-9ef2-49714549db80","HUMAN PRESCRIPTION DRUG","DAPTOMYCIN","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210629","","ANDA","ANDA213623","Meitheal Pharmaceuticals Inc.","500","mg/10mL","","N","20251231"
"8041","DAPTOMYCIN","DAPTOMYCIN","71288001695","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","71288-016","71288-016-95","71288-016_5d017d3b-63c6-49a0-9ef2-49714549db80","HUMAN PRESCRIPTION DRUG","DAPTOMYCIN","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210629","","ANDA","ANDA213623","Meitheal Pharmaceuticals Inc.","500","mg/10mL","","N","20251231"
"8042","DAPTOMYCIN","DAPTOMYCIN","71288001691","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","71288-016","71288-016-91","71288-016_5d017d3b-63c6-49a0-9ef2-49714549db80","HUMAN PRESCRIPTION DRUG","DAPTOMYCIN","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210629","","ANDA","ANDA213623","Meitheal Pharmaceuticals Inc.","500","mg/10mL","","N","20251231"
"8043","DAPTOMYCIN","DAPTOMYCIN","71288001791","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","71288-017","71288-017-91","71288-017_3c105327-7eb3-4555-b607-6ed8f29b0377","HUMAN PRESCRIPTION DRUG","DAPTOMYCIN","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220405","","ANDA","ANDA213786","Meitheal Pharmaceuticals Inc.","350","mg/7mL","","N","20251231"
"8044","DAPTOMYCIN","DAPTOMYCIN","71288001715","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","71288-017","71288-017-15","71288-017_3c105327-7eb3-4555-b607-6ed8f29b0377","HUMAN PRESCRIPTION DRUG","DAPTOMYCIN","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220405","","ANDA","ANDA213786","Meitheal Pharmaceuticals Inc.","350","mg/7mL","","N","20251231"
"8045","TIGECYCLINE","Tigecycline","71288001911","Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]","71288-019","71288-019-11","71288-019_f09be967-0036-46c3-9766-005ed39d15c8","HUMAN PRESCRIPTION DRUG","Tigecycline","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210513","","ANDA","ANDA214020","Meitheal Pharmaceuticals Inc.","50","mg/5mL","","N","20251231"
"8046","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","71288002211","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","71288-022","71288-022-11","71288-022_8783ba3b-c343-44ba-9a51-516751993478","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220728","","ANDA","ANDA215197","Meitheal Pharmaceuticals Inc.","500","mg/10mL","","N","20251231"
"8047","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","71288002321","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","71288-023","71288-023-21","71288-023_8783ba3b-c343-44ba-9a51-516751993478","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220728","","ANDA","ANDA215197","Meitheal Pharmaceuticals Inc.","1","g/20mL","","N","20251231"
"8048","VANCOMYCIN HYDROCHLORIDE","Vancomycin hydrochloride","71288002421","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","71288-024","71288-024-21","71288-024_c050d3db-83fa-4e01-a304-db41eb41086a","HUMAN PRESCRIPTION DRUG","Vancomycin hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220915","","ANDA","ANDA215195","Meitheal Pharmaceuticals Inc.","750","mg/15mL","","N","20251231"
"8049","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","71288002575","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","71288-025","71288-025-75","71288-025_b7b203d8-dec6-49c3-a147-2cfb5f38cbb3","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220727","","ANDA","ANDA215196","Meitheal Pharmaceuticals Inc.","5","g/100mL","","N","20251231"
"8050","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","71288002675","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","71288-026","71288-026-75","71288-026_b7b203d8-dec6-49c3-a147-2cfb5f38cbb3","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220727","","ANDA","ANDA215196","Meitheal Pharmaceuticals Inc.","10","g/95mL","","N","20251231"
"8051","VORICONAZOLE","Voriconazole","71288002730","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71288-027","71288-027-30","71288-027_61637e0c-2ce5-4c11-bda9-6079bfcd3250","HUMAN PRESCRIPTION DRUG","Voriconazole","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220509","","ANDA","ANDA214516","Meitheal Pharmaceuticals Inc.","10","mg/mL","","N","20251231"
"8052","MICAFUNGIN SODIUM","Micafungin sodium","71288002812","Echinocandin Antifungal [EPC], Lipopeptides [CS]","71288-028","71288-028-12","71288-028_9571440f-2c9b-4281-b907-0d53408d744e","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220928","","ANDA","ANDA215381","Meitheal Pharmaceuticals Inc.","50","mg/5mL","","N","20251231"
"8053","MICAFUNGIN SODIUM","Micafungin sodium","71288002811","Echinocandin Antifungal [EPC], Lipopeptides [CS]","71288-028","71288-028-11","71288-028_9571440f-2c9b-4281-b907-0d53408d744e","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220928","","ANDA","ANDA215381","Meitheal Pharmaceuticals Inc.","50","mg/5mL","","N","20251231"
"8054","MICAFUNGIN SODIUM","Micafungin sodium","71288002911","Echinocandin Antifungal [EPC], Lipopeptides [CS]","71288-029","71288-029-11","71288-029_9571440f-2c9b-4281-b907-0d53408d744e","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220928","","ANDA","ANDA215381","Meitheal Pharmaceuticals Inc.","100","mg/5mL","","N","20251231"
"8055","MICAFUNGIN SODIUM","Micafungin sodium","71288002912","Echinocandin Antifungal [EPC], Lipopeptides [CS]","71288-029","71288-029-12","71288-029_9571440f-2c9b-4281-b907-0d53408d744e","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20220928","","ANDA","ANDA215381","Meitheal Pharmaceuticals Inc.","100","mg/5mL","","N","20251231"
"8056","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin sodium and Sulbactam sodium","71288003192","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71288-031","71288-031-92","71288-031_f8b66438-eeee-4177-9a49-8fb725dc6672","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20051129","","ANDA","ANDA065222","Meitheal Pharmaceuticals Inc.","1; .5","g/1; g/1","","N","20261231"
"8057","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin sodium and Sulbactam sodium","71288003121","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71288-031","71288-031-21","71288-031_f8b66438-eeee-4177-9a49-8fb725dc6672","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20051129","","ANDA","ANDA065222","Meitheal Pharmaceuticals Inc.","1; .5","g/1; g/1","","N","20261231"
"8058","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin sodium and Sulbactam sodium","71288003292","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71288-032","71288-032-92","71288-032_8e5a2a5c-4069-44a5-8784-e93bde0408c5","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20051129","","ANDA","ANDA065222","Meitheal Pharmaceuticals Inc.","2; 1","g/1; g/1","","N","20251231"
"8059","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin sodium and Sulbactam sodium","71288003221","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71288-032","71288-032-21","71288-032_8e5a2a5c-4069-44a5-8784-e93bde0408c5","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20051129","","ANDA","ANDA065222","Meitheal Pharmaceuticals Inc.","2; 1","g/1; g/1","","N","20251231"
"8060","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin Sodium and Sulbactam Sodium","71288003375","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71288-033","71288-033-75","71288-033_3d2029ff-d114-4d0e-98b9-e90f1320e90e","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20061127","","ANDA","ANDA065314","Meitheal Pharmaceuticals Inc.","10; 5","g/1; g/1","","N","20261231"
"8061","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin Sodium and Sulbactam Sodium","71288003391","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71288-033","71288-033-91","71288-033_3d2029ff-d114-4d0e-98b9-e90f1320e90e","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20061127","","ANDA","ANDA065314","Meitheal Pharmaceuticals Inc.","10; 5","g/1; g/1","","N","20261231"
"8062","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71297024034","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71297-240","71297-240-34","71297-240_18975386-c292-a0cb-e063-6294a90aed18","HUMAN PRESCRIPTION DRUG","Augmentin","","FOR SUSPENSION","ORAL","20230901","","NDA","NDA050575","Allegis Holdings, LLC","125; 31.25","mg/5mL; mg/5mL","","N","20251231"
"8063","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71297024035","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71297-240","71297-240-35","71297-240_18975386-c292-a0cb-e063-6294a90aed18","HUMAN PRESCRIPTION DRUG","Augmentin","","FOR SUSPENSION","ORAL","20230901","","NDA","NDA050575","Allegis Holdings, LLC","125; 31.25","mg/5mL; mg/5mL","","N","20251231"
"8064","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","71297024036","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","71297-240","71297-240-36","71297-240_18975386-c292-a0cb-e063-6294a90aed18","HUMAN PRESCRIPTION DRUG","Augmentin","","FOR SUSPENSION","ORAL","20230901","","NDA","NDA050575","Allegis Holdings, LLC","125; 31.25","mg/5mL; mg/5mL","","N","20251231"
"8065","CLARITHROMYCIN","Clarithromycin","71335001701","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-0017","71335-0017-1","71335-0017_d0282505-f559-492d-a071-5a5d8385fd8d","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8066","CLARITHROMYCIN","Clarithromycin","71335001702","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-0017","71335-0017-2","71335-0017_d0282505-f559-492d-a071-5a5d8385fd8d","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8067","CLARITHROMYCIN","Clarithromycin","71335001703","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-0017","71335-0017-3","71335-0017_d0282505-f559-492d-a071-5a5d8385fd8d","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8068","CLARITHROMYCIN","Clarithromycin","71335001705","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-0017","71335-0017-5","71335-0017_d0282505-f559-492d-a071-5a5d8385fd8d","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8069","CLARITHROMYCIN","Clarithromycin","71335001706","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-0017","71335-0017-6","71335-0017_d0282505-f559-492d-a071-5a5d8385fd8d","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8070","CLARITHROMYCIN","Clarithromycin","71335001707","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-0017","71335-0017-7","71335-0017_d0282505-f559-492d-a071-5a5d8385fd8d","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8071","CLARITHROMYCIN","Clarithromycin","71335001708","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-0017","71335-0017-8","71335-0017_d0282505-f559-492d-a071-5a5d8385fd8d","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8072","CLARITHROMYCIN","Clarithromycin","71335001709","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-0017","71335-0017-9","71335-0017_d0282505-f559-492d-a071-5a5d8385fd8d","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8073","CLARITHROMYCIN","Clarithromycin","71335001704","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-0017","71335-0017-4","71335-0017_d0282505-f559-492d-a071-5a5d8385fd8d","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8074","NITROFURANTOIN","Nitrofurantion","71335002401","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-0024","71335-0024-1","71335-0024_a9820123-e497-4bef-9246-474fe272142b","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8075","NITROFURANTOIN","Nitrofurantion","71335002403","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-0024","71335-0024-3","71335-0024_a9820123-e497-4bef-9246-474fe272142b","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8076","NITROFURANTOIN","Nitrofurantion","71335002404","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-0024","71335-0024-4","71335-0024_a9820123-e497-4bef-9246-474fe272142b","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8077","NITROFURANTOIN","Nitrofurantion","71335002405","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-0024","71335-0024-5","71335-0024_a9820123-e497-4bef-9246-474fe272142b","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8078","NITROFURANTOIN","Nitrofurantion","71335002402","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-0024","71335-0024-2","71335-0024_a9820123-e497-4bef-9246-474fe272142b","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8079","NITROFURANTOIN","Nitrofurantion","71335002407","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-0024","71335-0024-7","71335-0024_a9820123-e497-4bef-9246-474fe272142b","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8080","NITROFURANTOIN","Nitrofurantion","71335002408","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-0024","71335-0024-8","71335-0024_a9820123-e497-4bef-9246-474fe272142b","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8081","NITROFURANTOIN","Nitrofurantion","71335002409","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-0024","71335-0024-9","71335-0024_a9820123-e497-4bef-9246-474fe272142b","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8082","NITROFURANTOIN","Nitrofurantion","71335002406","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-0024","71335-0024-6","71335-0024_a9820123-e497-4bef-9246-474fe272142b","HUMAN PRESCRIPTION DRUG","Nitrofurantion","","CAPSULE","ORAL","20160415","","ANDA","ANDA201722","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8083","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335007001","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0070","71335-0070-1","71335-0070_7e450b73-3a77-48fb-8552-4d85d44f966f","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8084","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335007002","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0070","71335-0070-2","71335-0070_7e450b73-3a77-48fb-8552-4d85d44f966f","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8085","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335007003","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0070","71335-0070-3","71335-0070_7e450b73-3a77-48fb-8552-4d85d44f966f","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8086","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335007000","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0070","71335-0070-0","71335-0070_7e450b73-3a77-48fb-8552-4d85d44f966f","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8087","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335007005","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0070","71335-0070-5","71335-0070_7e450b73-3a77-48fb-8552-4d85d44f966f","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8088","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335007006","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0070","71335-0070-6","71335-0070_7e450b73-3a77-48fb-8552-4d85d44f966f","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8089","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335007007","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0070","71335-0070-7","71335-0070_7e450b73-3a77-48fb-8552-4d85d44f966f","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8090","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335007004","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0070","71335-0070-4","71335-0070_7e450b73-3a77-48fb-8552-4d85d44f966f","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8091","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335007009","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0070","71335-0070-9","71335-0070_7e450b73-3a77-48fb-8552-4d85d44f966f","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8092","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335007008","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0070","71335-0070-8","71335-0070_7e450b73-3a77-48fb-8552-4d85d44f966f","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8093","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335020000","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0200","71335-0200-0","71335-0200_3a84d6bc-310b-48d6-857c-9f6c2734a57c","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8094","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335020001","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0200","71335-0200-1","71335-0200_3a84d6bc-310b-48d6-857c-9f6c2734a57c","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8095","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335020002","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0200","71335-0200-2","71335-0200_3a84d6bc-310b-48d6-857c-9f6c2734a57c","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8096","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335020004","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0200","71335-0200-4","71335-0200_3a84d6bc-310b-48d6-857c-9f6c2734a57c","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8097","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335020005","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0200","71335-0200-5","71335-0200_3a84d6bc-310b-48d6-857c-9f6c2734a57c","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8098","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335020006","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0200","71335-0200-6","71335-0200_3a84d6bc-310b-48d6-857c-9f6c2734a57c","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8099","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335020007","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0200","71335-0200-7","71335-0200_3a84d6bc-310b-48d6-857c-9f6c2734a57c","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8100","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335020008","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0200","71335-0200-8","71335-0200_3a84d6bc-310b-48d6-857c-9f6c2734a57c","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8101","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335020009","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0200","71335-0200-9","71335-0200_3a84d6bc-310b-48d6-857c-9f6c2734a57c","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8102","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335020003","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0200","71335-0200-3","71335-0200_3a84d6bc-310b-48d6-857c-9f6c2734a57c","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8103","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335032000","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0320","71335-0320-0","71335-0320_3a7a1f69-05e7-4517-b448-39cd6d06a143","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8104","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335032002","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0320","71335-0320-2","71335-0320_3a7a1f69-05e7-4517-b448-39cd6d06a143","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8105","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335032003","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0320","71335-0320-3","71335-0320_3a7a1f69-05e7-4517-b448-39cd6d06a143","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8106","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335032004","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0320","71335-0320-4","71335-0320_3a7a1f69-05e7-4517-b448-39cd6d06a143","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8107","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335032001","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0320","71335-0320-1","71335-0320_3a7a1f69-05e7-4517-b448-39cd6d06a143","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8108","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335032006","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0320","71335-0320-6","71335-0320_3a7a1f69-05e7-4517-b448-39cd6d06a143","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8109","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335032007","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0320","71335-0320-7","71335-0320_3a7a1f69-05e7-4517-b448-39cd6d06a143","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8110","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335032008","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0320","71335-0320-8","71335-0320_3a7a1f69-05e7-4517-b448-39cd6d06a143","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8111","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335032005","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0320","71335-0320-5","71335-0320_3a7a1f69-05e7-4517-b448-39cd6d06a143","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8112","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335032009","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-0320","71335-0320-9","71335-0320_3a7a1f69-05e7-4517-b448-39cd6d06a143","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8113","METRONIDAZOLE","Metronidazole","71335035800","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0358","71335-0358-0","71335-0358_8bc02400-bfe9-4bf1-93b4-f5d287812a8c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8114","METRONIDAZOLE","Metronidazole","71335035802","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0358","71335-0358-2","71335-0358_8bc02400-bfe9-4bf1-93b4-f5d287812a8c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8115","METRONIDAZOLE","Metronidazole","71335035803","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0358","71335-0358-3","71335-0358_8bc02400-bfe9-4bf1-93b4-f5d287812a8c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8116","METRONIDAZOLE","Metronidazole","71335035804","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0358","71335-0358-4","71335-0358_8bc02400-bfe9-4bf1-93b4-f5d287812a8c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8117","METRONIDAZOLE","Metronidazole","71335035801","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0358","71335-0358-1","71335-0358_8bc02400-bfe9-4bf1-93b4-f5d287812a8c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8118","METRONIDAZOLE","Metronidazole","71335035806","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0358","71335-0358-6","71335-0358_8bc02400-bfe9-4bf1-93b4-f5d287812a8c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8119","METRONIDAZOLE","Metronidazole","71335035807","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0358","71335-0358-7","71335-0358_8bc02400-bfe9-4bf1-93b4-f5d287812a8c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8120","METRONIDAZOLE","Metronidazole","71335035808","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0358","71335-0358-8","71335-0358_8bc02400-bfe9-4bf1-93b4-f5d287812a8c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8121","METRONIDAZOLE","Metronidazole","71335035809","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0358","71335-0358-9","71335-0358_8bc02400-bfe9-4bf1-93b4-f5d287812a8c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8122","METRONIDAZOLE","Metronidazole","71335035805","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0358","71335-0358-5","71335-0358_8bc02400-bfe9-4bf1-93b4-f5d287812a8c","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8123","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335040801","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0408","71335-0408-1","71335-0408_7d2d3be8-5b23-4e66-be62-cfedd2dbccd7","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8124","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335040802","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0408","71335-0408-2","71335-0408_7d2d3be8-5b23-4e66-be62-cfedd2dbccd7","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8125","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335040803","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0408","71335-0408-3","71335-0408_7d2d3be8-5b23-4e66-be62-cfedd2dbccd7","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8126","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335040804","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0408","71335-0408-4","71335-0408_7d2d3be8-5b23-4e66-be62-cfedd2dbccd7","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8127","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335040805","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0408","71335-0408-5","71335-0408_7d2d3be8-5b23-4e66-be62-cfedd2dbccd7","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8128","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335040806","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0408","71335-0408-6","71335-0408_7d2d3be8-5b23-4e66-be62-cfedd2dbccd7","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8129","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335040807","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0408","71335-0408-7","71335-0408_7d2d3be8-5b23-4e66-be62-cfedd2dbccd7","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8130","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335040808","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0408","71335-0408-8","71335-0408_7d2d3be8-5b23-4e66-be62-cfedd2dbccd7","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8131","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335040809","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0408","71335-0408-9","71335-0408_7d2d3be8-5b23-4e66-be62-cfedd2dbccd7","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8132","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","71335040800","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-0408","71335-0408-0","71335-0408_7d2d3be8-5b23-4e66-be62-cfedd2dbccd7","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20040910","","ANDA","ANDA076639","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8133","KETOCONAZOLE","Ketoconazole","71335043901","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71335-0439","71335-0439-1","71335-0439_555c71ae-9b39-4f18-bb45-d757a31a2a1d","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","19990615","","ANDA","ANDA075319","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8134","KETOCONAZOLE","Ketoconazole","71335043902","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71335-0439","71335-0439-2","71335-0439_555c71ae-9b39-4f18-bb45-d757a31a2a1d","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","19990615","","ANDA","ANDA075319","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8135","KETOCONAZOLE","Ketoconazole","71335043903","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71335-0439","71335-0439-3","71335-0439_555c71ae-9b39-4f18-bb45-d757a31a2a1d","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","19990615","","ANDA","ANDA075319","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8136","KETOCONAZOLE","Ketoconazole","71335043905","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71335-0439","71335-0439-5","71335-0439_555c71ae-9b39-4f18-bb45-d757a31a2a1d","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","19990615","","ANDA","ANDA075319","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8137","KETOCONAZOLE","Ketoconazole","71335043906","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71335-0439","71335-0439-6","71335-0439_555c71ae-9b39-4f18-bb45-d757a31a2a1d","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","19990615","","ANDA","ANDA075319","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8138","KETOCONAZOLE","Ketoconazole","71335043907","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71335-0439","71335-0439-7","71335-0439_555c71ae-9b39-4f18-bb45-d757a31a2a1d","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","19990615","","ANDA","ANDA075319","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8139","KETOCONAZOLE","Ketoconazole","71335043904","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71335-0439","71335-0439-4","71335-0439_555c71ae-9b39-4f18-bb45-d757a31a2a1d","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","19990615","","ANDA","ANDA075319","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8140","KETOCONAZOLE","Ketoconazole","71335043908","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71335-0439","71335-0439-8","71335-0439_555c71ae-9b39-4f18-bb45-d757a31a2a1d","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","19990615","","ANDA","ANDA075319","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8141","FLUCONAZOLE","fluconazole","71335068601","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0686","71335-0686-1","71335-0686_9734dcd0-c8ba-455b-89fa-e78063597742","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8142","FLUCONAZOLE","fluconazole","71335068602","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0686","71335-0686-2","71335-0686_9734dcd0-c8ba-455b-89fa-e78063597742","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8143","FLUCONAZOLE","fluconazole","71335068603","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0686","71335-0686-3","71335-0686_9734dcd0-c8ba-455b-89fa-e78063597742","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8144","FLUCONAZOLE","fluconazole","71335068604","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0686","71335-0686-4","71335-0686_9734dcd0-c8ba-455b-89fa-e78063597742","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8145","FLUCONAZOLE","fluconazole","71335068605","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0686","71335-0686-5","71335-0686_9734dcd0-c8ba-455b-89fa-e78063597742","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8146","FLUCONAZOLE","fluconazole","71335068606","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0686","71335-0686-6","71335-0686_9734dcd0-c8ba-455b-89fa-e78063597742","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8147","FLUCONAZOLE","fluconazole","71335068607","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0686","71335-0686-7","71335-0686_9734dcd0-c8ba-455b-89fa-e78063597742","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8148","FLUCONAZOLE","fluconazole","71335068608","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0686","71335-0686-8","71335-0686_9734dcd0-c8ba-455b-89fa-e78063597742","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8149","FLUCONAZOLE","fluconazole","71335068609","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0686","71335-0686-9","71335-0686_9734dcd0-c8ba-455b-89fa-e78063597742","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8150","FLUCONAZOLE","fluconazole","71335068600","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0686","71335-0686-0","71335-0686_9734dcd0-c8ba-455b-89fa-e78063597742","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8151","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71335076200","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71335-0762","71335-0762-0","71335-0762_4b2d2aad-d2b6-467d-a18c-9b346ae04ee5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"8152","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71335076201","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71335-0762","71335-0762-1","71335-0762_4b2d2aad-d2b6-467d-a18c-9b346ae04ee5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"8153","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71335076203","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71335-0762","71335-0762-3","71335-0762_4b2d2aad-d2b6-467d-a18c-9b346ae04ee5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"8154","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71335076204","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71335-0762","71335-0762-4","71335-0762_4b2d2aad-d2b6-467d-a18c-9b346ae04ee5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"8155","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71335076205","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71335-0762","71335-0762-5","71335-0762_4b2d2aad-d2b6-467d-a18c-9b346ae04ee5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"8156","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71335076202","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71335-0762","71335-0762-2","71335-0762_4b2d2aad-d2b6-467d-a18c-9b346ae04ee5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"8157","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71335076207","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71335-0762","71335-0762-7","71335-0762_4b2d2aad-d2b6-467d-a18c-9b346ae04ee5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"8158","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71335076208","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71335-0762","71335-0762-8","71335-0762_4b2d2aad-d2b6-467d-a18c-9b346ae04ee5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"8159","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71335076209","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71335-0762","71335-0762-9","71335-0762_4b2d2aad-d2b6-467d-a18c-9b346ae04ee5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"8160","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","71335076206","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","71335-0762","71335-0762-6","71335-0762_4b2d2aad-d2b6-467d-a18c-9b346ae04ee5","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Bryant Ranch Prepack","800; 160","mg/1; mg/1","","N","20251231"
"8161","FLUCONAZOLE","fluconazole","71335076900","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0769","71335-0769-0","71335-0769_b23c4215-a8ba-44ec-8c42-23be80e7953e","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8162","FLUCONAZOLE","fluconazole","71335076901","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0769","71335-0769-1","71335-0769_b23c4215-a8ba-44ec-8c42-23be80e7953e","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8163","FLUCONAZOLE","fluconazole","71335076902","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0769","71335-0769-2","71335-0769_b23c4215-a8ba-44ec-8c42-23be80e7953e","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8164","FLUCONAZOLE","fluconazole","71335076904","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0769","71335-0769-4","71335-0769_b23c4215-a8ba-44ec-8c42-23be80e7953e","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8165","FLUCONAZOLE","fluconazole","71335076905","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0769","71335-0769-5","71335-0769_b23c4215-a8ba-44ec-8c42-23be80e7953e","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8166","FLUCONAZOLE","fluconazole","71335076906","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0769","71335-0769-6","71335-0769_b23c4215-a8ba-44ec-8c42-23be80e7953e","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8167","FLUCONAZOLE","fluconazole","71335076907","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0769","71335-0769-7","71335-0769_b23c4215-a8ba-44ec-8c42-23be80e7953e","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8168","FLUCONAZOLE","fluconazole","71335076908","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0769","71335-0769-8","71335-0769_b23c4215-a8ba-44ec-8c42-23be80e7953e","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8169","FLUCONAZOLE","fluconazole","71335076909","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0769","71335-0769-9","71335-0769_b23c4215-a8ba-44ec-8c42-23be80e7953e","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8170","FLUCONAZOLE","fluconazole","71335076903","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-0769","71335-0769-3","71335-0769_b23c4215-a8ba-44ec-8c42-23be80e7953e","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20170406","","ANDA","ANDA208963","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8171","METRONIDAZOLE","Metronidazole","71335085800","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0858","71335-0858-0","71335-0858_ac72621d-0d70-448b-b53c-903c6fdb7ee2","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8172","METRONIDAZOLE","Metronidazole","71335085802","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0858","71335-0858-2","71335-0858_ac72621d-0d70-448b-b53c-903c6fdb7ee2","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8173","METRONIDAZOLE","Metronidazole","71335085803","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0858","71335-0858-3","71335-0858_ac72621d-0d70-448b-b53c-903c6fdb7ee2","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8174","METRONIDAZOLE","Metronidazole","71335085804","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0858","71335-0858-4","71335-0858_ac72621d-0d70-448b-b53c-903c6fdb7ee2","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8175","METRONIDAZOLE","Metronidazole","71335085801","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0858","71335-0858-1","71335-0858_ac72621d-0d70-448b-b53c-903c6fdb7ee2","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8176","METRONIDAZOLE","Metronidazole","71335085806","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0858","71335-0858-6","71335-0858_ac72621d-0d70-448b-b53c-903c6fdb7ee2","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8177","METRONIDAZOLE","Metronidazole","71335085807","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0858","71335-0858-7","71335-0858_ac72621d-0d70-448b-b53c-903c6fdb7ee2","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8178","METRONIDAZOLE","Metronidazole","71335085808","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0858","71335-0858-8","71335-0858_ac72621d-0d70-448b-b53c-903c6fdb7ee2","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8179","METRONIDAZOLE","Metronidazole","71335085809","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0858","71335-0858-9","71335-0858_ac72621d-0d70-448b-b53c-903c6fdb7ee2","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8180","METRONIDAZOLE","Metronidazole","71335085805","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-0858","71335-0858-5","71335-0858_ac72621d-0d70-448b-b53c-903c6fdb7ee2","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","19900930","","ANDA","ANDA070027","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8181","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","71335086300","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-0863","71335-0863-0","71335-0863_caeadb30-df1d-43b3-b661-5354294102d4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20170525","","ANDA","ANDA207372","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8182","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","71335086301","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-0863","71335-0863-1","71335-0863_caeadb30-df1d-43b3-b661-5354294102d4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20170525","","ANDA","ANDA207372","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8183","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","71335086303","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-0863","71335-0863-3","71335-0863_caeadb30-df1d-43b3-b661-5354294102d4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20170525","","ANDA","ANDA207372","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8184","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","71335086304","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-0863","71335-0863-4","71335-0863_caeadb30-df1d-43b3-b661-5354294102d4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20170525","","ANDA","ANDA207372","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8185","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","71335086305","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-0863","71335-0863-5","71335-0863_caeadb30-df1d-43b3-b661-5354294102d4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20170525","","ANDA","ANDA207372","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8186","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","71335086302","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-0863","71335-0863-2","71335-0863_caeadb30-df1d-43b3-b661-5354294102d4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20170525","","ANDA","ANDA207372","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8187","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","71335086307","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-0863","71335-0863-7","71335-0863_caeadb30-df1d-43b3-b661-5354294102d4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20170525","","ANDA","ANDA207372","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8188","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","71335086308","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-0863","71335-0863-8","71335-0863_caeadb30-df1d-43b3-b661-5354294102d4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20170525","","ANDA","ANDA207372","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8189","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","71335086309","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-0863","71335-0863-9","71335-0863_caeadb30-df1d-43b3-b661-5354294102d4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20170525","","ANDA","ANDA207372","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8190","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","71335086306","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-0863","71335-0863-6","71335-0863_caeadb30-df1d-43b3-b661-5354294102d4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20170525","","ANDA","ANDA207372","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8191","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","71335089701","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-0897","71335-0897-1","71335-0897_c325a7fe-e4d3-40df-a21d-e17a8e8a3b7b","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8192","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","71335089702","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-0897","71335-0897-2","71335-0897_c325a7fe-e4d3-40df-a21d-e17a8e8a3b7b","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8193","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","71335089703","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-0897","71335-0897-3","71335-0897_c325a7fe-e4d3-40df-a21d-e17a8e8a3b7b","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8194","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","71335089705","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-0897","71335-0897-5","71335-0897_c325a7fe-e4d3-40df-a21d-e17a8e8a3b7b","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8195","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","71335089706","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-0897","71335-0897-6","71335-0897_c325a7fe-e4d3-40df-a21d-e17a8e8a3b7b","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8196","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","71335089707","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-0897","71335-0897-7","71335-0897_c325a7fe-e4d3-40df-a21d-e17a8e8a3b7b","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8197","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","71335089704","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-0897","71335-0897-4","71335-0897_c325a7fe-e4d3-40df-a21d-e17a8e8a3b7b","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8198","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","71335089709","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-0897","71335-0897-9","71335-0897_c325a7fe-e4d3-40df-a21d-e17a8e8a3b7b","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8199","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","71335089708","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-0897","71335-0897-8","71335-0897_c325a7fe-e4d3-40df-a21d-e17a8e8a3b7b","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8200","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335091801","Allylamine Antifungal [EPC], Allylamine [CS]","71335-0918","71335-0918-1","71335-0918_cefa9c7f-1185-4cf4-9638-90cca0c11d27","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8201","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335091803","Allylamine Antifungal [EPC], Allylamine [CS]","71335-0918","71335-0918-3","71335-0918_cefa9c7f-1185-4cf4-9638-90cca0c11d27","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8202","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335091804","Allylamine Antifungal [EPC], Allylamine [CS]","71335-0918","71335-0918-4","71335-0918_cefa9c7f-1185-4cf4-9638-90cca0c11d27","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8203","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335091805","Allylamine Antifungal [EPC], Allylamine [CS]","71335-0918","71335-0918-5","71335-0918_cefa9c7f-1185-4cf4-9638-90cca0c11d27","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8204","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335091806","Allylamine Antifungal [EPC], Allylamine [CS]","71335-0918","71335-0918-6","71335-0918_cefa9c7f-1185-4cf4-9638-90cca0c11d27","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8205","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335091807","Allylamine Antifungal [EPC], Allylamine [CS]","71335-0918","71335-0918-7","71335-0918_cefa9c7f-1185-4cf4-9638-90cca0c11d27","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8206","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335091808","Allylamine Antifungal [EPC], Allylamine [CS]","71335-0918","71335-0918-8","71335-0918_cefa9c7f-1185-4cf4-9638-90cca0c11d27","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8207","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335091809","Allylamine Antifungal [EPC], Allylamine [CS]","71335-0918","71335-0918-9","71335-0918_cefa9c7f-1185-4cf4-9638-90cca0c11d27","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8208","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335091802","Allylamine Antifungal [EPC], Allylamine [CS]","71335-0918","71335-0918-2","71335-0918_cefa9c7f-1185-4cf4-9638-90cca0c11d27","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8209","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335102401","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1024","71335-1024-1","71335-1024_ea141ab9-3c46-4669-8ab5-615d2d0828d7","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"8210","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335102402","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1024","71335-1024-2","71335-1024_ea141ab9-3c46-4669-8ab5-615d2d0828d7","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"8211","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335102404","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1024","71335-1024-4","71335-1024_ea141ab9-3c46-4669-8ab5-615d2d0828d7","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"8212","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335102405","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1024","71335-1024-5","71335-1024_ea141ab9-3c46-4669-8ab5-615d2d0828d7","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"8213","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335102406","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1024","71335-1024-6","71335-1024_ea141ab9-3c46-4669-8ab5-615d2d0828d7","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"8214","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335102403","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1024","71335-1024-3","71335-1024_ea141ab9-3c46-4669-8ab5-615d2d0828d7","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"8215","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335102407","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1024","71335-1024-7","71335-1024_ea141ab9-3c46-4669-8ab5-615d2d0828d7","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"8216","NITROFURANTOIN","nitrofurantoin macrocrystals","71335106901","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1069","71335-1069-1","71335-1069_05e89273-b886-40bb-be42-7807d29f5dee","HUMAN PRESCRIPTION DRUG","nitrofurantoin","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8217","NITROFURANTOIN","nitrofurantoin macrocrystals","71335106903","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1069","71335-1069-3","71335-1069_05e89273-b886-40bb-be42-7807d29f5dee","HUMAN PRESCRIPTION DRUG","nitrofurantoin","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8218","NITROFURANTOIN","nitrofurantoin macrocrystals","71335106904","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1069","71335-1069-4","71335-1069_05e89273-b886-40bb-be42-7807d29f5dee","HUMAN PRESCRIPTION DRUG","nitrofurantoin","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8219","NITROFURANTOIN","nitrofurantoin macrocrystals","71335106905","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1069","71335-1069-5","71335-1069_05e89273-b886-40bb-be42-7807d29f5dee","HUMAN PRESCRIPTION DRUG","nitrofurantoin","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8220","NITROFURANTOIN","nitrofurantoin macrocrystals","71335106902","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1069","71335-1069-2","71335-1069_05e89273-b886-40bb-be42-7807d29f5dee","HUMAN PRESCRIPTION DRUG","nitrofurantoin","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8221","NITROFURANTOIN","nitrofurantoin macrocrystals","71335106907","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1069","71335-1069-7","71335-1069_05e89273-b886-40bb-be42-7807d29f5dee","HUMAN PRESCRIPTION DRUG","nitrofurantoin","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8222","NITROFURANTOIN","nitrofurantoin macrocrystals","71335106908","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1069","71335-1069-8","71335-1069_05e89273-b886-40bb-be42-7807d29f5dee","HUMAN PRESCRIPTION DRUG","nitrofurantoin","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8223","NITROFURANTOIN","nitrofurantoin macrocrystals","71335106909","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1069","71335-1069-9","71335-1069_05e89273-b886-40bb-be42-7807d29f5dee","HUMAN PRESCRIPTION DRUG","nitrofurantoin","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8224","NITROFURANTOIN","nitrofurantoin macrocrystals","71335106906","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1069","71335-1069-6","71335-1069_05e89273-b886-40bb-be42-7807d29f5dee","HUMAN PRESCRIPTION DRUG","nitrofurantoin","","CAPSULE","ORAL","20180215","","ANDA","ANDA205005","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8225","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335112401","Allylamine Antifungal [EPC], Allylamine [CS]","71335-1124","71335-1124-1","71335-1124_58d188ab-ecb7-4e4c-b6eb-f70773aa8818","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8226","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335112402","Allylamine Antifungal [EPC], Allylamine [CS]","71335-1124","71335-1124-2","71335-1124_58d188ab-ecb7-4e4c-b6eb-f70773aa8818","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8227","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335112404","Allylamine Antifungal [EPC], Allylamine [CS]","71335-1124","71335-1124-4","71335-1124_58d188ab-ecb7-4e4c-b6eb-f70773aa8818","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8228","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335112405","Allylamine Antifungal [EPC], Allylamine [CS]","71335-1124","71335-1124-5","71335-1124_58d188ab-ecb7-4e4c-b6eb-f70773aa8818","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8229","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335112406","Allylamine Antifungal [EPC], Allylamine [CS]","71335-1124","71335-1124-6","71335-1124_58d188ab-ecb7-4e4c-b6eb-f70773aa8818","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8230","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335112407","Allylamine Antifungal [EPC], Allylamine [CS]","71335-1124","71335-1124-7","71335-1124_58d188ab-ecb7-4e4c-b6eb-f70773aa8818","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8231","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335112408","Allylamine Antifungal [EPC], Allylamine [CS]","71335-1124","71335-1124-8","71335-1124_58d188ab-ecb7-4e4c-b6eb-f70773aa8818","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8232","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335112409","Allylamine Antifungal [EPC], Allylamine [CS]","71335-1124","71335-1124-9","71335-1124_58d188ab-ecb7-4e4c-b6eb-f70773aa8818","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8233","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","71335112403","Allylamine Antifungal [EPC], Allylamine [CS]","71335-1124","71335-1124-3","71335-1124_58d188ab-ecb7-4e4c-b6eb-f70773aa8818","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8234","NITROFURANTOIN","Nitrofurantoin Macrocrystals","71335113501","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1135","71335-1135-1","71335-1135_a2244c39-9b18-47c0-adc3-cd778e637ffc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8235","NITROFURANTOIN","Nitrofurantoin Macrocrystals","71335113502","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1135","71335-1135-2","71335-1135_a2244c39-9b18-47c0-adc3-cd778e637ffc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8236","NITROFURANTOIN","Nitrofurantoin Macrocrystals","71335113503","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1135","71335-1135-3","71335-1135_a2244c39-9b18-47c0-adc3-cd778e637ffc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8237","NITROFURANTOIN","Nitrofurantoin Macrocrystals","71335113505","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1135","71335-1135-5","71335-1135_a2244c39-9b18-47c0-adc3-cd778e637ffc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8238","NITROFURANTOIN","Nitrofurantoin Macrocrystals","71335113506","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1135","71335-1135-6","71335-1135_a2244c39-9b18-47c0-adc3-cd778e637ffc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8239","NITROFURANTOIN","Nitrofurantoin Macrocrystals","71335113507","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1135","71335-1135-7","71335-1135_a2244c39-9b18-47c0-adc3-cd778e637ffc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8240","NITROFURANTOIN","Nitrofurantoin Macrocrystals","71335113504","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1135","71335-1135-4","71335-1135_a2244c39-9b18-47c0-adc3-cd778e637ffc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8241","NITROFURANTOIN","Nitrofurantoin Macrocrystals","71335113509","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1135","71335-1135-9","71335-1135_a2244c39-9b18-47c0-adc3-cd778e637ffc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8242","NITROFURANTOIN","Nitrofurantoin Macrocrystals","71335113508","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-1135","71335-1135-8","71335-1135_a2244c39-9b18-47c0-adc3-cd778e637ffc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8243","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335115200","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1152","71335-1152-0","71335-1152_3bc30d61-cfc5-4855-834d-d82b9f9e040a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8244","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335115201","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1152","71335-1152-1","71335-1152_3bc30d61-cfc5-4855-834d-d82b9f9e040a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8245","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335115202","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1152","71335-1152-2","71335-1152_3bc30d61-cfc5-4855-834d-d82b9f9e040a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8246","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335115204","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1152","71335-1152-4","71335-1152_3bc30d61-cfc5-4855-834d-d82b9f9e040a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8247","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335115205","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1152","71335-1152-5","71335-1152_3bc30d61-cfc5-4855-834d-d82b9f9e040a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8248","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335115206","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1152","71335-1152-6","71335-1152_3bc30d61-cfc5-4855-834d-d82b9f9e040a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8249","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335115203","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1152","71335-1152-3","71335-1152_3bc30d61-cfc5-4855-834d-d82b9f9e040a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8250","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335115208","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1152","71335-1152-8","71335-1152_3bc30d61-cfc5-4855-834d-d82b9f9e040a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8251","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335115209","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1152","71335-1152-9","71335-1152_3bc30d61-cfc5-4855-834d-d82b9f9e040a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8252","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335115207","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1152","71335-1152-7","71335-1152_3bc30d61-cfc5-4855-834d-d82b9f9e040a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8253","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335122900","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1229","71335-1229-0","71335-1229_7030109d-5ce0-43f1-a5ed-16a3562acd40","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8254","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335122901","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1229","71335-1229-1","71335-1229_7030109d-5ce0-43f1-a5ed-16a3562acd40","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8255","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335122903","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1229","71335-1229-3","71335-1229_7030109d-5ce0-43f1-a5ed-16a3562acd40","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8256","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335122904","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1229","71335-1229-4","71335-1229_7030109d-5ce0-43f1-a5ed-16a3562acd40","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8257","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335122905","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1229","71335-1229-5","71335-1229_7030109d-5ce0-43f1-a5ed-16a3562acd40","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8258","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335122906","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1229","71335-1229-6","71335-1229_7030109d-5ce0-43f1-a5ed-16a3562acd40","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8259","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335122907","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1229","71335-1229-7","71335-1229_7030109d-5ce0-43f1-a5ed-16a3562acd40","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8260","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335122908","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1229","71335-1229-8","71335-1229_7030109d-5ce0-43f1-a5ed-16a3562acd40","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8261","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335122909","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1229","71335-1229-9","71335-1229_7030109d-5ce0-43f1-a5ed-16a3562acd40","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8262","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Tablets","71335122902","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1229","71335-1229-2","71335-1229_7030109d-5ce0-43f1-a5ed-16a3562acd40","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20190713","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8263","FLUCONAZOLE","Fluconazole","71335126801","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1268","71335-1268-1","71335-1268_37401a7b-6d0c-5f6e-e063-6294a90a3e36","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Bryant Ranch Prepack","150","mg/1","","N","20261231"
"8264","FLUCONAZOLE","Fluconazole","71335126802","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1268","71335-1268-2","71335-1268_37401a7b-6d0c-5f6e-e063-6294a90a3e36","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Bryant Ranch Prepack","150","mg/1","","N","20261231"
"8265","FLUCONAZOLE","Fluconazole","71335126803","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1268","71335-1268-3","71335-1268_37401a7b-6d0c-5f6e-e063-6294a90a3e36","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Bryant Ranch Prepack","150","mg/1","","N","20261231"
"8266","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335134700","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1347","71335-1347-0","71335-1347_b5894aa6-c36f-4290-8ede-b2a867cf2df2","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8267","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335134702","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1347","71335-1347-2","71335-1347_b5894aa6-c36f-4290-8ede-b2a867cf2df2","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8268","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335134703","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1347","71335-1347-3","71335-1347_b5894aa6-c36f-4290-8ede-b2a867cf2df2","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8269","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335134704","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1347","71335-1347-4","71335-1347_b5894aa6-c36f-4290-8ede-b2a867cf2df2","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8270","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335134701","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1347","71335-1347-1","71335-1347_b5894aa6-c36f-4290-8ede-b2a867cf2df2","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8271","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335134706","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1347","71335-1347-6","71335-1347_b5894aa6-c36f-4290-8ede-b2a867cf2df2","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8272","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335134707","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1347","71335-1347-7","71335-1347_b5894aa6-c36f-4290-8ede-b2a867cf2df2","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8273","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335134708","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1347","71335-1347-8","71335-1347_b5894aa6-c36f-4290-8ede-b2a867cf2df2","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8274","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335134705","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1347","71335-1347-5","71335-1347_b5894aa6-c36f-4290-8ede-b2a867cf2df2","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8275","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335134709","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1347","71335-1347-9","71335-1347_b5894aa6-c36f-4290-8ede-b2a867cf2df2","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8276","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335141201","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1412","71335-1412-1","71335-1412_27503215-1a2f-4f43-9df3-16b2f027d53a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8277","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335141202","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1412","71335-1412-2","71335-1412_27503215-1a2f-4f43-9df3-16b2f027d53a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8278","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335141203","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1412","71335-1412-3","71335-1412_27503215-1a2f-4f43-9df3-16b2f027d53a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8279","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335141204","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1412","71335-1412-4","71335-1412_27503215-1a2f-4f43-9df3-16b2f027d53a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8280","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335141205","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1412","71335-1412-5","71335-1412_27503215-1a2f-4f43-9df3-16b2f027d53a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8281","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335141206","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1412","71335-1412-6","71335-1412_27503215-1a2f-4f43-9df3-16b2f027d53a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8282","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335141207","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1412","71335-1412-7","71335-1412_27503215-1a2f-4f43-9df3-16b2f027d53a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8283","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335141208","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1412","71335-1412-8","71335-1412_27503215-1a2f-4f43-9df3-16b2f027d53a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8284","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335141209","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1412","71335-1412-9","71335-1412_27503215-1a2f-4f43-9df3-16b2f027d53a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8285","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335141200","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1412","71335-1412-0","71335-1412_27503215-1a2f-4f43-9df3-16b2f027d53a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8286","FLUCONAZOLE","Fluconazole","71335144801","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1448","71335-1448-1","71335-1448_ef05e10f-f066-4d73-a4cc-fbd1790d2863","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20140620","","ANDA","ANDA076658","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8287","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335148901","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1489","71335-1489-1","71335-1489_ee11ff48-5112-45a9-b629-4f9706f574b6","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8288","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335148902","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1489","71335-1489-2","71335-1489_ee11ff48-5112-45a9-b629-4f9706f574b6","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8289","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335148903","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1489","71335-1489-3","71335-1489_ee11ff48-5112-45a9-b629-4f9706f574b6","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8290","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335148900","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1489","71335-1489-0","71335-1489_ee11ff48-5112-45a9-b629-4f9706f574b6","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8291","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335148905","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1489","71335-1489-5","71335-1489_ee11ff48-5112-45a9-b629-4f9706f574b6","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8292","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335148906","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1489","71335-1489-6","71335-1489_ee11ff48-5112-45a9-b629-4f9706f574b6","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8293","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335148907","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1489","71335-1489-7","71335-1489_ee11ff48-5112-45a9-b629-4f9706f574b6","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8294","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335148904","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1489","71335-1489-4","71335-1489_ee11ff48-5112-45a9-b629-4f9706f574b6","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8295","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335148909","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1489","71335-1489-9","71335-1489_ee11ff48-5112-45a9-b629-4f9706f574b6","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8296","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","71335148908","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-1489","71335-1489-8","71335-1489_ee11ff48-5112-45a9-b629-4f9706f574b6","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8297","CLARITHROMYCIN","Clarithromycin","71335149301","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-1493","71335-1493-1","71335-1493_7b87c8aa-515f-4027-9c33-a91f080831d5","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8298","CLARITHROMYCIN","Clarithromycin","71335149303","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-1493","71335-1493-3","71335-1493_7b87c8aa-515f-4027-9c33-a91f080831d5","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8299","CLARITHROMYCIN","Clarithromycin","71335149304","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-1493","71335-1493-4","71335-1493_7b87c8aa-515f-4027-9c33-a91f080831d5","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8300","CLARITHROMYCIN","Clarithromycin","71335149305","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-1493","71335-1493-5","71335-1493_7b87c8aa-515f-4027-9c33-a91f080831d5","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8301","CLARITHROMYCIN","Clarithromycin","71335149306","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-1493","71335-1493-6","71335-1493_7b87c8aa-515f-4027-9c33-a91f080831d5","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8302","CLARITHROMYCIN","Clarithromycin","71335149307","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-1493","71335-1493-7","71335-1493_7b87c8aa-515f-4027-9c33-a91f080831d5","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8303","CLARITHROMYCIN","Clarithromycin","71335149308","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-1493","71335-1493-8","71335-1493_7b87c8aa-515f-4027-9c33-a91f080831d5","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8304","CLARITHROMYCIN","Clarithromycin","71335149309","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-1493","71335-1493-9","71335-1493_7b87c8aa-515f-4027-9c33-a91f080831d5","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8305","CLARITHROMYCIN","Clarithromycin","71335149302","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","71335-1493","71335-1493-2","71335-1493_7b87c8aa-515f-4027-9c33-a91f080831d5","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8306","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335152301","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1523","71335-1523-1","71335-1523_11b0ebff-52a1-4f47-bcf7-268f5750d218","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20180517","","ANDA","ANDA210577","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8307","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335152302","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1523","71335-1523-2","71335-1523_11b0ebff-52a1-4f47-bcf7-268f5750d218","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20180517","","ANDA","ANDA210577","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8308","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335152304","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1523","71335-1523-4","71335-1523_11b0ebff-52a1-4f47-bcf7-268f5750d218","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20180517","","ANDA","ANDA210577","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8309","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335152305","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1523","71335-1523-5","71335-1523_11b0ebff-52a1-4f47-bcf7-268f5750d218","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20180517","","ANDA","ANDA210577","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8310","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335152306","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1523","71335-1523-6","71335-1523_11b0ebff-52a1-4f47-bcf7-268f5750d218","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20180517","","ANDA","ANDA210577","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8311","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335152303","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1523","71335-1523-3","71335-1523_11b0ebff-52a1-4f47-bcf7-268f5750d218","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20180517","","ANDA","ANDA210577","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8312","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335152308","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1523","71335-1523-8","71335-1523_11b0ebff-52a1-4f47-bcf7-268f5750d218","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20180517","","ANDA","ANDA210577","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8313","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335152309","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1523","71335-1523-9","71335-1523_11b0ebff-52a1-4f47-bcf7-268f5750d218","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20180517","","ANDA","ANDA210577","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8314","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335152307","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1523","71335-1523-7","71335-1523_11b0ebff-52a1-4f47-bcf7-268f5750d218","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20180517","","ANDA","ANDA210577","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8315","METRONIDAZOLE","Metronidazole","71335168100","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1681","71335-1681-0","71335-1681_bf0721d6-e6ff-4afd-b09a-96fbcf8cc014","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8316","METRONIDAZOLE","Metronidazole","71335168101","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1681","71335-1681-1","71335-1681_bf0721d6-e6ff-4afd-b09a-96fbcf8cc014","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8317","METRONIDAZOLE","Metronidazole","71335168103","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1681","71335-1681-3","71335-1681_bf0721d6-e6ff-4afd-b09a-96fbcf8cc014","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8318","METRONIDAZOLE","Metronidazole","71335168104","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1681","71335-1681-4","71335-1681_bf0721d6-e6ff-4afd-b09a-96fbcf8cc014","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8319","METRONIDAZOLE","Metronidazole","71335168105","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1681","71335-1681-5","71335-1681_bf0721d6-e6ff-4afd-b09a-96fbcf8cc014","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8320","METRONIDAZOLE","Metronidazole","71335168102","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1681","71335-1681-2","71335-1681_bf0721d6-e6ff-4afd-b09a-96fbcf8cc014","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8321","METRONIDAZOLE","Metronidazole","71335168107","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1681","71335-1681-7","71335-1681_bf0721d6-e6ff-4afd-b09a-96fbcf8cc014","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8322","METRONIDAZOLE","Metronidazole","71335168108","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1681","71335-1681-8","71335-1681_bf0721d6-e6ff-4afd-b09a-96fbcf8cc014","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8323","METRONIDAZOLE","Metronidazole","71335168109","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1681","71335-1681-9","71335-1681_bf0721d6-e6ff-4afd-b09a-96fbcf8cc014","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8324","METRONIDAZOLE","Metronidazole","71335168106","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1681","71335-1681-6","71335-1681_bf0721d6-e6ff-4afd-b09a-96fbcf8cc014","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8325","METRONIDAZOLE","metronidazole","71335170301","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1703","71335-1703-1","71335-1703_408356ad-8fc4-409b-aa3c-83e5aacc4ece","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8326","METRONIDAZOLE","metronidazole","71335170302","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1703","71335-1703-2","71335-1703_408356ad-8fc4-409b-aa3c-83e5aacc4ece","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8327","METRONIDAZOLE","metronidazole","71335170303","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1703","71335-1703-3","71335-1703_408356ad-8fc4-409b-aa3c-83e5aacc4ece","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8328","METRONIDAZOLE","metronidazole","71335170304","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1703","71335-1703-4","71335-1703_408356ad-8fc4-409b-aa3c-83e5aacc4ece","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8329","METRONIDAZOLE","metronidazole","71335170305","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1703","71335-1703-5","71335-1703_408356ad-8fc4-409b-aa3c-83e5aacc4ece","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8330","METRONIDAZOLE","metronidazole","71335170306","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1703","71335-1703-6","71335-1703_408356ad-8fc4-409b-aa3c-83e5aacc4ece","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8331","METRONIDAZOLE","metronidazole","71335170307","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1703","71335-1703-7","71335-1703_408356ad-8fc4-409b-aa3c-83e5aacc4ece","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8332","METRONIDAZOLE","metronidazole","71335170308","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1703","71335-1703-8","71335-1703_408356ad-8fc4-409b-aa3c-83e5aacc4ece","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8333","METRONIDAZOLE","metronidazole","71335170309","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1703","71335-1703-9","71335-1703_408356ad-8fc4-409b-aa3c-83e5aacc4ece","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8334","METRONIDAZOLE","metronidazole","71335170300","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1703","71335-1703-0","71335-1703_408356ad-8fc4-409b-aa3c-83e5aacc4ece","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8335","AZITHROMYCIN DIHYDRATE","Azithromycin","71335175502","Macrolide Antimicrobial [EPC], Macrolides [CS]","71335-1755","71335-1755-2","71335-1755_b5d79719-b1dc-469f-a19c-f8ba615138f0","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210001","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8336","AZITHROMYCIN DIHYDRATE","Azithromycin","71335175503","Macrolide Antimicrobial [EPC], Macrolides [CS]","71335-1755","71335-1755-3","71335-1755_b5d79719-b1dc-469f-a19c-f8ba615138f0","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210001","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8337","AZITHROMYCIN DIHYDRATE","Azithromycin","71335175504","Macrolide Antimicrobial [EPC], Macrolides [CS]","71335-1755","71335-1755-4","71335-1755_b5d79719-b1dc-469f-a19c-f8ba615138f0","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210001","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8338","AZITHROMYCIN DIHYDRATE","Azithromycin","71335175501","Macrolide Antimicrobial [EPC], Macrolides [CS]","71335-1755","71335-1755-1","71335-1755_b5d79719-b1dc-469f-a19c-f8ba615138f0","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20190312","","ANDA","ANDA210001","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8339","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335177102","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1771","71335-1771-2","71335-1771_34ede119-f969-48e4-a54a-6050323002a7","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20201008","","ANDA","ANDA040081","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8340","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335177103","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1771","71335-1771-3","71335-1771_34ede119-f969-48e4-a54a-6050323002a7","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20201008","","ANDA","ANDA040081","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8341","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335177104","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1771","71335-1771-4","71335-1771_34ede119-f969-48e4-a54a-6050323002a7","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20201008","","ANDA","ANDA040081","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8342","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335177101","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1771","71335-1771-1","71335-1771_34ede119-f969-48e4-a54a-6050323002a7","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20201008","","ANDA","ANDA040081","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8343","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335177106","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1771","71335-1771-6","71335-1771_34ede119-f969-48e4-a54a-6050323002a7","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20201008","","ANDA","ANDA040081","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8344","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335177107","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1771","71335-1771-7","71335-1771_34ede119-f969-48e4-a54a-6050323002a7","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20201008","","ANDA","ANDA040081","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8345","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335177108","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1771","71335-1771-8","71335-1771_34ede119-f969-48e4-a54a-6050323002a7","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20201008","","ANDA","ANDA040081","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8346","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335177105","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1771","71335-1771-5","71335-1771_34ede119-f969-48e4-a54a-6050323002a7","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20201008","","ANDA","ANDA040081","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8347","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71335177109","Antimalarial [EPC], Antirheumatic Agent [EPC]","71335-1771","71335-1771-9","71335-1771_34ede119-f969-48e4-a54a-6050323002a7","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20201008","","ANDA","ANDA040081","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8348","METRONIDAZOLE","metronidazole","71335177501","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1775","71335-1775-1","71335-1775_64986496-b0c4-438d-9cd1-afc5ca4e3fed","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8349","METRONIDAZOLE","metronidazole","71335177502","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1775","71335-1775-2","71335-1775_64986496-b0c4-438d-9cd1-afc5ca4e3fed","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8350","METRONIDAZOLE","metronidazole","71335177503","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1775","71335-1775-3","71335-1775_64986496-b0c4-438d-9cd1-afc5ca4e3fed","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8351","METRONIDAZOLE","metronidazole","71335177504","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1775","71335-1775-4","71335-1775_64986496-b0c4-438d-9cd1-afc5ca4e3fed","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8352","METRONIDAZOLE","metronidazole","71335177505","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1775","71335-1775-5","71335-1775_64986496-b0c4-438d-9cd1-afc5ca4e3fed","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8353","METRONIDAZOLE","metronidazole","71335177506","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1775","71335-1775-6","71335-1775_64986496-b0c4-438d-9cd1-afc5ca4e3fed","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8354","METRONIDAZOLE","metronidazole","71335177507","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1775","71335-1775-7","71335-1775_64986496-b0c4-438d-9cd1-afc5ca4e3fed","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8355","METRONIDAZOLE","metronidazole","71335177508","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1775","71335-1775-8","71335-1775_64986496-b0c4-438d-9cd1-afc5ca4e3fed","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8356","METRONIDAZOLE","metronidazole","71335177509","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1775","71335-1775-9","71335-1775_64986496-b0c4-438d-9cd1-afc5ca4e3fed","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8357","METRONIDAZOLE","metronidazole","71335177500","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1775","71335-1775-0","71335-1775_64986496-b0c4-438d-9cd1-afc5ca4e3fed","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8358","METRONIDAZOLE","Metronidazole","71335183800","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1838","71335-1838-0","71335-1838_4de87bd8-34c2-40bf-bee0-51bbc9084680","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8359","METRONIDAZOLE","Metronidazole","71335183801","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1838","71335-1838-1","71335-1838_4de87bd8-34c2-40bf-bee0-51bbc9084680","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8360","METRONIDAZOLE","Metronidazole","71335183803","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1838","71335-1838-3","71335-1838_4de87bd8-34c2-40bf-bee0-51bbc9084680","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8361","METRONIDAZOLE","Metronidazole","71335183804","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1838","71335-1838-4","71335-1838_4de87bd8-34c2-40bf-bee0-51bbc9084680","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8362","METRONIDAZOLE","Metronidazole","71335183805","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1838","71335-1838-5","71335-1838_4de87bd8-34c2-40bf-bee0-51bbc9084680","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8363","METRONIDAZOLE","Metronidazole","71335183802","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1838","71335-1838-2","71335-1838_4de87bd8-34c2-40bf-bee0-51bbc9084680","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8364","METRONIDAZOLE","Metronidazole","71335183807","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1838","71335-1838-7","71335-1838_4de87bd8-34c2-40bf-bee0-51bbc9084680","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8365","METRONIDAZOLE","Metronidazole","71335183808","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1838","71335-1838-8","71335-1838_4de87bd8-34c2-40bf-bee0-51bbc9084680","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8366","METRONIDAZOLE","Metronidazole","71335183809","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1838","71335-1838-9","71335-1838_4de87bd8-34c2-40bf-bee0-51bbc9084680","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8367","METRONIDAZOLE","Metronidazole","71335183806","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1838","71335-1838-6","71335-1838_4de87bd8-34c2-40bf-bee0-51bbc9084680","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8368","KETOCONAZOLE","ketoconazole","71335184901","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71335-1849","71335-1849-1","71335-1849_e44810bf-246c-4043-bd20-28f512e0e347","HUMAN PRESCRIPTION DRUG","KETOCONAZOLE","","TABLET","ORAL","20200410","","ANDA","ANDA075912","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8369","KETOCONAZOLE","ketoconazole","71335184902","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71335-1849","71335-1849-2","71335-1849_e44810bf-246c-4043-bd20-28f512e0e347","HUMAN PRESCRIPTION DRUG","KETOCONAZOLE","","TABLET","ORAL","20200410","","ANDA","ANDA075912","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8370","KETOCONAZOLE","ketoconazole","71335184903","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71335-1849","71335-1849-3","71335-1849_e44810bf-246c-4043-bd20-28f512e0e347","HUMAN PRESCRIPTION DRUG","KETOCONAZOLE","","TABLET","ORAL","20200410","","ANDA","ANDA075912","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8371","KETOCONAZOLE","ketoconazole","71335184905","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71335-1849","71335-1849-5","71335-1849_e44810bf-246c-4043-bd20-28f512e0e347","HUMAN PRESCRIPTION DRUG","KETOCONAZOLE","","TABLET","ORAL","20200410","","ANDA","ANDA075912","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8372","KETOCONAZOLE","ketoconazole","71335184906","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71335-1849","71335-1849-6","71335-1849_e44810bf-246c-4043-bd20-28f512e0e347","HUMAN PRESCRIPTION DRUG","KETOCONAZOLE","","TABLET","ORAL","20200410","","ANDA","ANDA075912","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8373","KETOCONAZOLE","ketoconazole","71335184907","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71335-1849","71335-1849-7","71335-1849_e44810bf-246c-4043-bd20-28f512e0e347","HUMAN PRESCRIPTION DRUG","KETOCONAZOLE","","TABLET","ORAL","20200410","","ANDA","ANDA075912","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8374","KETOCONAZOLE","ketoconazole","71335184904","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71335-1849","71335-1849-4","71335-1849_e44810bf-246c-4043-bd20-28f512e0e347","HUMAN PRESCRIPTION DRUG","KETOCONAZOLE","","TABLET","ORAL","20200410","","ANDA","ANDA075912","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8375","KETOCONAZOLE","ketoconazole","71335184908","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71335-1849","71335-1849-8","71335-1849_e44810bf-246c-4043-bd20-28f512e0e347","HUMAN PRESCRIPTION DRUG","KETOCONAZOLE","","TABLET","ORAL","20200410","","ANDA","ANDA075912","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8376","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335186701","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1867","71335-1867-1","71335-1867_6ef39f10-95be-4fc5-b917-d8e9f5e8e05c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8377","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335186702","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1867","71335-1867-2","71335-1867_6ef39f10-95be-4fc5-b917-d8e9f5e8e05c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8378","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335186703","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1867","71335-1867-3","71335-1867_6ef39f10-95be-4fc5-b917-d8e9f5e8e05c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8379","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335186704","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1867","71335-1867-4","71335-1867_6ef39f10-95be-4fc5-b917-d8e9f5e8e05c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8380","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335186705","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1867","71335-1867-5","71335-1867_6ef39f10-95be-4fc5-b917-d8e9f5e8e05c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8381","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335186706","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1867","71335-1867-6","71335-1867_6ef39f10-95be-4fc5-b917-d8e9f5e8e05c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8382","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335186707","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1867","71335-1867-7","71335-1867_6ef39f10-95be-4fc5-b917-d8e9f5e8e05c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8383","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335186708","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1867","71335-1867-8","71335-1867_6ef39f10-95be-4fc5-b917-d8e9f5e8e05c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8384","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335186709","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1867","71335-1867-9","71335-1867_6ef39f10-95be-4fc5-b917-d8e9f5e8e05c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8385","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335186700","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-1867","71335-1867-0","71335-1867_6ef39f10-95be-4fc5-b917-d8e9f5e8e05c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8386","FLUCONAZOLE","Fluconazole","71335189500","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1895","71335-1895-0","71335-1895_0a2b1160-1a6c-414e-91b5-f3d2e3657c1f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8387","FLUCONAZOLE","Fluconazole","71335189502","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1895","71335-1895-2","71335-1895_0a2b1160-1a6c-414e-91b5-f3d2e3657c1f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8388","FLUCONAZOLE","Fluconazole","71335189503","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1895","71335-1895-3","71335-1895_0a2b1160-1a6c-414e-91b5-f3d2e3657c1f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8389","FLUCONAZOLE","Fluconazole","71335189504","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1895","71335-1895-4","71335-1895_0a2b1160-1a6c-414e-91b5-f3d2e3657c1f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8390","FLUCONAZOLE","Fluconazole","71335189501","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1895","71335-1895-1","71335-1895_0a2b1160-1a6c-414e-91b5-f3d2e3657c1f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8391","FLUCONAZOLE","Fluconazole","71335189506","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1895","71335-1895-6","71335-1895_0a2b1160-1a6c-414e-91b5-f3d2e3657c1f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8392","FLUCONAZOLE","Fluconazole","71335189507","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1895","71335-1895-7","71335-1895_0a2b1160-1a6c-414e-91b5-f3d2e3657c1f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8393","FLUCONAZOLE","Fluconazole","71335189508","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1895","71335-1895-8","71335-1895_0a2b1160-1a6c-414e-91b5-f3d2e3657c1f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8394","FLUCONAZOLE","Fluconazole","71335189505","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1895","71335-1895-5","71335-1895_0a2b1160-1a6c-414e-91b5-f3d2e3657c1f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8395","FLUCONAZOLE","Fluconazole","71335189509","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1895","71335-1895-9","71335-1895_0a2b1160-1a6c-414e-91b5-f3d2e3657c1f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8396","METRONIDAZOLE","Metronidazole","71335192200","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1922","71335-1922-0","71335-1922_cd3ddbd2-3cd3-4bf3-9089-b54f33e52ff1","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8397","METRONIDAZOLE","Metronidazole","71335192201","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1922","71335-1922-1","71335-1922_cd3ddbd2-3cd3-4bf3-9089-b54f33e52ff1","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8398","METRONIDAZOLE","Metronidazole","71335192203","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1922","71335-1922-3","71335-1922_cd3ddbd2-3cd3-4bf3-9089-b54f33e52ff1","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8399","METRONIDAZOLE","Metronidazole","71335192204","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1922","71335-1922-4","71335-1922_cd3ddbd2-3cd3-4bf3-9089-b54f33e52ff1","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8400","METRONIDAZOLE","Metronidazole","71335192205","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1922","71335-1922-5","71335-1922_cd3ddbd2-3cd3-4bf3-9089-b54f33e52ff1","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8401","METRONIDAZOLE","Metronidazole","71335192206","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1922","71335-1922-6","71335-1922_cd3ddbd2-3cd3-4bf3-9089-b54f33e52ff1","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8402","METRONIDAZOLE","Metronidazole","71335192207","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1922","71335-1922-7","71335-1922_cd3ddbd2-3cd3-4bf3-9089-b54f33e52ff1","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8403","METRONIDAZOLE","Metronidazole","71335192208","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1922","71335-1922-8","71335-1922_cd3ddbd2-3cd3-4bf3-9089-b54f33e52ff1","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8404","METRONIDAZOLE","Metronidazole","71335192209","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1922","71335-1922-9","71335-1922_cd3ddbd2-3cd3-4bf3-9089-b54f33e52ff1","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8405","METRONIDAZOLE","Metronidazole","71335192202","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71335-1922","71335-1922-2","71335-1922_cd3ddbd2-3cd3-4bf3-9089-b54f33e52ff1","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20150529","","ANDA","ANDA203974","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8406","FLUCONAZOLE","Fluconazole","71335194800","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1948","71335-1948-0","71335-1948_2fa2fcb0-3bc0-474c-83e0-c1b1140ac54b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8407","FLUCONAZOLE","Fluconazole","71335194801","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1948","71335-1948-1","71335-1948_2fa2fcb0-3bc0-474c-83e0-c1b1140ac54b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8408","FLUCONAZOLE","Fluconazole","71335194803","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1948","71335-1948-3","71335-1948_2fa2fcb0-3bc0-474c-83e0-c1b1140ac54b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8409","FLUCONAZOLE","Fluconazole","71335194804","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1948","71335-1948-4","71335-1948_2fa2fcb0-3bc0-474c-83e0-c1b1140ac54b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8410","FLUCONAZOLE","Fluconazole","71335194805","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1948","71335-1948-5","71335-1948_2fa2fcb0-3bc0-474c-83e0-c1b1140ac54b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8411","FLUCONAZOLE","Fluconazole","71335194802","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1948","71335-1948-2","71335-1948_2fa2fcb0-3bc0-474c-83e0-c1b1140ac54b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8412","FLUCONAZOLE","Fluconazole","71335194807","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1948","71335-1948-7","71335-1948_2fa2fcb0-3bc0-474c-83e0-c1b1140ac54b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8413","FLUCONAZOLE","Fluconazole","71335194808","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1948","71335-1948-8","71335-1948_2fa2fcb0-3bc0-474c-83e0-c1b1140ac54b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8414","FLUCONAZOLE","Fluconazole","71335194809","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1948","71335-1948-9","71335-1948_2fa2fcb0-3bc0-474c-83e0-c1b1140ac54b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8415","FLUCONAZOLE","Fluconazole","71335194806","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-1948","71335-1948-6","71335-1948_2fa2fcb0-3bc0-474c-83e0-c1b1140ac54b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8416","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335204601","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2046","71335-2046-1","71335-2046_d38a17e1-c308-40bc-9c11-ff97c8a8b19b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8417","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335204602","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2046","71335-2046-2","71335-2046_d38a17e1-c308-40bc-9c11-ff97c8a8b19b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8418","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335204603","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2046","71335-2046-3","71335-2046_d38a17e1-c308-40bc-9c11-ff97c8a8b19b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8419","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335204600","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2046","71335-2046-0","71335-2046_d38a17e1-c308-40bc-9c11-ff97c8a8b19b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8420","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335204605","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2046","71335-2046-5","71335-2046_d38a17e1-c308-40bc-9c11-ff97c8a8b19b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8421","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335204606","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2046","71335-2046-6","71335-2046_d38a17e1-c308-40bc-9c11-ff97c8a8b19b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8422","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335204607","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2046","71335-2046-7","71335-2046_d38a17e1-c308-40bc-9c11-ff97c8a8b19b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8423","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335204604","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2046","71335-2046-4","71335-2046_d38a17e1-c308-40bc-9c11-ff97c8a8b19b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8424","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335204609","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2046","71335-2046-9","71335-2046_d38a17e1-c308-40bc-9c11-ff97c8a8b19b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8425","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71335204608","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2046","71335-2046-8","71335-2046_d38a17e1-c308-40bc-9c11-ff97c8a8b19b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8426","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335205401","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2054","71335-2054-1","71335-2054_901ae0da-246f-4d15-ad36-5b468edc2802","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8427","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335205402","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2054","71335-2054-2","71335-2054_901ae0da-246f-4d15-ad36-5b468edc2802","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8428","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335205403","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2054","71335-2054-3","71335-2054_901ae0da-246f-4d15-ad36-5b468edc2802","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8429","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335205400","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2054","71335-2054-0","71335-2054_901ae0da-246f-4d15-ad36-5b468edc2802","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8430","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335205405","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2054","71335-2054-5","71335-2054_901ae0da-246f-4d15-ad36-5b468edc2802","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8431","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335205406","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2054","71335-2054-6","71335-2054_901ae0da-246f-4d15-ad36-5b468edc2802","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8432","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335205407","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2054","71335-2054-7","71335-2054_901ae0da-246f-4d15-ad36-5b468edc2802","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8433","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335205404","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2054","71335-2054-4","71335-2054_901ae0da-246f-4d15-ad36-5b468edc2802","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8434","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335205409","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2054","71335-2054-9","71335-2054_901ae0da-246f-4d15-ad36-5b468edc2802","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8435","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335205408","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2054","71335-2054-8","71335-2054_901ae0da-246f-4d15-ad36-5b468edc2802","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8436","NITROFURANTOIN","nitrofurantoin macrocrystals","71335207401","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2074","71335-2074-1","71335-2074_cde7dd6d-c987-4034-9488-8b97861f3abd","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Bryant Ranch Prepack","50","mg/1","","N","20251231"
"8437","NITROFURANTOIN","nitrofurantoin macrocrystals","71335207403","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2074","71335-2074-3","71335-2074_cde7dd6d-c987-4034-9488-8b97861f3abd","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Bryant Ranch Prepack","50","mg/1","","N","20251231"
"8438","NITROFURANTOIN","nitrofurantoin macrocrystals","71335207404","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2074","71335-2074-4","71335-2074_cde7dd6d-c987-4034-9488-8b97861f3abd","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Bryant Ranch Prepack","50","mg/1","","N","20251231"
"8439","NITROFURANTOIN","nitrofurantoin macrocrystals","71335207405","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2074","71335-2074-5","71335-2074_cde7dd6d-c987-4034-9488-8b97861f3abd","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Bryant Ranch Prepack","50","mg/1","","N","20251231"
"8440","NITROFURANTOIN","nitrofurantoin macrocrystals","71335207406","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2074","71335-2074-6","71335-2074_cde7dd6d-c987-4034-9488-8b97861f3abd","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Bryant Ranch Prepack","50","mg/1","","N","20251231"
"8441","NITROFURANTOIN","nitrofurantoin macrocrystals","71335207402","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2074","71335-2074-2","71335-2074_cde7dd6d-c987-4034-9488-8b97861f3abd","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20100927","","NDA","NDA016620","Bryant Ranch Prepack","50","mg/1","","N","20251231"
"8442","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335209701","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2097","71335-2097-1","71335-2097_2e9526cc-99ea-4195-a48a-d4968764401a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8443","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335209702","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2097","71335-2097-2","71335-2097_2e9526cc-99ea-4195-a48a-d4968764401a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8444","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335209703","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2097","71335-2097-3","71335-2097_2e9526cc-99ea-4195-a48a-d4968764401a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8445","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335209700","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2097","71335-2097-0","71335-2097_2e9526cc-99ea-4195-a48a-d4968764401a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8446","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335209705","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2097","71335-2097-5","71335-2097_2e9526cc-99ea-4195-a48a-d4968764401a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8447","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335209706","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2097","71335-2097-6","71335-2097_2e9526cc-99ea-4195-a48a-d4968764401a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8448","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335209707","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2097","71335-2097-7","71335-2097_2e9526cc-99ea-4195-a48a-d4968764401a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8449","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335209704","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2097","71335-2097-4","71335-2097_2e9526cc-99ea-4195-a48a-d4968764401a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8450","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335209709","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2097","71335-2097-9","71335-2097_2e9526cc-99ea-4195-a48a-d4968764401a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8451","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71335209708","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2097","71335-2097-8","71335-2097_2e9526cc-99ea-4195-a48a-d4968764401a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, COATED","ORAL","20200812","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8452","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335214102","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2141","71335-2141-2","71335-2141_dbd18052-a245-4b01-8654-0505c06cfb26","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8453","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335214103","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2141","71335-2141-3","71335-2141_dbd18052-a245-4b01-8654-0505c06cfb26","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8454","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335214104","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2141","71335-2141-4","71335-2141_dbd18052-a245-4b01-8654-0505c06cfb26","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8455","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335214101","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2141","71335-2141-1","71335-2141_dbd18052-a245-4b01-8654-0505c06cfb26","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8456","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335214106","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2141","71335-2141-6","71335-2141_dbd18052-a245-4b01-8654-0505c06cfb26","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8457","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335214107","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2141","71335-2141-7","71335-2141_dbd18052-a245-4b01-8654-0505c06cfb26","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8458","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335214108","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2141","71335-2141-8","71335-2141_dbd18052-a245-4b01-8654-0505c06cfb26","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8459","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335214105","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2141","71335-2141-5","71335-2141_dbd18052-a245-4b01-8654-0505c06cfb26","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8460","NITROFURANTOIN","nitrofurantoin macrocrystals","71335221201","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2212","71335-2212-1","71335-2212_286e68d4-754d-4900-9365-901ecccac6b0","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8461","NITROFURANTOIN","nitrofurantoin macrocrystals","71335221203","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2212","71335-2212-3","71335-2212_286e68d4-754d-4900-9365-901ecccac6b0","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8462","NITROFURANTOIN","nitrofurantoin macrocrystals","71335221204","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2212","71335-2212-4","71335-2212_286e68d4-754d-4900-9365-901ecccac6b0","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8463","NITROFURANTOIN","nitrofurantoin macrocrystals","71335221205","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2212","71335-2212-5","71335-2212_286e68d4-754d-4900-9365-901ecccac6b0","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8464","NITROFURANTOIN","nitrofurantoin macrocrystals","71335221202","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2212","71335-2212-2","71335-2212_286e68d4-754d-4900-9365-901ecccac6b0","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8465","NITROFURANTOIN","nitrofurantoin macrocrystals","71335221207","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2212","71335-2212-7","71335-2212_286e68d4-754d-4900-9365-901ecccac6b0","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8466","NITROFURANTOIN","nitrofurantoin macrocrystals","71335221208","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2212","71335-2212-8","71335-2212_286e68d4-754d-4900-9365-901ecccac6b0","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8467","NITROFURANTOIN","nitrofurantoin macrocrystals","71335221209","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2212","71335-2212-9","71335-2212_286e68d4-754d-4900-9365-901ecccac6b0","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8468","NITROFURANTOIN","nitrofurantoin macrocrystals","71335221206","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2212","71335-2212-6","71335-2212_286e68d4-754d-4900-9365-901ecccac6b0","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8469","FLUCONAZOLE","Fluconazole","71335223501","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-2235","71335-2235-1","71335-2235_29b45641-c685-4ae8-accb-23784c01ee86","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8470","FLUCONAZOLE","Fluconazole","71335223502","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-2235","71335-2235-2","71335-2235_29b45641-c685-4ae8-accb-23784c01ee86","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8471","FLUCONAZOLE","Fluconazole","71335223503","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-2235","71335-2235-3","71335-2235_29b45641-c685-4ae8-accb-23784c01ee86","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8472","FLUCONAZOLE","Fluconazole","71335223500","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-2235","71335-2235-0","71335-2235_29b45641-c685-4ae8-accb-23784c01ee86","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8473","FLUCONAZOLE","Fluconazole","71335223505","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-2235","71335-2235-5","71335-2235_29b45641-c685-4ae8-accb-23784c01ee86","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8474","FLUCONAZOLE","Fluconazole","71335223506","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-2235","71335-2235-6","71335-2235_29b45641-c685-4ae8-accb-23784c01ee86","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8475","FLUCONAZOLE","Fluconazole","71335223507","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-2235","71335-2235-7","71335-2235_29b45641-c685-4ae8-accb-23784c01ee86","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8476","FLUCONAZOLE","Fluconazole","71335223504","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-2235","71335-2235-4","71335-2235_29b45641-c685-4ae8-accb-23784c01ee86","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8477","FLUCONAZOLE","Fluconazole","71335223509","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-2235","71335-2235-9","71335-2235_29b45641-c685-4ae8-accb-23784c01ee86","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8478","FLUCONAZOLE","Fluconazole","71335223508","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-2235","71335-2235-8","71335-2235_29b45641-c685-4ae8-accb-23784c01ee86","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Bryant Ranch Prepack","200","mg/1","","N","20251231"
"8479","NITROFURANTOIN","nitrofurantoin macrocrystals","71335225402","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2254","71335-2254-2","71335-2254_7d6f0d9a-05d2-4e93-a94e-6ef7cc11563a","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Bryant Ranch Prepack","50","mg/1","","N","20251231"
"8480","NITROFURANTOIN","nitrofurantoin macrocrystals","71335225403","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2254","71335-2254-3","71335-2254_7d6f0d9a-05d2-4e93-a94e-6ef7cc11563a","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Bryant Ranch Prepack","50","mg/1","","N","20251231"
"8481","NITROFURANTOIN","nitrofurantoin macrocrystals","71335225404","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2254","71335-2254-4","71335-2254_7d6f0d9a-05d2-4e93-a94e-6ef7cc11563a","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Bryant Ranch Prepack","50","mg/1","","N","20251231"
"8482","NITROFURANTOIN","nitrofurantoin macrocrystals","71335225401","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2254","71335-2254-1","71335-2254_7d6f0d9a-05d2-4e93-a94e-6ef7cc11563a","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Bryant Ranch Prepack","50","mg/1","","N","20251231"
"8483","NITROFURANTOIN","nitrofurantoin macrocrystals","71335225406","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2254","71335-2254-6","71335-2254_7d6f0d9a-05d2-4e93-a94e-6ef7cc11563a","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Bryant Ranch Prepack","50","mg/1","","N","20251231"
"8484","NITROFURANTOIN","nitrofurantoin macrocrystals","71335225405","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","71335-2254","71335-2254-5","71335-2254_7d6f0d9a-05d2-4e93-a94e-6ef7cc11563a","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Bryant Ranch Prepack","50","mg/1","","N","20251231"
"8485","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335225502","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2255","71335-2255-2","71335-2255_f3e9bbf9-ad43-4ce6-aca0-d7ed0a4499fc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8486","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335225503","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2255","71335-2255-3","71335-2255_f3e9bbf9-ad43-4ce6-aca0-d7ed0a4499fc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8487","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335225504","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2255","71335-2255-4","71335-2255_f3e9bbf9-ad43-4ce6-aca0-d7ed0a4499fc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8488","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335225501","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2255","71335-2255-1","71335-2255_f3e9bbf9-ad43-4ce6-aca0-d7ed0a4499fc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8489","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335225506","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2255","71335-2255-6","71335-2255_f3e9bbf9-ad43-4ce6-aca0-d7ed0a4499fc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8490","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335225507","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2255","71335-2255-7","71335-2255_f3e9bbf9-ad43-4ce6-aca0-d7ed0a4499fc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8491","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335225508","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2255","71335-2255-8","71335-2255_f3e9bbf9-ad43-4ce6-aca0-d7ed0a4499fc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8492","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335225505","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2255","71335-2255-5","71335-2255_f3e9bbf9-ad43-4ce6-aca0-d7ed0a4499fc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8493","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335225509","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2255","71335-2255-9","71335-2255_f3e9bbf9-ad43-4ce6-aca0-d7ed0a4499fc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8494","FLUCONAZOLE","Fluconazole","71335226801","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","71335-2268","71335-2268-1","71335-2268_ffd22a45-58c4-4adc-aca8-b60a3f76ad31","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20201120","","ANDA","ANDA077253","Bryant Ranch Prepack","150","mg/1","","N","20251231"
"8495","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335232000","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2320","71335-2320-0","71335-2320_b4e52306-bf3a-4cca-ad23-21a806b68be5","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8496","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335232001","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2320","71335-2320-1","71335-2320_b4e52306-bf3a-4cca-ad23-21a806b68be5","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8497","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335232003","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2320","71335-2320-3","71335-2320_b4e52306-bf3a-4cca-ad23-21a806b68be5","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8498","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335232004","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2320","71335-2320-4","71335-2320_b4e52306-bf3a-4cca-ad23-21a806b68be5","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8499","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335232005","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2320","71335-2320-5","71335-2320_b4e52306-bf3a-4cca-ad23-21a806b68be5","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8500","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335232002","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2320","71335-2320-2","71335-2320_b4e52306-bf3a-4cca-ad23-21a806b68be5","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8501","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335232007","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2320","71335-2320-7","71335-2320_b4e52306-bf3a-4cca-ad23-21a806b68be5","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8502","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335232008","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2320","71335-2320-8","71335-2320_b4e52306-bf3a-4cca-ad23-21a806b68be5","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8503","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335232009","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2320","71335-2320-9","71335-2320_b4e52306-bf3a-4cca-ad23-21a806b68be5","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8504","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","71335232006","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2320","71335-2320-6","71335-2320_b4e52306-bf3a-4cca-ad23-21a806b68be5","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8505","MOXIFLOXACIN HYDROCHLORIDE","moxifloxacin hydrochloride","71335232901","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2329","71335-2329-1","71335-2329_4b941ff6-b0aa-4cd5-962b-1106fefe6326","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN HYDROCHLORIDE","","TABLET, FILM COATED","ORAL","20140304","","ANDA","ANDA202632","Bryant Ranch Prepack","400","mg/1","","N","20251231"
"8506","MOXIFLOXACIN HYDROCHLORIDE","moxifloxacin hydrochloride","71335232902","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2329","71335-2329-2","71335-2329_4b941ff6-b0aa-4cd5-962b-1106fefe6326","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN HYDROCHLORIDE","","TABLET, FILM COATED","ORAL","20140304","","ANDA","ANDA202632","Bryant Ranch Prepack","400","mg/1","","N","20251231"
"8507","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","71335237700","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2377","71335-2377-0","71335-2377_140ec378-126e-409d-8cbd-46f9e343a9ef","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8508","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","71335237702","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2377","71335-2377-2","71335-2377_140ec378-126e-409d-8cbd-46f9e343a9ef","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8509","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","71335237703","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2377","71335-2377-3","71335-2377_140ec378-126e-409d-8cbd-46f9e343a9ef","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8510","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","71335237704","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2377","71335-2377-4","71335-2377_140ec378-126e-409d-8cbd-46f9e343a9ef","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8511","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","71335237701","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2377","71335-2377-1","71335-2377_140ec378-126e-409d-8cbd-46f9e343a9ef","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8512","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","71335237706","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2377","71335-2377-6","71335-2377_140ec378-126e-409d-8cbd-46f9e343a9ef","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8513","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","71335237707","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2377","71335-2377-7","71335-2377_140ec378-126e-409d-8cbd-46f9e343a9ef","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8514","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","71335237708","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2377","71335-2377-8","71335-2377_140ec378-126e-409d-8cbd-46f9e343a9ef","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8515","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","71335237705","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2377","71335-2377-5","71335-2377_140ec378-126e-409d-8cbd-46f9e343a9ef","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8516","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","71335237709","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","71335-2377","71335-2377-9","71335-2377_140ec378-126e-409d-8cbd-46f9e343a9ef","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20261231"
"8517","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335241501","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2415","71335-2415-1","71335-2415_cf243932-ea5b-4599-bfb0-cf85e5c9ab3e","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8518","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335241503","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2415","71335-2415-3","71335-2415_cf243932-ea5b-4599-bfb0-cf85e5c9ab3e","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8519","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335241504","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2415","71335-2415-4","71335-2415_cf243932-ea5b-4599-bfb0-cf85e5c9ab3e","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8520","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335241505","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2415","71335-2415-5","71335-2415_cf243932-ea5b-4599-bfb0-cf85e5c9ab3e","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8521","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335241502","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2415","71335-2415-2","71335-2415_cf243932-ea5b-4599-bfb0-cf85e5c9ab3e","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8522","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335241507","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2415","71335-2415-7","71335-2415_cf243932-ea5b-4599-bfb0-cf85e5c9ab3e","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8523","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335241508","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2415","71335-2415-8","71335-2415_cf243932-ea5b-4599-bfb0-cf85e5c9ab3e","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8524","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335241506","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2415","71335-2415-6","71335-2415_cf243932-ea5b-4599-bfb0-cf85e5c9ab3e","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20190118","","ANDA","ANDA210662","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8525","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335242702","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2427","71335-2427-2","71335-2427_a0b7867e-8cf2-4359-a111-5efd925c3f24","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20200401","","ANDA","ANDA062752","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8526","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335242703","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2427","71335-2427-3","71335-2427_a0b7867e-8cf2-4359-a111-5efd925c3f24","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20200401","","ANDA","ANDA062752","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8527","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335242704","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2427","71335-2427-4","71335-2427_a0b7867e-8cf2-4359-a111-5efd925c3f24","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20200401","","ANDA","ANDA062752","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8528","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335242701","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2427","71335-2427-1","71335-2427_a0b7867e-8cf2-4359-a111-5efd925c3f24","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20200401","","ANDA","ANDA062752","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8529","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335242706","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2427","71335-2427-6","71335-2427_a0b7867e-8cf2-4359-a111-5efd925c3f24","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20200401","","ANDA","ANDA062752","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8530","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335242707","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2427","71335-2427-7","71335-2427_a0b7867e-8cf2-4359-a111-5efd925c3f24","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20200401","","ANDA","ANDA062752","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8531","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335242708","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2427","71335-2427-8","71335-2427_a0b7867e-8cf2-4359-a111-5efd925c3f24","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20200401","","ANDA","ANDA062752","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8532","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","71335242705","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71335-2427","71335-2427-5","71335-2427_a0b7867e-8cf2-4359-a111-5efd925c3f24","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","CAPSULE","ORAL","20200401","","ANDA","ANDA062752","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8533","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335243200","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2432","71335-2432-0","71335-2432_21aedcfa-369b-464d-8d50-0e0ca4338dcc","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8534","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335243201","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2432","71335-2432-1","71335-2432_21aedcfa-369b-464d-8d50-0e0ca4338dcc","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8535","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335243202","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2432","71335-2432-2","71335-2432_21aedcfa-369b-464d-8d50-0e0ca4338dcc","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8536","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335243204","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2432","71335-2432-4","71335-2432_21aedcfa-369b-464d-8d50-0e0ca4338dcc","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8537","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335243205","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2432","71335-2432-5","71335-2432_21aedcfa-369b-464d-8d50-0e0ca4338dcc","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8538","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335243206","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2432","71335-2432-6","71335-2432_21aedcfa-369b-464d-8d50-0e0ca4338dcc","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8539","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335243203","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2432","71335-2432-3","71335-2432_21aedcfa-369b-464d-8d50-0e0ca4338dcc","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8540","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335243208","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2432","71335-2432-8","71335-2432_21aedcfa-369b-464d-8d50-0e0ca4338dcc","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8541","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335243209","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2432","71335-2432-9","71335-2432_21aedcfa-369b-464d-8d50-0e0ca4338dcc","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8542","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335243207","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2432","71335-2432-7","71335-2432_21aedcfa-369b-464d-8d50-0e0ca4338dcc","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","300","mg/1","","N","20251231"
"8543","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335245000","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2450","71335-2450-0","71335-2450_a5fcba51-4ab6-4b4a-a73d-64dec62a2e52","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8544","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335245001","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2450","71335-2450-1","71335-2450_a5fcba51-4ab6-4b4a-a73d-64dec62a2e52","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8545","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335245002","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2450","71335-2450-2","71335-2450_a5fcba51-4ab6-4b4a-a73d-64dec62a2e52","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8546","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335245004","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2450","71335-2450-4","71335-2450_a5fcba51-4ab6-4b4a-a73d-64dec62a2e52","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8547","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335245005","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2450","71335-2450-5","71335-2450_a5fcba51-4ab6-4b4a-a73d-64dec62a2e52","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8548","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335245006","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2450","71335-2450-6","71335-2450_a5fcba51-4ab6-4b4a-a73d-64dec62a2e52","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8549","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335245003","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2450","71335-2450-3","71335-2450_a5fcba51-4ab6-4b4a-a73d-64dec62a2e52","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8550","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335245008","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2450","71335-2450-8","71335-2450_a5fcba51-4ab6-4b4a-a73d-64dec62a2e52","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8551","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335245009","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2450","71335-2450-9","71335-2450_a5fcba51-4ab6-4b4a-a73d-64dec62a2e52","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8552","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335245007","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2450","71335-2450-7","71335-2450_a5fcba51-4ab6-4b4a-a73d-64dec62a2e52","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8553","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335250201","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2502","71335-2502-1","71335-2502_64c0aefd-0ce3-4ad3-b39c-8bcb910bd02e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8554","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335250202","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2502","71335-2502-2","71335-2502_64c0aefd-0ce3-4ad3-b39c-8bcb910bd02e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8555","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335250203","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2502","71335-2502-3","71335-2502_64c0aefd-0ce3-4ad3-b39c-8bcb910bd02e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8556","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335250204","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2502","71335-2502-4","71335-2502_64c0aefd-0ce3-4ad3-b39c-8bcb910bd02e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8557","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335250205","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2502","71335-2502-5","71335-2502_64c0aefd-0ce3-4ad3-b39c-8bcb910bd02e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8558","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335250206","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2502","71335-2502-6","71335-2502_64c0aefd-0ce3-4ad3-b39c-8bcb910bd02e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8559","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335250207","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2502","71335-2502-7","71335-2502_64c0aefd-0ce3-4ad3-b39c-8bcb910bd02e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8560","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335250208","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2502","71335-2502-8","71335-2502_64c0aefd-0ce3-4ad3-b39c-8bcb910bd02e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8561","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335250209","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2502","71335-2502-9","71335-2502_64c0aefd-0ce3-4ad3-b39c-8bcb910bd02e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8562","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","71335250200","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","71335-2502","71335-2502-0","71335-2502_64c0aefd-0ce3-4ad3-b39c-8bcb910bd02e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8563","LINEZOLID","Linezolid","71335256501","Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","71335-2565","71335-2565-1","71335-2565_e9fe15d9-2946-4d61-8120-3762c180ae13","HUMAN PRESCRIPTION DRUG","Linezolid","","TABLET, FILM COATED","ORAL","20151221","","ANDA","ANDA205517","Bryant Ranch Prepack","600","mg/1","","N","20261231"
"8564","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","71335258102","Macrolide Antimicrobial [EPC], Macrolides [CS]","71335-2581","71335-2581-2","71335-2581_d3a94453-1704-4bb6-afd2-d678de7475a0","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8565","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","71335258103","Macrolide Antimicrobial [EPC], Macrolides [CS]","71335-2581","71335-2581-3","71335-2581_d3a94453-1704-4bb6-afd2-d678de7475a0","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8566","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","71335258104","Macrolide Antimicrobial [EPC], Macrolides [CS]","71335-2581","71335-2581-4","71335-2581_d3a94453-1704-4bb6-afd2-d678de7475a0","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8567","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","71335258101","Macrolide Antimicrobial [EPC], Macrolides [CS]","71335-2581","71335-2581-1","71335-2581_d3a94453-1704-4bb6-afd2-d678de7475a0","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8568","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335262300","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2623","71335-2623-0","71335-2623_39886120-eb1b-40a8-a299-cad98aba87de","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","150","mg/1","","N","20261231"
"8569","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335262301","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2623","71335-2623-1","71335-2623_39886120-eb1b-40a8-a299-cad98aba87de","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","150","mg/1","","N","20261231"
"8570","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335262302","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2623","71335-2623-2","71335-2623_39886120-eb1b-40a8-a299-cad98aba87de","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","150","mg/1","","N","20261231"
"8571","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335262304","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2623","71335-2623-4","71335-2623_39886120-eb1b-40a8-a299-cad98aba87de","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","150","mg/1","","N","20261231"
"8572","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335262305","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2623","71335-2623-5","71335-2623_39886120-eb1b-40a8-a299-cad98aba87de","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","150","mg/1","","N","20261231"
"8573","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335262306","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2623","71335-2623-6","71335-2623_39886120-eb1b-40a8-a299-cad98aba87de","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","150","mg/1","","N","20261231"
"8574","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335262303","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2623","71335-2623-3","71335-2623_39886120-eb1b-40a8-a299-cad98aba87de","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","150","mg/1","","N","20261231"
"8575","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335262308","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2623","71335-2623-8","71335-2623_39886120-eb1b-40a8-a299-cad98aba87de","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","150","mg/1","","N","20261231"
"8576","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335262309","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2623","71335-2623-9","71335-2623_39886120-eb1b-40a8-a299-cad98aba87de","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","150","mg/1","","N","20261231"
"8577","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","71335262307","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71335-2623","71335-2623-7","71335-2623_39886120-eb1b-40a8-a299-cad98aba87de","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Bryant Ranch Prepack","150","mg/1","","N","20261231"
"8578","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","71335967702","Allylamine Antifungal [EPC], Allylamine [CS]","71335-9677","71335-9677-2","71335-9677_ebbb6769-54f5-415e-a685-0c6baf35645d","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20220128","","ANDA","ANDA078163","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8579","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","71335967703","Allylamine Antifungal [EPC], Allylamine [CS]","71335-9677","71335-9677-3","71335-9677_ebbb6769-54f5-415e-a685-0c6baf35645d","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20220128","","ANDA","ANDA078163","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8580","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","71335967704","Allylamine Antifungal [EPC], Allylamine [CS]","71335-9677","71335-9677-4","71335-9677_ebbb6769-54f5-415e-a685-0c6baf35645d","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20220128","","ANDA","ANDA078163","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8581","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","71335967701","Allylamine Antifungal [EPC], Allylamine [CS]","71335-9677","71335-9677-1","71335-9677_ebbb6769-54f5-415e-a685-0c6baf35645d","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20220128","","ANDA","ANDA078163","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8582","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","71335967706","Allylamine Antifungal [EPC], Allylamine [CS]","71335-9677","71335-9677-6","71335-9677_ebbb6769-54f5-415e-a685-0c6baf35645d","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20220128","","ANDA","ANDA078163","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8583","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","71335967707","Allylamine Antifungal [EPC], Allylamine [CS]","71335-9677","71335-9677-7","71335-9677_ebbb6769-54f5-415e-a685-0c6baf35645d","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20220128","","ANDA","ANDA078163","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8584","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","71335967708","Allylamine Antifungal [EPC], Allylamine [CS]","71335-9677","71335-9677-8","71335-9677_ebbb6769-54f5-415e-a685-0c6baf35645d","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20220128","","ANDA","ANDA078163","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8585","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","71335967705","Allylamine Antifungal [EPC], Allylamine [CS]","71335-9677","71335-9677-5","71335-9677_ebbb6769-54f5-415e-a685-0c6baf35645d","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20220128","","ANDA","ANDA078163","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8586","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","71335967709","Allylamine Antifungal [EPC], Allylamine [CS]","71335-9677","71335-9677-9","71335-9677_ebbb6769-54f5-415e-a685-0c6baf35645d","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20220128","","ANDA","ANDA078163","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8587","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin, Neomycin Sulfate, Polymyxin B Sulfate","71338012173","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","71338-121","71338-121-73","71338-121_0eb0e8f6-0ce7-b5a2-e063-6394a90a9010","HUMAN OTC DRUG","Ecolab Triple Antibiotic","","OINTMENT","TOPICAL","20170320","","OTC MONOGRAPH DRUG","M004","Ecolabs Food Safety Specialties, Inc.","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"8588","MICONAZOLE NITRATE","MICONAZOLE NITRATE","71399007101","Azole Antifungal [EPC], Azoles [CS]","71399-0071","71399-0071-1","71399-0071_b1ef7656-ad4c-4c56-987a-18628f9d9dca","HUMAN OTC DRUG","MICONAZOLE Nitrate 2%","","CREAM","TOPICAL","20241119","","OTC MONOGRAPH DRUG","M005","Akron Pharma Inc.","2","g/100g","","N","20261231"
"8589","MICONAZOLE NITRATE","MICONAZOLE NITRATE","71399007103","Azole Antifungal [EPC], Azoles [CS]","71399-0071","71399-0071-3","71399-0071_b1ef7656-ad4c-4c56-987a-18628f9d9dca","HUMAN OTC DRUG","MICONAZOLE Nitrate 2%","","CREAM","TOPICAL","20241119","","OTC MONOGRAPH DRUG","M005","Akron Pharma Inc.","2","g/100g","","N","20261231"
"8590","MICONAZOLE NITRATE","MICONAZOLE NITRATE","71399007104","Azole Antifungal [EPC], Azoles [CS]","71399-0071","71399-0071-4","71399-0071_b1ef7656-ad4c-4c56-987a-18628f9d9dca","HUMAN OTC DRUG","MICONAZOLE Nitrate 2%","","CREAM","TOPICAL","20241119","","OTC MONOGRAPH DRUG","M005","Akron Pharma Inc.","2","g/100g","","N","20261231"
"8591","SULFACETAMIDE SODIUM","SODIUM SULFACETAMIDE","71399048002","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","71399-0480","71399-0480-2","71399-0480_fd982d15-1435-4bbf-a29f-71e8bdd4eb2f","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE","","LIQUID","TOPICAL","20240913","","UNAPPROVED DRUG OTHER","","Akron Pharma Inc","100","mg/mL","","N","20251231"
"8592","SULFACETAMIDE SODIUM","SODIUM SULFACETAMIDE","71399048006","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","71399-0480","71399-0480-6","71399-0480_fd982d15-1435-4bbf-a29f-71e8bdd4eb2f","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE","","LIQUID","TOPICAL","20240913","","UNAPPROVED DRUG OTHER","","Akron Pharma Inc","100","mg/mL","","N","20251231"
"8593","SULFACETAMIDE SODIUM","SODIUM SULFACETAMIDE","71399048008","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","71399-0480","71399-0480-8","71399-0480_fd982d15-1435-4bbf-a29f-71e8bdd4eb2f","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE","","LIQUID","TOPICAL","20240913","","UNAPPROVED DRUG OTHER","","Akron Pharma Inc","100","mg/mL","","N","20251231"
"8594","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","71399048206","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","71399-0482","71399-0482-6","71399-0482_869f17c5-f005-4d57-b97e-f98584ee34b9","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 9% - Sulfur 4%","","SUSPENSION","TOPICAL","20240913","","UNAPPROVED DRUG OTHER","","Akron Pharma Inc.","90; 40","mg/mL; mg/mL","","N","20251231"
"8595","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","71399048406","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","71399-0484","71399-0484-6","71399-0484_02efa27e-6f2e-4c57-84f5-e7750d5b4c08","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 9% - Sulfur 4.5% Wash","","LIQUID","TOPICAL","20240913","","UNAPPROVED DRUG OTHER","","Akron Pharma Inc.","90; 45","mg/g; mg/g","","N","20251231"
"8596","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","71399048508","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","71399-0485","71399-0485-8","71399-0485_c916e6d5-1e44-4619-b054-926ca7584056","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10% and Sulfur 2% Cleanser","","LIQUID","TOPICAL","20240913","","UNAPPROVED DRUG OTHER","","Akron Pharma Inc.","100; 20","mg/g; mg/g","","N","20251231"
"8597","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","71399048601","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","71399-0486","71399-0486-1","71399-0486_1d24578a-fa8b-479f-b3c0-8819c7375256","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser","","LIQUID","TOPICAL","20240913","","UNAPPROVED DRUG OTHER","","Akron Pharma Inc.","9.8; 4.8","mg/g; mg/g","","N","20251231"
"8598","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","71399048706","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","71399-0487","71399-0487-6","71399-0487_a4bb29b0-065f-428b-9d9b-bb4e564449d3","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 8% and Sulfur 4%","","SUSPENSION","TOPICAL","20240913","","UNAPPROVED DRUG OTHER","","Akron Pharma Inc.","80; 40","mg/mL; mg/mL","","N","20251231"
"8599","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","71399048806","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","71399-0488","71399-0488-6","71399-0488_6e9e8006-a0bc-4aaf-bc66-2cd7ed06983b","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10% and Sulfur 5% Cleanser","","LIQUID","TOPICAL","20240913","","UNAPPROVED DRUG OTHER","","Akron Pharma Inc.","100; 50","mg/g; mg/g","","N","20251231"
"8600","CLOTRIMAZOLE","Clotrimazole","71399050001","Azole Antifungal [EPC], Azoles [CS]","71399-0500","71399-0500-1","71399-0500_50223ed7-d945-4908-953d-f4ceaf0d0727","HUMAN OTC DRUG","Clotrimazole","","SOLUTION","TOPICAL","20240913","","OTC MONOGRAPH DRUG","M005","Akron Pharma Inc","1","g/mL","","N","20251231"
"8601","CLOTRIMAZOLE","Clotrimazole","71399050003","Azole Antifungal [EPC], Azoles [CS]","71399-0500","71399-0500-3","71399-0500_50223ed7-d945-4908-953d-f4ceaf0d0727","HUMAN OTC DRUG","Clotrimazole","","SOLUTION","TOPICAL","20240913","","OTC MONOGRAPH DRUG","M005","Akron Pharma Inc","1","g/mL","","N","20251231"
"8602","CLOTRIMAZOLE","Clotrimazole Topical Solution USP, 1%","71399066606","Azole Antifungal [EPC], Azoles [CS]","71399-0666","71399-0666-6","71399-0666_5fbee99b-e93b-4682-9629-98f4f65587fa","HUMAN PRESCRIPTION DRUG","Clotrimazole Topical Solution USP, 1%","","SOLUTION","TOPICAL","20231016","","ANDA","ANDA216569","Akron Pharma Inc.","10","mg/mL","","N","20251231"
"8603","CLOTRIMAZOLE","Clotrimazole Topical Solution USP, 1%","71399066603","Azole Antifungal [EPC], Azoles [CS]","71399-0666","71399-0666-3","71399-0666_5fbee99b-e93b-4682-9629-98f4f65587fa","HUMAN PRESCRIPTION DRUG","Clotrimazole Topical Solution USP, 1%","","SOLUTION","TOPICAL","20231016","","ANDA","ANDA216569","Akron Pharma Inc.","10","mg/mL","","N","20251231"
"8604","SULFACETAMIDE SODIUM","SODIUM SULFACETAMIDE","71399159908","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","71399-1599","71399-1599-8","71399-1599_777ad78c-cd6a-47c1-970d-fbf00d53e09f","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE","","SHAMPOO","TOPICAL","20240913","","UNAPPROVED DRUG OTHER","","Akron Pharma Inc","100","mg/mL","","N","20251231"
"8605","CLINDAMYCIN","Clindamycin Phosphate","71428000330","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71428-003","71428-003-30","71428-003_0e88c0f2-16c1-3684-e063-6394a90a12d0","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20190301","","ANDA","ANDA209846","Glasshouse Pharmaceuticals Limited Canada","10","mg/mL","","N","20251231"
"8606","CLINDAMYCIN","Clindamycin Phosphate","71428000360","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71428-003","71428-003-60","71428-003_0e88c0f2-16c1-3684-e063-6394a90a12d0","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20190301","","ANDA","ANDA209846","Glasshouse Pharmaceuticals Limited Canada","10","mg/mL","","N","20251231"
"8607","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","71467001401","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","71467-014","71467-014-01","71467-014_0d42a289-5edd-413e-8493-67d2c0154234","HUMAN PRESCRIPTION DRUG","VANCOMYCIN HYDROCHLORIDE","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS; ORAL","20240823","","NDA","NDA210274","Zhejiang Novus Pharma Co., Ltd.","10.25","g/g","","N","20261231"
"8608","TETRACYCLINE HYDROCHLORIDE","TETRACYCLINE HYDROCHLORIDE","71491010000","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71491-100","71491-100-00","71491-100_0b6dc9f9-4456-e765-e063-6394a90ac6c8","HUMAN OTC DRUG","Viabecline","","OINTMENT","TOPICAL","20170614","","OTC MONOGRAPH DRUG","M004","Accuria, LLC","30","mg/mL","","N","20251231"
"8609","TETRACYCLINE HYDROCHLORIDE","TETRACYCLINE HYDROCHLORIDE","71491010001","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","71491-100","71491-100-01","71491-100_0b6dc9f9-4456-e765-e063-6394a90ac6c8","HUMAN OTC DRUG","Viabecline","","OINTMENT","TOPICAL","20170614","","OTC MONOGRAPH DRUG","M004","Accuria, LLC","30","mg/mL","","N","20251231"
"8610","AMIKACIN","Amikacin","71558059028","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","71558-590","71558-590-28","71558-590_e7ce065f-9bf4-4bff-b3d3-244b8a64b2cc","HUMAN PRESCRIPTION DRUG","ARIKAYCE","","SUSPENSION","RESPIRATORY (INHALATION)","20181012","","NDA","NDA207356","Insmed Incorporated","590","mg/8.4mL","","N","20261231"
"8611","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","71610008183","Quinolone Antimicrobial [EPC], Quinolones [CS]","71610-081","71610-081-83","71610-081_56c4b5b6-b49e-4bcf-a25d-ec55fbac531d","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Aphena Pharma Solutions - Tennessee, LLC","500","mg/1","","N","20251231"
"8612","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71610010930","Quinolone Antimicrobial [EPC], Quinolones [CS]","71610-109","71610-109-30","71610-109_32ff40df-b3ad-4156-818b-587837737309","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Aphena Pharma Solutions - Tennessee, LLC","500","mg/1","","N","20251231"
"8613","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","71610015983","Quinolone Antimicrobial [EPC], Quinolones [CS]","71610-159","71610-159-83","71610-159_ed26d6d8-3eab-470a-80ce-d18fabbdfb3a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Aphena Pharma Solutions - Tennessee, LLC","500","mg/1","","N","20251231"
"8614","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71610047330","Antimalarial [EPC], Antirheumatic Agent [EPC]","71610-473","71610-473-30","71610-473_1546d08e-f1f4-7d0b-e063-6294a90a633f","HUMAN PRESCRIPTION DRUG","Plaquenil","","TABLET","ORAL","20130628","","NDA","NDA009768","Aphena Pharma Solutions - Tennessee, LLC","200","mg/1","","N","20251231"
"8615","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71610047353","Antimalarial [EPC], Antirheumatic Agent [EPC]","71610-473","71610-473-53","71610-473_1546d08e-f1f4-7d0b-e063-6294a90a633f","HUMAN PRESCRIPTION DRUG","Plaquenil","","TABLET","ORAL","20130628","","NDA","NDA009768","Aphena Pharma Solutions - Tennessee, LLC","200","mg/1","","N","20251231"
"8616","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71610047374","Antimalarial [EPC], Antirheumatic Agent [EPC]","71610-473","71610-473-74","71610-473_1546d08e-f1f4-7d0b-e063-6294a90a633f","HUMAN PRESCRIPTION DRUG","Plaquenil","","TABLET","ORAL","20130628","","NDA","NDA009768","Aphena Pharma Solutions - Tennessee, LLC","200","mg/1","","N","20251231"
"8617","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71610047380","Antimalarial [EPC], Antirheumatic Agent [EPC]","71610-473","71610-473-80","71610-473_1546d08e-f1f4-7d0b-e063-6294a90a633f","HUMAN PRESCRIPTION DRUG","Plaquenil","","TABLET","ORAL","20130628","","NDA","NDA009768","Aphena Pharma Solutions - Tennessee, LLC","200","mg/1","","N","20251231"
"8618","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","71610047304","Antimalarial [EPC], Antirheumatic Agent [EPC]","71610-473","71610-473-04","71610-473_1546d08e-f1f4-7d0b-e063-6294a90a633f","HUMAN PRESCRIPTION DRUG","Plaquenil","","TABLET","ORAL","20130628","","NDA","NDA009768","Aphena Pharma Solutions - Tennessee, LLC","200","mg/1","","N","20251231"
"8619","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","71610050653","Antimalarial [EPC], Antirheumatic Agent [EPC]","71610-506","71610-506-53","71610-506_2027b984-d53d-41c0-914b-ff66535e0e51","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Aphena Pharma Solutions - Tennessee, LLC","200","mg/1","","N","20251231"
"8620","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","71610050630","Antimalarial [EPC], Antirheumatic Agent [EPC]","71610-506","71610-506-30","71610-506_2027b984-d53d-41c0-914b-ff66535e0e51","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20080103","","ANDA","ANDA040657","Aphena Pharma Solutions - Tennessee, LLC","200","mg/1","","N","20251231"
"8621","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","71610070153","Antimalarial [EPC], Antirheumatic Agent [EPC]","71610-701","71610-701-53","71610-701_7576e78c-5a06-4d83-9f31-bca0a0cfbe87","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20180501","","ANDA","ANDA210441","Aphena Pharma Solutions - Tennessee, LLC","200","mg/1","","N","20251231"
"8622","HYDROXYCHLOROQUINE SULFATE","HYDROXYCHLOROQUINE SULFATE","71610070180","Antimalarial [EPC], Antirheumatic Agent [EPC]","71610-701","71610-701-80","71610-701_7576e78c-5a06-4d83-9f31-bca0a0cfbe87","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20180501","","ANDA","ANDA210441","Aphena Pharma Solutions - Tennessee, LLC","200","mg/1","","N","20251231"
"8623","ERYTHROMYCIN","erythromycin topical solution 2%","71656003060","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","71656-030","71656-030-60","71656-030_21b6729d-f82f-309a-e063-6394a90a8a36","HUMAN PRESCRIPTION DRUG","erythromycin topical solution 2%","","SOLUTION","TOPICAL","20240814","","ANDA","ANDA062687","Saptalis Pharmaceuticals, LLC LLC","20","mg/mL","","N","20251231"
"8624","METRONIDAZOLE","Metronidazole Oral","71656006620","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71656-066","71656-066-20","71656-066_33133447-3893-7028-e063-6394a90aa2be","HUMAN PRESCRIPTION DRUG","LIKMEZ","","SUSPENSION","ORAL","20231013","","NDA","NDA216755","Saptalis Pharmaceuticals, LLC","100","mg/mL","","N","20261231"
"8625","METRONIDAZOLE","Metronidazole Oral","71656006675","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71656-066","71656-066-75","71656-066_33133447-3893-7028-e063-6394a90aa2be","HUMAN PRESCRIPTION DRUG","LIKMEZ","","SUSPENSION","ORAL","20231013","","NDA","NDA216755","Saptalis Pharmaceuticals, LLC","100","mg/mL","","N","20261231"
"8626","METRONIDAZOLE","metronidazole","71656006770","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","71656-067","71656-067-70","71656-067_2bb2bd7b-190e-1821-e063-6294a90a5c0e","HUMAN PRESCRIPTION DRUG","metronidazole vaginal","","GEL","VAGINAL","20250303","","ANDA","ANDA216750","Saptalis Pharmaceuticals LLC","7.5","mg/g","","N","20261231"
"8627","KETOCONAZOLE","Ketoconazole","71713009704","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","71713-097","71713-097-04","71713-097_17306f85-843b-443b-bed9-7a185195b671","HUMAN PRESCRIPTION DRUG","Ketoconazole","","SHAMPOO, SUSPENSION","TOPICAL","20050411","","ANDA","ANDA076942","THIRTY MADISON INC","20","mg/mL","","N","20251231"
"8628","OMADACYCLINE","omadacycline","71715000102","Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]","71715-001","71715-001-02","71715-001_2e800cb7-f314-ad1d-e063-6294a90a4685","HUMAN PRESCRIPTION DRUG","NUZYRA","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190201","","NDA","NDA209817","Paratek Pharmaceuticals, Inc.","100","mg/5mL","","N","20261231"
"8629","OMADACYCLINE","omadacycline","71715000221","Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]","71715-002","71715-002-21","71715-002_2e800cb7-f314-ad1d-e063-6294a90a4685","HUMAN PRESCRIPTION DRUG","NUZYRA","","TABLET, FILM COATED","ORAL","20190201","","NDA","NDA209816","Paratek Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"8630","OMADACYCLINE","omadacycline","71715000227","Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]","71715-002","71715-002-27","71715-002_2e800cb7-f314-ad1d-e063-6294a90a4685","HUMAN PRESCRIPTION DRUG","NUZYRA","","TABLET, FILM COATED","ORAL","20190201","","NDA","NDA209816","Paratek Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"8631","MICONAZOLE NITRATE","miconazole nitrate","71730007014","Azole Antifungal [EPC], Azoles [CS]","71730-070","71730-070-14","71730-070_b2c480f5-6156-4aba-b6aa-7e74dd6b783a","HUMAN OTC DRUG","HERS Miconazole 3","","CREAM","VAGINAL","20190114","","ANDA","ANDA091366","Hims Inc","40","mg/g","","N","20251231"
"8632","ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; CEANOTHUS AMERICANUS LEAF; IODINE; NITRIC ACID; PHOSPHORIC ACID; PHOSPHORUS; QUININE SULFATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; SUS SCROFA SPLEEN","Spleen (Suis), Arsenicum Album, Carbo Vegetabilis, Ceanothus Americanus, Chininum Sulphuricum, Ignatia Amara, Iodium, Natrum Muriaticum, Nitricum Acidum, Phosphoricum Acidum, Phosphorus","71742001201","Antimalarial [EPC]","71742-0012","71742-0012-1","71742-0012_53f1621b-b6d5-4b35-baf3-1657e67cd5c1","HUMAN OTC DRUG","Spleen-Pro","T018","LIQUID","ORAL","20171026","","UNAPPROVED HOMEOPATHIC","","Guangzhou Renuma Medical Systems Co., Ltd","12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 6","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"8633","ERAVACYCLINE DIHYDROCHLORIDE","eravacycline","71773005012","Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]","71773-050","71773-050-12","71773-050_294ca864-10cd-474e-abd1-9f5112249853","HUMAN PRESCRIPTION DRUG","Xerava","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180910","","NDA","NDA211109","Tetraphase Pharmaceuticals, Inc.","50","mg/1","","N","20261231"
"8634","ERAVACYCLINE DIHYDROCHLORIDE","eravacycline","71773005005","Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]","71773-050","71773-050-05","71773-050_294ca864-10cd-474e-abd1-9f5112249853","HUMAN PRESCRIPTION DRUG","Xerava","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180910","","NDA","NDA211109","Tetraphase Pharmaceuticals, Inc.","50","mg/1","","N","20261231"
"8635","ERAVACYCLINE DIHYDROCHLORIDE","eravacycline","71773010012","Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]","71773-100","71773-100-12","71773-100_294ca864-10cd-474e-abd1-9f5112249853","HUMAN PRESCRIPTION DRUG","Xerava","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20180910","","NDA","NDA211109","Tetraphase Pharmaceuticals, Inc.","100","mg/1","","N","20261231"
"8636","NATAMYCIN","natamycin","71776000515","Polyene Antimicrobial [EPC], Polyenes [CS]","71776-005","71776-005-15","71776-005_2bedd05a-9b5b-3b29-e063-6394a90a0879","HUMAN PRESCRIPTION DRUG","NATACYN","","SUSPENSION/ DROPS","OPHTHALMIC","20210612","20260201","NDA","NDA050514","Eyevance Pharmaceuticals, LLC","50","mg/mL","","N",""
"8637","DEXAMETHASONE; TOBRAMYCIN","tobramycin / dexamethasone","71776003505","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","71776-035","71776-035-05","71776-035_2bd6e870-446a-02f4-e063-6394a90a27b0","HUMAN PRESCRIPTION DRUG","Tobradex ST","","SUSPENSION/ DROPS","OPHTHALMIC","20210519","","NDA","NDA050818","Eyevance Pharmaceuticals, LLC",".5; 3","mg/mL; mg/mL","","N","20261231"
"8638","DEXAMETHASONE; TOBRAMYCIN","tobramycin / dexamethasone","71776003501","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","71776-035","71776-035-01","71776-035_2bd6e870-446a-02f4-e063-6394a90a27b0","HUMAN PRESCRIPTION DRUG","Tobradex ST","","SUSPENSION/ DROPS","OPHTHALMIC","20210519","","NDA","NDA050818","Eyevance Pharmaceuticals, LLC",".5; 3","mg/mL; mg/mL","","N","20261231"
"8639","DAPTOMYCIN","daptomycin","71839010701","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","71839-107","71839-107-01","71839-107_577b6790-a484-4e8f-a7ca-0d1e2d2a0420","HUMAN PRESCRIPTION DRUG","daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190626","","ANDA","ANDA212513","BE Pharmaceuticals Inc.","500","mg/10mL","","N","20251231"
"8640","DAPTOMYCIN","daptomycin","71839010801","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","71839-108","71839-108-01","71839-108_84aa2283-c18e-442f-9e48-a05a58695769","HUMAN PRESCRIPTION DRUG","daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200820","","ANDA","ANDA213425","BE Pharmaceuticals Inc.","350","mg/7mL","","N","20251231"
"8641","DAPTOMYCIN","daptomycin","71839010810","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","71839-108","71839-108-10","71839-108_84aa2283-c18e-442f-9e48-a05a58695769","HUMAN PRESCRIPTION DRUG","daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200820","","ANDA","ANDA213425","BE Pharmaceuticals Inc.","350","mg/7mL","","N","20251231"
"8642","CEFAZOLIN SODIUM","Cefazolin","71872702701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71872-7027","71872-7027-1","71872-7027_fd165c82-ea9b-c943-e053-6294a90a6425","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20010918","","ANDA","ANDA065047","Medical Purchasing Solutions, LLC","330","mg/mL","","N","20251231"
"8643","AMPICILLIN SODIUM","Ampicillin Sodium","71872708601","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71872-7086","71872-7086-1","71872-7086_fc600b6f-0ddf-10ff-e053-6394a90a6ba5","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120201","","ANDA","ANDA065499","Medical Purchasing Solutions, LLC","1","g/1","","N","20251231"
"8644","AMPICILLIN SODIUM","Ampicillin Sodium","71872713901","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71872-7139","71872-7139-1","71872-7139_fc49f703-5d24-ab36-e053-6294a90a7be3","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20120201","","ANDA","ANDA065499","Medical Purchasing Solutions, LLC","2","g/1","","N","20251231"
"8645","CEFAZOLIN SODIUM","CEFAZOLIN","71872714101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","71872-7141","71872-7141-1","71872-7141_fbd8fbec-88d3-1726-e053-6294a90af96d","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170630","","ANDA","ANDA203661","Medical Purchasing Solutions, LLC","1","g/1","","N","20251231"
"8646","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","71872716501","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71872-7165","71872-7165-1","71872-7165_fbbf2fa2-4db9-8e4a-e053-6394a90a6f76","HUMAN PRESCRIPTION DRUG","Cleocin Phosphate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19721002","","NDA","NDA050441","Medical Purchasing Solutions, LLC","150","mg/mL","","N","20251231"
"8647","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","71872719101","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71872-7191","71872-7191-1","71872-7191_fb582ad8-1756-2041-e053-6294a90a6592","HUMAN PRESCRIPTION DRUG","Clindamycin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120515","","ANDA","ANDA090108","Medical Purchasing Solutions, LLC","150","mg/mL","","N","20251231"
"8648","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","71872719201","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71872-7192","71872-7192-1","71872-7192_fb582ad8-1754-2041-e053-6294a90a6592","HUMAN PRESCRIPTION DRUG","Clindamycin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120515","","ANDA","ANDA090108","Medical Purchasing Solutions, LLC","150","mg/mL","","N","20251231"
"8649","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","71872719701","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71872-7197","71872-7197-1","71872-7197_fb4af179-57f4-296b-e053-6294a90a7a82","HUMAN PRESCRIPTION DRUG","Cleocin Phosphate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19721002","","NDA","NDA050441","Medical Purchasing Solutions, LLC","150","mg/mL","","N","20251231"
"8650","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","71872719901","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71872-7199","71872-7199-1","71872-7199_fb46f35e-f32d-3994-e053-6394a90a8615","HUMAN PRESCRIPTION DRUG","Clindamycin","","INJECTION, SOLUTION","INTRAVENOUS","20120515","","ANDA","ANDA090109","Medical Purchasing Solutions, LLC","150","mg/mL","","N","20251231"
"8651","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","71872720001","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71872-7200","71872-7200-1","71872-7200_fb466c14-9c3e-a395-e053-6294a90a1010","HUMAN PRESCRIPTION DRUG","Cleocin Phosphate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19721002","","NDA","NDA050441","Medical Purchasing Solutions, LLC","150","mg/mL","","N","20251231"
"8652","AMPICILLIN SODIUM","Ampicillin Injection","71872720401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71872-7204","71872-7204-1","71872-7204_fae21111-25f7-bf9a-e053-6294a90ab215","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20190306","","ANDA","ANDA090354","Medical Purchasing Solutions, LLC","1","g/g","","N","20251231"
"8653","GENTAMICIN SULFATE","GENTAMICIN SULFATE","71872721601","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","71872-7216","71872-7216-1","71872-7216_fad0da7e-68e5-c873-e053-6294a90a6fac","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20151209","","ANDA","ANDA062420","Medical Purchasing Solutions, LLC","40","mg/mL","","N","20251231"
"8654","AMPICILLIN SODIUM","Ampicillin Injection","71872723001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71872-7230","71872-7230-1","71872-7230_fae6bd66-8eb7-cf03-e053-6394a90ad143","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20190306","","ANDA","ANDA090354","Medical Purchasing Solutions, LLC","2","g/2g","","N","20251231"
"8655","AMPICILLIN SODIUM","Ampicillin","71872724001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71872-7240","71872-7240-1","71872-7240_fb3345ac-1c37-35c8-e053-6294a90abc4d","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120510","","ANDA","ANDA062772","Medical Purchasing Solutions, LLC","2","g/1","","N","20251231"
"8656","AMPICILLIN SODIUM","Ampicillin","71872724901","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71872-7249","71872-7249-1","71872-7249_fa59caf4-b361-c99b-e053-6294a90a69e8","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120510","","ANDA","ANDA062772","Medical Purchasing Solutions, LLC","1","g/1","","N","20251231"
"8657","AMPICILLIN SODIUM","AMPICILLIN SODIUM","71872728001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71872-7280","71872-7280-1","71872-7280_fab6d66b-8b4b-649b-e053-6394a90a44ce","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210110","","ANDA","ANDA090583","Medical Purchasing Solutions, LLC","2","g/1","","N","20251231"
"8658","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","71872728401","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71872-7284","71872-7284-1","71872-7284_fab6c201-bb6d-449d-e053-6394a90ad686","HUMAN PRESCRIPTION DRUG","Clindamycin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120515","","ANDA","ANDA090108","Medical Purchasing Solutions, LLC","150","mg/mL","","N","20251231"
"8659","AMPICILLIN SODIUM","AMPICILLIN SODIUM","71872728601","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71872-7286","71872-7286-1","71872-7286_fab6b79c-304a-ae35-e053-6294a90aa343","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210110","","ANDA","ANDA090583","Medical Purchasing Solutions, LLC","1","g/1","","N","20251231"
"8660","GENTAMICIN SULFATE","GENTAMICIN SULFATE","71872731101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","71872-7311","71872-7311-1","71872-7311_09cf496c-8177-ebb7-e063-6394a90a745a","HUMAN PRESCRIPTION DRUG","Gentamicin","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20000810","","ANDA","ANDA062366","Medical Purchasing Solutions, LLC","40","mg/mL","","N","20251231"
"8661","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","71872732401","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","71872-7324","71872-7324-1","71872-7324_12ed9a6a-b8cc-92f2-e063-6294a90a6bb4","HUMAN PRESCRIPTION DRUG","Cleocin Phosphate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","19721002","","NDA","NDA050441","Medical Purchasing Solutions, LLC","150","mg/mL","","N","20251231"
"8662","AMPICILLIN SODIUM","Ampicillin","71872733201","Penicillin-class Antibacterial [EPC], Penicillins [CS]","71872-7332","71872-7332-1","71872-7332_29677fcc-f6f3-3908-e063-6294a90a4fc9","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20231110","","ANDA","ANDA201025","Medical Purchasing Solutions, LLC","1","g/1","","N","20251231"
"8663","GENTAMICIN SULFATE","GENTAMICIN SULFATE","71872733701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","71872-7337","71872-7337-1","71872-7337_3532c536-3b10-950e-e063-6294a90a51de","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","INJECTION, SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20050829","","ANDA","ANDA062420","Medical Purchasing Solutions, LLC","40","mg/mL","","N","20261231"
"8664","VALGANCICLOVIR","Valganciclovir","71921021012","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","71921-210","71921-210-12","71921-210_cc6c4939-7908-439c-b1b8-6b52e826c7a5","HUMAN PRESCRIPTION DRUG","Valganciclovir","","POWDER, FOR SOLUTION","ORAL","20230701","","ANDA","ANDA216317","Florida Pharmaceutical Products, LLC","50","mg/mL","","N","20251231"
"8665","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","71927001603","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","71927-016","71927-016-03","71927-016_0effc169-28e6-9eb0-e063-6394a90a432a","HUMAN OTC DRUG","American Safety and First Aid Triple Antibiotic","","OINTMENT","TOPICAL","20221017","","OTC MONOGRAPH DRUG","M004","Orazen Inc","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20251231"
"8666","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","71927002101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","71927-021","71927-021-01","71927-021_0814f4b9-3a5b-e425-e063-6394a90ad662","HUMAN OTC DRUG","Lil Drug Store Triple Antibiotic","","OINTMENT","TOPICAL","20231018","","OTC MONOGRAPH DRUG","M004","ORAZEN INC","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20251231"
"8667","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","71927002201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","71927-022","71927-022-01","71927-022_0814bc6d-5515-8353-e063-6394a90a0e16","HUMAN OTC DRUG","Circle K Triple Antibiotic","","OINTMENT","TOPICAL","20231018","","OTC MONOGRAPH DRUG","M004","ORAZEN INC","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20251231"
"8668","LEFAMULIN ACETATE","lefamulin acetate","72000011010","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Diterpenes [CS], Pleuromutilin Antibacterial [EPC]","72000-110","72000-110-10","72000-110_bc8a2422-eaec-4c34-8bc0-b726acc34bf3","HUMAN PRESCRIPTION DRUG","Xenleta","","TABLET, COATED","ORAL","20190909","","NDA","NDA211672","Nabriva Therapeutics US, Inc.","600","mg/1","","N","20251231"
"8669","LEFAMULIN ACETATE","lefamulin acetate","72000011030","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Diterpenes [CS], Pleuromutilin Antibacterial [EPC]","72000-110","72000-110-30","72000-110_bc8a2422-eaec-4c34-8bc0-b726acc34bf3","HUMAN PRESCRIPTION DRUG","Xenleta","","TABLET, COATED","ORAL","20190909","","NDA","NDA211672","Nabriva Therapeutics US, Inc.","600","mg/1","","N","20251231"
"8670","LEFAMULIN ACETATE","lefamulin acetate","72000012006","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Diterpenes [CS], Pleuromutilin Antibacterial [EPC]","72000-120","72000-120-06","72000-120_bc8a2422-eaec-4c34-8bc0-b726acc34bf3","HUMAN PRESCRIPTION DRUG","Xenleta","","INJECTION, SOLUTION","INTRAVENOUS","20190909","","NDA","NDA211673","Nabriva Therapeutics US, Inc.","150","mg/15mL","","N","20251231"
"8671","TEDIZOLID PHOSPHATE","tedizolid phosphate","72000031030","Breast Cancer Resistance Protein Inhibitors [MoA], Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","72000-310","72000-310-30","72000-310_73c31039-6198-45e1-aa8e-c47d58c1c67f","HUMAN PRESCRIPTION DRUG","SIVEXTRO","","TABLET, FILM COATED","ORAL","20140620","","NDA","NDA205435","Nabriva Therapeutics US, Inc.","200","mg/1","","N","20251231"
"8672","TEDIZOLID PHOSPHATE","tedizolid phosphate","72000031006","Breast Cancer Resistance Protein Inhibitors [MoA], Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","72000-310","72000-310-06","72000-310_73c31039-6198-45e1-aa8e-c47d58c1c67f","HUMAN PRESCRIPTION DRUG","SIVEXTRO","","TABLET, FILM COATED","ORAL","20140620","","NDA","NDA205435","Nabriva Therapeutics US, Inc.","200","mg/1","","N","20251231"
"8673","TEDIZOLID PHOSPHATE","tedizolid phosphate","72000032010","Breast Cancer Resistance Protein Inhibitors [MoA], Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]","72000-320","72000-320-10","72000-320_73c31039-6198-45e1-aa8e-c47d58c1c67f","HUMAN PRESCRIPTION DRUG","SIVEXTRO","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20140620","","NDA","NDA205436","Nabriva Therapeutics US, Inc.","200","mg/4mL","","N","20251231"
"8674","TETRACYCLINE HYDROCHLORIDE","TETRACYCLINE HYDROCHLORIDE","72053000000","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","72053-000","72053-000-00","72053-000_0b6dc9f9-4461-e765-e063-6394a90ac6c8","HUMAN OTC DRUG","Tetracycline 3 percent a First Aid Antibiotic","","OINTMENT","TOPICAL","20180401","","OTC MONOGRAPH DRUG","M004","Patient Focused Tele-Health, LLC","30","mg/g","","N","20251231"
"8675","TETRACYCLINE HYDROCHLORIDE","TETRACYCLINE HYDROCHLORIDE","72053000201","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","72053-002","72053-002-01","72053-002_0b6de7f3-1004-b75b-e063-6294a90af1f5","HUMAN OTC DRUG","APT T3X Tetracycline Hydrochloride First Aid Antibiotic","","OINTMENT","TOPICAL","20200901","","OTC MONOGRAPH DRUG","M004","Patient Focused Tele-Health, LLC","30","mg/g","","N","20251231"
"8676","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","72078006599","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","72078-065","72078-065-99","72078-065_40a88420-5fcb-4715-abc5-595a18fd08d0","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20240723","","NDA","NDA209481","Mylan Institutional LLC","1.75","g/35mL","","N","20251231"
"8677","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","72078006699","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","72078-066","72078-066-99","72078-066_40a88420-5fcb-4715-abc5-595a18fd08d0","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20240723","","NDA","NDA209481","Mylan Institutional LLC","2","g/40mL","","N","20251231"
"8678","CLOTRIMAZOLE","Clotrimazole","72127080100","Azole Antifungal [EPC], Azoles [CS]","72127-0801","72127-0801-0","72127-0801_3d075951-f8d5-4092-b28c-1d454e85771c","HUMAN OTC DRUG","Forticept Antifungal Foot Cream","","CREAM","TOPICAL","20200412","","OTC MONOGRAPH DRUG","M005","Lidan, Inc.",".01","kg/kg","","N","20261231"
"8679","CLOTRIMAZOLE","Clotrimazole","72127080600","Azole Antifungal [EPC], Azoles [CS]","72127-0806","72127-0806-0","72127-0806_ed6062d8-e888-413c-bd50-6c6ed86d8a19","HUMAN OTC DRUG","Forticept Antifungal Foot Gel","","GEL","TOPICAL","20200412","","OTC MONOGRAPH DRUG","M005","Lidan, Inc.",".01","kg/kg","","N","20261231"
"8680","SULCONAZOLE NITRATE","Sulconazole Nitrate","72143031160","Azole Antifungal [EPC], Azoles [CS]","72143-311","72143-311-60","72143-311_29f5c965-1a31-83b6-e063-6394a90adc49","HUMAN PRESCRIPTION DRUG","Sulconazole Nitrate","","CREAM","TOPICAL","20200204","","NDA","NDA018737","JG Pharma","10","mg/g","","N","20251231"
"8681","SULCONAZOLE NITRATE","Sulconazole Nitrate","72143032130","Azole Antifungal [EPC], Azoles [CS]","72143-321","72143-321-30","72143-321_fc60cb89-7eba-463c-91b9-1b21cd8637a5","HUMAN PRESCRIPTION DRUG","Sulconazole Nitrate","","SOLUTION","TOPICAL","20200224","","NDA","NDA018738","JG Pharma Inc.","10","mg/mL","","N","20251231"
"8682","CLINDAMYCIN PALMITATE HYDROCHLORIDE","Clindamycin Palmitate Hydrochloride","72162110701","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72162-1107","72162-1107-1","72162-1107_85dab5b6-bd1c-4ffa-94e1-f317d529b123","HUMAN PRESCRIPTION DRUG","Clindamycin Palmitate Hydrochloride","","GRANULE, FOR SOLUTION","ORAL","20100121","","ANDA","ANDA090902","Bryant Ranch Prepack","75","mg/5mL","","N","20251231"
"8683","NYSTATIN","Nystatin","72162112402","Polyene Antifungal [EPC], Polyenes [CS]","72162-1124","72162-1124-2","72162-1124_58946a22-16dc-4cdd-9898-8e1186c4bcbc","HUMAN PRESCRIPTION DRUG","Nystop","","POWDER","TOPICAL","19960816","","ANDA","ANDA064118","Bryant Ranch Prepack","100000","[USP'U]/g","","N","20261231"
"8684","NYSTATIN","Nystatin","72162112403","Polyene Antifungal [EPC], Polyenes [CS]","72162-1124","72162-1124-3","72162-1124_58946a22-16dc-4cdd-9898-8e1186c4bcbc","HUMAN PRESCRIPTION DRUG","Nystop","","POWDER","TOPICAL","19960816","","ANDA","ANDA064118","Bryant Ranch Prepack","100000","[USP'U]/g","","N","20261231"
"8685","NYSTATIN","Nystatin","72162112406","Polyene Antifungal [EPC], Polyenes [CS]","72162-1124","72162-1124-6","72162-1124_58946a22-16dc-4cdd-9898-8e1186c4bcbc","HUMAN PRESCRIPTION DRUG","Nystop","","POWDER","TOPICAL","19960816","","ANDA","ANDA064118","Bryant Ranch Prepack","100000","[USP'U]/g","","N","20261231"
"8686","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","72162112804","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","72162-1128","72162-1128-4","72162-1128_944d0c97-2c40-40b8-9029-d0f977e0c3e4","HUMAN PRESCRIPTION DRUG","TOBRAMYCIN AND DEXAMETHASONE","","SUSPENSION/ DROPS","OPHTHALMIC","20220317","","ANDA","ANDA212715","Bryant Ranch Prepack","1; 3","mg/mL; mg/mL","","N","20251231"
"8687","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","72162112807","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","72162-1128","72162-1128-7","72162-1128_944d0c97-2c40-40b8-9029-d0f977e0c3e4","HUMAN PRESCRIPTION DRUG","TOBRAMYCIN AND DEXAMETHASONE","","SUSPENSION/ DROPS","OPHTHALMIC","20220317","","ANDA","ANDA212715","Bryant Ranch Prepack","1; 3","mg/mL; mg/mL","","N","20251231"
"8688","DEXAMETHASONE; TOBRAMYCIN","tobramycin and dexamethasone","72162112802","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","72162-1128","72162-1128-2","72162-1128_944d0c97-2c40-40b8-9029-d0f977e0c3e4","HUMAN PRESCRIPTION DRUG","TOBRAMYCIN AND DEXAMETHASONE","","SUSPENSION/ DROPS","OPHTHALMIC","20220317","","ANDA","ANDA212715","Bryant Ranch Prepack","1; 3","mg/mL; mg/mL","","N","20251231"
"8689","VORICONAZOLE","voriconazole","72162119803","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72162-1198","72162-1198-3","72162-1198_350989fb-8ab1-94a3-e063-6394a90a1a9a","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET, FILM COATED","ORAL","20250513","","ANDA","ANDA200265","Bryant Ranch Prepack","200","mg/1","","N","20261231"
"8690","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","72162126200","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72162-1262","72162-1262-0","72162-1262_373aced9-859b-4b9c-b3bc-8257a9014ae4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8691","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","72162126201","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72162-1262","72162-1262-1","72162-1262_373aced9-859b-4b9c-b3bc-8257a9014ae4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8692","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","72162127503","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","72162-1275","72162-1275-3","72162-1275_4a91b2a9-37da-4e28-bd32-10d414ea3241","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20190928","","ANDA","ANDA207741","Bryant Ranch Prepack","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"8693","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","72162127506","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","72162-1275","72162-1275-6","72162-1275_4a91b2a9-37da-4e28-bd32-10d414ea3241","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20190928","","ANDA","ANDA207741","Bryant Ranch Prepack","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"8694","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","72162127502","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","72162-1275","72162-1275-2","72162-1275_4a91b2a9-37da-4e28-bd32-10d414ea3241","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20190928","","ANDA","ANDA207741","Bryant Ranch Prepack","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"8695","FLUCYTOSINE","Flucytosine","72162132601","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","72162-1326","72162-1326-1","72162-1326_a7e8a233-a46a-46c6-898f-b68e983a0d67","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170726","","NDA AUTHORIZED GENERIC","NDA017001","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8696","FLUCYTOSINE","Flucytosine","72162132703","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","72162-1327","72162-1327-3","72162-1327_3492794b-0233-92c1-e063-6294a90a185c","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170726","","NDA AUTHORIZED GENERIC","NDA017001","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8697","FLUCYTOSINE","Flucytosine","72162132701","Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]","72162-1327","72162-1327-1","72162-1327_3492794b-0233-92c1-e063-6294a90a185c","HUMAN PRESCRIPTION DRUG","Flucytosine","","CAPSULE","ORAL","20170726","","NDA AUTHORIZED GENERIC","NDA017001","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8698","RIBAVIRIN","Ribavirin","72162133102","Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","72162-1331","72162-1331-2","72162-1331_7174eb35-aaf9-4f21-a04e-178d6d4339f6","HUMAN PRESCRIPTION DRUG","Ribavirin","","POWDER, FOR SOLUTION","RESPIRATORY (INHALATION)","20200415","","NDA","NDA018859","Bryant Ranch Prepack","6","g/1","","N","20251231"
"8699","NYSTATIN","Nystatin","72162138503","Polyene Antifungal [EPC], Polyenes [CS]","72162-1385","72162-1385-3","72162-1385_b2b9a269-9700-42d4-889d-ad9737725df6","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20060921","","ANDA","ANDA062225","Bryant Ranch Prepack","100000","[USP'U]/g","","N","20261231"
"8700","NYSTATIN","Nystatin","72162138502","Polyene Antifungal [EPC], Polyenes [CS]","72162-1385","72162-1385-2","72162-1385_b2b9a269-9700-42d4-889d-ad9737725df6","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20060921","","ANDA","ANDA062225","Bryant Ranch Prepack","100000","[USP'U]/g","","N","20261231"
"8701","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","72162139506","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72162-1395","72162-1395-6","72162-1395_d668139a-2774-4472-a26e-ceda20670ac1","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","LOTION","TOPICAL","20210331","","ANDA","ANDA214604","Bryant Ranch Prepack","10","mg/mL","","N","20251231"
"8702","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin and triamcinolone acetonide","72162140302","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","72162-1403","72162-1403-2","72162-1403_0577b31f-790a-4451-83e1-4de5a1bed30e","HUMAN PRESCRIPTION DRUG","nystatin and triamcinolone acetonide","","OINTMENT","TOPICAL","20171018","","ANDA","ANDA207380","Bryant Ranch Prepack","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"8703","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin and triamcinolone acetonide","72162140306","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","72162-1403","72162-1403-6","72162-1403_0577b31f-790a-4451-83e1-4de5a1bed30e","HUMAN PRESCRIPTION DRUG","nystatin and triamcinolone acetonide","","OINTMENT","TOPICAL","20171018","","ANDA","ANDA207380","Bryant Ranch Prepack","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"8704","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin and triamcinolone acetonide","72162140303","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","72162-1403","72162-1403-3","72162-1403_0577b31f-790a-4451-83e1-4de5a1bed30e","HUMAN PRESCRIPTION DRUG","nystatin and triamcinolone acetonide","","OINTMENT","TOPICAL","20171018","","ANDA","ANDA207380","Bryant Ranch Prepack","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"8705","KETOCONAZOLE","Ketoconazole","72162140902","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","72162-1409","72162-1409-2","72162-1409_5f62607f-1eda-4b69-a2a3-17986ea0686b","HUMAN PRESCRIPTION DRUG","Ketoconazole","","SHAMPOO, SUSPENSION","TOPICAL","20100119","","ANDA","ANDA076419","Bryant Ranch Prepack","20","mg/mL","","N","20251231"
"8706","ECONAZOLE NITRATE","Econazole Nitrate","72162141002","Azole Antifungal [EPC], Azoles [CS]","72162-1410","72162-1410-2","72162-1410_e21cc7c8-d197-493b-83fb-6a530771c2b7","HUMAN PRESCRIPTION DRUG","Econazole Nitrate","","CREAM","TOPICAL","20060808","","ANDA","ANDA076479","Bryant Ranch Prepack","10","mg/g","","N","20261231"
"8707","ECONAZOLE NITRATE","Econazole Nitrate","72162141003","Azole Antifungal [EPC], Azoles [CS]","72162-1410","72162-1410-3","72162-1410_e21cc7c8-d197-493b-83fb-6a530771c2b7","HUMAN PRESCRIPTION DRUG","Econazole Nitrate","","CREAM","TOPICAL","20060808","","ANDA","ANDA076479","Bryant Ranch Prepack","10","mg/g","","N","20261231"
"8708","ECONAZOLE NITRATE","Econazole Nitrate","72162141004","Azole Antifungal [EPC], Azoles [CS]","72162-1410","72162-1410-4","72162-1410_e21cc7c8-d197-493b-83fb-6a530771c2b7","HUMAN PRESCRIPTION DRUG","Econazole Nitrate","","CREAM","TOPICAL","20060808","","ANDA","ANDA076479","Bryant Ranch Prepack","10","mg/g","","N","20261231"
"8709","KETOCONAZOLE","ketoconazole","72162141701","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","72162-1417","72162-1417-1","72162-1417_251364c4-cb46-490e-a6e4-bb95737322a8","HUMAN PRESCRIPTION DRUG","ketoconazole","","AEROSOL, FOAM","TOPICAL","20110830","","ANDA","ANDA091550","Bryant Ranch Prepack","2","g/100g","","N","20251231"
"8710","KETOCONAZOLE","ketoconazole","72162141702","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","72162-1417","72162-1417-2","72162-1417_251364c4-cb46-490e-a6e4-bb95737322a8","HUMAN PRESCRIPTION DRUG","ketoconazole","","AEROSOL, FOAM","TOPICAL","20110830","","ANDA","ANDA091550","Bryant Ranch Prepack","2","g/100g","","N","20251231"
"8711","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","72162141803","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72162-1418","72162-1418-3","72162-1418_34f7a1a5-66bf-5930-e063-6394a90a26ac","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20130917","","ANDA","ANDA064050","Bryant Ranch Prepack","10","mg/mL","","N","20261231"
"8712","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","72162141806","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72162-1418","72162-1418-6","72162-1418_34f7a1a5-66bf-5930-e063-6394a90a26ac","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20130917","","ANDA","ANDA064050","Bryant Ranch Prepack","10","mg/mL","","N","20261231"
"8713","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin, triamcinolone acetonide","72162143303","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","72162-1433","72162-1433-3","72162-1433_3492b828-cb5a-c5d3-e063-6294a90a4da6","HUMAN PRESCRIPTION DRUG","NYSTATIN AND TRIAMCINOLONE ACETONIDE","","CREAM","TOPICAL","20171127","","ANDA","ANDA208479","Bryant Ranch Prepack","100000; 1","[USP'U]/g; mg/g","","N","20261231"
"8714","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin, triamcinolone acetonide","72162143306","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","72162-1433","72162-1433-6","72162-1433_3492b828-cb5a-c5d3-e063-6294a90a4da6","HUMAN PRESCRIPTION DRUG","NYSTATIN AND TRIAMCINOLONE ACETONIDE","","CREAM","TOPICAL","20171127","","ANDA","ANDA208479","Bryant Ranch Prepack","100000; 1","[USP'U]/g; mg/g","","N","20261231"
"8715","NYSTATIN; TRIAMCINOLONE ACETONIDE","nystatin, triamcinolone acetonide","72162143302","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","72162-1433","72162-1433-2","72162-1433_3492b828-cb5a-c5d3-e063-6294a90a4da6","HUMAN PRESCRIPTION DRUG","NYSTATIN AND TRIAMCINOLONE ACETONIDE","","CREAM","TOPICAL","20171127","","ANDA","ANDA208479","Bryant Ranch Prepack","100000; 1","[USP'U]/g; mg/g","","N","20261231"
"8716","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","72162143606","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72162-1436","72162-1436-6","72162-1436_fe51a452-94ea-443d-91b8-e92f69c8e603","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PHOSPHATE","","GEL","TOPICAL","20210120","","ANDA","ANDA212104","Bryant Ranch Prepack","10","mg/g","","N","20251231"
"8717","ERYTHROMYCIN","Erythromycin","72162144306","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","72162-1443","72162-1443-6","72162-1443_15c39090-db70-46f1-90ca-57ec8147b32e","HUMAN PRESCRIPTION DRUG","Ery","","SWAB","TOPICAL","20080707","","ANDA","ANDA064126","Bryant Ranch Prepack","20","mg/mL","","N","20251231"
"8718","ERYTHROMYCIN","Erythromycin","72162144406","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","72162-1444","72162-1444-6","72162-1444_04a760c9-4888-4649-8162-9767d06d8a43","HUMAN PRESCRIPTION DRUG","Erythromycin","","GEL","TOPICAL","20080612","","ANDA","ANDA063211","Bryant Ranch Prepack","20","mg/g","","N","20251231"
"8719","ERYTHROMYCIN","Erythromycin","72162144403","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","72162-1444","72162-1444-3","72162-1444_04a760c9-4888-4649-8162-9767d06d8a43","HUMAN PRESCRIPTION DRUG","Erythromycin","","GEL","TOPICAL","20080612","","ANDA","ANDA063211","Bryant Ranch Prepack","20","mg/g","","N","20251231"
"8720","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","72162159501","Allylamine Antifungal [EPC], Allylamine [CS]","72162-1595","72162-1595-1","72162-1595_f9f34f4d-d49d-4921-9e3e-8b6e2fd16d9f","HUMAN PRESCRIPTION DRUG","Terbinafine Hydrochloride","","TABLET","ORAL","20101227","","ANDA","ANDA077714","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8721","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","72162161402","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","72162-1614","72162-1614-2","72162-1614_286d9610-fce8-4c00-a25e-fc028a852a1d","HUMAN PRESCRIPTION DRUG","Erythromycin Ethylsuccinate","","GRANULE, FOR SUSPENSION","ORAL","20160928","","NDA","NDA050207","Bryant Ranch Prepack","200","mg/5mL","","N","20251231"
"8722","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","72162166404","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","72162-1664","72162-1664-4","72162-1664_392ccc80-3b7c-40e9-b7e2-ab6f8b170888","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide and Sulfur","","LIQUID","TOPICAL","20211115","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","100; 50","mg/g; mg/g","","N","20251231"
"8723","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","72162166407","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","72162-1664","72162-1664-7","72162-1664_392ccc80-3b7c-40e9-b7e2-ab6f8b170888","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide and Sulfur","","LIQUID","TOPICAL","20211115","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","100; 50","mg/g; mg/g","","N","20251231"
"8724","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","72162166402","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","72162-1664","72162-1664-2","72162-1664_392ccc80-3b7c-40e9-b7e2-ab6f8b170888","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide and Sulfur","","LIQUID","TOPICAL","20211115","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","100; 50","mg/g; mg/g","","N","20251231"
"8725","SULFACETAMIDE SODIUM","Sodium Sulfacetamide","72162166502","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","72162-1665","72162-1665-2","72162-1665_233623bf-3ee7-437d-a8e6-1a71bc16f299","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide","","LIQUID","TOPICAL","20220115","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","100","mg/g","","N","20251231"
"8726","SULFACETAMIDE SODIUM","Sodium Sulfacetamide","72162166507","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","72162-1665","72162-1665-7","72162-1665_233623bf-3ee7-437d-a8e6-1a71bc16f299","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide","","LIQUID","TOPICAL","20220115","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","100","mg/g","","N","20251231"
"8727","SULFACETAMIDE SODIUM","Sodium Sulfacetamide","72162166504","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","72162-1665","72162-1665-4","72162-1665_233623bf-3ee7-437d-a8e6-1a71bc16f299","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide","","LIQUID","TOPICAL","20220115","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","100","mg/g","","N","20251231"
"8728","OFLOXACIN","Ofloxacin","72162170902","Quinolone Antimicrobial [EPC], Quinolones [CS]","72162-1709","72162-1709-2","72162-1709_7cd6a4b8-fd7f-4d2e-b20b-9d7d1109b69b","HUMAN PRESCRIPTION DRUG","Ofloxacin Otic","","SOLUTION","AURICULAR (OTIC)","20040514","","ANDA","ANDA076527","Bryant Ranch Prepack","3","mg/mL","","N","20251231"
"8729","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72162174001","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72162-1740","72162-1740-1","72162-1740_1c857923-9e16-49e7-9e35-cd0236601cc8","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","250","mg/1","","N","20261231"
"8730","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72162174102","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72162-1741","72162-1741-2","72162-1741_d2a899a6-43fe-42f7-b1b5-4731f74e3792","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8731","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72162174103","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72162-1741","72162-1741-3","72162-1741_d2a899a6-43fe-42f7-b1b5-4731f74e3792","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8732","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72162174104","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72162-1741","72162-1741-4","72162-1741_d2a899a6-43fe-42f7-b1b5-4731f74e3792","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8733","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72162174101","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72162-1741","72162-1741-1","72162-1741_d2a899a6-43fe-42f7-b1b5-4731f74e3792","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8734","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72162174106","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72162-1741","72162-1741-6","72162-1741_d2a899a6-43fe-42f7-b1b5-4731f74e3792","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8735","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72162174107","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72162-1741","72162-1741-7","72162-1741_d2a899a6-43fe-42f7-b1b5-4731f74e3792","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8736","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72162174108","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72162-1741","72162-1741-8","72162-1741_d2a899a6-43fe-42f7-b1b5-4731f74e3792","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8737","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72162174105","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72162-1741","72162-1741-5","72162-1741_d2a899a6-43fe-42f7-b1b5-4731f74e3792","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8738","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","72162177502","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","72162-1775","72162-1775-2","72162-1775_54c92a7b-4e08-4dde-9db7-db0ffabf25f1","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","POWDER, FOR SOLUTION","ORAL","20190909","","ANDA","ANDA061667","Bryant Ranch Prepack","250","mg/5mL","","N","20261231"
"8739","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","72162177504","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","72162-1775","72162-1775-4","72162-1775_54c92a7b-4e08-4dde-9db7-db0ffabf25f1","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","POWDER, FOR SOLUTION","ORAL","20190909","","ANDA","ANDA061667","Bryant Ranch Prepack","250","mg/5mL","","N","20261231"
"8740","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","72162177507","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","72162-1775","72162-1775-7","72162-1775_54c92a7b-4e08-4dde-9db7-db0ffabf25f1","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","POWDER, FOR SOLUTION","ORAL","20190909","","ANDA","ANDA061667","Bryant Ranch Prepack","250","mg/5mL","","N","20261231"
"8741","CLINDAMYCIN PALMITATE HYDROCHLORIDE","CLINDAMYCIN PALMITATE HYDROCHLORIDE","72162180901","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72162-1809","72162-1809-1","72162-1809_28ba03fd-0f9c-49c6-9bfb-cda5417801c6","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PALMITATE HYDROCHLORIDE","(Pediatric)","GRANULE, FOR SOLUTION","ORAL","20120911","","ANDA","ANDA201821","Bryant Ranch Prepack","75","mg/5mL","","N","20251231"
"8742","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","72162181502","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72162-1815","72162-1815-2","72162-1815_47b76c41-711d-4ff3-bfe4-314950e4b040","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20170525","","ANDA","ANDA207372","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8743","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","72162181504","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72162-1815","72162-1815-4","72162-1815_47b76c41-711d-4ff3-bfe4-314950e4b040","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20170525","","ANDA","ANDA207372","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8744","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","72162181508","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72162-1815","72162-1815-8","72162-1815_47b76c41-711d-4ff3-bfe4-314950e4b040","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20170525","","ANDA","ANDA207372","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8745","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","72162181509","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72162-1815","72162-1815-9","72162-1815_47b76c41-711d-4ff3-bfe4-314950e4b040","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20170525","","ANDA","ANDA207372","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8746","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","72162181503","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72162-1815","72162-1815-3","72162-1815_47b76c41-711d-4ff3-bfe4-314950e4b040","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20170525","","ANDA","ANDA207372","Bryant Ranch Prepack","25; 75","mg/1; mg/1","","N","20251231"
"8747","CEPHALEXIN","Cephalexin","72162183001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72162-1830","72162-1830-1","72162-1830_8cca69ed-8f6e-4c81-85d2-9861ea182215","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8748","CEPHALEXIN","Cephalexin","72162183002","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72162-1830","72162-1830-2","72162-1830_8cca69ed-8f6e-4c81-85d2-9861ea182215","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8749","CEPHALEXIN","Cephalexin","72162183005","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72162-1830","72162-1830-5","72162-1830_8cca69ed-8f6e-4c81-85d2-9861ea182215","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Bryant Ranch Prepack","500","mg/1","","N","20261231"
"8750","CEPHALEXIN","Cephalexin","72162183102","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72162-1831","72162-1831-2","72162-1831_bbd18e30-e61d-46a3-b558-6883ec6b29dd","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8751","CEPHALEXIN","Cephalexin","72162183105","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72162-1831","72162-1831-5","72162-1831_bbd18e30-e61d-46a3-b558-6883ec6b29dd","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8752","CEPHALEXIN","Cephalexin","72162183101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72162-1831","72162-1831-1","72162-1831_bbd18e30-e61d-46a3-b558-6883ec6b29dd","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8753","CEPHALEXIN","Cephalexin","72162183302","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72162-1833","72162-1833-2","72162-1833_44f4e82f-3f80-4a1a-af11-7b5c909d662d","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"8754","CEPHALEXIN","Cephalexin","72162183304","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72162-1833","72162-1833-4","72162-1833_44f4e82f-3f80-4a1a-af11-7b5c909d662d","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Bryant Ranch Prepack","750","mg/1","","N","20251231"
"8755","CEPHALEXIN","Cephalexin","72162185002","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72162-1850","72162-1850-2","72162-1850_8734cc9d-966b-4471-97df-c92477f0389e","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Bryant Ranch Prepack","125","mg/5mL","","N","20251231"
"8756","CEPHALEXIN","Cephalexin","72162185001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72162-1850","72162-1850-1","72162-1850_8734cc9d-966b-4471-97df-c92477f0389e","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Bryant Ranch Prepack","125","mg/5mL","","N","20251231"
"8757","CEPHALEXIN","Cephalexin","72162185101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72162-1851","72162-1851-1","72162-1851_df3f008c-1063-41fa-9694-356a0478a5ae","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Bryant Ranch Prepack","250","mg/5mL","","N","20251231"
"8758","CEPHALEXIN","Cephalexin","72162185102","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72162-1851","72162-1851-2","72162-1851_df3f008c-1063-41fa-9694-356a0478a5ae","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Bryant Ranch Prepack","250","mg/5mL","","N","20251231"
"8759","CEPHALEXIN","Cephalexin","72162185104","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72162-1851","72162-1851-4","72162-1851_df3f008c-1063-41fa-9694-356a0478a5ae","HUMAN PRESCRIPTION DRUG","Cephalexin","","FOR SUSPENSION","ORAL","20190328","","ANDA","ANDA210221","Bryant Ranch Prepack","250","mg/5mL","","N","20251231"
"8760","NYSTATIN","Nystatin","72162200703","Polyene Antifungal [EPC], Polyenes [CS]","72162-2007","72162-2007-3","72162-2007_8d48c259-ba34-4c5b-b3fe-f1108b33eab3","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20200624","","ANDA","ANDA207767","Bryant Ranch Prepack","100000","U/g","","N","20251231"
"8761","NYSTATIN","Nystatin","72162200702","Polyene Antifungal [EPC], Polyenes [CS]","72162-2007","72162-2007-2","72162-2007_8d48c259-ba34-4c5b-b3fe-f1108b33eab3","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20200624","","ANDA","ANDA207767","Bryant Ranch Prepack","100000","U/g","","N","20251231"
"8762","ERYTHROMYCIN","erythromycin","72162207506","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","72162-2075","72162-2075-6","72162-2075_4ddb7356-308f-4c0a-bda1-7c49fb7efe29","HUMAN PRESCRIPTION DRUG","erythromycin","","SOLUTION","TOPICAL","20111219","","ANDA","ANDA063038","Bryant Ranch Prepack","20","mg/mL","","N","20251231"
"8763","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate, Benzoyl Peroxide","72162207701","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72162-2077","72162-2077-1","72162-2077_1ce2692a-4384-4f6c-9de3-491692751388","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Benzoyl Peroxide","","GEL","TOPICAL","20190912","","ANDA","ANDA205397","Bryant Ranch Prepack","25; 10","mg/g; mg/g","","N","20251231"
"8764","MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE","moxifloxacin","72162210702","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72162-2107","72162-2107-2","72162-2107_5e65bcf7-98de-4ec2-adf9-cbb8ec0bbe68","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20170701","","ANDA","ANDA090080","Bryant Ranch Prepack","5","mg/mL","","N","20251231"
"8765","OFLOXACIN","ofloxacin","72162210802","Quinolone Antimicrobial [EPC], Quinolones [CS]","72162-2108","72162-2108-2","72162-2108_8c61bf7d-d887-4214-bbea-d6f16cc048d4","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION","OPHTHALMIC","20190301","","ANDA","ANDA076513","Bryant Ranch Prepack","3","mg/mL","","N","20251231"
"8766","CEPHALEXIN","Cephalexin","72162214505","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72162-2145","72162-2145-5","72162-2145_58759ee9-29d7-4b3e-8b95-d4857eeffadd","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","19900930","","ANDA","ANDA062702","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8767","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","72162214706","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72162-2147","72162-2147-6","72162-2147_e1d1616f-a099-43d4-ba18-9d04b17b301b","HUMAN PRESCRIPTION DRUG","clindamycin phosphate","","LOTION","TOPICAL","20020131","","ANDA","ANDA065067","Bryant Ranch Prepack","10","mg/mL","","N","20251231"
"8768","METRONIDAZOLE","Metronidazole","72162215906","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72162-2159","72162-2159-6","72162-2159_71adf84e-3467-4ef3-9156-72524d92ae6b","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","TOPICAL","20130701","","ANDA","ANDA090903","Bryant Ranch Prepack","10","mg/g","","N","20251231"
"8769","CLOTRIMAZOLE","Clotrimazole Topical Solution USP, 1%","72162217803","Azole Antifungal [EPC], Azoles [CS]","72162-2178","72162-2178-3","72162-2178_6a50410d-ef84-4b60-9bec-cf1d1166e461","HUMAN PRESCRIPTION DRUG","Clotrimazole Topical Solution USP, 1%","","SOLUTION","TOPICAL","20190725","","ANDA","ANDA212281","Bryant Ranch Prepack","10","mg/mL","","N","20251231"
"8770","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72162221002","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72162-2210","72162-2210-2","72162-2210_cef7f4b1-d750-4f09-aa7a-25afaf2020d5","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20020315","","ANDA","ANDA065064","Bryant Ranch Prepack","500; 125","mg/1; mg/1","","N","20251231"
"8771","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72162221102","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72162-2211","72162-2211-2","72162-2211_11986a98-d463-4906-a6f0-21b8f001cc4e","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20020314","","ANDA","ANDA065063","Bryant Ranch Prepack","875; 125","mg/1; mg/1","","N","20251231"
"8772","POSACONAZOLE","Posaconazole","72162224302","Azole Antifungal [EPC], Azoles [CS]","72162-2243","72162-2243-2","72162-2243_01fd7009-ab61-484a-bb31-57f98527d179","HUMAN PRESCRIPTION DRUG","Posaconazole","","TABLET, DELAYED RELEASE","ORAL","20230915","","ANDA","ANDA216488","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8773","POSACONAZOLE","Posaconazole","72162224306","Azole Antifungal [EPC], Azoles [CS]","72162-2243","72162-2243-6","72162-2243_01fd7009-ab61-484a-bb31-57f98527d179","HUMAN PRESCRIPTION DRUG","Posaconazole","","TABLET, DELAYED RELEASE","ORAL","20230915","","ANDA","ANDA216488","Bryant Ranch Prepack","100","mg/1","","N","20251231"
"8774","SULFACETAMIDE SODIUM; SULFUR","SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream","72162224604","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","72162-2246","72162-2246-4","72162-2246_3e06c249-bcc3-4ade-bb4d-1c63706d8f1b","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream","","CREAM","TOPICAL","20220515","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","100; 50","mg/g; mg/g","","N","20251231"
"8775","SULFACETAMIDE SODIUM; SULFUR","SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream","72162224602","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","72162-2246","72162-2246-2","72162-2246_3e06c249-bcc3-4ade-bb4d-1c63706d8f1b","HUMAN PRESCRIPTION DRUG","SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream","","CREAM","TOPICAL","20220515","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","100; 50","mg/g; mg/g","","N","20251231"
"8776","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","72162224702","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","72162-2247","72162-2247-2","72162-2247_2a71e154-b100-4154-947c-4e77ce8e40f6","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 8% and Sulfur 4% Cleanser","","LIQUID","TOPICAL","20220201","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","80; 40","mg/mL; mg/mL","","N","20251231"
"8777","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","72162224802","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","72162-2248","72162-2248-2","72162-2248_e0dbc79f-b35b-478f-8b27-bb7b4943ca4d","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10% and Sulfur 2% Cleanser","","LIQUID","TOPICAL","20220201","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","100; 20","mg/g; mg/g","","N","20251231"
"8778","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","72162224902","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","72162-2249","72162-2249-2","72162-2249_a8f83345-b460-4b30-aa81-103be03a891c","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 9% and Sulfur 4% Cleanser","","LIQUID","TOPICAL","20220201","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","90; 40","mg/mL; mg/mL","","N","20251231"
"8779","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","72162225002","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","72162-2250","72162-2250-2","72162-2250_2e78d74a-ba26-43a2-a3cc-5a84557cf8cf","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 9% and Sulfur 4.5% Cleanser","","LIQUID","TOPICAL","20220201","","UNAPPROVED DRUG OTHER","","Bryant Ranch Prepack","90; 45","mg/g; mg/g","","N","20251231"
"8780","METRONIDAZOLE","Metronidazole","72162225902","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72162-2259","72162-2259-2","72162-2259_23a9c9ca-e7a0-4c69-af20-621bacc1fff6","HUMAN PRESCRIPTION DRUG","Metronidazole","","CREAM","TOPICAL","20040528","","ANDA","ANDA076408","Bryant Ranch Prepack","7.5","mg/g","","N","20251231"
"8781","MUPIROCIN","Mupirocin","72162227002","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","72162-2270","72162-2270-2","72162-2270_a0abc962-2085-4d58-9c35-9fe4123a8192","HUMAN PRESCRIPTION DRUG","mupirocin","","OINTMENT","TOPICAL","20091030","","ANDA","ANDA065123","Bryant Ranch Prepack","20","mg/g","","N","20251231"
"8782","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","72162229902","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72162-2299","72162-2299-2","72162-2299_57b7e53e-9443-4acb-99ac-fd06160fbba5","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","GEL","TOPICAL","20210520","","ANDA","ANDA212433","Bryant Ranch Prepack","50; 10","mg/g; mg/g","","N","20261231"
"8783","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","72162230504","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","72162-2305","72162-2305-4","72162-2305_38c75f1c-f29c-4671-aa99-f9d3f7c650ef","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","CAPSULE","ORAL","20240115","","ANDA","ANDA210729","Bryant Ranch Prepack","125","mg/1","","N","20251231"
"8784","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","72162230604","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","72162-2306","72162-2306-4","72162-2306_91d9dc98-b742-4507-aea8-988c8bf4e6b3","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","CAPSULE","ORAL","20240115","","ANDA","ANDA210729","Bryant Ranch Prepack","250","mg/1","","N","20251231"
"8785","NYSTATIN","Nystatin","72162233302","Polyene Antifungal [EPC], Polyenes [CS]","72162-2333","72162-2333-2","72162-2333_c4299118-f831-4982-a864-b8cb9d4c363d","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20060915","","ANDA","ANDA062472","Bryant Ranch Prepack","100000","[USP'U]/g","","N","20261231"
"8786","NYSTATIN","Nystatin","72162233303","Polyene Antifungal [EPC], Polyenes [CS]","72162-2333","72162-2333-3","72162-2333_c4299118-f831-4982-a864-b8cb9d4c363d","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20060915","","ANDA","ANDA062472","Bryant Ranch Prepack","100000","[USP'U]/g","","N","20261231"
"8787","CLOTRIMAZOLE","Clotrimazole","72162234003","Azole Antifungal [EPC], Azoles [CS]","72162-2340","72162-2340-3","72162-2340_78fd5ceb-9154-4704-9c53-01f90226ef2e","HUMAN OTC DRUG","clotrimazole","","CREAM","TOPICAL","20110603","20260228","OTC MONOGRAPH DRUG","M005","Bryant Ranch Prepack","1","g/100g","","N",""
"8788","METRONIDAZOLE","Metronidazole","72162240302","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72162-2403","72162-2403-2","72162-2403_9e05f3f2-a880-4e10-af96-479bba15d947","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8789","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate and Benzoyl Peroxide","72162241902","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72162-2419","72162-2419-2","72162-2419_b2f3e16e-8838-4c12-b946-090a9c15c742","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Benzoyl Peroxide","","GEL","TOPICAL","20240920","","ANDA","ANDA209610","Bryant Ranch Prepack","37.5; 10","mg/g; mg/g","","N","20251231"
"8790","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","72162242502","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72162-2425","72162-2425-2","72162-2425_54fb9efb-e34f-4d04-922b-c80eeb1c1200","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8791","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","72162242503","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72162-2425","72162-2425-3","72162-2425_54fb9efb-e34f-4d04-922b-c80eeb1c1200","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8792","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","72162242504","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72162-2425","72162-2425-4","72162-2425_54fb9efb-e34f-4d04-922b-c80eeb1c1200","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8793","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","72162242501","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72162-2425","72162-2425-1","72162-2425_54fb9efb-e34f-4d04-922b-c80eeb1c1200","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8794","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","72162242505","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72162-2425","72162-2425-5","72162-2425_54fb9efb-e34f-4d04-922b-c80eeb1c1200","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Bryant Ranch Prepack","500","mg/1","","N","20251231"
"8795","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72162243302","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72162-2433","72162-2433-2","72162-2433_1fa0ff58-3b58-4542-8d1a-ba016ddfd489","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","Bryant Ranch Prepack","500; 125","mg/1; mg/1","","N","20251231"
"8796","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72162243301","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72162-2433","72162-2433-1","72162-2433_1fa0ff58-3b58-4542-8d1a-ba016ddfd489","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","Bryant Ranch Prepack","500; 125","mg/1; mg/1","","N","20251231"
"8797","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72162243401","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72162-2434","72162-2434-1","72162-2434_f76dd82b-2525-464c-b58c-048c3475977f","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","Bryant Ranch Prepack","875; 125","mg/1; mg/1","","N","20261231"
"8798","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72162243503","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72162-2435","72162-2435-3","72162-2435_ef7f8e15-fbf4-488d-9372-df0239a505df","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA205707","Bryant Ranch Prepack","250; 125","mg/1; mg/1","","N","20251231"
"8799","METRONIDAZOLE","metronidazole","72162246805","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72162-2468","72162-2468-5","72162-2468_33d9cd48-bb46-bad1-e063-6394a90a230f","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20250104","","ANDA","ANDA070772","Bryant Ranch Prepack","125","mg/1","","N","20261231"
"8800","METRONIDAZOLE","metronidazole","72162246802","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72162-2468","72162-2468-2","72162-2468_33d9cd48-bb46-bad1-e063-6394a90a230f","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20250104","","ANDA","ANDA070772","Bryant Ranch Prepack","125","mg/1","","N","20261231"
"8801","NYSTATIN","Nystatin","72162249603","Polyene Antifungal [EPC], Polyenes [CS]","72162-2496","72162-2496-3","72162-2496_e130edd4-92df-499c-a66f-9633e9d349ec","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20210825","","ANDA","ANDA213566","Bryant Ranch Prepack","100000","[USP'U]/g","","N","20261231"
"8802","NYSTATIN","Nystatin","72162249602","Polyene Antifungal [EPC], Polyenes [CS]","72162-2496","72162-2496-2","72162-2496_e130edd4-92df-499c-a66f-9633e9d349ec","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20210825","","ANDA","ANDA213566","Bryant Ranch Prepack","100000","[USP'U]/g","","N","20261231"
"8803","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","72189001502","Macrolide Antimicrobial [EPC], Macrolides [CS]","72189-015","72189-015-02","72189-015_2c4e8f12-2481-4a0d-e063-6394a90a58c5","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","TABLET, FILM COATED","ORAL","20190724","","ANDA","ANDA207398","Direct_Rx","500","mg/1","","N","20261231"
"8804","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","72189001503","Macrolide Antimicrobial [EPC], Macrolides [CS]","72189-015","72189-015-03","72189-015_2c4e8f12-2481-4a0d-e063-6394a90a58c5","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","TABLET, FILM COATED","ORAL","20190724","","ANDA","ANDA207398","Direct_Rx","500","mg/1","","N","20261231"
"8805","CEFDINIR","CEFDINIR","72189004332","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72189-043","72189-043-32","72189-043_2c4ea169-07c6-6bde-e063-6394a90a0890","HUMAN PRESCRIPTION DRUG","CEFDINIR","","POWDER, FOR SUSPENSION","ORAL","20191125","","ANDA","ANDA065259","DIRECT RX","250","mg/5mL","","N","20261231"
"8806","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","72189008706","Macrolide Antimicrobial [EPC], Macrolides [CS]","72189-087","72189-087-06","72189-087_26f851bf-1b84-d000-e063-6394a90a079c","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","TABLET, FILM COATED","ORAL","20200615","","ANDA","ANDA207370","DIRECT RX","250","mg/1","","N","20251231"
"8807","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","72189008710","Macrolide Antimicrobial [EPC], Macrolides [CS]","72189-087","72189-087-10","72189-087_26f851bf-1b84-d000-e063-6394a90a079c","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","TABLET, FILM COATED","ORAL","20200615","","ANDA","ANDA207370","DIRECT RX","250","mg/1","","N","20251231"
"8808","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","72189008803","Macrolide Antimicrobial [EPC], Macrolides [CS]","72189-088","72189-088-03","72189-088_26f851bf-1b84-d000-e063-6394a90a079c","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","TABLET, FILM COATED","ORAL","20200618","","ANDA","ANDA210001","DIRECT RX","500","mg/1","","N","20251231"
"8809","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","72189008802","Macrolide Antimicrobial [EPC], Macrolides [CS]","72189-088","72189-088-02","72189-088_26f851bf-1b84-d000-e063-6394a90a079c","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","TABLET, FILM COATED","ORAL","20200618","","ANDA","ANDA210001","DIRECT RX","500","mg/1","","N","20251231"
"8810","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN DIHYDRATE","72189008906","Macrolide Antimicrobial [EPC], Macrolides [CS]","72189-089","72189-089-06","72189-089_26f851bf-1b84-d000-e063-6394a90a079c","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN DIHYDRATE","","TABLET, FILM COATED","ORAL","20201015","","ANDA","ANDA208250","DIRECT RX","250","mg/1","","N","20251231"
"8811","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN DIHYDRATE","72189009002","Macrolide Antimicrobial [EPC], Macrolides [CS]","72189-090","72189-090-02","72189-090_2be8149b-0d04-e882-e063-6394a90a5b86","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN DIHYDRATE","","TABLET, FILM COATED","ORAL","20200522","","ANDA","ANDA208249","DIRECT RX","500","mg/1","","N","20261231"
"8812","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN DIHYDRATE","72189009003","Macrolide Antimicrobial [EPC], Macrolides [CS]","72189-090","72189-090-03","72189-090_2be8149b-0d04-e882-e063-6394a90a5b86","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN DIHYDRATE","","TABLET, FILM COATED","ORAL","20200522","","ANDA","ANDA208249","DIRECT RX","500","mg/1","","N","20261231"
"8813","AZITHROMYCIN DIHYDRATE","AZITHROMYCIN","72189009306","Macrolide Antimicrobial [EPC], Macrolides [CS]","72189-093","72189-093-06","72189-093_26f851bf-1b84-d000-e063-6394a90a079c","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","TABLET, FILM COATED","ORAL","20200515","","ANDA","ANDA210000","DIRECT RX","250","mg/1","","N","20251231"
"8814","CEFADROXIL","CEFADROXIL","72189010306","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72189-103","72189-103-06","72189-103_2be86c94-8c9d-1da3-e063-6294a90a1319","HUMAN PRESCRIPTION DRUG","CEFADROXIL","","CAPSULE","ORAL","20200612","","ANDA","ANDA065352","DIRECT RX","500","mg/1","","N","20261231"
"8815","CEFADROXIL","CEFADROXIL","72189010320","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72189-103","72189-103-20","72189-103_2be86c94-8c9d-1da3-e063-6294a90a1319","HUMAN PRESCRIPTION DRUG","CEFADROXIL","","CAPSULE","ORAL","20200612","","ANDA","ANDA065352","DIRECT RX","500","mg/1","","N","20261231"
"8816","OFLOXACIN","OFLOXACIN","72189010805","Quinolone Antimicrobial [EPC], Quinolones [CS]","72189-108","72189-108-05","72189-108_2be8eb66-533e-0815-e063-6294a90a115d","HUMAN PRESCRIPTION DRUG","OFLOXACIN OTIC","","SOLUTION","AURICULAR (OTIC)","20200608","","ANDA","ANDA076527","DIRECT RX","3","mg/mL","","N","20261231"
"8817","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin hydrochloride","72189011114","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72189-111","72189-111-14","72189-111_2be8ce9a-f024-b83a-e063-6294a90ac979","HUMAN PRESCRIPTION DRUG","CIPROFLOXACIN","","TABLET, FILM COATED","ORAL","20200612","","ANDA","ANDA077859","DIRECT RX","500","mg/1","","N","20261231"
"8818","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin hydrochloride","72189011120","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72189-111","72189-111-20","72189-111_2be8ce9a-f024-b83a-e063-6294a90ac979","HUMAN PRESCRIPTION DRUG","CIPROFLOXACIN","","TABLET, FILM COATED","ORAL","20200612","","ANDA","ANDA077859","DIRECT RX","500","mg/1","","N","20261231"
"8819","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin hydrochloride","72189011130","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72189-111","72189-111-30","72189-111_2be8ce9a-f024-b83a-e063-6294a90ac979","HUMAN PRESCRIPTION DRUG","CIPROFLOXACIN","","TABLET, FILM COATED","ORAL","20200612","","ANDA","ANDA077859","DIRECT RX","500","mg/1","","N","20261231"
"8820","FLUCONAZOLE","FLUCONAZOLE","72189014010","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72189-140","72189-140-10","72189-140_2becff06-7cc2-1200-e063-6294a90ad1ec","HUMAN PRESCRIPTION DRUG","FLUCONAZOLE","","TABLET","ORAL","20210824","","ANDA","ANDA208963","direct rx","100","mg/1","","N","20261231"
"8821","FLUCONAZOLE","FLUCONAZOLE","72189014301","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72189-143","72189-143-01","72189-143_2becff06-7cc2-1200-e063-6294a90ad1ec","HUMAN PRESCRIPTION DRUG","FLUCONAZOLE","","TABLET","ORAL","20201112","","ANDA","ANDA076658","direct rx","150","mg/1","","N","20261231"
"8822","FLUCONAZOLE","fluconazole","72189014901","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72189-149","72189-149-01","72189-149_2becff06-7cc2-1200-e063-6294a90ad1ec","HUMAN PRESCRIPTION DRUG","fluconazole","","TABLET","ORAL","20201111","","ANDA","ANDA208963","direct rx","150","mg/1","","N","20261231"
"8823","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","NITROFURANTOIN","72189017910","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72189-179","72189-179-10","72189-179_2be91ea1-1f2f-d635-e063-6294a90a4dd1","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20220118","","ANDA","ANDA077066","Directrx","25; 75","mg/1; mg/1","","N","20261231"
"8824","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","NITROFURANTOIN","72189017914","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72189-179","72189-179-14","72189-179_2be91ea1-1f2f-d635-e063-6294a90a4dd1","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20220118","","ANDA","ANDA077066","Directrx","25; 75","mg/1; mg/1","","N","20261231"
"8825","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","NITROFURANTOIN","72189017920","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72189-179","72189-179-20","72189-179_2be91ea1-1f2f-d635-e063-6294a90a4dd1","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN","","CAPSULE","ORAL","20220118","","ANDA","ANDA077066","Directrx","25; 75","mg/1; mg/1","","N","20261231"
"8826","KETOCONAZOLE","KETOCONAZOLE","72189018007","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","72189-180","72189-180-07","72189-180_2be953af-ba6e-e430-e063-6294a90a9a1a","HUMAN PRESCRIPTION DRUG","KETOCONAZOLE","","TABLET","ORAL","20210224","","ANDA","ANDA075912","Direct Rx","200","mg/1","","N","20261231"
"8827","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE","72189018215","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","72189-182","72189-182-15","72189-182_2be953af-ba6f-e430-e063-6294a90a9a1a","HUMAN PRESCRIPTION DRUG","CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE","","CREAM","TOPICAL","20210223","","ANDA","ANDA202894","Direct Rx",".5; 10","mg/g; mg/g","","N","20261231"
"8828","CEFDINIR","CEFDINIR","72189018532","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72189-185","72189-185-32","72189-185_2c4ea169-07c6-6bde-e063-6394a90a0890","HUMAN PRESCRIPTION DRUG","CEFDINIR","","POWDER, FOR SUSPENSION","ORAL","20210412","","ANDA","ANDA065473","DIRECT RX","125","mg/5mL","","N","20261231"
"8829","CEFDINIR","CEFDINIR","72189018632","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72189-186","72189-186-32","72189-186_2c4ea169-07c6-6bde-e063-6394a90a0890","HUMAN PRESCRIPTION DRUG","CEFDINIR","","POWDER, FOR SUSPENSION","ORAL","20210412","","ANDA","ANDA065473","DIRECT RX","250","mg/5mL","","N","20261231"
"8830","CLINDAMYCIN HYDROCHLORIDE","CLINDAMYCIN HYDROCHLORIDE","72189018921","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72189-189","72189-189-21","72189-189_35bea079-d836-5237-e063-6394a90a062b","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20210604","","ANDA","ANDA207402","DIRECT RX","300","mg/1","","N","20261231"
"8831","CLINDAMYCIN HYDROCHLORIDE","CLINDAMYCIN HYDROCHLORIDE","72189018928","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72189-189","72189-189-28","72189-189_35bea079-d836-5237-e063-6394a90a062b","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20210604","","ANDA","ANDA207402","DIRECT RX","300","mg/1","","N","20261231"
"8832","CLINDAMYCIN HYDROCHLORIDE","CLINDAMYCIN HYDROCHLORIDE","72189018930","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72189-189","72189-189-30","72189-189_35bea079-d836-5237-e063-6394a90a062b","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20210604","","ANDA","ANDA207402","DIRECT RX","300","mg/1","","N","20261231"
"8833","CIPROFLOXACIN HYDROCHLORIDE","CIPROFLOXACIN","72189024210","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72189-242","72189-242-10","72189-242_2c287767-b9e9-de36-e063-6394a90a5460","HUMAN PRESCRIPTION DRUG","CIPROFLOXACIN","","TABLET, FILM COATED","ORAL","20210723","","ANDA","ANDA075593","direct rx","500","mg/1","","N","20261231"
"8834","CIPROFLOXACIN HYDROCHLORIDE","CIPROFLOXACIN","72189024220","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72189-242","72189-242-20","72189-242_2c287767-b9e9-de36-e063-6394a90a5460","HUMAN PRESCRIPTION DRUG","CIPROFLOXACIN","","TABLET, FILM COATED","ORAL","20210723","","ANDA","ANDA075593","direct rx","500","mg/1","","N","20261231"
"8835","TERBINAFINE HYDROCHLORIDE","TERBINAFINE","72189024330","Allylamine Antifungal [EPC], Allylamine [CS]","72189-243","72189-243-30","72189-243_2c28596f-8fc8-42e5-e063-6294a90a0ad6","HUMAN PRESCRIPTION DRUG","TERBINAFINE","","TABLET","ORAL","20210723","","ANDA","ANDA078297","direct rx","250","mg/1","","N","20261231"
"8836","CEFDINIR","CEFDINIR","72189025932","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72189-259","72189-259-32","72189-259_2c4ea169-07c6-6bde-e063-6394a90a0890","HUMAN PRESCRIPTION DRUG","CEFDINIR","","POWDER, FOR SUSPENSION","ORAL","20210913","","ANDA","ANDA210534","DIRECT RX","250","mg/5mL","","N","20261231"
"8837","NYSTATIN","NYSTATIN","72189027815","Polyene Antifungal [EPC], Polyenes [CS]","72189-278","72189-278-15","72189-278_2c290c08-d35f-21b4-e063-6394a90a73b9","HUMAN PRESCRIPTION DRUG","NYSTATIN","","CREAM","ORAL; TOPICAL","20210930","","ANDA","ANDA064022","DIRECT RX","100000","[USP'U]/g","","N","20261231"
"8838","AMOXICILLIN; CLAVULANATE POTASSIUM","AMOXICILLIN AND CLAVULANATE POTASSIUM","72189028114","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72189-281","72189-281-14","72189-281_2c2908f5-e111-e912-e063-6294a90a01c9","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20211007","","ANDA","ANDA065064","DirectRx","500; 125","mg/1; mg/1","","N","20261231"
"8839","AMOXICILLIN; CLAVULANATE POTASSIUM","AMOXICILLIN AND CLAVULANATE POTASSIUM","72189028120","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72189-281","72189-281-20","72189-281_2c2908f5-e111-e912-e063-6294a90a01c9","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20211007","","ANDA","ANDA065064","DirectRx","500; 125","mg/1; mg/1","","N","20261231"
"8840","AMOXICILLIN","AMOXICILLIN","72189028532","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72189-285","72189-285-32","72189-285_2c2940b3-68cf-ce12-e063-6394a90aef2c","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","POWDER, FOR SUSPENSION","ORAL","20211021","","ANDA","ANDA065334","DirectRx","400","mg/5mL","","N","20261231"
"8841","CLARITHROMYCIN","Clarithromycin","72189029910","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","72189-299","72189-299-10","72189-299_2c2941fa-11d7-9f72-e063-6394a90af886","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20211202","","ANDA","ANDA065136","DirectRx","500","mg/1","","N","20261231"
"8842","CLARITHROMYCIN","Clarithromycin","72189029920","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","72189-299","72189-299-20","72189-299_2c2941fa-11d7-9f72-e063-6394a90af886","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20211202","","ANDA","ANDA065136","DirectRx","500","mg/1","","N","20261231"
"8843","CLARITHROMYCIN","Clarithromycin","72189029928","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","72189-299","72189-299-28","72189-299_2c2941fa-11d7-9f72-e063-6394a90af886","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20211202","","ANDA","ANDA065136","DirectRx","500","mg/1","","N","20261231"
"8844","CIPROFLOXACIN HYDROCHLORIDE","CIPROFLOXACIN","72189030006","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72189-300","72189-300-06","72189-300_2c294bda-345b-ad0e-e063-6294a90a0304","HUMAN PRESCRIPTION DRUG","CIPROFLOXACIN","","TABLET, FILM COATED","ORAL","20211203","","ANDA","ANDA076558","DirectRx","500","mg/1","","N","20261231"
"8845","CIPROFLOXACIN HYDROCHLORIDE","CIPROFLOXACIN","72189030020","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72189-300","72189-300-20","72189-300_2c294bda-345b-ad0e-e063-6294a90a0304","HUMAN PRESCRIPTION DRUG","CIPROFLOXACIN","","TABLET, FILM COATED","ORAL","20211203","","ANDA","ANDA076558","DirectRx","500","mg/1","","N","20261231"
"8846","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72189030406","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72189-304","72189-304-06","72189-304_2c295d71-a6a7-fce9-e063-6394a90a4492","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20211217","","ANDA","ANDA076558","DirectRx","250","mg/1","","N","20261231"
"8847","CEFDINIR","CEFDINIR","72189030814","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72189-308","72189-308-14","72189-308_2c3cf3d6-130e-5a5b-e063-6394a90aeefa","HUMAN PRESCRIPTION DRUG","CEFDINIR","","CAPSULE","ORAL","20220202","","ANDA","ANDA210220","DirectRx","300","mg/1","","N","20261231"
"8848","CEFDINIR","CEFDINIR","72189030820","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72189-308","72189-308-20","72189-308_2c3cf3d6-130e-5a5b-e063-6394a90aeefa","HUMAN PRESCRIPTION DRUG","CEFDINIR","","CAPSULE","ORAL","20220202","","ANDA","ANDA210220","DirectRx","300","mg/1","","N","20261231"
"8849","AZITHROMYCIN MONOHYDRATE","AZITHROMYCIN","72189031422","Macrolide Antimicrobial [EPC], Macrolides [CS]","72189-314","72189-314-22","72189-314_2c3cfbf7-a5af-5075-e063-6294a90a04e5","HUMAN PRESCRIPTION DRUG","AZITHROMYCIN","","POWDER, FOR SUSPENSION","ORAL","20220112","","ANDA","ANDA207531","DirectRx","200","mg/5mL","","N","20261231"
"8850","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ drops","72189032005","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","72189-320","72189-320-05","72189-320_32d607f3-fd60-9098-e063-6294a90a57af","HUMAN PRESCRIPTION DRUG","NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE","","SUSPENSION/ DROPS","TOPICAL","20220118","","ANDA","ANDA064135","DirectRx","1; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20261231"
"8851","MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE","MOXIFLOXACIN","72189032105","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72189-321","72189-321-05","72189-321_2c3d2dfe-0fff-b986-e063-6294a90a84c9","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN","","SOLUTION/ DROPS","OPHTHALMIC","20220207","","ANDA","ANDA202867","Direct Rx","5","mg/mL","","N","20261231"
"8852","CIPROFLOXACIN HYDROCHLORIDE","CIPROFLOXACIN","72189032306","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72189-323","72189-323-06","72189-323_2c3d4146-03d9-30a9-e063-6294a90ad471","HUMAN PRESCRIPTION DRUG","CIPROFLOXACIN","","TABLET, COATED","ORAL","20220221","","ANDA","ANDA208921","Direct Rx","250","mg/1","","N","20261231"
"8853","MOXIFLOXACIN HYDROCHLORIDE","MOXIFLOXACIN","72189033405","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72189-334","72189-334-05","72189-334_2c3d95a4-32d2-ef3b-e063-6294a90ac144","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN","","SOLUTION/ DROPS","OPHTHALMIC","20220308","","ANDA","ANDA202916","Direct Rx","5","mg/mL","","N","20261231"
"8854","FLUCONAZOLE","FLUCONAZOLE","72189034201","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72189-342","72189-342-01","72189-342_2c4c6a02-d9b4-a905-e063-6394a90ae1ea","HUMAN PRESCRIPTION DRUG","FLUCONAZOLE","","TABLET","ORAL","20220331","","ANDA","ANDA077253","Direct Rx","150","mg/1","","N","20261231"
"8855","GENTAMICIN SULFATE","Gentamicin Sulfate Opth Solution","72189035905","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","72189-359","72189-359-05","72189-359_2c4c8caf-089b-acf6-e063-6294a90a14c3","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate Opth Solution","","SOLUTION/ DROPS","OPHTHALMIC","20220617","","ANDA","ANDA064048","Direct_Rx","3","mg/mL","","N","20261231"
"8856","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin/Clav Pot Oral Susp","72189036732","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72189-367","72189-367-32","72189-367_2c4c9fa2-4c33-c1f5-e063-6294a90a4706","HUMAN PRESCRIPTION DRUG","Amoxicillin/Clav Pot Oral Susp","","POWDER, FOR SUSPENSION","ORAL","20220808","","ANDA","ANDA201090","Direct_Rx","400; 57","mg/5mL; mg/5mL","","N","20261231"
"8857","AMOXICILLIN","Amoxicillin Oral Susp","72189038532","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72189-385","72189-385-32","72189-385_2c4cbe6c-c27d-15fe-e063-6294a90ac409","HUMAN PRESCRIPTION DRUG","Amoxil","","POWDER, FOR SUSPENSION","ORAL","20221021","","ANDA","ANDA065325","DirectRx","400","mg/5mL","","N","20261231"
"8858","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystal","72189039514","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72189-395","72189-395-14","72189-395_1e79886c-8ce2-c6ef-e063-6394a90a7a83","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/Macrocrystal","","CAPSULE","ORAL","20221122","","ANDA","ANDA208516","Direct_Rx","25; 75","mg/1; mg/1","","N","20251231"
"8859","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystal","72189039520","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72189-395","72189-395-20","72189-395_1e79886c-8ce2-c6ef-e063-6394a90a7a83","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/Macrocrystal","","CAPSULE","ORAL","20221122","","ANDA","ANDA208516","Direct_Rx","25; 75","mg/1; mg/1","","N","20251231"
"8860","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin Monohydrate/Macrocrystal","72189039510","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72189-395","72189-395-10","72189-395_1e79886c-8ce2-c6ef-e063-6394a90a7a83","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Monohydrate/Macrocrystal","","CAPSULE","ORAL","20221122","","ANDA","ANDA208516","Direct_Rx","25; 75","mg/1; mg/1","","N","20251231"
"8861","NYSTATIN","Nystatin","72189040815","Polyene Antifungal [EPC], Polyenes [CS]","72189-408","72189-408-15","72189-408_2c4cf342-0925-a4ec-e063-6294a90a7a28","HUMAN PRESCRIPTION DRUG","Mycostatin","","CREAM","TOPICAL","20230105","","ANDA","ANDA062225","Direct_Rx","100000","[USP'U]/g","","N","20261231"
"8862","KETOCONAZOLE","Ketoconazole Cream","72189042230","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","72189-422","72189-422-30","72189-422_2c4d0d3f-009b-e010-e063-6294a90a1ae9","HUMAN PRESCRIPTION DRUG","Ketoconazole Cream","","CREAM","TOPICAL","20230207","","ANDA","ANDA212443","Direct_Rx","20","mg/g","","N","20261231"
"8863","CEFDINIR","Cefdinir","72189042320","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72189-423","72189-423-20","72189-423_2c4d38b9-5b23-a07e-e063-6294a90ae9c0","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20230208","","ANDA","ANDA065434","Direct_Rx","300","mg/1","","N","20261231"
"8864","CEFDINIR","Cefdinir","72189042314","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72189-423","72189-423-14","72189-423_2c4d38b9-5b23-a07e-e063-6294a90ae9c0","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20230208","","ANDA","ANDA065434","Direct_Rx","300","mg/1","","N","20261231"
"8865","KETOCONAZOLE","Ketoconazole","72189042807","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","72189-428","72189-428-07","72189-428_2c4d6606-d6a7-0085-e063-6294a90acaa2","HUMAN PRESCRIPTION DRUG","Ketoconazole","","TABLET","ORAL","20230301","","ANDA","ANDA075319","Direct_Rx","200","mg/1","","N","20261231"
"8866","CEFADROXIL","Cefadroxil","72189044506","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72189-445","72189-445-06","72189-445_2c4d982f-27ee-a7c8-e063-6394a90a9af0","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20230314","","ANDA","ANDA065392","Direct_Rx","500","mg/1","","N","20261231"
"8867","CEFADROXIL","Cefadroxil","72189044520","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72189-445","72189-445-20","72189-445_2c4d982f-27ee-a7c8-e063-6394a90a9af0","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20230314","","ANDA","ANDA065392","Direct_Rx","500","mg/1","","N","20261231"
"8868","AMOXICILLIN","Amoxicillin","72189046320","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72189-463","72189-463-20","72189-463_2c4de9c8-898d-f59d-e063-6294a90afdc1","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20230417","","ANDA","ANDA065228","Direct_Rx","875","mg/1","","N","20261231"
"8869","OFLOXACIN","Ofloxacin Ophth Soln","72189047205","Quinolone Antimicrobial [EPC], Quinolones [CS]","72189-472","72189-472-05","72189-472_2c4e05d7-5de1-f566-e063-6294a90acada","HUMAN PRESCRIPTION DRUG","Ofloxacin Ophth Soln","","SOLUTION/ DROPS","OPHTHALMIC","20230522","","ANDA","ANDA215886","Direct_Rx","3","mg/mL","","N","20261231"
"8870","OFLOXACIN","Olfoxacin Otic Soln","72189049005","Quinolone Antimicrobial [EPC], Quinolones [CS]","72189-490","72189-490-05","72189-490_2c4e3760-8446-4adb-e063-6394a90a5ffc","HUMAN PRESCRIPTION DRUG","Olfoxacin Otic Soln","","SOLUTION","AURICULAR (OTIC)","20230608","","ANDA","ANDA216130","Direct_Rx","3","mg/mL","","N","20261231"
"8871","CEFADROXIL","Cefadroxil","72189050620","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72189-506","72189-506-20","72189-506_1bcfe18a-6a47-6239-e063-6294a90af8d1","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20230807","","ANDA","ANDA065352","Direct_Rx","500","mg/1","","N","20251231"
"8872","CEFADROXIL","Cefadroxil","72189050606","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72189-506","72189-506-06","72189-506_1bcfe18a-6a47-6239-e063-6294a90af8d1","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20230807","","ANDA","ANDA065352","Direct_Rx","500","mg/1","","N","20251231"
"8873","FLUCONAZOLE","Fluconazole","72189051603","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72189-516","72189-516-03","72189-516_2c4e6424-181d-1db8-e063-6294a90a52d9","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20231005","","ANDA","ANDA077731","Direct_Rx","200","mg/1","","N","20261231"
"8874","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole/Betameth","72189051815","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","72189-518","72189-518-15","72189-518_2c4e7cbb-554b-2c9d-e063-6294a90ada98","HUMAN PRESCRIPTION DRUG","Clotrimazole/Betameth","","CREAM","TOPICAL","20231025","","ANDA","ANDA076002","Direct_Rx",".5; 10","mg/g; mg/g","","N","20261231"
"8875","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neo/Poly-B/Dex Ophth Oint","72189053235","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","72189-532","72189-532-35","72189-532_0ec1dfdf-b640-fb0c-e063-6294a90a843d","HUMAN PRESCRIPTION DRUG","Neo/Poly-B/Dex Ophth Oint","","OINTMENT","OPHTHALMIC","20240112","","ANDA","ANDA064063","Direct_Rx","1; 3.5; 10000","mg/g; mg/g; [USP'U]/g","","N","20251231"
"8876","CEFAZOLIN SODIUM","Cefazolin Sodium","72189058401","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72189-584","72189-584-01","72189-584_22dfc2e4-07a8-8d13-e063-6394a90a3e9f","HUMAN PRESCRIPTION DRUG","Cefazolin Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240924","","ANDA","ANDA203661","Direct_rx","1","g/1","","N","20251231"
"8877","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72189061606","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72189-616","72189-616-06","72189-616_2efbda2a-fc98-b7c5-e063-6294a90a362d","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20250225","","ANDA","ANDA208921","Direct_Rx","250","mg/1","","N","20261231"
"8878","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72189062320","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72189-623","72189-623-20","72189-623_351b41db-6230-a1eb-e063-6294a90a5667","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20250514","","ANDA","ANDA208921","Direct_Rx","500","mg/1","","N","20261231"
"8879","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72189062714","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72189-627","72189-627-14","72189-627_36d6c27d-45dd-3081-e063-6394a90a87e9","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20250605","","ANDA","ANDA077859","Direct_Rx","500","mg/1","","N","20261231"
"8880","MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE","Moxifloxacin Hydrochloride Tablets, 400 mg","72205000105","Quinolone Antimicrobial [EPC], Quinolones [CS]","72205-001","72205-001-05","72205-001_79a88ea4-ddf4-4ee9-acc2-91047ce636d5","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride Tablets, 400 mg","","TABLET, FILM COATED","ORAL","20180721","","ANDA","ANDA208682","Novadoz Pharmaceuticals LLC","400","mg/1","","N","20251231"
"8881","MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE","Moxifloxacin Hydrochloride Tablets, 400 mg","72205000130","Quinolone Antimicrobial [EPC], Quinolones [CS]","72205-001","72205-001-30","72205-001_79a88ea4-ddf4-4ee9-acc2-91047ce636d5","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride Tablets, 400 mg","","TABLET, FILM COATED","ORAL","20180721","","ANDA","ANDA208682","Novadoz Pharmaceuticals LLC","400","mg/1","","N","20251231"
"8882","MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE","Moxifloxacin Hydrochloride Tablets, 400 mg","72205000131","Quinolone Antimicrobial [EPC], Quinolones [CS]","72205-001","72205-001-31","72205-001_79a88ea4-ddf4-4ee9-acc2-91047ce636d5","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride Tablets, 400 mg","","TABLET, FILM COATED","ORAL","20180721","","ANDA","ANDA208682","Novadoz Pharmaceuticals LLC","400","mg/1","","N","20251231"
"8883","VALGANCICLOVIR HYDROCHLORIDE","valganciclovir hydrochloride","72205001901","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","72205-019","72205-019-01","72205-019_614ff447-7e5f-4ea6-ba85-ec1f6497b360","HUMAN PRESCRIPTION DRUG","valganciclovir hydrochloride","","FOR SOLUTION","ORAL","20220217","","ANDA","ANDA210169","Novadoz Pharmaceuticals LLC","50","mg/mL","","N","20251231"
"8884","POSACONAZOLE","posaconazole","72205016860","Azole Antifungal [EPC], Azoles [CS]","72205-168","72205-168-60","72205-168_0bdf77ae-3639-49c1-b7c7-533f9d073084","HUMAN PRESCRIPTION DRUG","posaconazole","","TABLET, COATED","ORAL","20250224","","ANDA","ANDA218434","Novadoz Pharmaceuticals LLC","100","mg/1","","N","20261231"
"8885","ERYTHROMYCIN","Erythromycin","72241003605","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","72241-036","72241-036-05","72241-036_eb7928f4-e0c7-4f23-a1a8-934d82f5eca4","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20210731","","ANDA","ANDA213628","Modavar Pharmaceuticals LLC","250","mg/1","","N","20251231"
"8886","ERYTHROMYCIN","Erythromycin","72241003622","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","72241-036","72241-036-22","72241-036_eb7928f4-e0c7-4f23-a1a8-934d82f5eca4","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20210731","","ANDA","ANDA213628","Modavar Pharmaceuticals LLC","250","mg/1","","N","20251231"
"8887","ERYTHROMYCIN","Erythromycin","72241003722","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","72241-037","72241-037-22","72241-037_eb7928f4-e0c7-4f23-a1a8-934d82f5eca4","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20210731","","ANDA","ANDA213628","Modavar Pharmaceuticals LLC","500","mg/1","","N","20251231"
"8888","ERYTHROMYCIN","Erythromycin","72241003705","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","72241-037","72241-037-05","72241-037_eb7928f4-e0c7-4f23-a1a8-934d82f5eca4","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20210731","","ANDA","ANDA213628","Modavar Pharmaceuticals LLC","500","mg/1","","N","20251231"
"8889","CASPOFUNGIN ACETATE","Caspofungin Acetate","72266010601","Echinocandin Antifungal [EPC], Lipopeptides [CS]","72266-106","72266-106-01","72266-106_33511a66-d80a-d052-e063-6294a90a9459","HUMAN PRESCRIPTION DRUG","Caspofungin Acetate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190402","","ANDA","ANDA207092","Fosun Pharma USA Inc.","5","mg/mL","","N","20261231"
"8890","CASPOFUNGIN ACETATE","Caspofungin Acetate","72266010701","Echinocandin Antifungal [EPC], Lipopeptides [CS]","72266-107","72266-107-01","72266-107_33511a66-d80a-d052-e063-6294a90a9459","HUMAN PRESCRIPTION DRUG","Caspofungin Acetate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190402","","ANDA","ANDA207092","Fosun Pharma USA Inc.","7","mg/mL","","N","20261231"
"8891","VORICONAZOLE","Voriconazole","72266013101","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72266-131","72266-131-01","72266-131_1808aece-8e8d-f8cf-e063-6294a90af7d2","HUMAN PRESCRIPTION DRUG","Voriconazole","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210104","","ANDA","ANDA211099","Fosun Pharma USA Inc.","10","mg/mL","","N","20251231"
"8892","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin Ophthalmic","72266015801","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72266-158","72266-158-01","72266-158_18986f71-95b9-fa65-e063-6394a90a940b","HUMAN PRESCRIPTION DRUG","Moxifloxacin Ophthalmic Solution","","SOLUTION/ DROPS","OPHTHALMIC","20200824","","ANDA","ANDA208778","Fosun Pharma USA Inc.","5","mg/mL","","N","20251231"
"8893","ERTAPENEM SODIUM","Ertapenem Sodium","72266015905","Carbapenems [CS], Penem Antibacterial [EPC]","72266-159","72266-159-05","72266-159_181c0b9d-794e-3e8a-e063-6394a90a7f16","HUMAN PRESCRIPTION DRUG","Ertapenem","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20211101","","ANDA","ANDA212040","Fosun Pharma USA Inc","1","g/1","","N","20251231"
"8894","ERTAPENEM SODIUM","Ertapenem Sodium","72266015910","Carbapenems [CS], Penem Antibacterial [EPC]","72266-159","72266-159-10","72266-159_181c0b9d-794e-3e8a-e063-6394a90a7f16","HUMAN PRESCRIPTION DRUG","Ertapenem","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20211101","","ANDA","ANDA212040","Fosun Pharma USA Inc","1","g/1","","N","20251231"
"8895","TOBRAMYCIN SULFATE","Tobramycin","72266016306","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","72266-163","72266-163-06","72266-163_1c499644-6570-e991-e063-6394a90a7b6c","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210811","","ANDA","ANDA211189","Fosun Pharma USA Inc","1.2","g/30mL","","N","20251231"
"8896","POLYMYXIN B SULFATE","POLYMYXIN B SULFATE","72266024910","Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","72266-249","72266-249-10","72266-249_26fe14ff-6246-5b49-e063-6394a90af4f6","HUMAN PRESCRIPTION DRUG","POLYMYXIN B","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC","20230831","","ANDA","ANDA207322","FOSUN PHARMA USA INC","500000","[USP'U]/1","","N","20251231"
"8897","CEPHALEXIN","Cephalexin","72287031001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72287-310","72287-310-01","72287-310_9ceaceed-1674-4e6d-8baf-44c4693549b3","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20180627","","ANDA","ANDA065253","AMELLA PHARMA, LLC","500","mg/1","","N","20251231"
"8898","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin, polymyxin B","72288006716","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","72288-067","72288-067-16","72288-067_d9d06540-0c3d-4b44-82d7-08ca7dcc2810","HUMAN OTC DRUG","basic care first aid antibiotic","","OINTMENT","TOPICAL","20210614","","OTC MONOGRAPH DRUG","M004","Amazon.com Services LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"8899","MICONAZOLE NITRATE","miconazole nitrate","72288007014","Azole Antifungal [EPC], Azoles [CS]","72288-070","72288-070-14","72288-070_e1457c13-6d35-41b2-b1e8-7e82b647a0c7","HUMAN OTC DRUG","basic care miconazole 3","","CREAM","VAGINAL","20210715","","ANDA","ANDA091366","Amazon.com Services LLC","40","mg/g","","N","20251231"
"8900","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride","72288025364","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","72288-253","72288-253-64","72288-253_3a4d128c-e6a2-4773-8fe5-00e698d9c907","HUMAN OTC DRUG","basic care first aid antibiotic and burn relief","","OINTMENT","TOPICAL","20210721","","OTC MONOGRAPH DRUG","M004","Amazon.com Services LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"8901","TIOCONAZOLE","Tioconazole","72288042654","Azole Antifungal [EPC], Azoles [CS]","72288-426","72288-426-54","72288-426_eb1be3da-66a1-47b0-807e-424afaaae094","HUMAN OTC DRUG","basic care tioconazole","","OINTMENT","VAGINAL","20210727","","ANDA","ANDA075915","Amazon.com Services LLC","6.5","g/100g","","N","20251231"
"8902","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl","72288067921","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","72288-679","72288-679-21","72288-679_3996a95d-8456-4fa8-9189-874a3d18b129","HUMAN OTC DRUG","Basic Care First Aid Antibiotic","","OINTMENT","TOPICAL","20210812","","OTC MONOGRAPH DRUG","M004","Amazon.com Services LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"8903","MICONAZOLE NITRATE","Miconazole nitrate","72288082529","Azole Antifungal [EPC], Azoles [CS]","72288-825","72288-825-29","72288-825_4a828083-f5a9-46c3-a07a-3d151f155025","HUMAN OTC DRUG","Basic Care Miconazole 7","","CREAM","VAGINAL","20210813","","ANDA","ANDA074760","Amazon.com Services LLC","2","g/100g","","N","20251231"
"8904","POSACONAZOLE","Posaconazole","72319002302","Azole Antifungal [EPC], Azoles [CS]","72319-023","72319-023-02","72319-023_3249c585-7620-444f-e063-6294a90ae5ac","HUMAN PRESCRIPTION DRUG","Posaconazole","","TABLET, DELAYED RELEASE","ORAL","20230915","","ANDA","ANDA216488","i3 Pharmaceuticals, LLC","100","mg/1","","N","20261231"
"8905","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","72336011275","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72336-112","72336-112-75","72336-112_a3cee7f6-af02-4e19-b230-1f3a023ceec7","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20250125","","ANDA","ANDA212842","Lifsa Drugs LLC","1","g/10mL","","N","20261231"
"8906","MICONAZOLE NITRATE","Anti-fungal Powder Miconazole Nitrate Talc Free","72446000771","Azole Antifungal [EPC], Azoles [CS]","72446-007","72446-007-71","72446-007_36aec48d-c3a0-70d3-e063-6394a90afb85","HUMAN OTC DRUG","Miconazole Nitrate","","POWDER","TOPICAL","20180901","20270131","OTC MONOGRAPH DRUG","M005","Hudson Health LLC","1.42","g/71g","","N",""
"8907","MICONAZOLE NITRATE","Anti-fungal Powder Miconazole Nitrate Talc Free","72446001401","Azole Antifungal [EPC], Azoles [CS]","72446-014","72446-014-01","72446-014_36ec5e8f-45a7-039c-e063-6294a90ab055","HUMAN OTC DRUG","Miconazole Nitrate","","POWDER","TOPICAL","20250603","","OTC MONOGRAPH DRUG","M005","Hudson Health LLC","20","mg/g","","N","20261231"
"8908","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin and tazobactam","72485040310","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72485-403","72485-403-10","72485-403_285bcfd1-4e01-811f-e063-6294a90a8b04","HUMAN PRESCRIPTION DRUG","piperacillin and tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20220414","","ANDA","ANDA065458","Armas Pharmaceuticals Inc.","3; .375","g/15mL; g/15mL","","N","20251231"
"8909","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin and tazobactam","72485040410","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72485-404","72485-404-10","72485-404_285c17c1-09c5-e092-e063-6394a90ab0a0","HUMAN PRESCRIPTION DRUG","piperacillin and tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20220414","","ANDA","ANDA065458","Armas Pharmaceuticals Inc.","4; .5","g/20mL; g/20mL","","N","20251231"
"8910","NAFCILLIN SODIUM","NAFCILLIN SODIUM","72485040510","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72485-405","72485-405-10","72485-405_090fe986-0ab2-c9a6-e063-6394a90ab171","HUMAN PRESCRIPTION DRUG","NAFCILLIN SODIUM","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20231101","","ANDA","ANDA200002","Armas Pharmaceuticals Inc.","1","g/1","","N","20251231"
"8911","NAFCILLIN SODIUM","NAFCILLIN SODIUM","72485040610","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72485-406","72485-406-10","72485-406_090fe986-0ab2-c9a6-e063-6394a90ab171","HUMAN PRESCRIPTION DRUG","NAFCILLIN SODIUM","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20231101","","ANDA","ANDA200002","Armas Pharmaceuticals Inc.","2","g/1","","N","20251231"
"8912","OXACILLIN SODIUM","Oxacillin","72485040910","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72485-409","72485-409-10","72485-409_0e186c32-67ad-af94-e063-6394a90a7203","HUMAN PRESCRIPTION DRUG","Oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220921","","ANDA","ANDA091486","Armas Pharmaceuticals Inc.","2","g/1","","N","20251231"
"8913","MEROPENEM","Meropenem","72485041101","Carbapenems [CS], Penem Antibacterial [EPC]","72485-411","72485-411-01","72485-411_0251fe30-65ad-120d-e063-6394a90a64c5","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20230810","","ANDA","ANDA216154","ARMAS PHARMACEUTICALS INC","500","mg/20mL","","N","20251231"
"8914","MEROPENEM","Meropenem","72485041125","Carbapenems [CS], Penem Antibacterial [EPC]","72485-411","72485-411-25","72485-411_0251fe30-65ad-120d-e063-6394a90a64c5","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20230810","","ANDA","ANDA216154","ARMAS PHARMACEUTICALS INC","500","mg/20mL","","N","20251231"
"8915","MEROPENEM","Meropenem","72485041110","Carbapenems [CS], Penem Antibacterial [EPC]","72485-411","72485-411-10","72485-411_0251fe30-65ad-120d-e063-6394a90a64c5","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20230810","","ANDA","ANDA216154","ARMAS PHARMACEUTICALS INC","500","mg/20mL","","N","20251231"
"8916","MEROPENEM","Meropenem","72485041201","Carbapenems [CS], Penem Antibacterial [EPC]","72485-412","72485-412-01","72485-412_0251fe30-65ad-120d-e063-6394a90a64c5","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20230531","","ANDA","ANDA216154","ARMAS PHARMACEUTICALS INC","1","g/20mL","","N","20251231"
"8917","MEROPENEM","Meropenem","72485041210","Carbapenems [CS], Penem Antibacterial [EPC]","72485-412","72485-412-10","72485-412_0251fe30-65ad-120d-e063-6394a90a64c5","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20230531","","ANDA","ANDA216154","ARMAS PHARMACEUTICALS INC","1","g/20mL","","N","20251231"
"8918","MEROPENEM","Meropenem","72485041225","Carbapenems [CS], Penem Antibacterial [EPC]","72485-412","72485-412-25","72485-412_0251fe30-65ad-120d-e063-6394a90a64c5","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20230531","","ANDA","ANDA216154","ARMAS PHARMACEUTICALS INC","1","g/20mL","","N","20251231"
"8919","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin sodium, sulbactam sodium","72485041610","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72485-416","72485-416-10","72485-416_25899d57-0479-c02e-e063-6294a90a51f9","HUMAN PRESCRIPTION DRUG","Ampicillin Sodium and Sulbactam Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20230721","","ANDA","ANDA201024","Armas Pharmaceuticals Inc.","1; .5","g/1; g/1","","N","20251231"
"8920","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin sodium, sulbactam sodium","72485041710","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72485-417","72485-417-10","72485-417_25899d57-0479-c02e-e063-6294a90a51f9","HUMAN PRESCRIPTION DRUG","Ampicillin Sodium and Sulbactam Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20230425","","ANDA","ANDA201024","Armas Pharmaceuticals Inc.","2; 1","g/1; g/1","","N","20251231"
"8921","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin sodium, sulbactam sodium","72485041815","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72485-418","72485-418-15","72485-418_35b47e8b-8241-ae28-e063-6294a90aa8eb","HUMAN PRESCRIPTION DRUG","Ampicillin Sodium and Sulbactam Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20250501","","ANDA","ANDA202197","Armas Pharmaceuticals Inc.","10; 5","g/15g; g/15g","","N","20261231"
"8922","AMPICILLIN SODIUM","Ampicillin","72485042110","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72485-421","72485-421-10","72485-421_09c7d2d2-6b69-53fd-e063-6294a90aefe7","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20231110","","ANDA","ANDA201025","Armas Pharmaceuticals Inc.","1","g/1","","N","20251231"
"8923","AMPICILLIN SODIUM","Ampicillin Sodium","72485042210","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72485-422","72485-422-10","72485-422_09c7d2d2-6b69-53fd-e063-6294a90aefe7","HUMAN PRESCRIPTION DRUG","Ampicillin sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20230425","","ANDA","ANDA201025","Armas Pharmaceuticals Inc.","2","g/1","","N","20251231"
"8924","AMPICILLIN SODIUM","Ampicillin","72485042310","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72485-423","72485-423-10","72485-423_35b75b77-7eef-91e7-e063-6294a90aeaf5","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20250501","","ANDA","ANDA202198","Armas Pharmaceuticals Inc.","10","g/1","","N","20261231"
"8925","OFLOXACIN","Ofloxacin","72485061310","Quinolone Antimicrobial [EPC], Quinolones [CS]","72485-613","72485-613-10","72485-613_086cc6db-b800-dc8f-e063-6294a90a4196","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20231014","","ANDA","ANDA076407","ARMAS PHARMACEUTICALS INC.","3","mg/mL","","N","20251231"
"8926","OFLOXACIN","Ofloxacin","72485061311","Quinolone Antimicrobial [EPC], Quinolones [CS]","72485-613","72485-613-11","72485-613_086cc6db-b800-dc8f-e063-6294a90a4196","HUMAN PRESCRIPTION DRUG","Ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20231014","","ANDA","ANDA076407","ARMAS PHARMACEUTICALS INC.","3","mg/mL","","N","20251231"
"8927","CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE","Ciprofloxacin and dexamethasone","72485062513","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72485-625","72485-625-13","72485-625_0a5b0305-9f16-b6a0-e063-6294a90aef9a","HUMAN PRESCRIPTION DRUG","Ciprofloxacin and dexamethasone","","SUSPENSION/ DROPS","AURICULAR (OTIC)","20231101","","ANDA","ANDA215768","ARMAS PHARMACEUTICALS INC.","3; 1","mg/mL; mg/mL","","N","20251231"
"8928","ERYTHROMYCIN","Erythromycin","72485067031","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","72485-670","72485-670-31","72485-670_086299e1-e483-5e65-e063-6394a90a29fb","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","20231018","","ANDA","ANDA064030","ARMAS PHARMACEUTICALS INC.","5","mg/g","","N","20251231"
"8929","ERYTHROMYCIN","Erythromycin","72485067035","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","72485-670","72485-670-35","72485-670_086299e1-e483-5e65-e063-6394a90a29fb","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","20231018","","ANDA","ANDA064030","ARMAS PHARMACEUTICALS INC.","5","mg/g","","N","20251231"
"8930","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","72559003558","Allylamine Antifungal [EPC], Allylamine [CS]","72559-035","72559-035-58","72559-035_37a42ef8-419e-aad9-e063-6294a90a6a2a","HUMAN OTC DRUG","Curist","Antifungal Relief","CREAM","TOPICAL","20241210","","ANDA","ANDA077511","Little Pharma, Inc.","1","g/100g","","N","20261231"
"8931","AMPICILLIN SODIUM","Ampicillin","72572001610","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72572-016","72572-016-10","72572-016_555b50ca-f4d4-42dc-bd21-15945738da23","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20201201","","ANDA","ANDA062719","Civica, Inc.","1","g/1","","N","20251231"
"8932","AMPICILLIN SODIUM","Ampicillin","72572001710","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72572-017","72572-017-10","72572-017_555b50ca-f4d4-42dc-bd21-15945738da23","HUMAN PRESCRIPTION DRUG","AMPICILLIN","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20201201","","ANDA","ANDA062797","Civica, Inc.","2","g/1","","N","20251231"
"8933","CEFAZOLIN SODIUM","Cefazolin","72572005525","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72572-055","72572-055-25","72572-055_d49bdd4d-0740-4c1d-9058-8abfd5d3430e","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220301","","ANDA","ANDA065047","Civica, Inc.","1","g/1","","N","20251231"
"8934","CEFAZOLIN SODIUM","Cefazolin","72572005610","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72572-056","72572-056-10","72572-056_77cfa8c7-af08-4ae8-80a6-1e6780a17d65","HUMAN PRESCRIPTION DRUG","Cefazolin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20220301","","ANDA","ANDA065143","Civica, Inc.","10","g/1","","N","20251231"
"8935","CEFTRIAXONE SODIUM","Ceftriaxone","72572006125","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72572-061","72572-061-25","72572-061_36b74132-c90c-4cda-bd0c-93855b45e205","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20200301","","ANDA","ANDA065342","Civica, Inc.","1","g/1","","N","20251231"
"8936","CEFTRIAXONE SODIUM","Ceftriaxone","72572006225","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72572-062","72572-062-25","72572-062_36b74132-c90c-4cda-bd0c-93855b45e205","HUMAN PRESCRIPTION DRUG","Ceftriaxone","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20200301","","ANDA","ANDA065342","Civica, Inc.","2","g/1","","N","20251231"
"8937","CLINDAMYCIN","Clindamycin in 5 Percent Dextrose","72572007424","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72572-074","72572-074-24","72572-074_e40b6e7f-1d37-4d0a-ace3-e5accc461e02","HUMAN PRESCRIPTION DRUG","Clindamycin in 5 Percent Dextrose","","INJECTION, SOLUTION","INTRAVENOUS","20220113","","ANDA","ANDA201692","Civica, Inc.","12","mg/mL","","N","20251231"
"8938","CLINDAMYCIN","Clindamycin in 5 Percent Dextrose","72572007624","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72572-076","72572-076-24","72572-076_e40b6e7f-1d37-4d0a-ace3-e5accc461e02","HUMAN PRESCRIPTION DRUG","Clindamycin in 5 Percent Dextrose","","INJECTION, SOLUTION","INTRAVENOUS","20220113","","ANDA","ANDA201692","Civica, Inc.","18","mg/mL","","N","20251231"
"8939","DAPTOMYCIN","Daptomycin","72572010001","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","72572-100","72572-100-01","72572-100_379772be-8d89-44c0-ad76-bdc2377f9705","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190903","","NDA","NDA209949","Civica, Inc.","350","mg/7mL","","N","20251231"
"8940","DAPTOMYCIN","Daptomycin","72572010201","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","72572-102","72572-102-01","72572-102_eca0ec1b-b9f1-45f3-a805-42c5337c943f","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190820","","ANDA","ANDA206005","Civica, Inc.","500","mg/10mL","","N","20251231"
"8941","MEROPENEM","MEROPENEM","72572041510","Carbapenems [CS], Penem Antibacterial [EPC]","72572-415","72572-415-10","72572-415_0e17040f-06bc-538c-e063-6294a90a5995","HUMAN PRESCRIPTION DRUG","MEROPENEM","","INJECTION","INTRAVENOUS","20200923","","ANDA","ANDA206086","Civica, Inc","500","mg/20mL","","N","20251231"
"8942","MEROPENEM","MEROPENEM","72572041610","Carbapenems [CS], Penem Antibacterial [EPC]","72572-416","72572-416-10","72572-416_0e17040f-06bc-538c-e063-6294a90a5995","HUMAN PRESCRIPTION DRUG","MEROPENEM","","INJECTION","INTRAVENOUS","20200923","","ANDA","ANDA206086","Civica, Inc","1","g/30mL","","N","20251231"
"8943","MICAFUNGIN SODIUM","Micafungin sodium","72572042701","Echinocandin Antifungal [EPC], Lipopeptides [CS]","72572-427","72572-427-01","72572-427_01ad2081-0a06-4eeb-940b-db59b0725597","HUMAN PRESCRIPTION DRUG","Micafungin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20210206","20251231","ANDA","ANDA211713","Civica, Inc.","100","mg/1","","N",""
"8944","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin sodium and tazobactam sodium","72572057310","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72572-573","72572-573-10","72572-573_682d4f3f-bbc2-4365-bdf6-0fa8323392d5","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20201201","","ANDA","ANDA065523","Civica, Inc.","3; .375","g/15mL; g/15mL","","N","20251231"
"8945","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin sodium and tazobactam sodium","72572057410","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72572-574","72572-574-10","72572-574_682d4f3f-bbc2-4365-bdf6-0fa8323392d5","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20210101","","ANDA","ANDA065523","Civica, Inc.","4; .5","g/20mL; g/20mL","","N","20251231"
"8946","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","72572080102","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","72572-801","72572-801-02","72572-801_a44fa817-9955-4e31-8626-39b9c84999a7","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190702","","ANDA","ANDA204107","Civica, Inc.","1","g/10mL","","N","20251231"
"8947","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","72572080301","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","72572-803","72572-803-01","72572-803_1eab4aa9-46b5-4597-a115-0e66f8fd044e","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190710","","ANDA","ANDA204125","Civica, Inc.","5","g/100mL","","N","20251231"
"8948","VANCOMYCIN HYDROCHLORIDE","Vancomycin Hydrochloride","72572080501","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","72572-805","72572-805-01","72572-805_1eab4aa9-46b5-4597-a115-0e66f8fd044e","HUMAN PRESCRIPTION DRUG","Vancomycin Hydrochloride","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190710","","ANDA","ANDA204125","Civica, Inc.","10","g/100mL","","N","20251231"
"8949","VORICONAZOLE","Voriconazole","72572087501","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72572-875","72572-875-01","72572-875_c8a168b1-e3e5-4729-9c9c-fb014bb20563","HUMAN PRESCRIPTION DRUG","Voriconazole","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230401","","ANDA","ANDA090862","Civica, Inc.","10","mg/mL","","N","20251231"
"8950","METRONIDAZOLE","metronidazole","72578000701","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72578-007","72578-007-01","72578-007_855f53ac-75a4-48d0-9845-1de91708154d","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Viona Pharmaceuticals Inc","250","mg/1","","N","20251231"
"8951","METRONIDAZOLE","metronidazole","72578000705","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72578-007","72578-007-05","72578-007_855f53ac-75a4-48d0-9845-1de91708154d","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Viona Pharmaceuticals Inc","250","mg/1","","N","20251231"
"8952","METRONIDAZOLE","metronidazole","72578000721","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72578-007","72578-007-21","72578-007_855f53ac-75a4-48d0-9845-1de91708154d","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Viona Pharmaceuticals Inc","250","mg/1","","N","20251231"
"8953","METRONIDAZOLE","metronidazole","72578000801","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72578-008","72578-008-01","72578-008_855f53ac-75a4-48d0-9845-1de91708154d","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Viona Pharmaceuticals Inc","500","mg/1","","N","20251231"
"8954","METRONIDAZOLE","metronidazole","72578000805","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72578-008","72578-008-05","72578-008_855f53ac-75a4-48d0-9845-1de91708154d","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Viona Pharmaceuticals Inc","500","mg/1","","N","20251231"
"8955","METRONIDAZOLE","metronidazole","72578000818","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72578-008","72578-008-18","72578-008_855f53ac-75a4-48d0-9845-1de91708154d","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Viona Pharmaceuticals Inc","500","mg/1","","N","20251231"
"8956","VORICONAZOLE","voriconazole","72578006205","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72578-062","72578-062-05","72578-062_5b77c153-5892-4a93-b300-0f916a5ba4db","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20190416","","ANDA","ANDA206747","Viona Pharmaceuticals Inc","50","mg/1","","N","20261231"
"8957","VORICONAZOLE","voriconazole","72578006206","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72578-062","72578-062-06","72578-062_5b77c153-5892-4a93-b300-0f916a5ba4db","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20190416","","ANDA","ANDA206747","Viona Pharmaceuticals Inc","50","mg/1","","N","20261231"
"8958","VORICONAZOLE","voriconazole","72578006210","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72578-062","72578-062-10","72578-062_5b77c153-5892-4a93-b300-0f916a5ba4db","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20190416","","ANDA","ANDA206747","Viona Pharmaceuticals Inc","50","mg/1","","N","20261231"
"8959","VORICONAZOLE","voriconazole","72578006216","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72578-062","72578-062-16","72578-062_5b77c153-5892-4a93-b300-0f916a5ba4db","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20190416","","ANDA","ANDA206747","Viona Pharmaceuticals Inc","50","mg/1","","N","20261231"
"8960","VORICONAZOLE","voriconazole","72578006277","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72578-062","72578-062-77","72578-062_5b77c153-5892-4a93-b300-0f916a5ba4db","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20190416","","ANDA","ANDA206747","Viona Pharmaceuticals Inc","50","mg/1","","N","20261231"
"8961","VORICONAZOLE","voriconazole","72578006201","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72578-062","72578-062-01","72578-062_5b77c153-5892-4a93-b300-0f916a5ba4db","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20190416","","ANDA","ANDA206747","Viona Pharmaceuticals Inc","50","mg/1","","N","20261231"
"8962","VORICONAZOLE","voriconazole","72578006305","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72578-063","72578-063-05","72578-063_5b77c153-5892-4a93-b300-0f916a5ba4db","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20190416","","ANDA","ANDA206747","Viona Pharmaceuticals Inc","200","mg/1","","N","20261231"
"8963","VORICONAZOLE","voriconazole","72578006306","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72578-063","72578-063-06","72578-063_5b77c153-5892-4a93-b300-0f916a5ba4db","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20190416","","ANDA","ANDA206747","Viona Pharmaceuticals Inc","200","mg/1","","N","20261231"
"8964","VORICONAZOLE","voriconazole","72578006310","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72578-063","72578-063-10","72578-063_5b77c153-5892-4a93-b300-0f916a5ba4db","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20190416","","ANDA","ANDA206747","Viona Pharmaceuticals Inc","200","mg/1","","N","20261231"
"8965","VORICONAZOLE","voriconazole","72578006301","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72578-063","72578-063-01","72578-063_5b77c153-5892-4a93-b300-0f916a5ba4db","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20190416","","ANDA","ANDA206747","Viona Pharmaceuticals Inc","200","mg/1","","N","20261231"
"8966","VORICONAZOLE","voriconazole","72578006377","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72578-063","72578-063-77","72578-063_5b77c153-5892-4a93-b300-0f916a5ba4db","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20190416","","ANDA","ANDA206747","Viona Pharmaceuticals Inc","200","mg/1","","N","20261231"
"8967","VORICONAZOLE","voriconazole","72578006316","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72578-063","72578-063-16","72578-063_5b77c153-5892-4a93-b300-0f916a5ba4db","HUMAN PRESCRIPTION DRUG","voriconazole","","TABLET","ORAL","20190416","","ANDA","ANDA206747","Viona Pharmaceuticals Inc","200","mg/1","","N","20261231"
"8968","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","72578008403","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72578-084","72578-084-03","72578-084_c9998922-ba46-4484-8acb-b7ad39ec4acf","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20200615","","ANDA","ANDA208767","Viona Pharmaceuticals Inc","10","mg/mL","","N","20251231"
"8969","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate","72578008402","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72578-084","72578-084-02","72578-084_c9998922-ba46-4484-8acb-b7ad39ec4acf","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20200615","","ANDA","ANDA208767","Viona Pharmaceuticals Inc","10","mg/mL","","N","20251231"
"8970","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","72578008802","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","72578-088","72578-088-02","72578-088_1a3aab5b-5427-414c-a40f-ed4ea70da502","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20200624","","ANDA","ANDA207764","Viona Pharmaceuticals Inc","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"8971","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","72578008804","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","72578-088","72578-088-04","72578-088_1a3aab5b-5427-414c-a40f-ed4ea70da502","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20200624","","ANDA","ANDA207764","Viona Pharmaceuticals Inc","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"8972","NYSTATIN; TRIAMCINOLONE ACETONIDE","Nystatin and Triamcinolone Acetonide","72578008801","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]","72578-088","72578-088-01","72578-088_1a3aab5b-5427-414c-a40f-ed4ea70da502","HUMAN PRESCRIPTION DRUG","Nystatin and Triamcinolone Acetonide","","OINTMENT","TOPICAL","20200624","","ANDA","ANDA207764","Viona Pharmaceuticals Inc","100000; 1","[USP'U]/g; mg/g","","N","20251231"
"8973","NYSTATIN","Nystatin","72578008901","Polyene Antifungal [EPC], Polyenes [CS]","72578-089","72578-089-01","72578-089_3d917a6c-4e9a-4c45-9e79-caf91f8b11b0","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20200624","","ANDA","ANDA207767","Viona Pharmaceuticals Inc","100000","U/g","","N","20251231"
"8974","NYSTATIN","Nystatin","72578008904","Polyene Antifungal [EPC], Polyenes [CS]","72578-089","72578-089-04","72578-089_3d917a6c-4e9a-4c45-9e79-caf91f8b11b0","HUMAN PRESCRIPTION DRUG","Nystatin","","OINTMENT","TOPICAL","20200624","","ANDA","ANDA207767","Viona Pharmaceuticals Inc","100000","U/g","","N","20251231"
"8975","TAVABOROLE","Tavaborole","72578010204","Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]","72578-102","72578-102-04","72578-102_266f7bbc-b540-4681-8144-cbb823f34f0e","HUMAN PRESCRIPTION DRUG","Tavaborole","","SOLUTION","TOPICAL","20230424","","ANDA","ANDA212294","Viona Pharmaceuticals Inc","43.5","mg/mL","","N","20251231"
"8976","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","72578011801","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72578-118","72578-118-01","72578-118_e1ccaf41-dfe5-4ebd-8bc8-824b64024c96","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20230920","","ANDA","ANDA216587","Viona Pharmaceuticals Inc","10","mg/g","","N","20251231"
"8977","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","72578011802","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72578-118","72578-118-02","72578-118_e1ccaf41-dfe5-4ebd-8bc8-824b64024c96","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20230920","","ANDA","ANDA216587","Viona Pharmaceuticals Inc","10","mg/g","","N","20251231"
"8978","METRONIDAZOLE","Metronidazole","72578012908","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72578-129","72578-129-08","72578-129_0310ff7e-f25e-4090-87ac-5a1fc5c5975f","HUMAN PRESCRIPTION DRUG","Metronidazole","","CREAM","TOPICAL","20230531","","ANDA","ANDA217128","Viona Pharmaceuticals Inc","7.5","mg/g","","N","20251231"
"8979","KETOCONAZOLE","Ketoconazole","72578015612","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","72578-156","72578-156-12","72578-156_122ec3a2-4c9a-4f27-8c82-643b968823e2","HUMAN PRESCRIPTION DRUG","Ketoconazole","","SHAMPOO","TOPICAL","20250308","","ANDA","ANDA218559","Viona Pharmaceuticals Inc","20","mg/mL","","N","20261231"
"8980","DAPTOMYCIN","Daptomycin","72603014701","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","72603-147","72603-147-01","72603-147_f9aa5759-84d0-be13-e053-6294a90af8c3","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230418","","ANDA","ANDA216445","NorthStar RxLLC","350","mg/7mL","","N","20251231"
"8981","DAPTOMYCIN","Daptomycin","72603015201","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","72603-152","72603-152-01","72603-152_f9aa5b99-344b-ab3f-e053-6294a90ade3a","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230418","","ANDA","ANDA216413","NorthStar RxLLC","500","mg/10mL","","N","20251231"
"8982","TOBRAMYCIN SULFATE","Tobramycin","72603016006","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","72603-160","72603-160-06","72603-160_e9ac0d06-849a-1348-2b6a-4ed2201c6628","HUMAN PRESCRIPTION DRUG","Tobramycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20240401","","ANDA","ANDA211189","Northstar Rx LLC","1.2","g/30mL","","N","20251231"
"8983","VALGANCICLOVIR HYDROCHLORIDE","VALGANCICLOVIR HYDROCHLORIDE","72603017401","Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]","72603-174","72603-174-01","72603-174_15d16e30-6403-f2a1-e063-6394a90a2db0","HUMAN PRESCRIPTION DRUG","VALGANCICLOVIR","","POWDER, FOR SOLUTION","ORAL","20240408","","ANDA","ANDA211475","NorthStar RxLLC","50","mg/mL","","N","20251231"
"8984","NITROFURANTOIN","Nitrofurantoin","72603017601","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","72603-176","72603-176-01","72603-176_14c9efac-c0b1-7afe-e063-6294a90a39e4","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","SUSPENSION","ORAL","20230417","","ANDA","ANDA216385","NorthStar Rx LLC","25","mg/5mL","","N","20251231"
"8985","NITROFURANTOIN","nitrofurantoin macrocrystals","72603018201","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","72603-182","72603-182-01","72603-182_3dfb2c77-98f5-4810-a491-b0b0198bd9c1","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20231201","","ANDA","ANDA217272","NorthStar RxLLC","25","mg/1","","N","20251231"
"8986","NITROFURANTOIN","nitrofurantoin macrocrystals","72603018301","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","72603-183","72603-183-01","72603-183_3dfb2c77-98f5-4810-a491-b0b0198bd9c1","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20231201","","ANDA","ANDA217272","NorthStar RxLLC","50","mg/1","","N","20251231"
"8987","NITROFURANTOIN","nitrofurantoin macrocrystals","72603018401","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","72603-184","72603-184-01","72603-184_3dfb2c77-98f5-4810-a491-b0b0198bd9c1","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20231201","","ANDA","ANDA217272","NorthStar RxLLC","100","mg/1","","N","20251231"
"8988","OFLOXACIN","ofloxacin otic","72603018601","Quinolone Antimicrobial [EPC], Quinolones [CS]","72603-186","72603-186-01","72603-186_1831737e-5035-4daf-9924-5a29ebb6b433","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION","AURICULAR (OTIC)","20231201","","ANDA","ANDA216130","NorthStar RxLLC","3","mg/mL","","N","20251231"
"8989","OFLOXACIN","ofloxacin otic","72603018602","Quinolone Antimicrobial [EPC], Quinolones [CS]","72603-186","72603-186-02","72603-186_1831737e-5035-4daf-9924-5a29ebb6b433","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION","AURICULAR (OTIC)","20231201","","ANDA","ANDA216130","NorthStar RxLLC","3","mg/mL","","N","20251231"
"8990","OFLOXACIN","ofloxacin","72603019201","Quinolone Antimicrobial [EPC], Quinolones [CS]","72603-192","72603-192-01","72603-192_223e63df-93af-49f0-86ae-dd4d7042f96a","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20231201","","ANDA","ANDA215886","NorthStar RxLLC","3","mg/mL","","N","20251231"
"8991","OFLOXACIN","ofloxacin","72603019202","Quinolone Antimicrobial [EPC], Quinolones [CS]","72603-192","72603-192-02","72603-192_223e63df-93af-49f0-86ae-dd4d7042f96a","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20231201","","ANDA","ANDA215886","NorthStar RxLLC","3","mg/mL","","N","20251231"
"8992","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","72603019601","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72603-196","72603-196-01","72603-196_1080bf1e-86d4-4f7a-9b1b-2823a389dbcc","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20231201","","ANDA","ANDA217357","NorthStar RxLLC","25; 75","mg/1; mg/1","","N","20251231"
"8993","PENICILLIN G POTASSIUM","Penicillin G Potassium","72603021010","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72603-210","72603-210-10","72603-210_9ff380db-0dfa-4fb5-afa1-cb93dc34d83e","HUMAN PRESCRIPTION DRUG","Penicillin G Potassium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240301","","ANDA","ANDA065448","NorthStar Rx, LLC","5000000","[iU]/1","","N","20251231"
"8994","PENICILLIN G POTASSIUM","Penicillin G Potassium","72603021001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72603-210","72603-210-01","72603-210_9ff380db-0dfa-4fb5-afa1-cb93dc34d83e","HUMAN PRESCRIPTION DRUG","Penicillin G Potassium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240301","","ANDA","ANDA065448","NorthStar Rx, LLC","5000000","[iU]/1","","N","20251231"
"8995","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin sodium and Sulbactam sodium","72603022001","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72603-220","72603-220-01","72603-220_c9fe0e6e-db1d-49ec-a16b-aa1de5ae7d5a","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240301","","ANDA","ANDA065222","NorthStar Rx, LLC","1; .5","g/1; g/1","","N","20251231"
"8996","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin sodium and Sulbactam sodium","72603022010","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72603-220","72603-220-10","72603-220_c9fe0e6e-db1d-49ec-a16b-aa1de5ae7d5a","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240301","","ANDA","ANDA065222","NorthStar Rx, LLC","1; .5","g/1; g/1","","N","20251231"
"8997","AMPICILLIN SODIUM","ampicillin sodium","72603022110","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72603-221","72603-221-10","72603-221_ccfb8b44-c373-40a6-8fc9-afd9584e5970","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240301","","ANDA","ANDA062719","NorthStar Rx, LLC","500","mg/1","","N","20251231"
"8998","ATOVAQUONE","Atovaquone","72603024801","Antimalarial [EPC], Antiprotozoal [EPC]","72603-248","72603-248-01","72603-248_15e36ffa-2f19-ac0a-e063-6394a90afe22","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20240501","","ANDA","ANDA210692","NorthStar RxLLC","750","mg/5mL","","N","20251231"
"8999","PYRIMETHAMINE","Pyrimethamine","72603026201","Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]","72603-262","72603-262-01","72603-262_4802a9a9-e843-46db-9d52-338895c7c538","HUMAN PRESCRIPTION DRUG","Pyrimethamine","","TABLET","ORAL","20241001","20260901","ANDA","ANDA216983","NorthStar Rx LLC","25","mg/1","","N",""
"9000","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate Topical Solution USP, 1%","72603032102","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72603-321","72603-321-02","72603-321_407f6d80-7de0-45d9-8ad2-5b95d233b96d","HUMAN PRESCRIPTION DRUG","Clindamycin Phoaphate Topical Solution USP, 1%","","SOLUTION","TOPICAL","20241114","","ANDA","ANDA209914","Northstar Rx LLC","10","mg/mL","","N","20251231"
"9001","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate Topical Solution USP, 1%","72603032101","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72603-321","72603-321-01","72603-321_407f6d80-7de0-45d9-8ad2-5b95d233b96d","HUMAN PRESCRIPTION DRUG","Clindamycin Phoaphate Topical Solution USP, 1%","","SOLUTION","TOPICAL","20241114","","ANDA","ANDA209914","Northstar Rx LLC","10","mg/mL","","N","20251231"
"9002","BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","72603032201","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72603-322","72603-322-01","72603-322_2fcf4e8d-dd05-49c2-948b-10abbb52e4bc","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","GEL","TOPICAL","20241114","","ANDA","ANDA212433","Northstar Rx LLC","50; 10","mg/g; mg/g","","N","20251231"
"9003","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin sodium and Sulbactam sodium","72603033510","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72603-335","72603-335-10","72603-335_c9fe0e6e-db1d-49ec-a16b-aa1de5ae7d5a","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240301","","ANDA","ANDA065222","NorthStar Rx, LLC","2; 1","g/1; g/1","","N","20251231"
"9004","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin sodium and Sulbactam sodium","72603033501","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72603-335","72603-335-01","72603-335_c9fe0e6e-db1d-49ec-a16b-aa1de5ae7d5a","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240301","","ANDA","ANDA065222","NorthStar Rx, LLC","2; 1","g/1; g/1","","N","20251231"
"9005","PENICILLIN G POTASSIUM","Penicillin G Potassium","72603034501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72603-345","72603-345-01","72603-345_9ff380db-0dfa-4fb5-afa1-cb93dc34d83e","HUMAN PRESCRIPTION DRUG","Penicillin G Potassium","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20240301","","ANDA","ANDA065448","NorthStar Rx, LLC","20000000","[iU]/1","","N","20251231"
"9006","AMPICILLIN SODIUM","ampicillin sodium","72603036310","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72603-363","72603-363-10","72603-363_ccfb8b44-c373-40a6-8fc9-afd9584e5970","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240301","","ANDA","ANDA062719","NorthStar Rx, LLC","1","g/1","","N","20251231"
"9007","TOBRAMYCIN","Tobramycin","72603043056","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","72603-430","72603-430-56","72603-430_0d806a34-e83d-4ce4-9da2-1630c49790a8","HUMAN PRESCRIPTION DRUG","TOBRAMYCIN","","SOLUTION","RESPIRATORY (INHALATION)","20240801","","ANDA","ANDA214478","NorthStar RxLLC","300","mg/5mL","","N","20251231"
"9008","AMPICILLIN SODIUM; SULBACTAM SODIUM","Ampicillin sodium and Sulbactam sodium","72603044401","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72603-444","72603-444-01","72603-444_e02cc3e5-4a65-4312-b2b3-ea77601525e7","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240301","","ANDA","ANDA065314","NorthStar Rx, LLC","10; 5","g/1; g/1","","N","20251231"
"9009","NAFCILLIN SODIUM","Nafcillin Sodium","72603045301","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72603-453","72603-453-01","72603-453_ada50f84-5fb6-480b-a385-bb95d1181ce7","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240701","","ANDA","ANDA090002","NorthStar Rx, LLC","2","g/8mL","","N","20251231"
"9010","NAFCILLIN SODIUM","Nafcillin Sodium","72603045310","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72603-453","72603-453-10","72603-453_ada50f84-5fb6-480b-a385-bb95d1181ce7","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240701","","ANDA","ANDA090002","NorthStar Rx, LLC","2","g/8mL","","N","20251231"
"9011","AMPICILLIN SODIUM","ampicillin sodium","72603045410","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72603-454","72603-454-10","72603-454_ccfb8b44-c373-40a6-8fc9-afd9584e5970","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20240301","","ANDA","ANDA062797","NorthStar Rx, LLC","2","g/1","","N","20251231"
"9012","NAFCILLIN SODIUM","NAFCILLIN","72603056701","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72603-567","72603-567-01","72603-567_bb7b7287-b298-42c3-940f-bebe779e73ee","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20240301","","ANDA","ANDA090005","NorthStar Rx, LLC","10","g/100mL","","N","20251231"
"9013","AMPICILLIN SODIUM","Ampicillin Sodium","72603057801","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72603-578","72603-578-01","72603-578_ded2f0fe-8fdf-4ec1-ad0d-1f5ddc15cba5","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20240301","","ANDA","ANDA201404","NorthStar Rx, LLC","10","g/100mL","","N","20251231"
"9014","TOBRAMYCIN","Tobramycin","72603063056","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","72603-630","72603-630-56","72603-630_9bb2abbd-9e7c-401e-ab46-4bcbd51c8bd7","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","RESPIRATORY (INHALATION)","20240801","","ANDA","ANDA216725","NorthStar RxLLC","300","mg/4mL","","N","20251231"
"9015","CASPOFUNGIN ACETATE","caspofungin acetate","72611070001","Echinocandin Antifungal [EPC], Lipopeptides [CS]","72611-700","72611-700-01","72611-700_cd35fffa-6cd7-dcdd-e75c-dbdf00279671","HUMAN PRESCRIPTION DRUG","caspofungin acetate","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200331","20251101","ANDA","ANDA207092","Almaject, Inc.","5","mg/mL","","N",""
"9016","PYRIMETHAMINE","pyrimethamine","72647033001","Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]","72647-330","72647-330-01","72647-330_d61ffa19-149f-4402-884a-4d16becb80ba","HUMAN PRESCRIPTION DRUG","Pyrimethamine","","TABLET","ORAL","20200313","","NDA AUTHORIZED GENERIC","NDA008578","OAKRUM PHARMA, LLC","25","mg/1","","N","20251231"
"9017","PYRIMETHAMINE","pyrimethamine","72647033003","Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]","72647-330","72647-330-03","72647-330_d61ffa19-149f-4402-884a-4d16becb80ba","HUMAN PRESCRIPTION DRUG","Pyrimethamine","","TABLET","ORAL","20200313","","NDA AUTHORIZED GENERIC","NDA008578","OAKRUM PHARMA, LLC","25","mg/1","","N","20251231"
"9018","MICONAZOLE NITRATE","MICONAZOLE NITRATE","72654000101","Azole Antifungal [EPC], Azoles [CS]","72654-001","72654-001-01","72654-001_0d771f4d-fd0d-cd5d-e063-6394a90a0720","HUMAN OTC DRUG","Fungus Master Antifungal Treatment","","LOTION","TOPICAL","20191101","","OTC MONOGRAPH DRUG","M005","Ebanel Laboratories, Inc","20","mg/mL","","N","20251231"
"9019","MICONAZOLE NITRATE","MICONAZOLE NITRATE","72654000102","Azole Antifungal [EPC], Azoles [CS]","72654-001","72654-001-02","72654-001_0d771f4d-fd0d-cd5d-e063-6394a90a0720","HUMAN OTC DRUG","Fungus Master Antifungal Treatment","","LOTION","TOPICAL","20191101","","OTC MONOGRAPH DRUG","M005","Ebanel Laboratories, Inc","20","mg/mL","","N","20251231"
"9020","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate, Pramoxine HCL","72663016160","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","72663-161","72663-161-60","72663-161_023cafb4-3709-43d4-8e78-b8eb1eaef4ee","HUMAN OTC DRUG","Welly Bravery Triple Antibiotic with Pain Relief","","OINTMENT","TOPICAL","20190131","","OTC MONOGRAPH FINAL","part333B","Welly Health PBC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"9021","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate","72663016258","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","72663-162","72663-162-58","72663-162_aa14bfb5-5dbe-448a-b6ed-4b5fcdcd7e4e","HUMAN OTC DRUG","Welly Bravery Triple Antibiotic","","OINTMENT","TOPICAL","20110123","","OTC MONOGRAPH FINAL","part333B","Welly Health PBC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"9022","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","72663056034","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","72663-560","72663-560-34","72663-560_2cdef8a8-b026-c5cc-e063-6294a90af78d","HUMAN OTC DRUG","Antibiotic","","OINTMENT","TOPICAL","20190225","","OTC MONOGRAPH DRUG","M004","Welly Health PBC","6; 3.5; .77","mg/mL; mg/mL; mg/mL","","N","20261231"
"9023","AZITHROMYCIN DIHYDRATE","Azithromycin","72673008160","Macrolide Antimicrobial [EPC], Macrolides [CS]","72673-081","72673-081-60","72673-081_33c08972-1589-0c23-e063-6294a90a4836","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20250427","","ANDA","ANDA217036","Zhejiang Poly Pharm. Co., Ltd.","200","mg/5mL","","N","20261231"
"9024","AZITHROMYCIN DIHYDRATE","Azithromycin","72673008290","Macrolide Antimicrobial [EPC], Macrolides [CS]","72673-082","72673-082-90","72673-082_33c08972-1589-0c23-e063-6294a90a4836","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20250427","","ANDA","ANDA217036","Zhejiang Poly Pharm. Co., Ltd.","200","mg/5mL","","N","20261231"
"9025","AZITHROMYCIN DIHYDRATE","Azithromycin","72673008312","Macrolide Antimicrobial [EPC], Macrolides [CS]","72673-083","72673-083-12","72673-083_33c08972-1589-0c23-e063-6294a90a4836","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20250427","","ANDA","ANDA217036","Zhejiang Poly Pharm. Co., Ltd.","200","mg/5mL","","N","20261231"
"9026","AZITHROMYCIN DIHYDRATE","Azithromycin","72673008430","Macrolide Antimicrobial [EPC], Macrolides [CS]","72673-084","72673-084-30","72673-084_33c08972-1589-0c23-e063-6294a90a4836","HUMAN PRESCRIPTION DRUG","Azithromycin","","POWDER, FOR SUSPENSION","ORAL","20250427","","ANDA","ANDA217036","Zhejiang Poly Pharm. Co., Ltd.","100","mg/5mL","","N","20261231"
"9027","FLUCONAZOLE","Fluconazole","72673009114","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72673-091","72673-091-14","72673-091_2a1314f3-3a42-edca-e063-6294a90ae84e","HUMAN PRESCRIPTION DRUG","Fluconazole","","POWDER, FOR SUSPENSION","ORAL","20250401","","ANDA","ANDA215738","Zhejiang Poly Pharm. Co., Ltd.","40","mg/mL","","N","20251231"
"9028","VORICONAZOLE","voriconazole","72673011130","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72673-111","72673-111-30","72673-111_32669bf5-b300-fb86-e063-6394a90a02a9","HUMAN PRESCRIPTION DRUG","voriconazole","","POWDER, FOR SUSPENSION","ORAL","20250411","","ANDA","ANDA216805","Zhejiang Poly Pharm Co., Ltd.","40","mg/mL","","N","20261231"
"9029","METRONIDAZOLE","Metronidazole","72789000514","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72789-005","72789-005-14","72789-005_20ae0a6a-5e34-7d6c-e063-6394a90a62cf","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET, FILM COATED","ORAL","20140601","","ANDA","ANDA203458","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9030","METRONIDAZOLE","Metronidazole","72789000706","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72789-007","72789-007-06","72789-007_20ae36b5-6600-6d2b-e063-6294a90ab6a8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9031","METRONIDAZOLE","Metronidazole","72789000709","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72789-007","72789-007-09","72789-007_20ae36b5-6600-6d2b-e063-6294a90ab6a8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9032","METRONIDAZOLE","Metronidazole","72789000714","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72789-007","72789-007-14","72789-007_20ae36b5-6600-6d2b-e063-6294a90ab6a8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9033","METRONIDAZOLE","Metronidazole","72789000704","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72789-007","72789-007-04","72789-007_20ae36b5-6600-6d2b-e063-6294a90ab6a8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9034","METRONIDAZOLE","Metronidazole","72789000728","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72789-007","72789-007-28","72789-007_20ae36b5-6600-6d2b-e063-6294a90ab6a8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9035","METRONIDAZOLE","Metronidazole","72789000730","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72789-007","72789-007-30","72789-007_20ae36b5-6600-6d2b-e063-6294a90ab6a8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9036","METRONIDAZOLE","Metronidazole","72789000779","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72789-007","72789-007-79","72789-007_20ae36b5-6600-6d2b-e063-6294a90ab6a8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9037","METRONIDAZOLE","Metronidazole","72789000721","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72789-007","72789-007-21","72789-007_20ae36b5-6600-6d2b-e063-6294a90ab6a8","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9038","METRONIDAZOLE","Metronidazole","72789001104","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72789-011","72789-011-04","72789-011_20ae6a28-2d92-7bab-e063-6394a90a5a0d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9039","METRONIDAZOLE","Metronidazole","72789001114","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72789-011","72789-011-14","72789-011_20ae6a28-2d92-7bab-e063-6394a90a5a0d","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20161201","","ANDA","ANDA079067","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9040","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","72789001804","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","72789-018","72789-018-04","72789-018_3143fb81-1052-c193-e063-6394a90a18e8","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","PD-Rx Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"9041","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","72789001806","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","72789-018","72789-018-06","72789-018_3143fb81-1052-c193-e063-6394a90a18e8","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","PD-Rx Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"9042","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","72789001810","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","72789-018","72789-018-10","72789-018_3143fb81-1052-c193-e063-6394a90a18e8","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","PD-Rx Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"9043","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","72789001802","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","72789-018","72789-018-02","72789-018_3143fb81-1052-c193-e063-6394a90a18e8","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","PD-Rx Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"9044","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","72789001820","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","72789-018","72789-018-20","72789-018_3143fb81-1052-c193-e063-6394a90a18e8","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","PD-Rx Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"9045","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","72789001828","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","72789-018","72789-018-28","72789-018_3143fb81-1052-c193-e063-6394a90a18e8","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","PD-Rx Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"9046","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","72789001840","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","72789-018","72789-018-40","72789-018_3143fb81-1052-c193-e063-6394a90a18e8","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","PD-Rx Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"9047","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","72789001814","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","72789-018","72789-018-14","72789-018_3143fb81-1052-c193-e063-6394a90a18e8","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","PD-Rx Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"9048","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","72789001860","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","72789-018","72789-018-60","72789-018_3143fb81-1052-c193-e063-6394a90a18e8","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","PD-Rx Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"9049","CEFUROXIME AXETIL","Cefuroxime axetil","72789003520","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72789-035","72789-035-20","72789-035_303d9134-594c-63c6-e063-6394a90a4edf","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9050","CEFUROXIME AXETIL","Cefuroxime axetil","72789003560","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72789-035","72789-035-60","72789-035_303d9134-594c-63c6-e063-6394a90a4edf","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9051","CEFUROXIME AXETIL","Cefuroxime axetil","72789003514","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72789-035","72789-035-14","72789-035_303d9134-594c-63c6-e063-6394a90a4edf","HUMAN PRESCRIPTION DRUG","Cefuroxime axetil","","TABLET, FILM COATED","ORAL","20101201","","ANDA","ANDA065496","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9052","MOXIFLOXACIN HYDROCHLORIDE","moxifloxacin hydrochloride","72789003710","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-037","72789-037-10","72789-037_37664595-6235-30e3-e063-6294a90a7658","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN HYDROCHLORIDE","","TABLET, FILM COATED","ORAL","20140304","","ANDA","ANDA202632","PD-Rx Pharmaceuticals, Inc.","400","mg/1","","N","20261231"
"9053","MOXIFLOXACIN HYDROCHLORIDE","moxifloxacin hydrochloride","72789003810","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-038","72789-038-10","72789-038_376663da-c0eb-077c-e063-6294a90a2b86","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN HYDROCHLORIDE","","TABLET, FILM COATED","ORAL","20140304","","ANDA","ANDA202632","PD-Rx Pharmaceuticals, Inc.","400","mg/1","","N","20261231"
"9054","KETOCONAZOLE","KETOCONAZOLE","72789005230","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","72789-052","72789-052-30","72789-052_23fb72d9-adbe-35a9-e063-6394a90ad8e6","HUMAN PRESCRIPTION DRUG","KETOCONAZOLE","","TABLET","ORAL","20180626","","ANDA","ANDA210457","PD-Rx Pharmaceuticals, Inc.","200","mg/1","","N","20251231"
"9055","CEFDINIR","Cefdinir","72789005414","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72789-054","72789-054-14","72789-054_14be1635-644d-93a9-e063-6394a90a19fb","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"9056","CEFDINIR","Cefdinir","72789005420","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72789-054","72789-054-20","72789-054_14be1635-644d-93a9-e063-6394a90a19fb","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"9057","CEFDINIR","Cefdinir","72789006120","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72789-061","72789-061-20","72789-061_14d30603-495a-7e6f-e063-6294a90a6364","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20080107","","ANDA","ANDA065434","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"9058","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","72789006302","Macrolide Antimicrobial [EPC], Macrolides [CS]","72789-063","72789-063-02","72789-063_3143fad2-0bca-0bf2-e063-6294a90aa8c4","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","20261031","ANDA","ANDA208249","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N",""
"9059","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","72789006414","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","72789-064","72789-064-14","72789-064_3403cd92-3140-e0c6-e063-6294a90a5a1c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","PD-Rx Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"9060","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","72789006420","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","72789-064","72789-064-20","72789-064_3403cd92-3140-e0c6-e063-6294a90a5a1c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","PD-Rx Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"9061","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","72789006406","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","72789-064","72789-064-06","72789-064_3403cd92-3140-e0c6-e063-6294a90a5a1c","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","PD-Rx Pharmaceuticals, Inc.","800; 160","mg/1; mg/1","","N","20261231"
"9062","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72789006520","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-065","72789-065-20","72789-065_3403f8c6-f561-fe54-e063-6294a90a972b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20091010","","ANDA","ANDA076126","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9063","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","72789006603","Macrolide Antimicrobial [EPC], Macrolides [CS]","72789-066","72789-066-03","72789-066_3403fa61-54f8-0789-e063-6294a90ac82c","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","20261031","ANDA","ANDA208249","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N",""
"9064","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","72789006607","Macrolide Antimicrobial [EPC], Macrolides [CS]","72789-066","72789-066-07","72789-066_3403fa61-54f8-0789-e063-6294a90ac82c","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","20261031","ANDA","ANDA208249","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N",""
"9065","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","72789006679","Macrolide Antimicrobial [EPC], Macrolides [CS]","72789-066","72789-066-79","72789-066_3403fa61-54f8-0789-e063-6294a90ac82c","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","20261031","ANDA","ANDA208249","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N",""
"9066","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","72789006602","Macrolide Antimicrobial [EPC], Macrolides [CS]","72789-066","72789-066-02","72789-066_3403fa61-54f8-0789-e063-6294a90ac82c","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","20261031","ANDA","ANDA208249","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N",""
"9067","MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE","Moxifloxacin Hydrochloride Tablets, 400 mg","72789008010","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-080","72789-080-10","72789-080_23fbdedd-afab-e476-e063-6294a90ac410","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride Tablets, 400 mg","","TABLET, FILM COATED","ORAL","20180721","","ANDA","ANDA208682","PD-Rx Pharmaceuticals, Inc.","400","mg/1","","N","20251231"
"9068","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","72789008104","Macrolide Antimicrobial [EPC], Macrolides [CS]","72789-081","72789-081-04","72789-081_31442118-2505-0be0-e063-6294a90a12d1","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","20261130","ANDA","ANDA208250","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N",""
"9069","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72789010802","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-108","72789-108-02","72789-108_2d674063-ffb5-adfa-e063-6394a90a402c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9070","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72789010806","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-108","72789-108-06","72789-108_2d674063-ffb5-adfa-e063-6394a90a402c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9071","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72789010814","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-108","72789-108-14","72789-108_2d674063-ffb5-adfa-e063-6394a90a402c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9072","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72789010820","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-108","72789-108-20","72789-108_2d674063-ffb5-adfa-e063-6394a90a402c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9073","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72789010828","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-108","72789-108-28","72789-108_2d674063-ffb5-adfa-e063-6394a90a402c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9074","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72789010830","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-108","72789-108-30","72789-108_2d674063-ffb5-adfa-e063-6394a90a402c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9075","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72789010810","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-108","72789-108-10","72789-108_2d674063-ffb5-adfa-e063-6394a90a402c","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9076","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72789011801","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-118","72789-118-01","72789-118_2d674f1c-80e1-5feb-e063-6294a90a2aeb","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9077","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72789011820","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-118","72789-118-20","72789-118_2d674f1c-80e1-5feb-e063-6294a90a2aeb","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9078","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72789012401","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-124","72789-124-01","72789-124_2d675959-9721-1fd0-e063-6294a90aad29","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"9079","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72789012550","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-125","72789-125-50","72789-125_2d675959-9721-1fd0-e063-6294a90aad29","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","PD-Rx Pharmaceuticals, Inc.","750","mg/1","","N","20261231"
"9080","PENICILLIN V POTASSIUM","Penicillin V Potassium","72789014620","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72789-146","72789-146-20","72789-146_1d0e2b81-91de-bbb4-e063-6394a90ab40c","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"9081","PENICILLIN V POTASSIUM","Penicillin V Potassium","72789014628","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72789-146","72789-146-28","72789-146_1d0e2b81-91de-bbb4-e063-6394a90ab40c","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"9082","PENICILLIN V POTASSIUM","Penicillin V Potassium","72789014606","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72789-146","72789-146-06","72789-146_1d0e2b81-91de-bbb4-e063-6394a90ab40c","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20080429","","ANDA","ANDA065435","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"9083","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72789014703","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72789-147","72789-147-03","72789-147_2d68789b-9227-435b-e063-6294a90a22fe","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20261231"
"9084","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72789014710","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72789-147","72789-147-10","72789-147_2d68789b-9227-435b-e063-6294a90a22fe","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20261231"
"9085","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72789014714","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72789-147","72789-147-14","72789-147_2d68789b-9227-435b-e063-6294a90a22fe","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20261231"
"9086","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72789014720","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72789-147","72789-147-20","72789-147_2d68789b-9227-435b-e063-6294a90a22fe","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20261231"
"9087","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72789014704","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72789-147","72789-147-04","72789-147_2d68789b-9227-435b-e063-6294a90a22fe","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20261231"
"9088","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72789014730","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72789-147","72789-147-30","72789-147_2d68789b-9227-435b-e063-6294a90a22fe","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20261231"
"9089","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72789014728","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72789-147","72789-147-28","72789-147_2d68789b-9227-435b-e063-6294a90a22fe","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20261231"
"9090","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789016709","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-167","72789-167-09","72789-167_3766d547-3a82-45f2-e063-6394a90a62ad","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20261231"
"9091","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789016720","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-167","72789-167-20","72789-167_3766d547-3a82-45f2-e063-6394a90a62ad","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20261231"
"9092","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789016721","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-167","72789-167-21","72789-167_3766d547-3a82-45f2-e063-6394a90a62ad","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20261231"
"9093","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789016740","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-167","72789-167-40","72789-167_3766d547-3a82-45f2-e063-6394a90a62ad","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20261231"
"9094","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789016730","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-167","72789-167-30","72789-167_3766d547-3a82-45f2-e063-6394a90a62ad","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20261231"
"9095","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","72789016930","Macrolide Antimicrobial [EPC], Macrolides [CS]","72789-169","72789-169-30","72789-169_31456bbc-ff43-7ac8-e063-6294a90adf9b","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","20261031","ANDA","ANDA208249","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N",""
"9096","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","72789017030","Macrolide Antimicrobial [EPC], Macrolides [CS]","72789-170","72789-170-30","72789-170_31454bd4-5f03-b888-e063-6294a90a67e9","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","20261130","ANDA","ANDA208250","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N",""
"9097","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789018006","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-180","72789-180-06","72789-180_3766f400-5b81-d33b-e063-6294a90a1e9a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","PD-Rx Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"9098","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789018008","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-180","72789-180-08","72789-180_3766f400-5b81-d33b-e063-6294a90a1e9a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","PD-Rx Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"9099","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789018015","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-180","72789-180-15","72789-180_3766f400-5b81-d33b-e063-6294a90a1e9a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","PD-Rx Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"9100","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789018004","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-180","72789-180-04","72789-180_3766f400-5b81-d33b-e063-6294a90a1e9a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","PD-Rx Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"9101","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789018021","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-180","72789-180-21","72789-180_3766f400-5b81-d33b-e063-6294a90a1e9a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","PD-Rx Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"9102","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789018028","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-180","72789-180-28","72789-180_3766f400-5b81-d33b-e063-6294a90a1e9a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","PD-Rx Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"9103","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789018030","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-180","72789-180-30","72789-180_3766f400-5b81-d33b-e063-6294a90a1e9a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","PD-Rx Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"9104","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789018020","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-180","72789-180-20","72789-180_3766f400-5b81-d33b-e063-6294a90a1e9a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","PD-Rx Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"9105","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789018042","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-180","72789-180-42","72789-180_3766f400-5b81-d33b-e063-6294a90a1e9a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","PD-Rx Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"9106","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789018056","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-180","72789-180-56","72789-180_3766f400-5b81-d33b-e063-6294a90a1e9a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","PD-Rx Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"9107","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789018040","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-180","72789-180-40","72789-180_3766f400-5b81-d33b-e063-6294a90a1e9a","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","PD-Rx Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"9108","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72789019306","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-193","72789-193-06","72789-193_2d6a1bfd-184b-822d-e063-6294a90a76ae","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"9109","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72789019312","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-193","72789-193-12","72789-193_2d6a1bfd-184b-822d-e063-6294a90a76ae","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"9110","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72789019314","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-193","72789-193-14","72789-193_2d6a1bfd-184b-822d-e063-6294a90a76ae","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"9111","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72789019320","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-193","72789-193-20","72789-193_2d6a1bfd-184b-822d-e063-6294a90a76ae","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"9112","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","72789019310","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-193","72789-193-10","72789-193_2d6a1bfd-184b-822d-e063-6294a90a76ae","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"9113","METRONIDAZOLE","metronidazole","72789019506","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72789-195","72789-195-06","72789-195_21521179-5763-9381-e063-6294a90a6ece","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"9114","METRONIDAZOLE","metronidazole","72789019521","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72789-195","72789-195-21","72789-195_21521179-5763-9381-e063-6294a90a6ece","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"9115","METRONIDAZOLE","metronidazole","72789019530","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","72789-195","72789-195-30","72789-195_21521179-5763-9381-e063-6294a90a6ece","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"9116","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789020709","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-207","72789-207-09","72789-207_236bf857-10e1-127c-e063-6394a90ad5ef","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"9117","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789020720","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-207","72789-207-20","72789-207_236bf857-10e1-127c-e063-6394a90ad5ef","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"9118","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789020721","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-207","72789-207-21","72789-207_236bf857-10e1-127c-e063-6394a90ad5ef","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"9119","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789020740","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-207","72789-207-40","72789-207_236bf857-10e1-127c-e063-6394a90ad5ef","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"9120","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","72789020730","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","72789-207","72789-207-30","72789-207_236bf857-10e1-127c-e063-6394a90ad5ef","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","PD-Rx Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"9121","FLUCONAZOLE","Fluconazole","72789020902","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72789-209","72789-209-02","72789-209_32fb9b13-bf4c-10c0-e063-6394a90a0301","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","PD-Rx Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"9122","FLUCONAZOLE","Fluconazole","72789020979","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72789-209","72789-209-79","72789-209_32fb9b13-bf4c-10c0-e063-6394a90a0301","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20210422","","ANDA","ANDA078423","PD-Rx Pharmaceuticals, Inc.","150","mg/1","","N","20261231"
"9123","PENICILLIN V POTASSIUM","Penicillin V Potassium","72789022201","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72789-222","72789-222-01","72789-222_303e8b4c-0957-d7d8-e063-6294a90a3c7e","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9124","PENICILLIN V POTASSIUM","Penicillin V Potassium","72789022230","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72789-222","72789-222-30","72789-222_303e8b4c-0957-d7d8-e063-6294a90a3c7e","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9125","PENICILLIN V POTASSIUM","Penicillin V Potassium","72789022301","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72789-223","72789-223-01","72789-223_303e8b4c-0957-d7d8-e063-6294a90a3c7e","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"9126","AMOXICILLIN","Amoxicillin","72789022401","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72789-224","72789-224-01","72789-224_2357756e-8fe4-a3bf-e063-6394a90a3651","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, COATED","ORAL","20060329","","ANDA","ANDA065255","PD-Rx Pharmaceuticals, Inc.","875","mg/1","","N","20251231"
"9127","AMOXICILLIN","Amoxicillin","72789022582","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72789-225","72789-225-82","72789-225_274aaccd-a22c-e9b9-e063-6394a90a501b","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20070301","","ANDA","ANDA065291","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9128","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin","72789023310","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-233","72789-233-10","72789-233_240f5575-e27d-3ecc-e063-6394a90ad169","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","TABLET, FILM COATED","ORAL","20140305","","ANDA","ANDA076938","PD-Rx Pharmaceuticals, Inc.","400","mg/1","","N","20251231"
"9129","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","72789023410","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72789-234","72789-234-10","72789-234_21644829-2e7c-dc8e-e063-6294a90aa4ae","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","PD-Rx Pharmaceuticals, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"9130","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","72789024206","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72789-242","72789-242-06","72789-242_216473d5-4853-1e8f-e063-6294a90ac304","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","PD-Rx Pharmaceuticals, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"9131","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","72789024210","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72789-242","72789-242-10","72789-242_216473d5-4853-1e8f-e063-6294a90ac304","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","PD-Rx Pharmaceuticals, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"9132","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","72789024214","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72789-242","72789-242-14","72789-242_216473d5-4853-1e8f-e063-6294a90ac304","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","PD-Rx Pharmaceuticals, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"9133","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","72789024202","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72789-242","72789-242-02","72789-242_216473d5-4853-1e8f-e063-6294a90ac304","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","PD-Rx Pharmaceuticals, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"9134","PENICILLIN V POTASSIUM","Penicillin V Potassium","72789024528","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72789-245","72789-245-28","72789-245_330e989a-528e-9232-e063-6294a90a1773","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"9135","PENICILLIN V POTASSIUM","Penicillin V Potassium","72789024540","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72789-245","72789-245-40","72789-245_330e989a-528e-9232-e063-6294a90a1773","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"9136","PENICILLIN V POTASSIUM","Penicillin V Potassium","72789024520","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72789-245","72789-245-20","72789-245_330e989a-528e-9232-e063-6294a90a1773","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"9137","CEPHALEXIN","Cephalexin","72789025182","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72789-251","72789-251-82","72789-251_274abb0e-d88c-756b-e063-6394a90a6810","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9138","CEPHALEXIN","Cephalexin","72789025201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","72789-252","72789-252-01","72789-252_240f9beb-b7d4-9367-e063-6394a90a6f88","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"9139","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72789025320","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72789-253","72789-253-20","72789-253_2d6cb852-ad4e-5981-e063-6394a90a9bdf","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20261231"
"9140","AMOXICILLIN","Amoxicillin","72789025421","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72789-254","72789-254-21","72789-254_21655b75-86ca-6abd-e063-6294a90adf7b","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20070301","","ANDA","ANDA065291","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9141","AMOXICILLIN","Amoxicillin","72789025460","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72789-254","72789-254-60","72789-254_21655b75-86ca-6abd-e063-6294a90adf7b","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20070301","","ANDA","ANDA065291","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9142","AMOXICILLIN","Amoxicillin","72789025430","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72789-254","72789-254-30","72789-254_21655b75-86ca-6abd-e063-6294a90adf7b","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20070301","","ANDA","ANDA065291","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9143","NITROFURANTOIN","Nitrofurantoin Macrocrystals","72789027010","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","72789-270","72789-270-10","72789-270_1187797b-64ce-7536-e063-6294a90a603f","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Macrocrystals","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","PD-Rx Pharmaceuticals, Inc.","100","mg/1","","N","20251231"
"9144","NITROFURANTOIN","Nitrofurantoin Macrocrystals","72789027014","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","72789-270","72789-270-14","72789-270_1187797b-64ce-7536-e063-6294a90a603f","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Macrocrystals","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","PD-Rx Pharmaceuticals, Inc.","100","mg/1","","N","20251231"
"9145","NITROFURANTOIN","Nitrofurantoin Macrocrystals","72789027002","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","72789-270","72789-270-02","72789-270_1187797b-64ce-7536-e063-6294a90a603f","HUMAN PRESCRIPTION DRUG","Nitrofurantoin Macrocrystals","","CAPSULE","ORAL","20070308","","ANDA","ANDA073652","PD-Rx Pharmaceuticals, Inc.","100","mg/1","","N","20251231"
"9146","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72789030206","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-302","72789-302-06","72789-302_3803a8a1-be49-e2f4-e063-6294a90ac977","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"9147","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72789030210","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-302","72789-302-10","72789-302_3803a8a1-be49-e2f4-e063-6294a90ac977","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"9148","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72789030214","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-302","72789-302-14","72789-302_3803a8a1-be49-e2f4-e063-6294a90ac977","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"9149","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72789030220","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-302","72789-302-20","72789-302_3803a8a1-be49-e2f4-e063-6294a90ac977","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"9150","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72789030212","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-302","72789-302-12","72789-302_3803a8a1-be49-e2f4-e063-6294a90ac977","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"9151","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72789033006","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-330","72789-330-06","72789-330_3805ef07-2431-0df7-e063-6394a90ac45b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9152","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72789033014","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-330","72789-330-14","72789-330_3805ef07-2431-0df7-e063-6394a90ac45b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9153","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72789033020","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-330","72789-330-20","72789-330_3805ef07-2431-0df7-e063-6394a90ac45b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9154","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72789033028","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-330","72789-330-28","72789-330_3805ef07-2431-0df7-e063-6394a90ac45b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9155","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72789033010","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-330","72789-330-10","72789-330_3805ef07-2431-0df7-e063-6394a90ac45b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9156","NITROFURANTOIN","nitrofurantoin macrocrystals","72789034014","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","72789-340","72789-340-14","72789-340_373a52aa-03d1-3290-e063-6294a90ae504","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","PD-Rx Pharmaceuticals, Inc.","100","mg/1","","N","20261231"
"9157","NITROFURANTOIN","nitrofurantoin macrocrystals","72789034010","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","72789-340","72789-340-10","72789-340_373a52aa-03d1-3290-e063-6294a90ae504","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","PD-Rx Pharmaceuticals, Inc.","100","mg/1","","N","20261231"
"9158","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin Hydrochloride","72789035010","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-350","72789-350-10","72789-350_31f59929-703b-e61b-e063-6394a90aec8a","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride","","TABLET, FILM COATED","ORAL","20140304","","ANDA","ANDA202632","PD-Rx Pharmaceuticals, Inc.","400","mg/1","","N","20261231"
"9159","PENICILLIN V POTASSIUM","Penicillin V Potassium","72789036628","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72789-366","72789-366-28","72789-366_1e8f338a-9d6c-7ff2-e063-6294a90a0f81","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20131011","","ANDA","ANDA090549","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"9160","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72789036814","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-368","72789-368-14","72789-368_3807a122-42a9-ee3a-e063-6394a90aa6b1","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9161","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","72789038606","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72789-386","72789-386-06","72789-386_153600df-6794-a45f-e063-6294a90afbca","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","PD-Rx Pharmaceuticals, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"9162","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","72789038610","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72789-386","72789-386-10","72789-386_153600df-6794-a45f-e063-6294a90afbca","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","PD-Rx Pharmaceuticals, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"9163","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","72789038614","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72789-386","72789-386-14","72789-386_153600df-6794-a45f-e063-6294a90afbca","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","PD-Rx Pharmaceuticals, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"9164","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin","72789038710","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","72789-387","72789-387-10","72789-387_137b0cc9-67f8-5db8-e063-6294a90a79b6","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","","CAPSULE","ORAL","20180101","","ANDA","ANDA208516","PD-Rx Pharmaceuticals, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"9165","AMOXICILLIN","Amoxicillin","72789038814","Penicillin-class Antibacterial [EPC], Penicillins [CS]","72789-388","72789-388-14","72789-388_2177ed05-9730-bc69-e063-6294a90aaf88","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, COATED","ORAL","20060329","","ANDA","ANDA065255","PD-Rx Pharmaceuticals, Inc.","875","mg/1","","N","20251231"
"9166","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","72789039490","Allylamine Antifungal [EPC], Allylamine [CS]","72789-394","72789-394-90","72789-394_1ef05cd9-42db-c94c-e063-6294a90afa49","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"9167","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","72789039442","Allylamine Antifungal [EPC], Allylamine [CS]","72789-394","72789-394-42","72789-394_1ef05cd9-42db-c94c-e063-6294a90afa49","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20070702","","ANDA","ANDA078297","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"9168","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72789041814","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72789-418","72789-418-14","72789-418_2177d587-50ae-d2d2-e063-6294a90a72a3","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065101","PD-Rx Pharmaceuticals, Inc.","500; 125","mg/1; mg/1","","N","20251231"
"9169","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72789042114","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72789-421","72789-421-14","72789-421_2e823ce6-255d-6afd-e063-6394a90a7e33","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20261231"
"9170","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","72789044502","Macrolide Antimicrobial [EPC], Macrolides [CS]","72789-445","72789-445-02","72789-445_28f08774-e0c3-db2b-e063-6294a90ac162","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9171","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","72789044507","Macrolide Antimicrobial [EPC], Macrolides [CS]","72789-445","72789-445-07","72789-445_28f08774-e0c3-db2b-e063-6294a90ac162","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9172","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","72789044579","Macrolide Antimicrobial [EPC], Macrolides [CS]","72789-445","72789-445-79","72789-445_28f08774-e0c3-db2b-e063-6294a90ac162","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9173","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72789045614","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72789-456","72789-456-14","72789-456_29061a40-cbb4-0ad0-e063-6394a90adc49","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"9174","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","72789045914","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","72789-459","72789-459-14","72789-459_29060f32-1033-e91a-e063-6394a90aa5d3","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","PD-Rx Pharmaceuticals, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"9175","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","72789048304","Macrolide Antimicrobial [EPC], Macrolides [CS]","72789-483","72789-483-04","72789-483_2c52a646-c97e-6323-e063-6394a90a313f","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208250","PD-Rx Pharmaceuticals, Inc.","250","mg/1","","N","20261231"
"9176","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","72789051130","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72789-511","72789-511-30","72789-511_369d0502-2a38-37e7-e063-6394a90a16e6","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20240209","","ANDA","ANDA077859","PD-Rx Pharmaceuticals, Inc.","500","mg/1","","N","20261231"
"9177","MICONAZOLE NITRATE","Miconazole Nitrate 2%","72839009602","Azole Antifungal [EPC], Azoles [CS]","72839-096","72839-096-02","72839-096_2cb64938-48cd-2213-e063-6394a90a92af","HUMAN OTC DRUG","DCH Labs Antifungal Jock","","POWDER","TOPICAL","20220114","","OTC MONOGRAPH DRUG","M005","Derma Care Research Labs, LLC","2","g/100g","","N","20261231"
"9178","MICONAZOLE NITRATE","Miconazole Nitrate 2%","72839096102","Azole Antifungal [EPC], Azoles [CS]","72839-961","72839-961-02","72839-961_29b73d29-5847-610c-e063-6394a90aca16","HUMAN OTC DRUG","Warrior Antifungal Foot","","POWDER","TOPICAL","20210202","","OTC MONOGRAPH DRUG","M005","Derma Care Research Labs, LLC","2","g/100g","","N","20251231"
"9179","VORICONAZOLE","voriconazole","72843044101","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","72843-441","72843-441-01","72843-441_37fd1318-4e96-c496-e063-6394a90a90e3","HUMAN PRESCRIPTION DRUG","Voriconazole","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20200831","","ANDA","ANDA211264","UBI Pharma Inc.","10","mg/mL","","N","20261231"
"9180","CIPROFLOXACIN HYDROCHLORIDE","CIPROFLOXACIN HYDROCHLORIDE","72888010221","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72888-102","72888-102-21","72888-102_30142b39-1441-7d9f-e063-6394a90ac169","HUMAN PRESCRIPTION DRUG","CIPROFLOXACIN HYDROCHLORIDE","","SOLUTION","OPHTHALMIC","20220316","","ANDA","ANDA075928","Advagen Pharma Limited","3","mg/mL","","N","20261231"
"9181","CIPROFLOXACIN HYDROCHLORIDE","CIPROFLOXACIN HYDROCHLORIDE","72888010222","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72888-102","72888-102-22","72888-102_30142b39-1441-7d9f-e063-6394a90ac169","HUMAN PRESCRIPTION DRUG","CIPROFLOXACIN HYDROCHLORIDE","","SOLUTION","OPHTHALMIC","20220316","","ANDA","ANDA075928","Advagen Pharma Limited","3","mg/mL","","N","20261231"
"9182","CIPROFLOXACIN HYDROCHLORIDE","CIPROFLOXACIN HYDROCHLORIDE","72888010223","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","72888-102","72888-102-23","72888-102_30142b39-1441-7d9f-e063-6394a90ac169","HUMAN PRESCRIPTION DRUG","CIPROFLOXACIN HYDROCHLORIDE","","SOLUTION","OPHTHALMIC","20220316","","ANDA","ANDA075928","Advagen Pharma Limited","3","mg/mL","","N","20261231"
"9183","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","72976000901","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","72976-009","72976-009-01","72976-009_0eff6a6e-09ea-2a66-e063-6294a90ae58f","HUMAN OTC DRUG","Ever Ready First Aid Triple Antibiotic","","OINTMENT","TOPICAL","20221123","","OTC MONOGRAPH DRUG","M004","EVER READY FIRST AID","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20251231"
"9184","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","72976001701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","72976-017","72976-017-01","72976-017_0eb46f57-a383-c64a-e063-6294a90a5800","HUMAN OTC DRUG","ER Triple Antibiotic","","OINTMENT","TOPICAL","20240111","","OTC MONOGRAPH DRUG","M004","EVER READY FIRST AID","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20251231"
"9185","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","73043000620","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","73043-006","73043-006-20","73043-006_a51715ae-3a5c-4502-a9d9-a7469d5adc69","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20241101","","ANDA","ANDA209991","Devatis, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"9186","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","73043000720","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","73043-007","73043-007-20","73043-007_a51715ae-3a5c-4502-a9d9-a7469d5adc69","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20241101","","ANDA","ANDA209992","Devatis, Inc.","500; 125","mg/1; mg/1","","N","20251231"
"9187","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","73043000801","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","73043-008","73043-008-01","73043-008_2d94ce8d-5992-45c0-bf59-a8e12d226462","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20241101","","ANDA","ANDA209351","Devatis Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"9188","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","73043000803","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","73043-008","73043-008-03","73043-008_2d94ce8d-5992-45c0-bf59-a8e12d226462","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20241101","","ANDA","ANDA209351","Devatis Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"9189","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","73043000802","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","73043-008","73043-008-02","73043-008_2d94ce8d-5992-45c0-bf59-a8e12d226462","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20241101","","ANDA","ANDA209351","Devatis Inc.","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"9190","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","73043000901","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","73043-009","73043-009-01","73043-009_8942c376-8b1a-4716-9b90-de14ab22c4fb","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20241101","","ANDA","ANDA210416","Devatis, Inc.","400; 57","mg/5mL; mg/5mL","","N","20261231"
"9191","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","73043000902","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","73043-009","73043-009-02","73043-009_8942c376-8b1a-4716-9b90-de14ab22c4fb","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20241101","","ANDA","ANDA210416","Devatis, Inc.","400; 57","mg/5mL; mg/5mL","","N","20261231"
"9192","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","73043000903","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","73043-009","73043-009-03","73043-009_8942c376-8b1a-4716-9b90-de14ab22c4fb","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20241101","","ANDA","ANDA210416","Devatis, Inc.","400; 57","mg/5mL; mg/5mL","","N","20261231"
"9193","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","73043001002","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","73043-010","73043-010-02","73043-010_e5eda5f6-317c-43ac-b1d7-c6ce635593da","HUMAN PRESCRIPTION DRUG","amoxicillin and clavulanate potassium","","POWDER, FOR SUSPENSION","ORAL","20240705","","ANDA","ANDA210374","Devatis, Inc.","250; 62.5","mg/5mL; mg/5mL","","N","20261231"
"9194","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","73043001003","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","73043-010","73043-010-03","73043-010_e5eda5f6-317c-43ac-b1d7-c6ce635593da","HUMAN PRESCRIPTION DRUG","amoxicillin and clavulanate potassium","","POWDER, FOR SUSPENSION","ORAL","20240705","","ANDA","ANDA210374","Devatis, Inc.","250; 62.5","mg/5mL; mg/5mL","","N","20261231"
"9195","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","73043001001","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","73043-010","73043-010-01","73043-010_e5eda5f6-317c-43ac-b1d7-c6ce635593da","HUMAN PRESCRIPTION DRUG","amoxicillin and clavulanate potassium","","POWDER, FOR SUSPENSION","ORAL","20240705","","ANDA","ANDA210374","Devatis, Inc.","250; 62.5","mg/5mL; mg/5mL","","N","20261231"
"9196","ERYTHROMYCIN","Erythromycin","73082001030","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","73082-010","73082-010-30","73082-010_70c37150-654e-46d8-8931-e2e395f4bceb","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20191005","","ANDA","ANDA213628","Orange Pharmaceuticals USA LLC","250","mg/1","","N","20251231"
"9197","ERYTHROMYCIN","Erythromycin","73082001001","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","73082-010","73082-010-01","73082-010_70c37150-654e-46d8-8931-e2e395f4bceb","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20191005","","ANDA","ANDA213628","Orange Pharmaceuticals USA LLC","250","mg/1","","N","20251231"
"9198","ERYTHROMYCIN","Erythromycin","73082002001","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","73082-020","73082-020-01","73082-020_70c37150-654e-46d8-8931-e2e395f4bceb","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20191005","","ANDA","ANDA213628","Orange Pharmaceuticals USA LLC","500","mg/1","","N","20251231"
"9199","ERYTHROMYCIN","Erythromycin","73082002030","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","73082-020","73082-020-30","73082-020_70c37150-654e-46d8-8931-e2e395f4bceb","HUMAN PRESCRIPTION DRUG","Erythromycin","","TABLET, FILM COATED","ORAL","20191005","","ANDA","ANDA213628","Orange Pharmaceuticals USA LLC","500","mg/1","","N","20251231"
"9200","POSACONAZOLE","Posaconazole","73141002302","Azole Antifungal [EPC], Azoles [CS]","73141-023","73141-023-02","73141-023_3249fa0e-2b53-ebfb-e063-6394a90a2d78","HUMAN PRESCRIPTION DRUG","Posaconazole","","TABLET, DELAYED RELEASE","ORAL","20240516","","ANDA","ANDA216488","A2A Integrated Pharmaceuticals","100","mg/1","","N","20261231"
"9201","ATOVAQUONE","Atovaquone","73141010442","Antimalarial [EPC], Antiprotozoal [EPC]","73141-104","73141-104-42","73141-104_2abada7d-4115-54ca-e063-6394a90a3d4f","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20241129","","ANDA","ANDA212918","A2A Integrated Pharmaceuticals, LLC","750","mg/5mL","","N","20261231"
"9202","SERTACONAZOLE NITRATE","Sertaconazole Nitrate","73159000460","Azole Antifungal [EPC], Azoles [CS]","73159-004","73159-004-60","73159-004_28e14b24-611e-9c6f-e063-6294a90ac043","HUMAN PRESCRIPTION DRUG","Ertaczo","","CREAM","TOPICAL","20241126","","NDA","NDA021385","Lacer Pharma, LLC","20","mg/g","","N","20251231"
"9203","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","73233012505","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","73233-125","73233-125-05","73233-125_3622b293-f4bd-af1d-e063-6394a90a1c1b","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20250530","","OTC MONOGRAPH DRUG","M004","Express Companies, Inc.","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20261231"
"9204","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC","73288000501","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","73288-005","73288-005-01","73288-005_2807d80b-8ebd-8e60-e063-6394a90a1b2a","HUMAN OTC DRUG","First Aid Antibiotic","","OINTMENT","TOPICAL","20191001","","OTC MONOGRAPH DRUG","M004","NINGBO TIANBO FIRST AID PRODUCT CO., LTD.","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20251231"
"9205","CLOTRIMAZOLE","Clotrimazole","73352057001","Azole Antifungal [EPC], Azoles [CS]","73352-570","73352-570-01","73352-570_0d1bbd89-93bb-4c6e-9253-b48746977d19","HUMAN OTC DRUG","Trimazole","","CREAM","TOPICAL","20240610","","OTC MONOGRAPH DRUG","M005","Trifluent Pharma LLC","1","g/100g","","N","20251231"
"9206","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, polymyxin B sulfate, neomycin sulfate","73408092973","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","73408-929","73408-929-73","73408-929_20bf8208-dbb9-662a-e063-6294a90a7315","HUMAN OTC DRUG","Thompson Triple Antibiotic","","OINTMENT","TOPICAL","20220801","20250901","OTC MONOGRAPH DRUG","M004","Thompson","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N",""
"9207","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","73408093073","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","73408-930","73408-930-73","73408-930_0f28cf0c-6d42-a8fb-e063-6394a90a8636","HUMAN OTC DRUG","Crane Safety Triple Antibiotic","","OINTMENT","TOPICAL","20210601","20250901","OTC MONOGRAPH DRUG","M004","Crane Safety LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N",""
"9208","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","73408093473","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","73408-934","73408-934-73","73408-934_0f28cf0c-6d42-a8fb-e063-6394a90a8636","HUMAN OTC DRUG","Crane Safety Triple Antibiotic","","OINTMENT","TOPICAL","20200117","","OTC MONOGRAPH DRUG","M004","Crane Safety LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"9209","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","73408098373","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","73408-983","73408-983-73","73408-983_20bf801f-4ff8-9cca-e063-6294a90a55cb","HUMAN OTC DRUG","Thompson Triple Antibiotic","","OINTMENT","TOPICAL","20230501","","OTC MONOGRAPH DRUG","M004","Thompson","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"9210","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","73473030030","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","73473-300","73473-300-30","73473-300_3d9aef28-a7ba-47ea-83f0-87f2f2530f7f","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20250103","","ANDA","ANDA211872","Solaris Pharma Corporation","10","mg/g","","N","20261231"
"9211","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","73473030060","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","73473-300","73473-300-60","73473-300_3d9aef28-a7ba-47ea-83f0-87f2f2530f7f","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20250103","","ANDA","ANDA211872","Solaris Pharma Corporation","10","mg/g","","N","20261231"
"9212","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","73473030275","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","73473-302","73473-302-75","73473-302_3a42199c-8c43-4fe7-83fc-4dd5af82279d","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","GEL","TOPICAL","20240915","","ANDA","ANDA212842","Solaris Pharma Corporation","1","g/10mL","","N","20251231"
"9213","METRONIDAZOLE","Metronidazole","73473030370","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","73473-303","73473-303-70","73473-303_02bcb14f-bf85-43d3-a585-85d04289fde9","HUMAN PRESCRIPTION DRUG","Metronidazole","","GEL","VAGINAL","20250103","","ANDA","ANDA213648","Solaris Pharma Corporation","7.5","mg/g","","N","20261231"
"9214","CLINDAMYCIN PHOSPHATE; TRETINOIN","clindamycin phosphate and tretinoin","73473030630","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]","73473-306","73473-306-30","73473-306_b52c449c-1499-46c3-a10a-3e803c307af2","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Tretinoin","","GEL","TOPICAL","20250103","","ANDA","ANDA212845","Solaris Pharma Corporation","10; .25","mg/g; mg/g","","N","20261231"
"9215","CLINDAMYCIN PHOSPHATE; TRETINOIN","clindamycin phosphate and tretinoin","73473030660","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]","73473-306","73473-306-60","73473-306_b52c449c-1499-46c3-a10a-3e803c307af2","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate and Tretinoin","","GEL","TOPICAL","20250103","","ANDA","ANDA212845","Solaris Pharma Corporation","10; .25","mg/g; mg/g","","N","20261231"
"9216","NEOMYCIN SULFATE","Neomycin Sulfate","73473090105","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","73473-901","73473-901-05","73473-901_1a3c064f-ec1a-b9b4-e063-6394a90a1e5e","HUMAN PRESCRIPTION DRUG","Neomycin Sulfate","","TABLET","ORAL","20230601","","ANDA","ANDA065220","Solaris Pharma Corporation","500","mg/1","","N","20251231"
"9217","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","73581021002","Benzylamine Antifungal [EPC], Benzylamines [CS]","73581-210","73581-210-02","73581-210_28f1c1a3-1e21-38a8-e063-6394a90a699e","HUMAN OTC DRUG","Butenafine Hydrochloride","","CREAM","TOPICAL","20231012","","ANDA","ANDA205181","YYBA CORP","10","mg/g","","N","20251231"
"9218","CLOTRIMAZOLE","CLOTRIMAZOLE","73581044900","Azole Antifungal [EPC], Azoles [CS]","73581-449","73581-449-00","73581-449_11e21b4d-1e91-da19-e063-6294a90aae1a","HUMAN OTC DRUG","WELMATE Clotrimazole Topical Solution","","LIQUID","TOPICAL","20240219","","OTC MONOGRAPH DRUG","M005","YYBA CORP","10","mg/mL","","N","20251231"
"9219","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, and POLYMYXIN B SULFATE","73598100401","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","73598-1004","73598-1004-1","73598-1004_1b96edfa-c13e-41e7-a0a4-bdfcdccd6bc3","HUMAN OTC DRUG","TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20000202","","OTC MONOGRAPH DRUG","M004","JHK Inc dba American Safety & First Aid","400; 3.5; 5000","[iU]/.5g; mg/.5g; [iU]/.5g","","N","20251231"
"9220","CEPHALEXIN","Cephalexin","73614020203","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","73614-202","73614-202-03","73614-202_2dcc6b23-698a-358d-e063-6394a90af228","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Brisk Pharmaceuticals","500","mg/1","","N","20261231"
"9221","CLINDAMYCIN HYDROCHLORIDE","Clindamycin Hydrochloride","73614020403","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","73614-204","73614-204-03","73614-204_2de041be-1d37-ee95-e063-6294a90a2091","HUMAN PRESCRIPTION DRUG","Clindamycin Hydrochloride","","CAPSULE","ORAL","20230310","","ANDA","ANDA216957","Brisk Pharmaceuticals","150","mg/1","","N","20261231"
"9222","CLOTRIMAZOLE","Clotrimazole 1% Antifungal Cream","73715000401","Azole Antifungal [EPC], Azoles [CS]","73715-004","73715-004-01","73715-004_0fa95b2a-768b-ee79-e063-6294a90aa056","HUMAN OTC DRUG","Clotrimazole 1% Topical Antifungal Cream","","CREAM","TOPICAL","20201221","","OTC MONOGRAPH DRUG","M005","Mohnark Pharmaceuticals Inc.","1","g/100g","","N","20251231"
"9223","MICONAZOLE NITRATE","Miconazole Nitrate","73736011505","Azole Antifungal [EPC], Azoles [CS]","73736-115","73736-115-05","73736-115_d5efdca4-a729-4a3a-b5c6-1b5c49612fcc","HUMAN OTC DRUG","Dr. Rainer s Vaginal Cream","","CREAM","TOPICAL","20200323","","OTC MONOGRAPH DRUG","M005","Plexoris Health Care Products, Llc","2","g/100mL","","N","20251231"
"9224","OTESECONAZOLE","oteseconazole","74695082318","Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA]","74695-823","74695-823-18","74695-823_3c8f52d8-02b3-47bd-9ed0-5ca4766e8937","HUMAN PRESCRIPTION DRUG","VIVJOA","","CAPSULE","ORAL","20220711","","NDA","NDA215888","Mycovia Pharmaceuticals, Inc.","150","mg/1","","N","20251231"
"9225","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","75568001501","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","75568-015","75568-015-01","75568-015_09b970f3-aac9-4a5a-e063-6294a90af72d","HUMAN OTC DRUG","Careland Triple Antibiotic","","OINTMENT","TOPICAL","20231030","","OTC MONOGRAPH DRUG","M004","Planet (Anhui) Pharmaceutical Co., Ltd.","400; 3.5; 5000","[CFU]/g; mg/g; [CFU]/g","","N","20251231"
"9226","IBREXAFUNGERP CITRATE","ibrexafungerp","75788011504","Glucan Synthase Inhibitors [MoA], Triterpenes [CS], Triterpenoid Antifungal [EPC]","75788-115","75788-115-04","75788-115_261c6505-3bb1-1631-e063-6294a90aaaa2","HUMAN PRESCRIPTION DRUG","BREXAFEMME","","TABLET, FILM COATED","ORAL","20210701","","NDA","NDA214900","SCYNEXIS, INC.","150","mg/1","","N","20251231"
"9227","OFLOXACIN","OFLOXACIN","75834011205","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-112","75834-112-05","75834-112_67a823b3-3e2d-4483-98e5-99fbddc0c8f5","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20160715","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","400","mg/1","","N","20251231"
"9228","OFLOXACIN","OFLOXACIN","75834011250","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-112","75834-112-50","75834-112_67a823b3-3e2d-4483-98e5-99fbddc0c8f5","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20160715","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","400","mg/1","","N","20251231"
"9229","OFLOXACIN","OFLOXACIN","75834011201","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-112","75834-112-01","75834-112_67a823b3-3e2d-4483-98e5-99fbddc0c8f5","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20160715","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","400","mg/1","","N","20251231"
"9230","OFLOXACIN","OFLOXACIN","75834011901","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-119","75834-119-01","75834-119_67a823b3-3e2d-4483-98e5-99fbddc0c8f5","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20160715","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"9231","OFLOXACIN","OFLOXACIN","75834011950","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-119","75834-119-50","75834-119_67a823b3-3e2d-4483-98e5-99fbddc0c8f5","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20160715","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"9232","OFLOXACIN","OFLOXACIN","75834011905","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-119","75834-119-05","75834-119_67a823b3-3e2d-4483-98e5-99fbddc0c8f5","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20160715","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"9233","OFLOXACIN","OFLOXACIN","75834012001","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-120","75834-120-01","75834-120_67a823b3-3e2d-4483-98e5-99fbddc0c8f5","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20160715","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","200","mg/1","","N","20251231"
"9234","OFLOXACIN","OFLOXACIN","75834012005","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-120","75834-120-05","75834-120_67a823b3-3e2d-4483-98e5-99fbddc0c8f5","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20160715","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","200","mg/1","","N","20251231"
"9235","OFLOXACIN","OFLOXACIN","75834012050","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-120","75834-120-50","75834-120_67a823b3-3e2d-4483-98e5-99fbddc0c8f5","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20160715","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","200","mg/1","","N","20251231"
"9236","OFLOXACIN","OFLOXACIN","75834019901","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-199","75834-199-01","75834-199_991170ff-e65c-421f-b7f0-95f78e459844","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20190125","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","200","mg/1","","N","20251231"
"9237","OFLOXACIN","OFLOXACIN","75834019905","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-199","75834-199-05","75834-199_991170ff-e65c-421f-b7f0-95f78e459844","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20190125","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","200","mg/1","","N","20251231"
"9238","OFLOXACIN","OFLOXACIN","75834019950","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-199","75834-199-50","75834-199_991170ff-e65c-421f-b7f0-95f78e459844","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20190125","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","200","mg/1","","N","20251231"
"9239","OFLOXACIN","OFLOXACIN","75834020005","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-200","75834-200-05","75834-200_991170ff-e65c-421f-b7f0-95f78e459844","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20190125","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"9240","OFLOXACIN","OFLOXACIN","75834020050","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-200","75834-200-50","75834-200_991170ff-e65c-421f-b7f0-95f78e459844","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20190125","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"9241","OFLOXACIN","OFLOXACIN","75834020001","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-200","75834-200-01","75834-200_991170ff-e65c-421f-b7f0-95f78e459844","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20190125","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","300","mg/1","","N","20251231"
"9242","OFLOXACIN","OFLOXACIN","75834020101","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-201","75834-201-01","75834-201_991170ff-e65c-421f-b7f0-95f78e459844","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20190125","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","400","mg/1","","N","20251231"
"9243","OFLOXACIN","OFLOXACIN","75834020150","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-201","75834-201-50","75834-201_991170ff-e65c-421f-b7f0-95f78e459844","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20190125","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","400","mg/1","","N","20251231"
"9244","OFLOXACIN","OFLOXACIN","75834020105","Quinolone Antimicrobial [EPC], Quinolones [CS]","75834-201","75834-201-05","75834-201_991170ff-e65c-421f-b7f0-95f78e459844","HUMAN PRESCRIPTION DRUG","OFLOXACIN","","TABLET, COATED","ORAL","20190125","","ANDA","ANDA091656","Nivagen Pharmaceuticals, Inc.","400","mg/1","","N","20251231"
"9245","ERYTHROMYCIN","ERYTHROMYCIN","75834024201","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","75834-242","75834-242-01","75834-242_e40dea9d-181d-4775-8912-ac1fc0d84b23","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, FILM COATED","ORAL","20210715","","ANDA","ANDA213628","Nivagen Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"9246","ERYTHROMYCIN","ERYTHROMYCIN","75834024230","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","75834-242","75834-242-30","75834-242_e40dea9d-181d-4775-8912-ac1fc0d84b23","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, FILM COATED","ORAL","20210715","","ANDA","ANDA213628","Nivagen Pharmaceuticals, Inc.","250","mg/1","","N","20251231"
"9247","ERYTHROMYCIN","ERYTHROMYCIN","75834024301","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","75834-243","75834-243-01","75834-243_e40dea9d-181d-4775-8912-ac1fc0d84b23","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, FILM COATED","ORAL","20210715","","ANDA","ANDA213628","Nivagen Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9248","ERYTHROMYCIN","ERYTHROMYCIN","75834024330","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","75834-243","75834-243-30","75834-243_e40dea9d-181d-4775-8912-ac1fc0d84b23","HUMAN PRESCRIPTION DRUG","ERYTHROMYCIN","","TABLET, FILM COATED","ORAL","20210715","","ANDA","ANDA213628","Nivagen Pharmaceuticals, Inc.","500","mg/1","","N","20251231"
"9249","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","75834029401","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","75834-294","75834-294-01","75834-294_7f06e8f4-15fb-4e18-b57e-457e7e20d331","HUMAN PRESCRIPTION DRUG","Erythromycin Ethylsuccinate","","SUSPENSION","ORAL","20230201","","ANDA","ANDA216212","Nivagen Pharmaceuticals, Inc.","400","mg/5mL","","N","20251231"
"9250","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","75834029501","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","75834-295","75834-295-01","75834-295_7f06e8f4-15fb-4e18-b57e-457e7e20d331","HUMAN PRESCRIPTION DRUG","Erythromycin Ethylsuccinate","","SUSPENSION","ORAL","20230201","","ANDA","ANDA216212","Nivagen Pharmaceuticals, Inc.","200","mg/5mL","","N","20251231"
"9251","TRIMETHOPRIM","Trimethoprim","75907004301","Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]","75907-043","75907-043-01","75907-043_3523d9e9-608e-4a43-6a70-acb8c84aff7b","HUMAN PRESCRIPTION DRUG","Trimethoprim","","TABLET","ORAL","20240130","","NDA","NDA018679","Dr. Reddy's Labratories Inc.","100","mg/1","","N","20251231"
"9252","NYSTATIN","Nystatin","75907006030","Polyene Antifungal [EPC], Polyenes [CS]","75907-060","75907-060-30","75907-060_f635996b-25e1-c80b-32d0-eb75ee46a25f","HUMAN PRESCRIPTION DRUG","Nystatin","","POWDER","TOPICAL","20240528","","ANDA","ANDA065203","Dr. Reddy's Labratories Inc.","100000","[USP'U]/g","","N","20251231"
"9253","NYSTATIN","Nystatin","75907006044","Polyene Antifungal [EPC], Polyenes [CS]","75907-060","75907-060-44","75907-060_f635996b-25e1-c80b-32d0-eb75ee46a25f","HUMAN PRESCRIPTION DRUG","Nystatin","","POWDER","TOPICAL","20240528","","ANDA","ANDA065203","Dr. Reddy's Labratories Inc.","100000","[USP'U]/g","","N","20251231"
"9254","NYSTATIN","Nystatin","75907006060","Polyene Antifungal [EPC], Polyenes [CS]","75907-060","75907-060-60","75907-060_f635996b-25e1-c80b-32d0-eb75ee46a25f","HUMAN PRESCRIPTION DRUG","Nystatin","","POWDER","TOPICAL","20240528","","ANDA","ANDA065203","Dr. Reddy's Labratories Inc.","100000","[USP'U]/g","","N","20251231"
"9255","ERYTHROMYCIN","erythromycin","75907007601","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","75907-076","75907-076-01","75907-076_9f969a04-65b6-cc13-e808-d5cc538b3010","HUMAN PRESCRIPTION DRUG","erythromycin","","CAPSULE, DELAYED RELEASE PELLETS","ORAL","20240901","","NDA AUTHORIZED GENERIC","NDA050536","Dr. Reddy's Labratories Inc.","250","mg/1","","N","20251231"
"9256","TOBRAMYCIN","Tobramycin","76204002956","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","76204-029","76204-029-56","76204-029_2cf172b2-a082-0637-e063-6394a90a2001","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","RESPIRATORY (INHALATION)","20250325","","ANDA","ANDA201422","Ritedose Pharmaceuticals, LLC","300","mg/5mL","","N","20261231"
"9257","TERBINAFINE HYDROCHLORIDE","Terbinafine","76282020901","Allylamine Antifungal [EPC], Allylamine [CS]","76282-209","76282-209-01","76282-209_dc86cdd6-0a8a-4e5c-b3c4-8b05388af862","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20120425","","ANDA","ANDA077533","Exelan Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"9258","TERBINAFINE HYDROCHLORIDE","Terbinafine","76282020905","Allylamine Antifungal [EPC], Allylamine [CS]","76282-209","76282-209-05","76282-209_dc86cdd6-0a8a-4e5c-b3c4-8b05388af862","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20120425","","ANDA","ANDA077533","Exelan Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"9259","TERBINAFINE HYDROCHLORIDE","Terbinafine","76282020930","Allylamine Antifungal [EPC], Allylamine [CS]","76282-209","76282-209-30","76282-209_dc86cdd6-0a8a-4e5c-b3c4-8b05388af862","HUMAN PRESCRIPTION DRUG","Terbinafine","","TABLET","ORAL","20120425","","ANDA","ANDA077533","Exelan Pharmaceuticals Inc.","250","mg/1","","N","20251231"
"9260","PRIMAQUINE PHOSPHATE","Primaquine Phosphate","76385010201","Antimalarial [EPC]","76385-102","76385-102-01","76385-102_1d35dd58-60df-4350-9c8b-153a9bae08af","HUMAN PRESCRIPTION DRUG","Primaquine Phosphate","","TABLET","ORAL","20140801","","ANDA","ANDA204476","Unichem Pharmaceuticals (USA), Inc.","15","mg/1","","N","20261231"
"9261","AMOXICILLIN","Amoxicillin","76420000301","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-003","76420-003-01","76420-003_203ead37-92bb-9348-e063-6294a90ab111","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Asclemed USA, Inc.","875","mg/1","","N","20251231"
"9262","AMOXICILLIN","Amoxicillin","76420000320","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-003","76420-003-20","76420-003_203ead37-92bb-9348-e063-6294a90ab111","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Asclemed USA, Inc.","875","mg/1","","N","20251231"
"9263","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","76420000520","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","76420-005","76420-005-20","76420-005_ae61a16a-506a-9c59-e053-2995a90a4704","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","Asclemed USA, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"9264","AZITHROMYCIN MONOHYDRATE","Azithromycin","76420000606","Macrolide Antimicrobial [EPC], Macrolides [CS]","76420-006","76420-006-06","76420-006_04472220-f8c1-1f1a-e063-6294a90a2bb2","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065225","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9265","CEPHALEXIN","Cephalexin","76420003440","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-034","76420-034-40","76420-034_e436e361-d938-7d6d-e053-2995a90a10e4","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9266","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","76420004506","Quinolone Antimicrobial [EPC], Quinolones [CS]","76420-045","76420-045-06","76420-045_ae77a7d7-f644-7b8f-e053-2a95a90a23e5","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9267","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","76420004514","Quinolone Antimicrobial [EPC], Quinolones [CS]","76420-045","76420-045-14","76420-045_ae77a7d7-f644-7b8f-e053-2a95a90a23e5","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9268","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","76420004520","Quinolone Antimicrobial [EPC], Quinolones [CS]","76420-045","76420-045-20","76420-045_ae77a7d7-f644-7b8f-e053-2a95a90a23e5","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9269","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","76420004530","Quinolone Antimicrobial [EPC], Quinolones [CS]","76420-045","76420-045-30","76420-045_ae77a7d7-f644-7b8f-e053-2a95a90a23e5","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9270","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","76420004510","Quinolone Antimicrobial [EPC], Quinolones [CS]","76420-045","76420-045-10","76420-045_ae77a7d7-f644-7b8f-e053-2a95a90a23e5","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9271","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","76420004606","Macrolide Antimicrobial [EPC], Macrolides [CS]","76420-046","76420-046-06","76420-046_ae7775dd-3ddd-58b8-e053-2995a90ad046","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20190701","","ANDA","ANDA208250","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9272","CLARITHROMYCIN","Clarithromycin","76420005114","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","76420-051","76420-051-14","76420-051_b21449e8-c203-520d-e053-2995a90ad298","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9273","CLARITHROMYCIN","Clarithromycin","76420005120","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","76420-051","76420-051-20","76420-051_b21449e8-c203-520d-e053-2995a90ad298","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9274","CEPHALEXIN","Cephalexin","76420005228","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-052","76420-052-28","76420-052_b21440a7-8193-47fc-e053-2995a90ae2f3","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9275","RIFAMPIN","Rifampin","76420006014","Rifamycin Antibacterial [EPC], Rifamycins [CS]","76420-060","76420-060-14","76420-060_b1aea89e-52fb-b32e-e053-2995a90a032b","HUMAN PRESCRIPTION DRUG","Rifampin","","CAPSULE","ORAL","19970528","","ANDA","ANDA064150","Asclemed USA, Inc.","300","mg/1","","N","20251231"
"9276","RIFAMPIN","Rifampin","76420006030","Rifamycin Antibacterial [EPC], Rifamycins [CS]","76420-060","76420-060-30","76420-060_b1aea89e-52fb-b32e-e053-2995a90a032b","HUMAN PRESCRIPTION DRUG","Rifampin","","CAPSULE","ORAL","19970528","","ANDA","ANDA064150","Asclemed USA, Inc.","300","mg/1","","N","20251231"
"9277","RIFAMPIN","Rifampin","76420006060","Rifamycin Antibacterial [EPC], Rifamycins [CS]","76420-060","76420-060-60","76420-060_b1aea89e-52fb-b32e-e053-2995a90a032b","HUMAN PRESCRIPTION DRUG","Rifampin","","CAPSULE","ORAL","19970528","","ANDA","ANDA064150","Asclemed USA, Inc.","300","mg/1","","N","20251231"
"9278","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","76420006406","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","76420-064","76420-064-06","76420-064_ae77a5c0-a27b-770c-e053-2a95a90a6a96","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Asclemed USA, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"9279","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","76420006410","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","76420-064","76420-064-10","76420-064_ae77a5c0-a27b-770c-e053-2a95a90a6a96","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Asclemed USA, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"9280","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","76420006420","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","76420-064","76420-064-20","76420-064_ae77a5c0-a27b-770c-e053-2a95a90a6a96","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Asclemed USA, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"9281","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","76420006428","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","76420-064","76420-064-28","76420-064_ae77a5c0-a27b-770c-e053-2a95a90a6a96","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Asclemed USA, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"9282","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","76420006430","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","76420-064","76420-064-30","76420-064_ae77a5c0-a27b-770c-e053-2a95a90a6a96","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Asclemed USA, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"9283","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","76420006414","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","76420-064","76420-064-14","76420-064_ae77a5c0-a27b-770c-e053-2a95a90a6a96","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Asclemed USA, Inc.","800; 160","mg/1; mg/1","","N","20251231"
"9284","SULFACETAMIDE SODIUM","Sulfacetamide Sodium","76420007615","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","76420-076","76420-076-15","76420-076_ead2d6e4-62f6-3b3c-e053-2a95a90a4ccd","HUMAN PRESCRIPTION DRUG","Sulfacetamide Sodium","","SOLUTION","OPHTHALMIC","20030325","","ANDA","ANDA089560","Asclemed USA, Inc.","100","mg/mL","","N","20251231"
"9285","SULFACETAMIDE SODIUM","sulfacetamide sodium","76420009015","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","76420-090","76420-090-15","76420-090_b26a1d2a-bf50-4787-e053-2a95a90a951b","HUMAN PRESCRIPTION DRUG","Sulfacetamide Sodium","","SOLUTION/ DROPS","OPHTHALMIC","19941228","","ANDA","ANDA040066","Asclemed USA, Inc.","100","mg/mL","","N","20251231"
"9286","TOBRAMYCIN","Tobramycin","76420009205","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","76420-092","76420-092-05","76420-092_b2696acf-8175-16fb-e053-2a95a90aa378","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION/ DROPS","OPHTHALMIC","20170628","","ANDA","ANDA207444","Asclemed USA, Inc.","3","mg/mL","","N","20251231"
"9287","HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone","76420010410","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","76420-104","76420-104-10","76420-104_b2ddcdd0-72c2-99df-e053-2a95a90a8818","HUMAN PRESCRIPTION DRUG","Neomycin and Polymyxin B Sulfates and Hydrocortisone","","SOLUTION/ DROPS","AURICULAR (OTIC)","19951229","","ANDA","ANDA064053","Asclemed USA, Inc.","10; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"9288","AMOXICILLIN","Amoxicillin","76420011230","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-112","76420-112-30","76420-112_c6979c55-d3e2-7094-e053-2a95a90a77b6","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9289","MUPIROCIN","Mupirocin","76420012822","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","76420-128","76420-128-22","76420-128_b3ba247a-da42-b643-e053-2a95a90aa969","HUMAN PRESCRIPTION DRUG","mupirocin","","OINTMENT","TOPICAL","20091030","","ANDA","ANDA065123","Asclemed USA, Inc.","20","mg/g","","N","20251231"
"9290","GENTAMICIN SULFATE","Gentamicin Sulfate","76420013705","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","76420-137","76420-137-05","76420-137_d96467a9-dbc5-20ab-e053-2a95a90addb8","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","SOLUTION","OPHTHALMIC","19960405","","ANDA","ANDA062196","Asclemed USA, Inc.","3","mg/mL","","N","20251231"
"9291","AMOXICILLIN","Amoxicillin","76420013820","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-138","76420-138-20","76420-138_d964632f-4590-9500-e053-2995a90a992d","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, COATED","ORAL","20060329","","ANDA","ANDA065255","Asclemed USA, Inc.","875","mg/1","","N","20251231"
"9292","FLUCONAZOLE","Fluconazole","76420016401","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","76420-164","76420-164-01","76420-164_d964ddff-cfca-92ad-e053-2995a90a6568","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20201120","","ANDA","ANDA077253","Asclemed USA, Inc.","150","mg/1","","N","20251231"
"9293","DICLOXACILLIN SODIUM","Dicloxacillin Sodium","76420018320","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-183","76420-183-20","76420-183_b41444ca-246e-b54e-e053-2a95a90ae0e7","HUMAN PRESCRIPTION DRUG","Dicloxacillin Sodium","","CAPSULE","ORAL","19900930","","ANDA","ANDA062286","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9294","AMOXICILLIN","Amoxicillin","76420019221","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-192","76420-192-21","76420-192_d19616e7-f7df-d290-e053-2995a90ae266","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19940930","","ANDA","ANDA064076","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9295","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420019510","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-195","76420-195-10","76420-195_e9294cf2-886b-1f04-e053-2995a90a3984","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"9296","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420019514","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-195","76420-195-14","76420-195_e9294cf2-886b-1f04-e053-2995a90a3984","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"9297","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420019520","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-195","76420-195-20","76420-195_e9294cf2-886b-1f04-e053-2995a90a3984","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"9298","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420019501","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-195","76420-195-01","76420-195_e9294cf2-886b-1f04-e053-2995a90a3984","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"9299","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420019560","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-195","76420-195-60","76420-195_e9294cf2-886b-1f04-e053-2995a90a3984","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"9300","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420019590","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-195","76420-195-90","76420-195_e9294cf2-886b-1f04-e053-2995a90a3984","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"9301","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420019530","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-195","76420-195-30","76420-195_e9294cf2-886b-1f04-e053-2995a90a3984","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20050406","","ANDA","ANDA077066","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20251231"
"9302","ERYTHROMYCIN","Erythromycin","76420019603","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","76420-196","76420-196-03","76420-196_d1fbbd69-37b7-7ae4-e053-2a95a90a8398","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","19940729","","ANDA","ANDA064067","Asclemed USA, Inc.","5","mg/g","","N","20251231"
"9303","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420020201","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-202","76420-202-01","76420-202_fab215a4-0e6e-767a-e053-6294a90a89ed","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Asclemed USA, Inc.","300","mg/1","","N","20251231"
"9304","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420020212","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-202","76420-202-12","76420-202_fab215a4-0e6e-767a-e053-6294a90a89ed","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Asclemed USA, Inc.","300","mg/1","","N","20251231"
"9305","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420020220","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-202","76420-202-20","76420-202_fab215a4-0e6e-767a-e053-6294a90a89ed","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Asclemed USA, Inc.","300","mg/1","","N","20251231"
"9306","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420020260","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-202","76420-202-60","76420-202_fab215a4-0e6e-767a-e053-6294a90a89ed","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Asclemed USA, Inc.","300","mg/1","","N","20251231"
"9307","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420020290","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-202","76420-202-90","76420-202_fab215a4-0e6e-767a-e053-6294a90a89ed","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Asclemed USA, Inc.","300","mg/1","","N","20251231"
"9308","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420020230","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-202","76420-202-30","76420-202_fab215a4-0e6e-767a-e053-6294a90a89ed","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Asclemed USA, Inc.","300","mg/1","","N","20251231"
"9309","SILVER SULFADIAZINE","Silver Sulfadiazine","76420020825","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","76420-208","76420-208-25","76420-208_d9c1d5d3-ee58-76e3-e053-2995a90ae559","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","20110504","","NDA","NDA018578","Asclemed USA, Inc.","10","g/1000g","","N","20251231"
"9310","SILVER SULFADIAZINE","Silver Sulfadiazine","76420020850","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","76420-208","76420-208-50","76420-208_d9c1d5d3-ee58-76e3-e053-2995a90ae559","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","20110504","","NDA","NDA018578","Asclemed USA, Inc.","10","g/1000g","","N","20251231"
"9311","ERYTHROMYCIN","Erythromycin","76420021230","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","76420-212","76420-212-30","76420-212_d9ae93e7-f4a8-1df3-e053-2a95a90ae5b1","HUMAN PRESCRIPTION DRUG","Erythromycin","","OINTMENT","OPHTHALMIC","19960718","","ANDA","ANDA064030","Asclemed USA, Inc.","5","mg/g","","N","20251231"
"9312","AZITHROMYCIN DIHYDRATE","Azithromycin","76420021306","Macrolide Antimicrobial [EPC], Macrolides [CS]","76420-213","76420-213-06","76420-213_23b371e7-b120-3dc4-e063-6294a90a585d","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20051114","","ANDA","ANDA065211","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9313","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","76420021406","Quinolone Antimicrobial [EPC], Quinolones [CS]","76420-214","76420-214-06","76420-214_d9b54ffb-864f-1ca8-e053-2995a90a5144","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9314","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","76420021414","Quinolone Antimicrobial [EPC], Quinolones [CS]","76420-214","76420-214-14","76420-214_d9b54ffb-864f-1ca8-e053-2995a90a5144","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9315","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","76420021420","Quinolone Antimicrobial [EPC], Quinolones [CS]","76420-214","76420-214-20","76420-214_d9b54ffb-864f-1ca8-e053-2995a90a5144","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9316","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","76420021430","Quinolone Antimicrobial [EPC], Quinolones [CS]","76420-214","76420-214-30","76420-214_d9b54ffb-864f-1ca8-e053-2995a90a5144","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9317","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","76420021410","Quinolone Antimicrobial [EPC], Quinolones [CS]","76420-214","76420-214-10","76420-214_d9b54ffb-864f-1ca8-e053-2995a90a5144","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA076558","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9318","GENTAMICIN SULFATE","Gentamicin Sulfate","76420025405","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","76420-254","76420-254-05","76420-254_e425b6aa-1415-785f-e053-2a95a90a4350","HUMAN PRESCRIPTION DRUG","Gentamicin Sulfate","","SOLUTION/ DROPS","OPHTHALMIC","19940511","","ANDA","ANDA064048","Asclemed USA, Inc.","3","mg/mL","","N","20251231"
"9319","CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE","ciprofloxacin hydrochloride and hydrocortisone","76420027310","Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Quinolone Antimicrobial [EPC], Quinolones [CS]","76420-273","76420-273-10","76420-273_e80fc4b5-cf91-6430-e053-2995a90a8128","HUMAN PRESCRIPTION DRUG","CIPRO","HC","SUSPENSION/ DROPS","AURICULAR (OTIC)","19990315","","NDA","NDA020805","Asclemed USA, Inc.","2; 10","mg/mL; mg/mL","","N","20251231"
"9320","CEPHALEXIN","Cephalexin","76420028701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-287","76420-287-01","76420-287_e9294cf2-8837-1f04-e053-2995a90a3984","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9321","CEPHALEXIN","Cephalexin","76420028801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-288","76420-288-01","76420-288_e9294cf2-8837-1f04-e053-2995a90a3984","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9322","CEFDINIR","Cefdinir","76420032701","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-327","76420-327-01","76420-327_331b63bf-fd36-155d-e063-6294a90aec23","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20060531","","ANDA","ANDA065259","Asclemed USA, Inc.","125","mg/5mL","","N","20261231"
"9323","CEFDINIR","Cefdinir","76420032760","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-327","76420-327-60","76420-327_331b63bf-fd36-155d-e063-6294a90aec23","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20060531","","ANDA","ANDA065259","Asclemed USA, Inc.","125","mg/5mL","","N","20261231"
"9324","CEFDINIR","Cefdinir","76420032860","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-328","76420-328-60","76420-328_331b63bf-fd36-155d-e063-6294a90aec23","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070507","","ANDA","ANDA065259","Asclemed USA, Inc.","250","mg/5mL","","N","20261231"
"9325","CEFDINIR","Cefdinir","76420032801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-328","76420-328-01","76420-328_331b63bf-fd36-155d-e063-6294a90aec23","HUMAN PRESCRIPTION DRUG","Cefdinir","","POWDER, FOR SUSPENSION","ORAL","20070507","","ANDA","ANDA065259","Asclemed USA, Inc.","250","mg/5mL","","N","20261231"
"9326","MOXIFLOXACIN HYDROCHLORIDE","Moxifloxacin Hydrochloride","76420033103","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-331","76420-331-03","76420-331_331b69c5-5ad7-a90a-e063-6394a90acfd6","HUMAN PRESCRIPTION DRUG","Moxifloxacin Hydrochloride","","SOLUTION","OPHTHALMIC","20210210","","ANDA","ANDA212616","Asclemed USA, Inc.","5","mg/mL","","N","20261231"
"9327","CEPHALEXIN","Cephalexin","76420038020","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-380","76420-380-20","76420-380_37fd1346-326e-c502-e063-6394a90a7427","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210721","","ANDA","ANDA065229","ASCLEMED USA INC.","500","mg/1","","N","20261231"
"9328","CEPHALEXIN","Cephalexin","76420038021","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-380","76420-380-21","76420-380_37fd1346-326e-c502-e063-6394a90a7427","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210721","","ANDA","ANDA065229","ASCLEMED USA INC.","500","mg/1","","N","20261231"
"9329","CEPHALEXIN","Cephalexin","76420038028","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-380","76420-380-28","76420-380_37fd1346-326e-c502-e063-6394a90a7427","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210721","","ANDA","ANDA065229","ASCLEMED USA INC.","500","mg/1","","N","20261231"
"9330","CEPHALEXIN","Cephalexin","76420038030","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-380","76420-380-30","76420-380_37fd1346-326e-c502-e063-6394a90a7427","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210721","","ANDA","ANDA065229","ASCLEMED USA INC.","500","mg/1","","N","20261231"
"9331","CEPHALEXIN","Cephalexin","76420038014","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-380","76420-380-14","76420-380_37fd1346-326e-c502-e063-6394a90a7427","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210721","","ANDA","ANDA065229","ASCLEMED USA INC.","500","mg/1","","N","20261231"
"9332","CEPHALEXIN","Cephalexin","76420038130","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-381","76420-381-30","76420-381_37fcfb65-1e95-e2ba-e063-6294a90a2022","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20190819","","ANDA","ANDA090836","ASCLEMED USA INC.","250","mg/1","","N","20261231"
"9333","CEPHALEXIN","Cephalexin","76420038140","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-381","76420-381-40","76420-381_37fcfb65-1e95-e2ba-e063-6294a90a2022","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20190819","","ANDA","ANDA090836","ASCLEMED USA INC.","250","mg/1","","N","20261231"
"9334","CEPHALEXIN","Cephalexin","76420038128","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-381","76420-381-28","76420-381_37fcfb65-1e95-e2ba-e063-6294a90a2022","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20190819","","ANDA","ANDA090836","ASCLEMED USA INC.","250","mg/1","","N","20261231"
"9335","AZITHROMYCIN MONOHYDRATE","Azithromycin","76420040306","Macrolide Antimicrobial [EPC], Macrolides [CS]","76420-403","76420-403-06","76420-403_37fce346-d60a-f2b1-e063-6294a90a632b","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065225","ASCLEMED USA INC.","250","mg/1","","N","20261231"
"9336","AZITHROMYCIN DIHYDRATE","Azithromycin","76420040406","Macrolide Antimicrobial [EPC], Macrolides [CS]","76420-404","76420-404-06","76420-404_37fd3847-b883-06dc-e063-6394a90ad234","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20051114","","ANDA","ANDA065211","ASCLEMED USA INC.","250","mg/1","","N","20261231"
"9337","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","76420040501","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","76420-405","76420-405-01","76420-405_3810e86a-b46f-14d1-e063-6394a90a1ae7","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","ASCLEMED USA INC.","800; 160","mg/1; mg/1","","N","20261231"
"9338","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","76420040505","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","76420-405","76420-405-05","76420-405_3810e86a-b46f-14d1-e063-6394a90a1ae7","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","ASCLEMED USA INC.","800; 160","mg/1; mg/1","","N","20261231"
"9339","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","76420040510","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","76420-405","76420-405-10","76420-405_3810e86a-b46f-14d1-e063-6394a90a1ae7","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","ASCLEMED USA INC.","800; 160","mg/1; mg/1","","N","20261231"
"9340","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","76420040514","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","76420-405","76420-405-14","76420-405_3810e86a-b46f-14d1-e063-6394a90a1ae7","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","ASCLEMED USA INC.","800; 160","mg/1; mg/1","","N","20261231"
"9341","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","76420040520","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","76420-405","76420-405-20","76420-405_3810e86a-b46f-14d1-e063-6394a90a1ae7","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","ASCLEMED USA INC.","800; 160","mg/1; mg/1","","N","20261231"
"9342","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","76420040506","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","76420-405","76420-405-06","76420-405_3810e86a-b46f-14d1-e063-6394a90a1ae7","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","ASCLEMED USA INC.","800; 160","mg/1; mg/1","","N","20261231"
"9343","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","76420040530","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","76420-405","76420-405-30","76420-405_3810e86a-b46f-14d1-e063-6394a90a1ae7","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","ASCLEMED USA INC.","800; 160","mg/1; mg/1","","N","20261231"
"9344","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","76420040528","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","76420-405","76420-405-28","76420-405_3810e86a-b46f-14d1-e063-6394a90a1ae7","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","ASCLEMED USA INC.","800; 160","mg/1; mg/1","","N","20261231"
"9345","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","76420050120","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","76420-501","76420-501-20","76420-501_1ad2509a-4b56-b766-e063-6294a90a3d7c","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20200501","","ANDA","ANDA065063","Asclemed USA, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"9346","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","76420050330","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","76420-503","76420-503-30","76420-503_1ad2509a-4b56-b766-e063-6294a90a3d7c","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20151101","","ANDA","ANDA065189","Asclemed USA, Inc.","250; 125","mg/1; mg/1","","N","20251231"
"9347","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","76420050720","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","76420-507","76420-507-20","76420-507_1ad2509a-4b56-b766-e063-6294a90a3d7c","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20151101","","ANDA","ANDA065064","Asclemed USA, Inc.","500; 125","mg/1; mg/1","","N","20251231"
"9348","AMOXICILLIN","Amoxicillin","76420050850","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-508","76420-508-50","76420-508_ec75f13d-67a5-ddb2-e053-2a95a90a1b69","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9349","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","76420052920","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","76420-529","76420-529-20","76420-529_efb3276f-d284-59b5-e053-2a95a90ab9fb","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065096","Asclemed USA, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"9350","AMOXICILLIN","Amoxicillin","76420054550","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-545","76420-545-50","76420-545_f7278cd0-99b5-9e8e-e053-6294a90a66e7","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","19900930","","ANDA","ANDA061926","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9351","AMOXICILLIN","Amoxicillin","76420057315","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-573","76420-573-15","76420-573_fe4d14a5-07d5-9345-e053-6294a90a78b2","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA061931","Asclemed USA, Inc.","250","mg/5mL","","N","20251231"
"9352","AMOXICILLIN","Amoxicillin","76420057380","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-573","76420-573-80","76420-573_fe4d14a5-07d5-9345-e053-6294a90a78b2","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA061931","Asclemed USA, Inc.","250","mg/5mL","","N","20251231"
"9353","AMOXICILLIN","Amoxicillin","76420057310","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-573","76420-573-10","76420-573_fe4d14a5-07d5-9345-e053-6294a90a78b2","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","19900930","","ANDA","ANDA061931","Asclemed USA, Inc.","250","mg/5mL","","N","20251231"
"9354","FLUCONAZOLE","FLUCONAZOLE","76420058701","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","76420-587","76420-587-01","76420-587_044738e8-265d-d820-e063-6394a90a9e68","HUMAN PRESCRIPTION DRUG","FLUCONAZOLE","","TABLET","ORAL","20040729","","ANDA","ANDA076665","Asclemed USA, Inc.","150","mg/1","","N","20251231"
"9355","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","76420058802","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-588","76420-588-02","76420-588_045968a3-3bad-28cf-e063-6394a90a4fe1","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","SOLUTION","OPHTHALMIC","20181101","","ANDA","ANDA077568","Asclemed USA, Inc.","3","mg/mL","","N","20251231"
"9356","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","76420058810","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-588","76420-588-10","76420-588_045968a3-3bad-28cf-e063-6394a90a4fe1","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","SOLUTION","OPHTHALMIC","20181101","","ANDA","ANDA077568","Asclemed USA, Inc.","3","mg/mL","","N","20251231"
"9357","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","76420058805","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-588","76420-588-05","76420-588_045968a3-3bad-28cf-e063-6394a90a4fe1","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","SOLUTION","OPHTHALMIC","20181101","","ANDA","ANDA077568","Asclemed USA, Inc.","3","mg/mL","","N","20251231"
"9358","AZITHROMYCIN MONOHYDRATE","Azithromycin","76420058903","Macrolide Antimicrobial [EPC], Macrolides [CS]","76420-589","76420-589-03","76420-589_04472220-f8c1-1f1a-e063-6294a90a2bb2","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065223","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9359","CEPHALEXIN","Cephalexin","76420059210","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-592","76420-592-10","76420-592_044738e8-2630-d820-e063-6394a90a9e68","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9360","CEPHALEXIN","Cephalexin","76420059310","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-593","76420-593-10","76420-593_044738e8-2630-d820-e063-6394a90a9e68","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Asclemed USA, Inc.","333","mg/1","","N","20251231"
"9361","CEPHALEXIN","Cephalexin","76420059410","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-594","76420-594-10","76420-594_044738e8-2630-d820-e063-6394a90a9e68","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110120","","ANDA","ANDA090836","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9362","CEPHALEXIN","Cephalexin","76420059510","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-595","76420-595-10","76420-595_044738e8-2630-d820-e063-6394a90a9e68","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20120604","","ANDA","ANDA090836","Asclemed USA, Inc.","750","mg/1","","N","20251231"
"9363","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","76420059610","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-596","76420-596-10","76420-596_045b6441-f12b-f2b4-e063-6394a90ad0ac","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170630","","ANDA","ANDA203702","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9364","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","76420059601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-596","76420-596-01","76420-596_045b6441-f12b-f2b4-e063-6394a90ad0ac","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170630","","ANDA","ANDA203702","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9365","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","76420060701","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","76420-607","76420-607-01","76420-607_04ab2de4-f463-1b52-e063-6394a90a5fc6","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","Asclemed USA, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"9366","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","76420060720","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","76420-607","76420-607-20","76420-607_04ab2de4-f463-1b52-e063-6394a90a5fc6","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","Asclemed USA, Inc.","875; 125","mg/1; mg/1","","N","20251231"
"9367","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","76420060820","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","76420-608","76420-608-20","76420-608_04ab2de4-f498-1b52-e063-6394a90a5fc6","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20021031","","ANDA","ANDA065101","Asclemed USA, Inc.","500; 125","mg/1; mg/1","","N","20251231"
"9368","ERYTHROMYCIN","erythromycin","76420061203","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","76420-612","76420-612-03","76420-612_0523a539-bb30-676e-e063-6394a90af39b","HUMAN PRESCRIPTION DRUG","erythromycin","","OINTMENT","OPHTHALMIC","20140508","","ANDA","ANDA062447","Asclemed USA, Inc.","5","mg/g","","N","20251231"
"9369","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061412","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-614","76420-614-12","76420-614_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","300","mg/1","","N","20251231"
"9370","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061420","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-614","76420-614-20","76420-614_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","300","mg/1","","N","20251231"
"9371","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061421","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-614","76420-614-21","76420-614_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","300","mg/1","","N","20251231"
"9372","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061430","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-614","76420-614-30","76420-614_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","300","mg/1","","N","20251231"
"9373","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061460","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-614","76420-614-60","76420-614_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","300","mg/1","","N","20251231"
"9374","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061490","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-614","76420-614-90","76420-614_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","300","mg/1","","N","20251231"
"9375","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061401","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-614","76420-614-01","76420-614_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","300","mg/1","","N","20251231"
"9376","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061501","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-615","76420-615-01","76420-615_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","75","mg/1","","N","20251231"
"9377","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061512","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-615","76420-615-12","76420-615_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","75","mg/1","","N","20251231"
"9378","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061520","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-615","76420-615-20","76420-615_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","75","mg/1","","N","20251231"
"9379","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061530","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-615","76420-615-30","76420-615_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","75","mg/1","","N","20251231"
"9380","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061560","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-615","76420-615-60","76420-615_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","75","mg/1","","N","20251231"
"9381","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061590","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-615","76420-615-90","76420-615_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","75","mg/1","","N","20251231"
"9382","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061521","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-615","76420-615-21","76420-615_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","75","mg/1","","N","20251231"
"9383","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061612","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-616","76420-616-12","76420-616_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","150","mg/1","","N","20251231"
"9384","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061620","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-616","76420-616-20","76420-616_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","150","mg/1","","N","20251231"
"9385","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061621","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-616","76420-616-21","76420-616_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","150","mg/1","","N","20251231"
"9386","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061630","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-616","76420-616-30","76420-616_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","150","mg/1","","N","20251231"
"9387","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061660","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-616","76420-616-60","76420-616_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","150","mg/1","","N","20251231"
"9388","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061690","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-616","76420-616-90","76420-616_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","150","mg/1","","N","20251231"
"9389","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","76420061601","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","76420-616","76420-616-01","76420-616_054ad3e6-3c9c-e6d2-e063-6294a90ab46f","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20190107","","ANDA","ANDA207402","Asclemed USA, Inc.","150","mg/1","","N","20251231"
"9390","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","76420064301","Antimalarial [EPC], Antirheumatic Agent [EPC]","76420-643","76420-643-01","76420-643_091085d0-27cf-a5cc-e063-6294a90a78ce","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20190905","","ANDA","ANDA210959","Asclemed USA, Inc.","200","mg/1","","N","20251231"
"9391","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","76420064360","Antimalarial [EPC], Antirheumatic Agent [EPC]","76420-643","76420-643-60","76420-643_091085d0-27cf-a5cc-e063-6294a90a78ce","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20190905","","ANDA","ANDA210959","Asclemed USA, Inc.","200","mg/1","","N","20251231"
"9392","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","76420064390","Antimalarial [EPC], Antirheumatic Agent [EPC]","76420-643","76420-643-90","76420-643_091085d0-27cf-a5cc-e063-6294a90a78ce","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20190905","","ANDA","ANDA210959","Asclemed USA, Inc.","200","mg/1","","N","20251231"
"9393","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","76420064330","Antimalarial [EPC], Antirheumatic Agent [EPC]","76420-643","76420-643-30","76420-643_091085d0-27cf-a5cc-e063-6294a90a78ce","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20190905","","ANDA","ANDA210959","Asclemed USA, Inc.","200","mg/1","","N","20251231"
"9394","AZITHROMYCIN DIHYDRATE","Azithromycin","76420064906","Macrolide Antimicrobial [EPC], Macrolides [CS]","76420-649","76420-649-06","76420-649_0dc7bda4-7a99-9041-e063-6294a90a5157","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20220411","","ANDA","ANDA210000","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9395","CEPHALEXIN","Cephalexin","76420073600","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-736","76420-736-00","76420-736_1b62bc14-7a3a-dd94-e063-6294a90a84ba","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210720","","ANDA","ANDA065229","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9396","CEPHALEXIN","Cephalexin","76420073601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-736","76420-736-01","76420-736_1b62bc14-7a3a-dd94-e063-6294a90a84ba","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210720","","ANDA","ANDA065229","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9397","CEPHALEXIN","Cephalexin","76420073620","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-736","76420-736-20","76420-736_1b62bc14-7a3a-dd94-e063-6294a90a84ba","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210720","","ANDA","ANDA065229","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9398","CEPHALEXIN","Cephalexin","76420073621","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-736","76420-736-21","76420-736_1b62bc14-7a3a-dd94-e063-6294a90a84ba","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210720","","ANDA","ANDA065229","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9399","CEPHALEXIN","Cephalexin","76420073628","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-736","76420-736-28","76420-736_1b62bc14-7a3a-dd94-e063-6294a90a84ba","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210720","","ANDA","ANDA065229","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9400","CEPHALEXIN","Cephalexin","76420073614","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-736","76420-736-14","76420-736_1b62bc14-7a3a-dd94-e063-6294a90a84ba","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210720","","ANDA","ANDA065229","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9401","CEPHALEXIN","Cephalexin","76420073640","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-736","76420-736-40","76420-736_1b62bc14-7a3a-dd94-e063-6294a90a84ba","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210720","","ANDA","ANDA065229","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9402","CEPHALEXIN","Cephalexin","76420073630","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-736","76420-736-30","76420-736_1b62bc14-7a3a-dd94-e063-6294a90a84ba","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210720","","ANDA","ANDA065229","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9403","OFLOXACIN","ofloxacin otic","76420074805","Quinolone Antimicrobial [EPC], Quinolones [CS]","76420-748","76420-748-05","76420-748_1aaaf971-7d69-9422-e063-6394a90a2a69","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION","AURICULAR (OTIC)","20220715","","ANDA","ANDA216130","Asclemed USA, Inc.","3","mg/mL","","N","20251231"
"9404","OFLOXACIN","ofloxacin otic","76420074910","Quinolone Antimicrobial [EPC], Quinolones [CS]","76420-749","76420-749-10","76420-749_1aaaf971-7d69-9422-e063-6394a90a2a69","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION","AURICULAR (OTIC)","20220715","","ANDA","ANDA216130","Asclemed USA, Inc.","3","mg/mL","","N","20251231"
"9405","CEPHALEXIN","Cephalexin","76420075428","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-754","76420-754-28","76420-754_1bb09c78-f794-4b3b-e063-6394a90a8936","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20190819","","ANDA","ANDA090836","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9406","CEPHALEXIN","Cephalexin","76420075430","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-754","76420-754-30","76420-754_1bb09c78-f794-4b3b-e063-6394a90a8936","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20190819","","ANDA","ANDA090836","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9407","CEPHALEXIN","Cephalexin","76420075440","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-754","76420-754-40","76420-754_1bb09c78-f794-4b3b-e063-6394a90a8936","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20190819","","ANDA","ANDA090836","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9408","TOBRAMYCIN","Tobramycin","76420079105","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","76420-791","76420-791-05","76420-791_14111f01-7d9a-6602-e063-6294a90a47a8","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","OPHTHALMIC","19931129","","ANDA","ANDA064052","Asclemed USA, Inc.","3","mg/mL","","N","20251231"
"9409","METRONIDAZOLE","metronidazole","76420080001","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","76420-800","76420-800-01","76420-800_174d0504-a4e2-2f2a-e063-6394a90a1390","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9410","METRONIDAZOLE","metronidazole","76420080021","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","76420-800","76420-800-21","76420-800_174d0504-a4e2-2f2a-e063-6394a90a1390","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9411","METRONIDAZOLE","metronidazole","76420080025","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","76420-800","76420-800-25","76420-800_174d0504-a4e2-2f2a-e063-6394a90a1390","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9412","METRONIDAZOLE","metronidazole","76420080030","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","76420-800","76420-800-30","76420-800_174d0504-a4e2-2f2a-e063-6394a90a1390","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9413","METRONIDAZOLE","metronidazole","76420080060","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","76420-800","76420-800-60","76420-800_174d0504-a4e2-2f2a-e063-6394a90a1390","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9414","METRONIDAZOLE","metronidazole","76420080090","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","76420-800","76420-800-90","76420-800_174d0504-a4e2-2f2a-e063-6394a90a1390","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9415","METRONIDAZOLE","metronidazole","76420080005","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","76420-800","76420-800-05","76420-800_174d0504-a4e2-2f2a-e063-6394a90a1390","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9416","METRONIDAZOLE","metronidazole","76420080105","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","76420-801","76420-801-05","76420-801_174d0504-a4e2-2f2a-e063-6394a90a1390","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9417","METRONIDAZOLE","metronidazole","76420080121","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","76420-801","76420-801-21","76420-801_174d0504-a4e2-2f2a-e063-6394a90a1390","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9418","METRONIDAZOLE","metronidazole","76420080130","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","76420-801","76420-801-30","76420-801_174d0504-a4e2-2f2a-e063-6394a90a1390","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9419","METRONIDAZOLE","metronidazole","76420080101","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","76420-801","76420-801-01","76420-801_174d0504-a4e2-2f2a-e063-6394a90a1390","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9420","METRONIDAZOLE","metronidazole","76420080160","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","76420-801","76420-801-60","76420-801_174d0504-a4e2-2f2a-e063-6394a90a1390","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9421","METRONIDAZOLE","metronidazole","76420080190","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","76420-801","76420-801-90","76420-801_174d0504-a4e2-2f2a-e063-6394a90a1390","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9422","METRONIDAZOLE","metronidazole","76420080150","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","76420-801","76420-801-50","76420-801_174d0504-a4e2-2f2a-e063-6394a90a1390","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20190223","","ANDA","ANDA206560","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9423","AMOXICILLIN","Amoxicillin","76420081901","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-819","76420-819-01","76420-819_1bc435f9-12b8-ccff-e063-6294a90a951a","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065378","Asclemed USA, Inc.","400","mg/5mL","","N","20251231"
"9424","AMOXICILLIN","Amoxicillin","76420081975","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-819","76420-819-75","76420-819_1bc435f9-12b8-ccff-e063-6294a90a951a","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065378","Asclemed USA, Inc.","400","mg/5mL","","N","20251231"
"9425","AMOXICILLIN","Amoxicillin","76420081950","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-819","76420-819-50","76420-819_1bc435f9-12b8-ccff-e063-6294a90a951a","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20070326","","ANDA","ANDA065378","Asclemed USA, Inc.","400","mg/5mL","","N","20251231"
"9426","CEPHALEXIN","Cephalexin","76420083130","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-831","76420-831-30","76420-831_247cf995-f553-60a9-e063-6394a90ad8d1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20230907","","ANDA","ANDA065229","Asclemed USA, Inc","500","mg/1","","N","20251231"
"9427","CEPHALEXIN","Cephalexin","76420083140","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-831","76420-831-40","76420-831_247cf995-f553-60a9-e063-6394a90ad8d1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20230907","","ANDA","ANDA065229","Asclemed USA, Inc","500","mg/1","","N","20251231"
"9428","CEPHALEXIN","Cephalexin","76420083142","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-831","76420-831-42","76420-831_247cf995-f553-60a9-e063-6394a90ad8d1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20230907","","ANDA","ANDA065229","Asclemed USA, Inc","500","mg/1","","N","20251231"
"9429","CEPHALEXIN","Cephalexin","76420083110","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","76420-831","76420-831-10","76420-831_247cf995-f553-60a9-e063-6394a90ad8d1","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20230907","","ANDA","ANDA065229","Asclemed USA, Inc","500","mg/1","","N","20251231"
"9430","AMOXICILLIN","Amoxicillin","76420083205","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-832","76420-832-05","76420-832_1f9dd2b3-12f6-c5c3-e063-6294a90a8065","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9431","AMOXICILLIN","Amoxicillin","76420083220","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-832","76420-832-20","76420-832_1f9dd2b3-12f6-c5c3-e063-6294a90a8065","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9432","AMOXICILLIN","Amoxicillin","76420083230","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-832","76420-832-30","76420-832_1f9dd2b3-12f6-c5c3-e063-6294a90a8065","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9433","AMOXICILLIN","Amoxicillin","76420083250","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-832","76420-832-50","76420-832_1f9dd2b3-12f6-c5c3-e063-6294a90a8065","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9434","AMOXICILLIN","Amoxicillin","76420083201","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-832","76420-832-01","76420-832_1f9dd2b3-12f6-c5c3-e063-6294a90a8065","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Asclemed USA, Inc.","250","mg/1","","N","20251231"
"9435","AMOXICILLIN","Amoxicillin","76420083301","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-833","76420-833-01","76420-833_1f9dd2b3-12f6-c5c3-e063-6294a90a8065","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9436","AMOXICILLIN","Amoxicillin","76420083305","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-833","76420-833-05","76420-833_1f9dd2b3-12f6-c5c3-e063-6294a90a8065","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9437","AMOXICILLIN","Amoxicillin","76420083330","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-833","76420-833-30","76420-833_1f9dd2b3-12f6-c5c3-e063-6294a90a8065","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9438","AMOXICILLIN","Amoxicillin","76420083350","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-833","76420-833-50","76420-833_1f9dd2b3-12f6-c5c3-e063-6294a90a8065","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9439","AMOXICILLIN","Amoxicillin","76420083320","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-833","76420-833-20","76420-833_1f9dd2b3-12f6-c5c3-e063-6294a90a8065","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20051109","","ANDA","ANDA065271","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9440","AMOXICILLIN","Amoxicillin","76420083801","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-838","76420-838-01","76420-838_203ead37-92bb-9348-e063-6294a90ab111","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9441","AMOXICILLIN","Amoxicillin","76420083820","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-838","76420-838-20","76420-838_203ead37-92bb-9348-e063-6294a90ab111","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, FILM COATED","ORAL","20051109","","ANDA","ANDA065256","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9442","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","76420085005","Antimalarial [EPC], Antirheumatic Agent [EPC]","76420-850","76420-850-05","76420-850_21587ffd-a2a5-f093-e063-6394a90a6658","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20191001","","ANDA","ANDA040657","Asclemed USA, Inc.","200","mg/1","","N","20251231"
"9443","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","76420085030","Antimalarial [EPC], Antirheumatic Agent [EPC]","76420-850","76420-850-30","76420-850_21587ffd-a2a5-f093-e063-6394a90a6658","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20191001","","ANDA","ANDA040657","Asclemed USA, Inc.","200","mg/1","","N","20251231"
"9444","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","76420085060","Antimalarial [EPC], Antirheumatic Agent [EPC]","76420-850","76420-850-60","76420-850_21587ffd-a2a5-f093-e063-6394a90a6658","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20191001","","ANDA","ANDA040657","Asclemed USA, Inc.","200","mg/1","","N","20251231"
"9445","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","76420085090","Antimalarial [EPC], Antirheumatic Agent [EPC]","76420-850","76420-850-90","76420-850_21587ffd-a2a5-f093-e063-6394a90a6658","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20191001","","ANDA","ANDA040657","Asclemed USA, Inc.","200","mg/1","","N","20251231"
"9446","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","76420085001","Antimalarial [EPC], Antirheumatic Agent [EPC]","76420-850","76420-850-01","76420-850_21587ffd-a2a5-f093-e063-6394a90a6658","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20191001","","ANDA","ANDA040657","Asclemed USA, Inc.","200","mg/1","","N","20251231"
"9447","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","76420085950","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","76420-859","76420-859-50","76420-859_25322eee-f92a-5838-e063-6394a90aa376","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","Asclemed USA, Inc.","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"9448","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","76420085975","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","76420-859","76420-859-75","76420-859_25322eee-f92a-5838-e063-6394a90aa376","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","Asclemed USA, Inc.","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"9449","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","76420085901","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","76420-859","76420-859-01","76420-859_25322eee-f92a-5838-e063-6394a90aa376","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","Asclemed USA, Inc.","200; 28.5","mg/5mL; mg/5mL","","N","20251231"
"9450","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","76420086401","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","76420-864","76420-864-01","76420-864_25322eee-f92a-5838-e063-6394a90aa376","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","Asclemed USA, Inc.","400; 57","mg/5mL; mg/5mL","","N","20251231"
"9451","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","76420086475","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","76420-864","76420-864-75","76420-864_25322eee-f92a-5838-e063-6394a90aa376","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","Asclemed USA, Inc.","400; 57","mg/5mL; mg/5mL","","N","20251231"
"9452","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","76420086450","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","76420-864","76420-864-50","76420-864_25322eee-f92a-5838-e063-6394a90aa376","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201090","Asclemed USA, Inc.","400; 57","mg/5mL; mg/5mL","","N","20251231"
"9453","AMOXICILLIN","Amoxicillin","76420087105","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-871","76420-871-05","76420-871_26377eb9-ab0a-505d-e063-6394a90af5db","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20171212","","ANDA","ANDA065271","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9454","AMOXICILLIN","Amoxicillin","76420087106","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-871","76420-871-06","76420-871_26377eb9-ab0a-505d-e063-6394a90af5db","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20171212","","ANDA","ANDA065271","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9455","AMOXICILLIN","Amoxicillin","76420087107","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-871","76420-871-07","76420-871_26377eb9-ab0a-505d-e063-6394a90af5db","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20171212","","ANDA","ANDA065271","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9456","AMOXICILLIN","Amoxicillin","76420087103","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-871","76420-871-03","76420-871_26377eb9-ab0a-505d-e063-6394a90af5db","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20171212","","ANDA","ANDA065271","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9457","AMOXICILLIN","Amoxicillin","76420087109","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-871","76420-871-09","76420-871_26377eb9-ab0a-505d-e063-6394a90af5db","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20171212","","ANDA","ANDA065271","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9458","AMOXICILLIN","Amoxicillin","76420087108","Penicillin-class Antibacterial [EPC], Penicillins [CS]","76420-871","76420-871-08","76420-871_26377eb9-ab0a-505d-e063-6394a90af5db","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20171212","","ANDA","ANDA065271","Asclemed USA, Inc.","500","mg/1","","N","20251231"
"9459","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420088400","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-884","76420-884-00","76420-884_2b480a86-eebf-c37e-e063-6394a90ae54b","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20261231"
"9460","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420088401","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-884","76420-884-01","76420-884_2b480a86-eebf-c37e-e063-6394a90ae54b","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20261231"
"9461","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420088407","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-884","76420-884-07","76420-884_2b480a86-eebf-c37e-e063-6394a90ae54b","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20261231"
"9462","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420088412","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-884","76420-884-12","76420-884_2b480a86-eebf-c37e-e063-6394a90ae54b","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20261231"
"9463","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420088414","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-884","76420-884-14","76420-884_2b480a86-eebf-c37e-e063-6394a90ae54b","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20261231"
"9464","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420088420","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-884","76420-884-20","76420-884_2b480a86-eebf-c37e-e063-6394a90ae54b","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20261231"
"9465","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420088428","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-884","76420-884-28","76420-884_2b480a86-eebf-c37e-e063-6394a90ae54b","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20261231"
"9466","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420088430","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-884","76420-884-30","76420-884_2b480a86-eebf-c37e-e063-6394a90ae54b","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20261231"
"9467","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420088460","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-884","76420-884-60","76420-884_2b480a86-eebf-c37e-e063-6394a90ae54b","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20261231"
"9468","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420088490","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-884","76420-884-90","76420-884_2b480a86-eebf-c37e-e063-6394a90ae54b","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20261231"
"9469","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","76420088410","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","76420-884","76420-884-10","76420-884_2b480a86-eebf-c37e-e063-6394a90ae54b","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20220222","","ANDA","ANDA211013","Asclemed USA, Inc.","25; 75","mg/1; mg/1","","N","20261231"
"9470","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","76420092801","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-928","76420-928-01","76420-928_31646bd6-de78-bcbd-e063-6294a90a0e1b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Asclemed USA, Inc.","250","mg/1","","N","20261231"
"9471","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","76420092830","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-928","76420-928-30","76420-928_31646bd6-de78-bcbd-e063-6294a90a0e1b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Asclemed USA, Inc.","250","mg/1","","N","20261231"
"9472","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","76420092860","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-928","76420-928-60","76420-928_31646bd6-de78-bcbd-e063-6294a90a0e1b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Asclemed USA, Inc.","250","mg/1","","N","20261231"
"9473","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","76420092890","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-928","76420-928-90","76420-928_31646bd6-de78-bcbd-e063-6294a90a0e1b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Asclemed USA, Inc.","250","mg/1","","N","20261231"
"9474","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","76420092820","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-928","76420-928-20","76420-928_31646bd6-de78-bcbd-e063-6294a90a0e1b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Asclemed USA, Inc.","250","mg/1","","N","20261231"
"9475","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","76420092901","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-929","76420-929-01","76420-929_31646bd6-de78-bcbd-e063-6294a90a0e1b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Asclemed USA, Inc.","500","mg/1","","N","20261231"
"9476","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","76420092920","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-929","76420-929-20","76420-929_31646bd6-de78-bcbd-e063-6294a90a0e1b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Asclemed USA, Inc.","500","mg/1","","N","20261231"
"9477","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","76420092930","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-929","76420-929-30","76420-929_31646bd6-de78-bcbd-e063-6294a90a0e1b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Asclemed USA, Inc.","500","mg/1","","N","20261231"
"9478","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","76420092960","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-929","76420-929-60","76420-929_31646bd6-de78-bcbd-e063-6294a90a0e1b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Asclemed USA, Inc.","500","mg/1","","N","20261231"
"9479","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","76420092905","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-929","76420-929-05","76420-929_31646bd6-de78-bcbd-e063-6294a90a0e1b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Asclemed USA, Inc.","500","mg/1","","N","20261231"
"9480","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","76420092990","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-929","76420-929-90","76420-929_31646bd6-de78-bcbd-e063-6294a90a0e1b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Asclemed USA, Inc.","500","mg/1","","N","20261231"
"9481","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","76420094203","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-942","76420-942-03","76420-942_3175dedd-a620-17ae-e063-6294a90aa1e8","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20040507","","NDA AUTHORIZED GENERIC","NDA019992","Asclemed USA, Inc.","3","mg/mL","","N","20261231"
"9482","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","76420094205","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-942","76420-942-05","76420-942_3175dedd-a620-17ae-e063-6294a90aa1e8","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20040507","","NDA AUTHORIZED GENERIC","NDA019992","Asclemed USA, Inc.","3","mg/mL","","N","20261231"
"9483","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","76420094210","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","76420-942","76420-942-10","76420-942_3175dedd-a620-17ae-e063-6294a90aa1e8","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","SOLUTION/ DROPS","OPHTHALMIC","20040507","","NDA AUTHORIZED GENERIC","NDA019992","Asclemed USA, Inc.","3","mg/mL","","N","20261231"
"9484","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B","76436040211","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","76436-402","76436-402-11","76436-402_1d4f9c6a-f79d-22fc-e063-6394a90a5a3e","HUMAN OTC DRUG","SOFSKIN TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20240715","","OTC MONOGRAPH DRUG","M004","Viny Health and Beauty Products Inc","400; 5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"9485","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL","76436040311","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","76436-403","76436-403-11","76436-403_1d4fbdc6-1738-584b-e063-6394a90a5497","HUMAN OTC DRUG","SOFSKIN TRIPLE ANTIBIOTIC","PLUS PAIN RELIEF","OINTMENT","TOPICAL","20240715","","OTC MONOGRAPH DRUG","M004","Viny Health and Beauty Products Inc","500; 5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"9486","CHLORHEXIDINE DIGLUCONATE; METRONIDAZOLE","Mouthwash","76986000501","Decreased Cell Wall Integrity [PE], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","76986-005","76986-005-01","76986-005_2c1a7eed-6a7d-eeb2-e063-6394a90aafcc","HUMAN OTC DRUG","SEACALL Mouthwash","","LIQUID","ORAL","20250120","","OTC MONOGRAPH DRUG","M022","Guangdong Quadrant Ecological Technology Co., Ltd.",".6; .2","g/100mL; g/100mL","","N","20261231"
"9487","MICONAZOLE NITRATE","MICONAZOLE NITRATE","77338004125","Azole Antifungal [EPC], Azoles [CS]","77338-041","77338-041-25","77338-041_1bbb26c7-7122-8c78-e063-6394a90ae6a6","HUMAN OTC DRUG","MICONAZOLE Nitrate 2% Cream ANTIFUNGAL","","CREAM","TOPICAL","20160322","","OTC MONOGRAPH DRUG","M005","ASTONEA LABS PRIVATE LIMITED","2","g/100g","","N","20251231"
"9488","MICONAZOLE NITRATE","Antifungal","77338016503","Azole Antifungal [EPC], Azoles [CS]","77338-165","77338-165-03","77338-165_1bbac946-d7d1-b388-e063-6294a90a812e","HUMAN OTC DRUG","Astonea Miconazole nitrate","","POWDER","TOPICAL","20220819","","OTC MONOGRAPH DRUG","M005","ASTONEA LABS PRIVATE LIMITED","2","g/100g","","N","20251231"
"9489","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin,Neomycin,Polymxin, Pramoxine","77338022901","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","77338-229","77338-229-01","77338-229_0d8128c5-9bfb-c706-e063-6294a90a1aa0","HUMAN OTC DRUG","AstoneaTriple Antibiotic Pain Relief","","OINTMENT","TOPICAL","20230501","","OTC MONOGRAPH DRUG","M004","ASTONEA LABS PRIVATE LIMITED","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"9490","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate","77338030254","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","77338-302","77338-302-54","77338-302_1bbad68f-2934-5848-e063-6394a90a448d","HUMAN OTC DRUG","Astonea","First Aid","OINTMENT","TOPICAL","20220502","","OTC MONOGRAPH DRUG","M004","ASTONEA LABS PRIVATE LIMITED","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"9491","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate","77338030253","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","77338-302","77338-302-53","77338-302_1bbad68f-2934-5848-e063-6394a90a448d","HUMAN OTC DRUG","Astonea","First Aid","OINTMENT","TOPICAL","20220502","","OTC MONOGRAPH DRUG","M004","ASTONEA LABS PRIVATE LIMITED","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"9492","CLOTRIMAZOLE","Clotrimazole","77338031244","Azole Antifungal [EPC], Azoles [CS]","77338-312","77338-312-44","77338-312_1bbb0211-ebfc-bdeb-e063-6294a90af56a","HUMAN OTC DRUG","Astonea Clotrimazole 1%","Athletes Foot","CREAM","TOPICAL","20200304","","OTC MONOGRAPH DRUG","M005","ASTONEA LABS PRIVATE LIMITED","10","mg/g","","N","20251231"
"9493","CLOTRIMAZOLE","Clotrimazole","77338031248","Azole Antifungal [EPC], Azoles [CS]","77338-312","77338-312-48","77338-312_1bbb0211-ebfc-bdeb-e063-6294a90af56a","HUMAN OTC DRUG","Astonea Clotrimazole 1%","Athletes Foot","CREAM","TOPICAL","20200304","","OTC MONOGRAPH DRUG","M005","ASTONEA LABS PRIVATE LIMITED","10","mg/g","","N","20251231"
"9494","CLINDAMYCIN PHOSPHATE","clindamycin phosphate","78206018901","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","78206-189","78206-189-01","78206-189_11f9157a-6a2a-47f4-a674-a0be4155e3f4","HUMAN PRESCRIPTION DRUG","XACIATO","","GEL","VAGINAL","20231013","","NDA","NDA215650","Organon LLC","100","mg/5g","","N","20251231"
"9495","EFLORNITHINE HYDROCHLORIDE","EFLORNITHINE HYDROCHLORIDE","78670015001","Antiprotozoal [EPC], Decarboxylase Inhibitor [EPC], Decarboxylase Inhibitors [MoA]","78670-150","78670-150-01","78670-150_49c998c7-d0b4-4527-8e34-dc5edc59a40f","HUMAN PRESCRIPTION DRUG","iwilfin","","TABLET","ORAL","20240115","","NDA","NDA215500","USWM, LLC","250","mg/1","","N","20261231"
"9496","SULFACETAMIDE SODIUM; SULFUR","sulfacetamide sodium and sulfur","79043018008","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","79043-180","79043-180-08","79043-180_1cf9dc00-2292-18ac-e063-6394a90a4ec6","HUMAN PRESCRIPTION DRUG","Clenia Plus","Sodium Sulfacetamide - Sulfur","SUSPENSION","TOPICAL","20210310","","UNAPPROVED DRUG OTHER","","Scite Pharma, LLC","90; 42.5","mg/mL; mg/mL","","N","20251231"
"9497","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","79481008601","Benzylamine Antifungal [EPC], Benzylamines [CS]","79481-0086","79481-0086-1","79481-0086_2de3ce03-4b62-8386-e063-6294a90a4052","HUMAN OTC DRUG","Butenafine Hydrochloride","","CREAM","TOPICAL","20231130","","ANDA","ANDA205181","MEIJER DISTRIBUTION INC","10","mg/g","","N","20261231"
"9498","MICONAZOLE NITRATE","Miconazole Nitrate","79481050501","Azole Antifungal [EPC], Azoles [CS]","79481-0505","79481-0505-1","79481-0505_247518f5-fa3d-95b3-e063-6394a90abcaa","HUMAN OTC DRUG","Antifungal Athletes Foot","","AEROSOL, POWDER","TOPICAL","20230816","","OTC MONOGRAPH DRUG","M005","Meijer Distribution Inc","20","mg/g","","N","20251231"
"9499","MICONAZOLE NITRATE","Miconazole Nitrate","79481059901","Azole Antifungal [EPC], Azoles [CS]","79481-0599","79481-0599-1","79481-0599_24749154-29df-e123-e063-6394a90ad8da","HUMAN OTC DRUG","Antifungal Miconazole Liquid Continuous","","AEROSOL, SPRAY","TOPICAL","20230816","","OTC MONOGRAPH DRUG","M005","Meijer Distribution Inc","20","mg/g","","N","20251231"
"9500","MICONAZOLE NITRATE","Miconazole Nitrate","79481060201","Azole Antifungal [EPC], Azoles [CS]","79481-0602","79481-0602-1","79481-0602_247a8a89-9a79-7d71-e063-6394a90aaeb1","HUMAN OTC DRUG","Jock Itch","","AEROSOL, SPRAY","TOPICAL","20200801","","OTC MONOGRAPH DRUG","M005","Meijer Distribution Inc.","20","mg/g","","N","20251231"
"9501","MICONAZOLE NITRATE","Miconazole Nitrate","79481062101","Azole Antifungal [EPC], Azoles [CS]","79481-0621","79481-0621-1","79481-0621_24767957-72c9-b85e-e063-6394a90a0dd1","HUMAN OTC DRUG","Anti-fungal Powder Miconazole Nitrate","","POWDER","TOPICAL","20230828","","OTC MONOGRAPH DRUG","M005","Meijer Distribution Inc","20","mg/g","","N","20251231"
"9502","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin, Polymyxin B, Pramoxine HCl","79481080901","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","79481-0809","79481-0809-1","79481-0809_bab672c9-566d-4492-8320-d630cedf88d9","HUMAN OTC DRUG","first aid antibiotic and pain relief","","CREAM","TOPICAL","20210420","","OTC MONOGRAPH DRUG","M004","Meijer, Inc.","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"9503","NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Neomycin, Polymyxin B, Pramoxine HCl","79481080900","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","79481-0809","79481-0809-0","79481-0809_bab672c9-566d-4492-8320-d630cedf88d9","HUMAN OTC DRUG","first aid antibiotic and pain relief","","CREAM","TOPICAL","20210420","","OTC MONOGRAPH DRUG","M004","Meijer, Inc.","3.5; 10000; 10","mg/g; [USP'U]/g; mg/g","","N","20251231"
"9504","CLOTRIMAZOLE","Clotrimazole","79503010530","Azole Antifungal [EPC], Azoles [CS]","79503-105","79503-105-30","79503-105_fe3d0c53-d146-42ac-a550-a1d321dc88fc","HUMAN OTC DRUG","Clotrimazole Cream 1%","","CREAM","TOPICAL","20210819","20250701","OTC MONOGRAPH DRUG","M005","Ezricare Llc","10","mg/g","","N",""
"9505","MICONAZOLE NITRATE","Miconazole Nitrate","79503010630","Azole Antifungal [EPC], Azoles [CS]","79503-106","79503-106-30","79503-106_74714e6a-ccd9-46d4-9027-bd13eb29b897","HUMAN OTC DRUG","Miconazole Nitrate Cream 2%","","CREAM","TOPICAL","20210819","20250701","OTC MONOGRAPH DRUG","M005","Ezricare Llc","20","mg/g","","N",""
"9506","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate","79503010830","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","79503-108","79503-108-30","79503-108_f511b6b3-0601-4a64-97b0-41dfa9a435dd","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20210901","20250701","OTC MONOGRAPH DRUG","M004","Ezricare Llc","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N",""
"9507","MICONAZOLE NITRATE","Athletes Foot Powder Spray Talc Free","79903001446","Azole Antifungal [EPC], Azoles [CS]","79903-014","79903-014-46","79903-014_29681518-77a7-7eb0-e063-6394a90a0faa","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, POWDER","TOPICAL","20210301","","OTC MONOGRAPH DRUG","M005","Wal-Mart Stores, Inc","2.6","g/130g","","N","20251231"
"9508","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride","79903009301","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","79903-093","79903-093-01","79903-093_32b36188-4f8a-4172-a45c-83159e7a068f","HUMAN OTC DRUG","Equate Antibiotic Plus Pain, Itch, Scar Relief","","CREAM","TOPICAL","20211118","","OTC MONOGRAPH DRUG","M004","WalMart","500; 3.5; 10000; 10","[iU]/g; mg/g; [iU]/g; mg/g","","N","20261231"
"9509","CLINDAMYCIN PHOSPHATE","Clindamycin Phosphate Topical","80005013109","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","80005-131","80005-131-09","80005-131_92566a29-e1a5-4cd3-8625-bfef067a819f","HUMAN PRESCRIPTION DRUG","Clindamycin Phosphate","","SOLUTION","TOPICAL","20250616","","ANDA","ANDA219612","Carnegie Pharmaceuticals, LLC","10","mg/mL","","N","20261231"
"9510","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","80005015218","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","80005-152","80005-152-18","80005-152_ad0b7a24-6fae-4dfd-a308-4fd9c543d7e1","HUMAN PRESCRIPTION DRUG","E.E.S","","GRANULE, FOR SUSPENSION","ORAL","20250115","","NDA","NDA050207","Carnegie Pharmaceuticals LLC","200","mg/5mL","","N","20261231"
"9511","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","80005015334","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","80005-153","80005-153-34","80005-153_ad0b7a24-6fae-4dfd-a308-4fd9c543d7e1","HUMAN PRESCRIPTION DRUG","E.E.S","","GRANULE, FOR SUSPENSION","ORAL","20250115","","NDA","NDA050207","Carnegie Pharmaceuticals LLC","200","mg/5mL","","N","20261231"
"9512","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","80005015518","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","80005-155","80005-155-18","80005-155_d05c0828-9fce-4a60-a2ac-d9a1fbf17792","HUMAN PRESCRIPTION DRUG","Ery-Ped","","SUSPENSION","ORAL","20250115","","NDA","NDA050207","Carnegie Pharmaceuticals LLC","400","mg/5mL","","N","20261231"
"9513","ERYTHROMYCIN ETHYLSUCCINATE","Erythromycin Ethylsuccinate","80005016108","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","80005-161","80005-161-08","80005-161_ad0b7a24-6fae-4dfd-a308-4fd9c543d7e1","HUMAN PRESCRIPTION DRUG","E.E.S","400","TABLET","ORAL","20250115","","ANDA","ANDA061905","Carnegie Pharmaceuticals LLC","400","mg/1","","N","20261231"
"9514","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","80425000101","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","80425-0001","80425-0001-1","80425-0001_2a96f37d-03f7-678c-e063-6394a90ae0c6","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","DS","TABLET","ORAL","20100913","","ANDA","ANDA076899","Advanced Rx Pharmacy of Tennessee, LLC","800; 160","mg/1; mg/1","","N","20251231"
"9515","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","80425000201","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","80425-0002","80425-0002-1","80425-0002_2a9804bb-d5c4-5a9a-e063-6294a90a973d","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","DS","TABLET","ORAL","20100216","","ANDA","ANDA090624","Advanced Rx Pharmacy of Tennessee, LLC","800; 160","mg/1; mg/1","","N","20251231"
"9516","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","80425000302","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","80425-0003","80425-0003-2","80425-0003_2a98001f-209b-c78f-e063-6294a90a1067","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","DS","TABLET","ORAL","20100216","","ANDA","ANDA090624","Advanced Rx Pharmacy of Tennessee, LLC","800; 160","mg/1; mg/1","","N","20251231"
"9517","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","80425000303","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","80425-0003","80425-0003-3","80425-0003_2a98001f-209b-c78f-e063-6294a90a1067","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","DS","TABLET","ORAL","20100216","","ANDA","ANDA090624","Advanced Rx Pharmacy of Tennessee, LLC","800; 160","mg/1; mg/1","","N","20251231"
"9518","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","80425000304","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","80425-0003","80425-0003-4","80425-0003_2a98001f-209b-c78f-e063-6294a90a1067","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","DS","TABLET","ORAL","20100216","","ANDA","ANDA090624","Advanced Rx Pharmacy of Tennessee, LLC","800; 160","mg/1; mg/1","","N","20251231"
"9519","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","80425000301","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","80425-0003","80425-0003-1","80425-0003_2a98001f-209b-c78f-e063-6294a90a1067","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","DS","TABLET","ORAL","20100216","","ANDA","ANDA090624","Advanced Rx Pharmacy of Tennessee, LLC","800; 160","mg/1; mg/1","","N","20251231"
"9520","CEPHALEXIN","Cephalexin","80425000402","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0004","80425-0004-2","80425-0004_137a5de3-ab83-e2ab-e063-6294a90a6209","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20220914","","ANDA","ANDA065253","ADVANCED RX PHARMACY OF TENNESSEE, LLC","500","mg/1","","N","20251231"
"9521","CEPHALEXIN","Cephalexin","80425000403","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0004","80425-0004-3","80425-0004_137a5de3-ab83-e2ab-e063-6294a90a6209","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20220914","","ANDA","ANDA065253","ADVANCED RX PHARMACY OF TENNESSEE, LLC","500","mg/1","","N","20251231"
"9522","CEPHALEXIN","Cephalexin","80425000404","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0004","80425-0004-4","80425-0004_137a5de3-ab83-e2ab-e063-6294a90a6209","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20220914","","ANDA","ANDA065253","ADVANCED RX PHARMACY OF TENNESSEE, LLC","500","mg/1","","N","20251231"
"9523","CEPHALEXIN","Cephalexin","80425000401","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0004","80425-0004-1","80425-0004_137a5de3-ab83-e2ab-e063-6294a90a6209","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20220914","","ANDA","ANDA065253","ADVANCED RX PHARMACY OF TENNESSEE, LLC","500","mg/1","","N","20251231"
"9524","CEPHALEXIN","Cephalexin","80425000406","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0004","80425-0004-6","80425-0004_137a5de3-ab83-e2ab-e063-6294a90a6209","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20220914","","ANDA","ANDA065253","ADVANCED RX PHARMACY OF TENNESSEE, LLC","500","mg/1","","N","20251231"
"9525","CEPHALEXIN","Cephalexin","80425000407","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0004","80425-0004-7","80425-0004_137a5de3-ab83-e2ab-e063-6294a90a6209","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20220914","","ANDA","ANDA065253","ADVANCED RX PHARMACY OF TENNESSEE, LLC","500","mg/1","","N","20251231"
"9526","CEPHALEXIN","Cephalexin","80425000405","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0004","80425-0004-5","80425-0004_137a5de3-ab83-e2ab-e063-6294a90a6209","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20220914","","ANDA","ANDA065253","ADVANCED RX PHARMACY OF TENNESSEE, LLC","500","mg/1","","N","20251231"
"9527","CEPHALEXIN","Cephalexin","80425000501","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0005","80425-0005-1","80425-0005_0f3ed48b-be43-1ecb-e063-6294a90a6eb0","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","ADVANCED RX PHARMACY OF TENNESSEE, LLC","500","mg/1","","N","20251231"
"9528","CEPHALEXIN","Cephalexin","80425000503","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0005","80425-0005-3","80425-0005_0f3ed48b-be43-1ecb-e063-6294a90a6eb0","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","ADVANCED RX PHARMACY OF TENNESSEE, LLC","500","mg/1","","N","20251231"
"9529","CEPHALEXIN","Cephalexin","80425000502","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0005","80425-0005-2","80425-0005_0f3ed48b-be43-1ecb-e063-6294a90a6eb0","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","ADVANCED RX PHARMACY OF TENNESSEE, LLC","500","mg/1","","N","20251231"
"9530","CEPHALEXIN","Cephalexin","80425000602","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0006","80425-0006-2","80425-0006_2a97df38-1192-6d39-e063-6394a90a34c0","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","ADVANCED RX PHARMACY OF TENNESSEE, LLC","500","mg/1","","N","20251231"
"9531","CEPHALEXIN","Cephalexin","80425000601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0006","80425-0006-1","80425-0006_2a97df38-1192-6d39-e063-6394a90a34c0","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20060111","","ANDA","ANDA065229","ADVANCED RX PHARMACY OF TENNESSEE, LLC","500","mg/1","","N","20251231"
"9532","CLINDAMYCIN HYDROCHLORIDE","Clindamycin HCL","80425010301","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","80425-0103","80425-0103-1","80425-0103_2a99aae5-c901-7940-e063-6294a90a4146","HUMAN PRESCRIPTION DRUG","Clindamycin HCL","","CAPSULE","ORAL","20010323","","ANDA","ANDA065061","Advanced Rx of Tennessee, LLC","300","mg/1","","N","20251231"
"9533","CEPHALEXIN","Cephalexin","80425012101","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0121","80425-0121-1","80425-0121_0f2824d5-e8e8-b3d6-e063-6294a90a3379","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9534","CEPHALEXIN","Cephalexin","80425012102","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0121","80425-0121-2","80425-0121_0f2824d5-e8e8-b3d6-e063-6294a90a3379","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9535","CEPHALEXIN","Cephalexin","80425012104","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0121","80425-0121-4","80425-0121_0f2824d5-e8e8-b3d6-e063-6294a90a3379","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9536","CEPHALEXIN","Cephalexin","80425012105","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0121","80425-0121-5","80425-0121_0f2824d5-e8e8-b3d6-e063-6294a90a3379","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9537","CEPHALEXIN","Cephalexin","80425012106","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0121","80425-0121-6","80425-0121_0f2824d5-e8e8-b3d6-e063-6294a90a3379","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9538","CEPHALEXIN","Cephalexin","80425012107","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0121","80425-0121-7","80425-0121_0f2824d5-e8e8-b3d6-e063-6294a90a3379","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9539","CEPHALEXIN","Cephalexin","80425012103","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0121","80425-0121-3","80425-0121_0f2824d5-e8e8-b3d6-e063-6294a90a3379","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20110119","","ANDA","ANDA090836","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9540","CLINDAMYCIN HYDROCHLORIDE","Clindamycin HCL","80425014502","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","80425-0145","80425-0145-2","80425-0145_2a999573-1034-813a-e063-6294a90a49b1","HUMAN PRESCRIPTION DRUG","Clindamycin HCL","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Advanced Rx Pharmacy of Tennessee, LLC","300","mg/1","","N","20251231"
"9541","CLINDAMYCIN HYDROCHLORIDE","Clindamycin HCL","80425014503","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","80425-0145","80425-0145-3","80425-0145_2a999573-1034-813a-e063-6294a90a49b1","HUMAN PRESCRIPTION DRUG","Clindamycin HCL","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Advanced Rx Pharmacy of Tennessee, LLC","300","mg/1","","N","20251231"
"9542","CLINDAMYCIN HYDROCHLORIDE","Clindamycin HCL","80425014501","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","80425-0145","80425-0145-1","80425-0145_2a999573-1034-813a-e063-6294a90a49b1","HUMAN PRESCRIPTION DRUG","Clindamycin HCL","","CAPSULE","ORAL","20090826","","ANDA","ANDA065442","Advanced Rx Pharmacy of Tennessee, LLC","300","mg/1","","N","20251231"
"9543","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","80425016401","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","80425-0164","80425-0164-1","80425-0164_2a99a670-af2f-299d-e063-6294a90a05d2","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9544","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","80425016402","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","80425-0164","80425-0164-2","80425-0164_2a99a670-af2f-299d-e063-6294a90a05d2","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20040609","","ANDA","ANDA075593","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9545","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","80425018001","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","80425-0180","80425-0180-1","80425-0180_2d324dc5-6376-be6b-e063-6394a90a82dd","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","Advanced Rx Pharmacy of Tennessee, LLC","875; 125","mg/1; mg/1","","N","20261231"
"9546","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","80425018002","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","80425-0180","80425-0180-2","80425-0180_2d324dc5-6376-be6b-e063-6394a90a82dd","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","Advanced Rx Pharmacy of Tennessee, LLC","875; 125","mg/1; mg/1","","N","20261231"
"9547","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","80425018003","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","80425-0180","80425-0180-3","80425-0180_2d324dc5-6376-be6b-e063-6394a90a82dd","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20170301","","ANDA","ANDA204755","Advanced Rx Pharmacy of Tennessee, LLC","875; 125","mg/1; mg/1","","N","20261231"
"9548","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin HCL","80425019201","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","80425-0192","80425-0192-1","80425-0192_2a99a80e-d072-27e6-e063-6294a90ae0fe","HUMAN PRESCRIPTION DRUG","Ciprofloxacin HCL","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9549","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin HCL","80425019202","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","80425-0192","80425-0192-2","80425-0192_2a99a80e-d072-27e6-e063-6294a90ae0fe","HUMAN PRESCRIPTION DRUG","Ciprofloxacin HCL","","TABLET, FILM COATED","ORAL","20070426","","ANDA","ANDA077859","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9550","CEFADROXIL","Cefadroxil","80425019802","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0198","80425-0198-2","80425-0198_10f671c2-e1e0-da2f-e063-6394a90a8724","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20221102","","ANDA","ANDA065352","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9551","CEFADROXIL","Cefadroxil","80425019803","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0198","80425-0198-3","80425-0198_10f671c2-e1e0-da2f-e063-6394a90a8724","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20221102","","ANDA","ANDA065352","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9552","CEFADROXIL","Cefadroxil","80425019801","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0198","80425-0198-1","80425-0198_10f671c2-e1e0-da2f-e063-6394a90a8724","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20221102","","ANDA","ANDA065352","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9553","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","80425021801","Macrolide Antimicrobial [EPC], Macrolides [CS]","80425-0218","80425-0218-1","80425-0218_2a9aa671-d0a1-2254-e063-6294a90a9f79","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20230109","","ANDA","ANDA208250","Advanced Rx Pharmacy of Tennessee, LLC","250","mg/1","","N","20251231"
"9554","AZITHROMYCIN MONOHYDRATE","Azithromycin","80425021901","Macrolide Antimicrobial [EPC], Macrolides [CS]","80425-0219","80425-0219-1","80425-0219_2a9aa22e-db40-217b-e063-6294a90a4c41","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20230109","","ANDA","ANDA065225","Advanced Rx Pharmacy of Tennessee, LLC","250","mg/1","","N","20251231"
"9555","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","80425022001","Macrolide Antimicrobial [EPC], Macrolides [CS]","80425-0220","80425-0220-1","80425-0220_2a9ae6d7-0498-3bd5-e063-6394a90a651e","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20230109","","ANDA","ANDA208249","Advanced Rx of Tennessee, LLC","500","mg/1","","N","20251231"
"9556","SILVER SULFADIAZINE","Silver Sulfadiazine","80425022101","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","80425-0221","80425-0221-1","80425-0221_2a9b1617-60ce-f8ce-e063-6294a90ab02c","HUMAN PRESCRIPTION DRUG","Silver Sulfadiazine","","CREAM","TOPICAL","20230112","","NDA","NDA018810","Advanced Rx Pharmacy of Tennessee, LLC","10","mg/g","","N","20251231"
"9557","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE","80425022901","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","80425-0229","80425-0229-1","80425-0229_2a9b1617-60d0-f8ce-e063-6294a90ab02c","HUMAN PRESCRIPTION DRUG","NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE","","OINTMENT","OPHTHALMIC","20230111","","ANDA","ANDA064063","Advanced Rx Pharmacy of Tennessee, LLC","1; 3.5; 10000","mg/g; mg/g; [USP'U]/g","","N","20251231"
"9558","MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE","Moxifloxacin","80425023901","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","80425-0239","80425-0239-1","80425-0239_2a9aa671-d0a2-2254-e063-6294a90a9f79","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20230111","","ANDA","ANDA090080","Advanced Rx Pharmacy of Tennessee, LLC","5","mg/mL","","N","20251231"
"9559","MUPIROCIN","Mupirocin","80425024601","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","80425-0246","80425-0246-1","80425-0246_2a9ae6d7-049b-3bd5-e063-6394a90a651e","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20230111","","ANDA","ANDA065085","Advanced Rx Pharmacy of Tennessee, LLC","20","mg/g","","N","20251231"
"9560","MUPIROCIN","Mupirocin","80425025401","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","80425-0254","80425-0254-1","80425-0254_2a9ae6d7-049c-3bd5-e063-6394a90a651e","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20230111","","ANDA","ANDA065170","Advanced Rx Pharmacy of Tennessee, LLC","20","mg/g","","N","20251231"
"9561","DEXAMETHASONE; TOBRAMYCIN","Tobramycin and dexamethasone","80425026001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","80425-0260","80425-0260-1","80425-0260_2a9b792b-f417-e859-e063-6394a90a30e2","HUMAN PRESCRIPTION DRUG","Tobramycin and dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","20230215","","ANDA","ANDA212715","Advanced Rx Pharmacy of Tennessee, LLC","1; 3","mg/mL; mg/mL","","N","20251231"
"9562","AMOXICILLIN","Amoxicillin","80425026901","Penicillin-class Antibacterial [EPC], Penicillins [CS]","80425-0269","80425-0269-1","80425-0269_2a9b792b-f418-e859-e063-6394a90a30e2","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20230215","","ANDA","ANDA065271","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9563","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","80425027901","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","80425-0279","80425-0279-1","80425-0279_2d322d81-a3e4-325a-e063-6294a90a4ba5","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20230303","","ANDA","ANDA091568","Advanced Rx Pharmacy of Tennessee, LLC","875; 125","mg/1; mg/1","","N","20261231"
"9564","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","80425027903","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","80425-0279","80425-0279-3","80425-0279_2d322d81-a3e4-325a-e063-6294a90a4ba5","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20230303","","ANDA","ANDA091568","Advanced Rx Pharmacy of Tennessee, LLC","875; 125","mg/1; mg/1","","N","20261231"
"9565","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","80425027902","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","80425-0279","80425-0279-2","80425-0279_2d322d81-a3e4-325a-e063-6294a90a4ba5","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20230303","","ANDA","ANDA091568","Advanced Rx Pharmacy of Tennessee, LLC","875; 125","mg/1; mg/1","","N","20261231"
"9566","TOBRAMYCIN","Tobramycin","80425034101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","80425-0341","80425-0341-1","80425-0341_2862f6ad-689c-d683-e063-6394a90a89d1","HUMAN PRESCRIPTION DRUG","Tobramycin","","SOLUTION","OPHTHALMIC","20230524","","ANDA","ANDA064052","Advanced Rx Pharmacy of Tennessee, LLC","3","mg/mL","","N","20251231"
"9567","BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","Clotrimazole and Betamethasone Dipropionate","80425034401","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","80425-0344","80425-0344-1","80425-0344_2a9bfe6a-6d75-b262-e063-6294a90a1cf3","HUMAN PRESCRIPTION DRUG","Clotrimazole and Betamethasone Dipropionate","","CREAM","TOPICAL","20230615","","ANDA","ANDA075673","Advanced Rx Pharmacy of Tennessee, LLC",".5; 10","mg/g; mg/g","","N","20251231"
"9568","DEXAMETHASONE; TOBRAMYCIN","Tobramycin and Dexamethasone","80425036601","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","80425-0366","80425-0366-1","80425-0366_2a998d83-7bae-3f5e-e063-6294a90acd3d","HUMAN PRESCRIPTION DRUG","Tobramycin and Dexamethasone","","SUSPENSION/ DROPS","OPHTHALMIC","20231102","","NDA AUTHORIZED GENERIC","NDA050592","Advanced Rx of Tennessee, LLC","1; 3","mg/mL; mg/mL","","N","20251231"
"9569","MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE","Moxifloxacin","80425037901","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","80425-0379","80425-0379-1","80425-0379_14307586-424f-091a-e063-6394a90aee1f","HUMAN PRESCRIPTION DRUG","Moxifloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20240321","","ANDA","ANDA202867","Advanced Rx Pharmacy of Tennessee, LLC","5","mg/mL","","N","20251231"
"9570","CEFADROXIL","Cefadroxil","80425040002","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0400","80425-0400-2","80425-0400_1a50a2bf-9704-4104-e063-6294a90af4df","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20240607","","ANDA","ANDA065352","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9571","CEFADROXIL","Cefadroxil","80425040003","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0400","80425-0400-3","80425-0400_1a50a2bf-9704-4104-e063-6294a90af4df","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20240607","","ANDA","ANDA065352","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9572","CEFADROXIL","Cefadroxil","80425040001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0400","80425-0400-1","80425-0400_1a50a2bf-9704-4104-e063-6294a90af4df","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20240607","","ANDA","ANDA065352","Advanced Rx Pharmacy of Tennessee, LLC","500","mg/1","","N","20251231"
"9573","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","80425041201","Macrolide Antimicrobial [EPC], Macrolides [CS]","80425-0412","80425-0412-1","80425-0412_1d0e96cf-245e-cfb7-e063-6294a90a4ced","HUMAN PRESCRIPTION DRUG","azithromycin dihydrate","","TABLET","ORAL","20240710","","ANDA","ANDA065399","Advanced Rx of Tennessee, LLC","500","mg/1","","N","20251231"
"9574","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","80425041602","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","80425-0416","80425-0416-2","80425-0416_1d7633a0-d956-7990-e063-6294a90a5f2d","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20240716","","ANDA","ANDA207402","Advanced Rx of Tennessee, LLC","300","mg/1","","N","20251231"
"9575","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","80425041603","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","80425-0416","80425-0416-3","80425-0416_1d7633a0-d956-7990-e063-6294a90a5f2d","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20240716","","ANDA","ANDA207402","Advanced Rx of Tennessee, LLC","300","mg/1","","N","20251231"
"9576","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","80425041601","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","80425-0416","80425-0416-1","80425-0416_1d7633a0-d956-7990-e063-6294a90a5f2d","HUMAN PRESCRIPTION DRUG","CLINDAMYCIN HYDROCHLORIDE","","CAPSULE","ORAL","20240716","","ANDA","ANDA207402","Advanced Rx of Tennessee, LLC","300","mg/1","","N","20251231"
"9577","AZITHROMYCIN DIHYDRATE","azithromycin dihydrate","80425043101","Macrolide Antimicrobial [EPC], Macrolides [CS]","80425-0431","80425-0431-1","80425-0431_20ae1090-cc58-39fd-e063-6294a90adfab","HUMAN PRESCRIPTION DRUG","azithromycin dihydrate","","TABLET","ORAL","20240827","","ANDA","ANDA065398","Advanced Rx of Tennessee, LLC","250","mg/1","","N","20251231"
"9578","CEFADROXIL","Cefadroxil","80425043201","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0432","80425-0432-1","80425-0432_205ca6df-b799-b6b1-e063-6294a90a6e5c","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20240823","","ANDA","ANDA065392","Advanced Rx of Tennessee, LLC","500","mg/1","","N","20251231"
"9579","CEFADROXIL","Cefadroxil","80425043202","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0432","80425-0432-2","80425-0432_205ca6df-b799-b6b1-e063-6294a90a6e5c","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20240823","","ANDA","ANDA065392","Advanced Rx of Tennessee, LLC","500","mg/1","","N","20251231"
"9580","CEFADROXIL","Cefadroxil","80425043203","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","80425-0432","80425-0432-3","80425-0432_205ca6df-b799-b6b1-e063-6294a90a6e5c","HUMAN PRESCRIPTION DRUG","Cefadroxil","","CAPSULE","ORAL","20240823","","ANDA","ANDA065392","Advanced Rx of Tennessee, LLC","500","mg/1","","N","20251231"
"9581","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","80425049201","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","80425-0492","80425-0492-1","80425-0492_2d325eb5-e49e-6529-e063-6294a90a5cc1","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20250202","","ANDA","ANDA208921","Advanced Rx of Tennessee, LLC","500","mg/1","","N","20261231"
"9582","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","80425049202","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","80425-0492","80425-0492-2","80425-0492_2d325eb5-e49e-6529-e063-6294a90a5cc1","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20250202","","ANDA","ANDA208921","Advanced Rx of Tennessee, LLC","500","mg/1","","N","20261231"
"9583","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","80425049302","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","80425-0493","80425-0493-2","80425-0493_30caad43-7ca1-c06c-e063-6294a90afdeb","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","TABLET, FILM COATED","ORAL","20250320","","ANDA","ANDA076593","Advanced Rx of Tennessee, LLC","500","mg/1","","N","20261231"
"9584","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","80425049301","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","80425-0493","80425-0493-1","80425-0493_30caad43-7ca1-c06c-e063-6294a90afdeb","HUMAN PRESCRIPTION DRUG","Ciprofloxacin Hydrochloride","","TABLET, FILM COATED","ORAL","20250320","","ANDA","ANDA076593","Advanced Rx of Tennessee, LLC","500","mg/1","","N","20261231"
"9585","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","80425049901","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","80425-0499","80425-0499-1","80425-0499_30cb2b47-f440-5e22-e063-6294a90a8b3d","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","SOLUTION","OPHTHALMIC","20250320","","ANDA","ANDA077568","Advanced Rx of Tennessee, LLC","3","mg/mL","","N","20261231"
"9586","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","80425051402","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","80425-0514","80425-0514-2","80425-0514_331277b8-8300-d082-e063-6394a90a4dd3","HUMAN PRESCRIPTION DRUG","vancomycin hydrochloride","","CAPSULE","ORAL","20250418","","NDA AUTHORIZED GENERIC","NDA050606","Advanced Rx of Tennessee, LLC","250","mg/1","","N","20261231"
"9587","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","80425051403","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","80425-0514","80425-0514-3","80425-0514_331277b8-8300-d082-e063-6394a90a4dd3","HUMAN PRESCRIPTION DRUG","vancomycin hydrochloride","","CAPSULE","ORAL","20250418","","NDA AUTHORIZED GENERIC","NDA050606","Advanced Rx of Tennessee, LLC","250","mg/1","","N","20261231"
"9588","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","80425051404","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","80425-0514","80425-0514-4","80425-0514_331277b8-8300-d082-e063-6394a90a4dd3","HUMAN PRESCRIPTION DRUG","vancomycin hydrochloride","","CAPSULE","ORAL","20250418","","NDA AUTHORIZED GENERIC","NDA050606","Advanced Rx of Tennessee, LLC","250","mg/1","","N","20261231"
"9589","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","80425051401","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","80425-0514","80425-0514-1","80425-0514_331277b8-8300-d082-e063-6394a90a4dd3","HUMAN PRESCRIPTION DRUG","vancomycin hydrochloride","","CAPSULE","ORAL","20250418","","NDA AUTHORIZED GENERIC","NDA050606","Advanced Rx of Tennessee, LLC","250","mg/1","","N","20261231"
"9590","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","80425051406","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","80425-0514","80425-0514-6","80425-0514_331277b8-8300-d082-e063-6394a90a4dd3","HUMAN PRESCRIPTION DRUG","vancomycin hydrochloride","","CAPSULE","ORAL","20250418","","NDA AUTHORIZED GENERIC","NDA050606","Advanced Rx of Tennessee, LLC","250","mg/1","","N","20261231"
"9591","VANCOMYCIN HYDROCHLORIDE","vancomycin hydrochloride","80425051405","Glycopeptide Antibacterial [EPC], Glycopeptides [CS]","80425-0514","80425-0514-5","80425-0514_331277b8-8300-d082-e063-6394a90a4dd3","HUMAN PRESCRIPTION DRUG","vancomycin hydrochloride","","CAPSULE","ORAL","20250418","","NDA AUTHORIZED GENERIC","NDA050606","Advanced Rx of Tennessee, LLC","250","mg/1","","N","20261231"
"9592","CLOTRIMAZOLE","Drs. Clotrimazole","80489000201","Azole Antifungal [EPC], Azoles [CS]","80489-002","80489-002-01","80489-002_2b522583-1d23-f3bb-e063-6394a90a76a7","HUMAN OTC DRUG","Clotrimazole","","CREAM","TOPICAL","20210101","","OTC MONOGRAPH DRUG","M005","OL PHARMA TECH,LLC","10","mg/g","","N","20261231"
"9593","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment","80489001201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","80489-012","80489-012-01","80489-012_2b51ff20-db0e-8b5d-e063-6294a90a88d0","HUMAN OTC DRUG","Drs. pharmacy triple antibiotic","","OINTMENT","TOPICAL","20210216","","OTC MONOGRAPH DRUG","M003","OL PHARMA TECH, LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"9594","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment","80489001202","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","80489-012","80489-012-02","80489-012_2b51ff20-db0e-8b5d-e063-6294a90a88d0","HUMAN OTC DRUG","Drs. pharmacy triple antibiotic","","OINTMENT","TOPICAL","20210216","","OTC MONOGRAPH DRUG","M003","OL PHARMA TECH, LLC","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"9595","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment","80489041202","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","80489-412","80489-412-02","80489-412_16273c4b-6574-a479-e063-6294a90a5567","HUMAN OTC DRUG","Drs pharmacy triple antibiotic Pain plus itch plus Scar","","OINTMENT","TOPICAL","20210216","","OTC MONOGRAPH DRUG","M003","OL PHARMA TECH, LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"9596","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment","80489041201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","80489-412","80489-412-01","80489-412_16273c4b-6574-a479-e063-6294a90a5567","HUMAN OTC DRUG","Drs pharmacy triple antibiotic Pain plus itch plus Scar","","OINTMENT","TOPICAL","20210216","","OTC MONOGRAPH DRUG","M003","OL PHARMA TECH, LLC","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"9597","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine","80489075701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","80489-757","80489-757-01","80489-757_2b5279c4-6ef3-23fd-e063-6394a90a1857","HUMAN OTC DRUG","Drs. Pharmacy Triple Antibiotic Plus","","OINTMENT","TOPICAL","20210905","","OTC MONOGRAPH DRUG","M003","OL PHARMA TECH, LLC Drs PHARMACY","400; 3.5; 5000; 10","[USP'U]/1000mg; mg/1000mg; [USP'U]/1000mg; mg/1000mg","","N","20261231"
"9598","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine","80489075702","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","80489-757","80489-757-02","80489-757_2b5279c4-6ef3-23fd-e063-6394a90a1857","HUMAN OTC DRUG","Drs. Pharmacy Triple Antibiotic Plus","","OINTMENT","TOPICAL","20210905","","OTC MONOGRAPH DRUG","M003","OL PHARMA TECH, LLC Drs PHARMACY","400; 3.5; 5000; 10","[USP'U]/1000mg; mg/1000mg; [USP'U]/1000mg; mg/1000mg","","N","20261231"
"9599","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine","80489085701","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","80489-857","80489-857-01","80489-857_1626ff4b-c914-8681-e063-6294a90a1a2f","HUMAN OTC DRUG","Drs. Pharmacy Triple Antibiotic Plus Pain relief","","OINTMENT","TOPICAL","20210905","","OTC MONOGRAPH DRUG","M003","OL PHARMA TECH, LLC Drs PHARMACY","500; 3.5; 10000; 10","[USP'U]/1000mg; mg/1000mg; [USP'U]/1000mg; mg/1000mg","","N","20251231"
"9600","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine","80489085702","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","80489-857","80489-857-02","80489-857_1626ff4b-c914-8681-e063-6294a90a1a2f","HUMAN OTC DRUG","Drs. Pharmacy Triple Antibiotic Plus Pain relief","","OINTMENT","TOPICAL","20210905","","OTC MONOGRAPH DRUG","M003","OL PHARMA TECH, LLC Drs PHARMACY","500; 3.5; 10000; 10","[USP'U]/1000mg; mg/1000mg; [USP'U]/1000mg; mg/1000mg","","N","20251231"
"9601","CLOTRIMAZOLE","CLOTRIMAZOLE","80684003901","Azole Antifungal [EPC], Azoles [CS]","80684-039","80684-039-01","80684-039_08a0ce90-0c11-15f4-e063-6294a90a6ca7","HUMAN OTC DRUG","Thera plus Antifungal Clotrimazole","","CREAM","TOPICAL","20220130","","OTC MONOGRAPH DRUG","M005","FOURSTAR GROUP USA, INC.","10","mg/g","","N","20251231"
"9602","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","80684014000","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","80684-140","80684-140-00","80684-140_2f875649-660d-a9dd-e063-6394a90ab302","HUMAN OTC DRUG","Thera Plus Original Strength Triple Antibiotic","","OINTMENT","TOPICAL","20250303","","OTC MONOGRAPH DRUG","M004","FOURSTAR GROUP USA, INC.","400; 3.5; 5000","U/g; mg/g; U/g","","N","20261231"
"9603","PAROMOMYCIN SULFATE","PAROMOMYCIN SULFATE","80725025001","Antiprotozoal [EPC]","80725-250","80725-250-01","80725-250_218563ce-a4f4-490b-99fe-eabc713bbdba","HUMAN PRESCRIPTION DRUG","Humatin","","CAPSULE","ORAL","20210408","","ANDA","ANDA065173","Waylis Therapeutics LLC","250","mg/1","","N","20251231"
"9604","METRONIDAZOLE","Metronidazole","80830246509","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","80830-2465","80830-2465-9","80830-2465_2b9ea1b9-471d-4fbe-9e25-f38a1e7fb730","HUMAN PRESCRIPTION DRUG","Metronidazole","","INJECTION, SOLUTION","INTRAVENOUS","20230617","","ANDA","ANDA217665","Amneal Pharmaceuticals Private Limited","500","mg/100mL","","N","20261231"
"9605","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","81033001240","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","81033-012","81033-012-40","81033-012_35063fad-e644-2b68-e063-6394a90aedc8","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","SUSPENSION","ORAL","20220705","","ANDA","ANDA077612","Kesin Pharma","200; 40","mg/5mL; mg/5mL","","N","20261231"
"9606","MUPIROCIN","Mupirocin","81033002099","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","81033-020","81033-020-99","81033-020_36357344-6528-ef04-e063-6394a90a8fa9","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20211015","20251231","ANDA","ANDA090480","Kesin Pharma Corporation","20","mg/g","","N",""
"9607","MUPIROCIN","Mupirocin","81033002050","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","81033-020","81033-020-50","81033-020_36357344-6528-ef04-e063-6394a90a8fa9","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20211015","20251231","ANDA","ANDA090480","Kesin Pharma Corporation","20","mg/g","","N",""
"9608","MUPIROCIN","Mupirocin Ointment","81033003250","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","81033-032","81033-032-50","81033-032_36357344-6528-ef04-e063-6394a90a8fa9","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20250528","","ANDA","ANDA065123","Kesin Pharma Corporation","20","mg/g","","N","20261231"
"9609","MUPIROCIN","Mupirocin Ointment","81033003299","RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]","81033-032","81033-032-99","81033-032_36357344-6528-ef04-e063-6394a90a8fa9","HUMAN PRESCRIPTION DRUG","Mupirocin","","OINTMENT","TOPICAL","20250528","","ANDA","ANDA065123","Kesin Pharma Corporation","20","mg/g","","N","20261231"
"9610","METRONIDAZOLE","Metronidazole Oral","81033006620","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","81033-066","81033-066-20","81033-066_2a82e6d7-cff9-deca-e063-6394a90a4817","HUMAN PRESCRIPTION DRUG","LIKMEZ","","SUSPENSION","ORAL","20231013","","NDA","NDA216755","Kesin Pharma Corporation","100","mg/mL","","N","20251231"
"9611","ATOVAQUONE","Atovaquone","81033010442","Antimalarial [EPC], Antiprotozoal [EPC]","81033-104","81033-104-42","81033-104_285fbafd-f38f-49df-e063-6394a90a42c9","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20240617","","ANDA","ANDA212918","Kesin Pharma","750","mg/5mL","","N","20251231"
"9612","ATOVAQUONE","Atovaquone","81033010450","Antimalarial [EPC], Antiprotozoal [EPC]","81033-104","81033-104-50","81033-104_285fbafd-f38f-49df-e063-6394a90a42c9","HUMAN PRESCRIPTION DRUG","Atovaquone","","SUSPENSION","ORAL","20240617","","ANDA","ANDA212918","Kesin Pharma","750","mg/5mL","","N","20251231"
"9613","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin sodium and Tazobactam sodium","81284015110","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81284-151","81284-151-10","81284-151_5e55a3fe-170f-4509-a4dd-307a6b24fc71","HUMAN PRESCRIPTION DRUG","PIPERACILLIN AND TAZOBACTAM","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190801","","ANDA","ANDA207847","Provepharm Inc.","2; .25","g/10mL; g/10mL","","N","20261231"
"9614","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin sodium and Tazobactam sodium","81284015210","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81284-152","81284-152-10","81284-152_5e55a3fe-170f-4509-a4dd-307a6b24fc71","HUMAN PRESCRIPTION DRUG","PIPERACILLIN AND TAZOBACTAM","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190801","","ANDA","ANDA207847","Provepharm Inc.","3; .375","g/15mL; g/15mL","","N","20261231"
"9615","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin sodium and Tazobactam sodium","81284015310","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81284-153","81284-153-10","81284-153_5e55a3fe-170f-4509-a4dd-307a6b24fc71","HUMAN PRESCRIPTION DRUG","PIPERACILLIN AND TAZOBACTAM","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190801","","ANDA","ANDA207847","Provepharm Inc.","4; .5","g/20mL; g/20mL","","N","20261231"
"9616","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin sodium and Tazobactam sodium","81284015401","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81284-154","81284-154-01","81284-154_1c01a9c8-0256-4129-adc7-38d1f3cf2183","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20230111","","ANDA","ANDA207848","Provepharm Inc.","12; 1.5","g/60mL; g/60mL","","N","20261231"
"9617","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","Piperacillin sodium and Tazobactam sodium","81284015501","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81284-155","81284-155-01","81284-155_1c01a9c8-0256-4129-adc7-38d1f3cf2183","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20190801","","ANDA","ANDA207848","Provepharm Inc.","36; 4.5","g/180mL; g/180mL","","N","20261231"
"9618","PENICILLIN G BENZATHINE","benzathine benzylpenicillin","81284052300","Penicillin-class Antibacterial [EPC], Penicillins [CS]","81284-523","81284-523-00","81284-523_5eb42da3-7f4f-4071-9a35-14565343b49c","HUMAN PRESCRIPTION DRUG","EXTENCILLINE","","INJECTION, POWDER, FOR SUSPENSION","INTRAMUSCULAR","20231221","","UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE","","Provepharm Inc.","1200000","[iU]/1","","N","20251231"
"9619","PENICILLIN G BENZATHINE","benzathine benzylpenicillin","81284052400","Penicillin-class Antibacterial [EPC], Penicillins [CS]","81284-524","81284-524-00","81284-524_5eb42da3-7f4f-4071-9a35-14565343b49c","HUMAN PRESCRIPTION DRUG","EXTENCILLINE","","INJECTION, POWDER, FOR SUSPENSION","INTRAMUSCULAR","20231221","","UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE","","Provepharm Inc.","2400000","[iU]/1","","N","20251231"
"9620","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","81417000301","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","81417-003","81417-003-01","81417-003_0f004632-b86c-c5b6-e063-6394a90ac1ce","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20220829","","OTC MONOGRAPH DRUG","M004","Sled Distribution, LLC","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20251231"
"9621","QUININE ARSENITE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED; VESPA CRABRO","Chininum arsenicosum, Natrum phosphoricum, Nux voomica, Vespa crabro","81425000310","Allergens [CS], Antimalarial [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]","81425-003","81425-003-10","81425-003_d082b7ab-b5f2-4f14-81bd-2b1809257fbb","HUMAN OTC DRUG","LUMO Booz Hangover Companiion","","TABLET, CHEWABLE","ORAL","20231015","","UNAPPROVED HOMEOPATHIC","","Applied Bioenergetics, LLC","30; 30; 30; 30","[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1","","N","20251231"
"9622","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","81542020212","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","81542-202","81542-202-12","81542-202_36c18a52-2828-aaa0-e063-6294a90a6ce1","HUMAN PRESCRIPTION DRUG","SULFACETAMIDE SODIUM, SULFUR","","SOLUTION","TOPICAL","20230208","","UNAPPROVED DRUG OTHER","","Bantry Pharma, LLC","100; 50","mg/mL; mg/mL","","N","20261231"
"9623","ECONAZOLE NITRATE","econazole nitrate","81811010070","Azole Antifungal [EPC], Azoles [CS]","81811-100","81811-100-70","81811-100_0bb5d729-5109-e387-e063-6394a90a1fce","HUMAN PRESCRIPTION DRUG","Ecoza","","AEROSOL, FOAM","TOPICAL","20231204","","NDA","NDA205175","Resilia Pharmaceuticals, Inc.","10","mg/g","","N","20251231"
"9624","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","81929000301","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","81929-003","81929-003-01","81929-003_09ce4763-a8f8-7cff-e063-6294a90a851c","HUMAN OTC DRUG","Vitacilina First Aid Antibiotic","","OINTMENT","TOPICAL","20220701","","OTC MONOGRAPH DRUG","M004","Taisho Pharmaceutical California Inc.","400; 3.5; 5000","U/g; mg/g; U/g","","N","20251231"
"9625","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","81929000302","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","81929-003","81929-003-02","81929-003_09ce4763-a8f8-7cff-e063-6294a90a851c","HUMAN OTC DRUG","Vitacilina First Aid Antibiotic","","OINTMENT","TOPICAL","20220701","","OTC MONOGRAPH DRUG","M004","Taisho Pharmaceutical California Inc.","400; 3.5; 5000","U/g; mg/g; U/g","","N","20251231"
"9626","CEFACLOR","cefaclor","81948625001","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","81948-6250","81948-6250-1","81948-6250_a6a7fcf7-b9dc-4dac-b127-418588586a8a","HUMAN PRESCRIPTION DRUG","Cefaclor","","SUSPENSION","ORAL","20221101","","ANDA","ANDA065412","Azorian Pharma, LLC","250","mg/5mL","","N","20251231"
"9627","MEROPENEM","Meropenem","81962000002","Carbapenems [CS], Penem Antibacterial [EPC]","81962-000","81962-000-02","81962-000_2c72bd6a-b34c-4bfe-e063-6294a90abea6","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20230531","","ANDA","ANDA216154","BROOKS STERISCIENCE LIMITED","500","mg/20mL","","N","20261231"
"9628","MEROPENEM","Meropenem","81962000003","Carbapenems [CS], Penem Antibacterial [EPC]","81962-000","81962-000-03","81962-000_2c72bd6a-b34c-4bfe-e063-6294a90abea6","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20230531","","ANDA","ANDA216154","BROOKS STERISCIENCE LIMITED","500","mg/20mL","","N","20261231"
"9629","MEROPENEM","Meropenem","81962000001","Carbapenems [CS], Penem Antibacterial [EPC]","81962-000","81962-000-01","81962-000_2c72bd6a-b34c-4bfe-e063-6294a90abea6","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20230531","","ANDA","ANDA216154","BROOKS STERISCIENCE LIMITED","500","mg/20mL","","N","20261231"
"9630","MEROPENEM","Meropenem","81962000101","Carbapenems [CS], Penem Antibacterial [EPC]","81962-001","81962-001-01","81962-001_2c72bd6a-b34c-4bfe-e063-6294a90abea6","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20230531","","ANDA","ANDA216154","BROOKS STERISCIENCE LIMITED","1","g/20mL","","N","20261231"
"9631","MEROPENEM","Meropenem","81962000102","Carbapenems [CS], Penem Antibacterial [EPC]","81962-001","81962-001-02","81962-001_2c72bd6a-b34c-4bfe-e063-6294a90abea6","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20230531","","ANDA","ANDA216154","BROOKS STERISCIENCE LIMITED","1","g/20mL","","N","20261231"
"9632","MEROPENEM","Meropenem","81962000103","Carbapenems [CS], Penem Antibacterial [EPC]","81962-001","81962-001-03","81962-001_2c72bd6a-b34c-4bfe-e063-6294a90abea6","HUMAN PRESCRIPTION DRUG","Meropenem","","INJECTION","INTRAVENOUS","20230531","","ANDA","ANDA216154","BROOKS STERISCIENCE LIMITED","1","g/20mL","","N","20261231"
"9633","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","81964000351","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81964-003","81964-003-51","81964-003_c310871a-ee00-42f4-b846-cd12cebc39bd","HUMAN PRESCRIPTION DRUG","AUGMENTIN ES-600","","FOR SUSPENSION","ORAL","20220715","","NDA","NDA050755","USAntibiotics, LLC","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"9634","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","81964000354","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81964-003","81964-003-54","81964-003_c310871a-ee00-42f4-b846-cd12cebc39bd","HUMAN PRESCRIPTION DRUG","AUGMENTIN ES-600","","FOR SUSPENSION","ORAL","20220715","","NDA","NDA050755","USAntibiotics, LLC","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"9635","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","81964000369","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81964-003","81964-003-69","81964-003_c310871a-ee00-42f4-b846-cd12cebc39bd","HUMAN PRESCRIPTION DRUG","AUGMENTIN ES-600","","FOR SUSPENSION","ORAL","20220715","","NDA","NDA050755","USAntibiotics, LLC","600; 42.9","mg/5mL; mg/5mL","","N","20261231"
"9636","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","81964020351","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81964-203","81964-203-51","81964-203_137770f3-26e1-48fb-80d4-141e7a41951a","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","FOR SUSPENSION","ORAL","20220919","","NDA AUTHORIZED GENERIC","NDA050755","USAntibiotics, LLC","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"9637","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","81964020354","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81964-203","81964-203-54","81964-203_137770f3-26e1-48fb-80d4-141e7a41951a","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","FOR SUSPENSION","ORAL","20220919","","NDA AUTHORIZED GENERIC","NDA050755","USAntibiotics, LLC","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"9638","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","81964020369","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81964-203","81964-203-69","81964-203_137770f3-26e1-48fb-80d4-141e7a41951a","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","FOR SUSPENSION","ORAL","20220919","","NDA AUTHORIZED GENERIC","NDA050755","USAntibiotics, LLC","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"9639","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","81964020410","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81964-204","81964-204-10","81964-204_0fec57b0-b956-4e34-b0bb-4364e17e1043","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","FOR SUSPENSION","ORAL","20221205","","NDA AUTHORIZED GENERIC","NDA050575","USAntibiotics, LLC","250; 62.5","mg/5mL; mg/5mL","","N","20251231"
"9640","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","81964020415","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81964-204","81964-204-15","81964-204_0fec57b0-b956-4e34-b0bb-4364e17e1043","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","FOR SUSPENSION","ORAL","20221205","","NDA AUTHORIZED GENERIC","NDA050575","USAntibiotics, LLC","250; 62.5","mg/5mL; mg/5mL","","N","20251231"
"9641","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","81964020407","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81964-204","81964-204-07","81964-204_0fec57b0-b956-4e34-b0bb-4364e17e1043","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","FOR SUSPENSION","ORAL","20221205","","NDA AUTHORIZED GENERIC","NDA050575","USAntibiotics, LLC","250; 62.5","mg/5mL; mg/5mL","","N","20251231"
"9642","AMOXICILLIN","Amoxicillin","81964020501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","81964-205","81964-205-01","81964-205_3596a066-4a99-1e8b-e063-6294a90a7346","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20220915","","ANDA","ANDA062216","USAntibiotics, LLC","500","mg/1","","N","20261231"
"9643","AMOXICILLIN","Amoxicillin","81964020505","Penicillin-class Antibacterial [EPC], Penicillins [CS]","81964-205","81964-205-05","81964-205_3596a066-4a99-1e8b-e063-6294a90a7346","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20220915","","ANDA","ANDA062216","USAntibiotics, LLC","500","mg/1","","N","20261231"
"9644","AMOXICILLIN","Amoxicillin","81964020560","Penicillin-class Antibacterial [EPC], Penicillins [CS]","81964-205","81964-205-60","81964-205_3596a066-4a99-1e8b-e063-6294a90a7346","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20220915","","ANDA","ANDA062216","USAntibiotics, LLC","500","mg/1","","N","20261231"
"9645","AMOXICILLIN","Amoxicillin","81964020510","Penicillin-class Antibacterial [EPC], Penicillins [CS]","81964-205","81964-205-10","81964-205_3596a066-4a99-1e8b-e063-6294a90a7346","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20220915","","ANDA","ANDA062216","USAntibiotics, LLC","500","mg/1","","N","20261231"
"9646","AMOXICILLIN","Amoxicillin","81964020750","Penicillin-class Antibacterial [EPC], Penicillins [CS]","81964-207","81964-207-50","81964-207_377d03ad-55c2-5539-e063-6394a90add12","HUMAN PRESCRIPTION DRUG","Amoxicillin","","FOR SUSPENSION","ORAL","20240401","","NDA AUTHORIZED GENERIC","NDA050760","USAntibiotics, LLC","400","mg/5mL","","N","20261231"
"9647","AMOXICILLIN","Amoxicillin","81964020751","Penicillin-class Antibacterial [EPC], Penicillins [CS]","81964-207","81964-207-51","81964-207_377d03ad-55c2-5539-e063-6394a90add12","HUMAN PRESCRIPTION DRUG","Amoxicillin","","FOR SUSPENSION","ORAL","20240401","","NDA AUTHORIZED GENERIC","NDA050760","USAntibiotics, LLC","400","mg/5mL","","N","20261231"
"9648","AMOXICILLIN","Amoxicillin","81964020752","Penicillin-class Antibacterial [EPC], Penicillins [CS]","81964-207","81964-207-52","81964-207_377d03ad-55c2-5539-e063-6394a90add12","HUMAN PRESCRIPTION DRUG","Amoxicillin","","FOR SUSPENSION","ORAL","20240401","","NDA AUTHORIZED GENERIC","NDA050760","USAntibiotics, LLC","400","mg/5mL","","N","20261231"
"9649","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","81964021201","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81964-212","81964-212-01","81964-212_0fec57b0-b956-4e34-b0bb-4364e17e1043","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","FOR SUSPENSION","ORAL","20221205","","NDA AUTHORIZED GENERIC","NDA050575","USAntibiotics, LLC","125; 31.25","mg/5mL; mg/5mL","","N","20251231"
"9650","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","81964021203","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81964-212","81964-212-03","81964-212_0fec57b0-b956-4e34-b0bb-4364e17e1043","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","FOR SUSPENSION","ORAL","20221205","","NDA AUTHORIZED GENERIC","NDA050575","USAntibiotics, LLC","125; 31.25","mg/5mL; mg/5mL","","N","20251231"
"9651","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","81964021205","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81964-212","81964-212-05","81964-212_0fec57b0-b956-4e34-b0bb-4364e17e1043","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","FOR SUSPENSION","ORAL","20221205","","NDA AUTHORIZED GENERIC","NDA050575","USAntibiotics, LLC","125; 31.25","mg/5mL; mg/5mL","","N","20251231"
"9652","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","81964022114","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81964-221","81964-221-14","81964-221_0fec57b0-b956-4e34-b0bb-4364e17e1043","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, COATED","ORAL","20221121","","NDA AUTHORIZED GENERIC","NDA050720","USAntibiotics, LLC","875; 125","mg/1; mg/1","","N","20251231"
"9653","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","81964022101","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","81964-221","81964-221-01","81964-221_0fec57b0-b956-4e34-b0bb-4364e17e1043","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, COATED","ORAL","20221121","","NDA AUTHORIZED GENERIC","NDA050720","USAntibiotics, LLC","875; 125","mg/1; mg/1","","N","20251231"
"9654","AMOXICILLIN","Amoxicillin","81964022505","Penicillin-class Antibacterial [EPC], Penicillins [CS]","81964-225","81964-225-05","81964-225_3596a066-4a99-1e8b-e063-6294a90a7346","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20220915","","ANDA","ANDA062216","USAntibiotics, LLC","250","mg/1","","N","20261231"
"9655","AMOXICILLIN","Amoxicillin","81964022501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","81964-225","81964-225-01","81964-225_3596a066-4a99-1e8b-e063-6294a90a7346","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20220915","","ANDA","ANDA062216","USAntibiotics, LLC","250","mg/1","","N","20261231"
"9656","AMOXICILLIN","Amoxicillin","81964035010","Penicillin-class Antibacterial [EPC], Penicillins [CS]","81964-350","81964-350-10","81964-350_3596a066-4a99-1e8b-e063-6294a90a7346","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20250515","","ANDA","ANDA062216","USAntibiotics, LLC","500","mg/1","","N","20261231"
"9657","AMOXICILLIN","Amoxicillin","81964035060","Penicillin-class Antibacterial [EPC], Penicillins [CS]","81964-350","81964-350-60","81964-350_3596a066-4a99-1e8b-e063-6294a90a7346","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20250515","","ANDA","ANDA062216","USAntibiotics, LLC","500","mg/1","","N","20261231"
"9658","AMOXICILLIN","Amoxicillin","81964035098","Penicillin-class Antibacterial [EPC], Penicillins [CS]","81964-350","81964-350-98","81964-350_3596a066-4a99-1e8b-e063-6294a90a7346","HUMAN PRESCRIPTION DRUG","AMOXICILLIN","","CAPSULE","ORAL","20250515","","ANDA","ANDA062216","USAntibiotics, LLC","500","mg/1","","N","20261231"
"9659","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine sulfate","82009004505","Antimalarial [EPC], Antirheumatic Agent [EPC]","82009-045","82009-045-05","82009-045_ddd9bc99-2f96-4baf-82a4-6fb27a3bdc07","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine sulfate","","TABLET, FILM COATED","ORAL","20220930","","ANDA","ANDA040657","Quallent Pharmaceuticals Health LLC","200","mg/1","","N","20251231"
"9660","EFLORNITHINE HYDROCHLORIDE","Eflornithine Hydrochloride","82160012501","Antiprotozoal [EPC], Decarboxylase Inhibitor [EPC], Decarboxylase Inhibitors [MoA]","82160-125","82160-125-01","82160-125_2a912c1b-7042-e496-e063-6294a90a532c","HUMAN PRESCRIPTION DRUG","Florexa","","CREAM","TOPICAL","20120209","","UNAPPROVED DRUG OTHER","","Pella Pharmaceuticals Co. Ltd","4170","mg/30g","","N","20251231"
"9661","ERYTHROMYCIN","Erythromycin","82160012601","Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]","82160-126","82160-126-01","82160-126_2a91378f-edcc-7b98-e063-6394a90aba35","HUMAN PRESCRIPTION DRUG","Spotex","","GEL","TOPICAL","20130910","","UNAPPROVED DRUG OTHER","","Pella Pharmaceuticals Co. Ltd","1200","mg/30g","","N","20251231"
"9662","SULFACETAMIDE SODIUM; SULFUR","sulfacetamide sodium and sulfur","82429010706","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","82429-107","82429-107-06","82429-107_0839eb1f-14f7-5ffb-e063-6394a90a2991","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10% and Sulfur 5% Cleanser","","RINSE","TOPICAL","20221010","","UNAPPROVED DRUG OTHER","","Gabar Health Sciences Corp.","10; 5","mg/g; mg/g","","N","20251231"
"9663","SULFACETAMIDE SODIUM; SULFUR","sulfacetamide sodium and sulfur","82429010708","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","82429-107","82429-107-08","82429-107_0839eb1f-14f7-5ffb-e063-6394a90a2991","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10% and Sulfur 5% Cleanser","","RINSE","TOPICAL","20221010","","UNAPPROVED DRUG OTHER","","Gabar Health Sciences Corp.","10; 5","mg/g; mg/g","","N","20251231"
"9664","SULFACETAMIDE SODIUM; SULFUR","sulfacetamide sodium and sulfur","82429010712","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","82429-107","82429-107-12","82429-107_0839eb1f-14f7-5ffb-e063-6394a90a2991","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10% and Sulfur 5% Cleanser","","RINSE","TOPICAL","20221010","","UNAPPROVED DRUG OTHER","","Gabar Health Sciences Corp.","10; 5","mg/g; mg/g","","N","20251231"
"9665","SULFACETAMIDE SODIUM; SULFUR","Sodium Sulfacetamide, Sulfur","82429010808","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","82429-108","82429-108-08","82429-108_10188954-e5fc-71a1-e063-6294a90a34b2","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 10% and Sulfur 2% Cleanser","","LIQUID","TOPICAL","20231030","","UNAPPROVED DRUG OTHER","","Gabar Health Sciences Corp.","10; 2","mg/g; mg/g","","N","20251231"
"9666","SULFACETAMIDE SODIUM; SULFUR","Sodium Sulfacetamide, Sulfur","82429010910","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","82429-109","82429-109-10","82429-109_0836a1d0-c352-6c32-e063-6294a90add2f","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser","","RINSE","TOPICAL","20221010","","UNAPPROVED DRUG OTHER","","Gabar Health Sciences Corp.","98; 48","mg/g; mg/g","","N","20251231"
"9667","SULFACETAMIDE SODIUM; SULFUR","SULFACETAMIDE SODIUM, SULFUR","82429012616","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","82429-126","82429-126-16","82429-126_08368bc6-272c-a9f2-e063-6394a90a3ab9","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 8% and Sulfur 4% Cleanser","","LIQUID","TOPICAL","20230405","","UNAPPROVED DRUG OTHER","","Gabar Health Sciences Corp.","80; 40","mg/g; mg/g","","N","20251231"
"9668","SULFACETAMIDE SODIUM","SODIUM SULFACETAMIDE","82429012708","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","82429-127","82429-127-08","82429-127_1018739e-c85c-ee01-e063-6394a90abf27","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide Wash 10%","","LIQUID","TOPICAL","20231020","","UNAPPROVED DRUG OTHER","","Gabar Health Sciences Corp.","100","mg/g","","N","20251231"
"9669","SULFACETAMIDE SODIUM","SODIUM SULFACETAMIDE","82429012716","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","82429-127","82429-127-16","82429-127_1018739e-c85c-ee01-e063-6394a90abf27","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide Wash 10%","","LIQUID","TOPICAL","20231020","","UNAPPROVED DRUG OTHER","","Gabar Health Sciences Corp.","100","mg/g","","N","20251231"
"9670","SULFACETAMIDE SODIUM; SULFUR","Sodium Sulfacetamide, Sulfur","82429012816","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","82429-128","82429-128-16","82429-128_0ffb3e93-3fbc-49dc-e063-6294a90a0246","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 9% and Sulfur 4% Cleanser","","LIQUID","TOPICAL","20231030","","UNAPPROVED DRUG OTHER","","Gabar Health Sciences Corp.","90; 4","mg/g; mg/g","","N","20251231"
"9671","SULFACETAMIDE SODIUM; SULFUR","Sulfacetamide Sodium and Sulfur","82429030121","Sulfonamide Antibacterial [EPC], Sulfonamides [CS]","82429-301","82429-301-21","82429-301_08367dde-b657-c569-e063-6294a90a7b97","HUMAN PRESCRIPTION DRUG","Sodium Sulfacetamide 9% and Sulfur 4.5% Wash","","RINSE","TOPICAL","20221010","","UNAPPROVED DRUG OTHER","","Gabar Health Sciences Corp.","10; 5","mg/g; mg/g","","N","20251231"
"9672","CLOTRIMAZOLE","Clotrimazole 1%","82442002228","Azole Antifungal [EPC], Azoles [CS]","82442-022","82442-022-28","82442-022_6c785d7a-8921-4ea5-b878-eadfc62258c0","HUMAN OTC DRUG","Up and Up Athletes Foot","","CREAM","TOPICAL","20240801","","OTC MONOGRAPH DRUG","M005","Target Corporation","10","mg/g","","N","20251231"
"9673","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin and tazobactam","82449050002","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","82449-500","82449-500-02","82449-500_2858b88c-e86d-6c28-e063-6394a90aad99","HUMAN PRESCRIPTION DRUG","piperacillin and tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20160630","","ANDA","ANDA065458","Steriscience Specialties Private Limited","2; .25","g/10mL; g/10mL","","N","20251231"
"9674","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin and tazobactam","82449050102","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","82449-501","82449-501-02","82449-501_2858b88c-e86d-6c28-e063-6394a90aad99","HUMAN PRESCRIPTION DRUG","piperacillin and tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20150814","","ANDA","ANDA065458","Steriscience Specialties Private Limited","3; .375","g/15mL; g/15mL","","N","20251231"
"9675","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin and tazobactam","82449050202","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","82449-502","82449-502-02","82449-502_2858b88c-e86d-6c28-e063-6394a90aad99","HUMAN PRESCRIPTION DRUG","piperacillin and tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20160630","","ANDA","ANDA065458","Steriscience Specialties Private Limited","4; .5","g/20mL; g/20mL","","N","20251231"
"9676","NAFCILLIN SODIUM","NAFCILLIN SODIUM","82449050302","Penicillin-class Antibacterial [EPC], Penicillins [CS]","82449-503","82449-503-02","82449-503_07e8b20a-f473-78ed-e063-6394a90a3340","HUMAN PRESCRIPTION DRUG","NAFCILLIN SODIUM","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20231017","","ANDA","ANDA200002","Steriscience Specialties Private Limited","1","g/1","","N","20251231"
"9677","NAFCILLIN SODIUM","NAFCILLIN SODIUM","82449050402","Penicillin-class Antibacterial [EPC], Penicillins [CS]","82449-504","82449-504-02","82449-504_07e8b20a-f473-78ed-e063-6394a90a3340","HUMAN PRESCRIPTION DRUG","NAFCILLIN SODIUM","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20231017","","ANDA","ANDA200002","Steriscience Specialties Private Limited","2","g/1","","N","20251231"
"9678","OXACILLIN SODIUM","oxacillin","82449050602","Penicillin-class Antibacterial [EPC], Penicillins [CS]","82449-506","82449-506-02","82449-506_28599ecf-4a95-58d2-e063-6394a90a3086","HUMAN PRESCRIPTION DRUG","oxacillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20220921","","ANDA","ANDA091486","Steriscience Specialties Private Limited","2","g/1","","N","20251231"
"9679","AMPICILLIN SODIUM","Ampicillin","82449051110","Penicillin-class Antibacterial [EPC], Penicillins [CS]","82449-511","82449-511-10","82449-511_fb85df45-6918-776e-e053-6294a90a2aaf","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20230512","","ANDA","ANDA201025","Steriscience Specialties Private Limited","1","g/1","","N","20251231"
"9680","AMPICILLIN SODIUM","Ampicillin","82449051210","Penicillin-class Antibacterial [EPC], Penicillins [CS]","82449-512","82449-512-10","82449-512_fb85df45-6918-776e-e053-6294a90a2aaf","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20230512","","ANDA","ANDA201025","Steriscience Specialties Private Limited","2","g/1","","N","20251231"
"9681","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin sodium and sulbactam sodium","82449051301","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","82449-513","82449-513-01","82449-513_304b3bd5-8c30-a3a7-e063-6394a90a5592","HUMAN PRESCRIPTION DRUG","ampicillin sodium and sulbactam sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20230414","","ANDA","ANDA201024","Steriscience Specialties Private Limited","1; .5","g/1; g/1","","N","20261231"
"9682","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin sodium and sulbactam sodium","82449051302","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","82449-513","82449-513-02","82449-513_304b3bd5-8c30-a3a7-e063-6394a90a5592","HUMAN PRESCRIPTION DRUG","ampicillin sodium and sulbactam sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20230414","","ANDA","ANDA201024","Steriscience Specialties Private Limited","1; .5","g/1; g/1","","N","20261231"
"9683","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin sodium and sulbactam sodium","82449051402","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","82449-514","82449-514-02","82449-514_304b3bd5-8c30-a3a7-e063-6394a90a5592","HUMAN PRESCRIPTION DRUG","ampicillin sodium and sulbactam sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20230414","","ANDA","ANDA201024","Steriscience Specialties Private Limited","2; 1","g/1; g/1","","N","20261231"
"9684","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin sodium and sulbactam sodium","82449051401","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","82449-514","82449-514-01","82449-514_304b3bd5-8c30-a3a7-e063-6394a90a5592","HUMAN PRESCRIPTION DRUG","ampicillin sodium and sulbactam sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20230414","","ANDA","ANDA201024","Steriscience Specialties Private Limited","2; 1","g/1; g/1","","N","20261231"
"9685","AMPICILLIN SODIUM","Ampicillin","82449051501","Penicillin-class Antibacterial [EPC], Penicillins [CS]","82449-515","82449-515-01","82449-515_35b4dd5c-331d-f591-e063-6394a90ae874","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20250501","","ANDA","ANDA202198","Steriscience Specialties Private Limited","10","g/1","","N","20261231"
"9686","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin sodium, sulbactam sodium","82449051601","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","82449-516","82449-516-01","82449-516_35b3155e-7531-3779-e063-6394a90a4929","HUMAN PRESCRIPTION DRUG","Ampicillin Sodium and Sulbactam Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20250501","","ANDA","ANDA202197","STERISCIENCE SPECIALTIES PRIVATE LIMITED","10; 5","g/15g; g/15g","","N","20261231"
"9687","AMPICILLIN SODIUM","Ampicillin","82449090210","Penicillin-class Antibacterial [EPC], Penicillins [CS]","82449-902","82449-902-10","82449-902_fb85df45-6918-776e-e053-6294a90a2aaf","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20230512","","ANDA","ANDA201025","Steriscience Specialties Private Limited","250","mg/1","","N","20251231"
"9688","AMPICILLIN SODIUM","Ampicillin","82449090310","Penicillin-class Antibacterial [EPC], Penicillins [CS]","82449-903","82449-903-10","82449-903_fb85df45-6918-776e-e053-6294a90a2aaf","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20230512","","ANDA","ANDA201025","Steriscience Specialties Private Limited","500","mg/1","","N","20251231"
"9689","CLOTRIMAZOLE","CLOTRIMAZOLE","82460034400","Azole Antifungal [EPC], Azoles [CS]","82460-344","82460-344-00","82460-344_09e32c60-2b51-0226-e063-6294a90a6a2f","HUMAN OTC DRUG","SIMPLY VITAL Antifungal Cream","","CREAM","TOPICAL","20220725","","OTC MONOGRAPH DRUG","M005","ALPHA PLANTS INC","10","mg/mL","","N","20251231"
"9690","AZITHROMYCIN MONOHYDRATE","azithromycin monohydrate","82584030702","Macrolide Antimicrobial [EPC], Macrolides [CS]","82584-307","82584-307-02","82584-307_1e292167-581f-b1db-e063-6394a90ae8a1","HUMAN PRESCRIPTION DRUG","AZASITE","","SOLUTION/ DROPS","OPHTHALMIC","20221101","","NDA","NDA050810","Thea Pharma Inc.","10","mg/mL","","N","20251231"
"9691","AZITHROMYCIN MONOHYDRATE","azithromycin monohydrate","82584030703","Macrolide Antimicrobial [EPC], Macrolides [CS]","82584-307","82584-307-03","82584-307_1e292167-581f-b1db-e063-6394a90ae8a1","HUMAN PRESCRIPTION DRUG","AZASITE","","SOLUTION/ DROPS","OPHTHALMIC","20221101","","NDA","NDA050810","Thea Pharma Inc.","10","mg/mL","","N","20251231"
"9692","HYDROXYCHLOROQUINE SULFATE","hydroxychloroquine sulfate","82619013101","Antimalarial [EPC], Antirheumatic Agent [EPC]","82619-131","82619-131-01","82619-131_fe07b47d-8835-473f-a233-2c8cddbd1aa0","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20250508","","ANDA","ANDA040150","Creekwood Pharmaceuticals LLC","200","mg/1","","N","20261231"
"9693","HYDROXYCHLOROQUINE SULFATE","hydroxychloroquine sulfate","82619013102","Antimalarial [EPC], Antirheumatic Agent [EPC]","82619-131","82619-131-02","82619-131_fe07b47d-8835-473f-a233-2c8cddbd1aa0","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20250508","","ANDA","ANDA040150","Creekwood Pharmaceuticals LLC","200","mg/1","","N","20261231"
"9694","HYDROXYCHLOROQUINE SULFATE","hydroxychloroquine sulfate","82619013103","Antimalarial [EPC], Antirheumatic Agent [EPC]","82619-131","82619-131-03","82619-131_fe07b47d-8835-473f-a233-2c8cddbd1aa0","HUMAN PRESCRIPTION DRUG","HYDROXYCHLOROQUINE SULFATE","","TABLET","ORAL","20250508","","ANDA","ANDA040150","Creekwood Pharmaceuticals LLC","200","mg/1","","N","20261231"
"9695","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","82644008760","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","82644-087","82644-087-60","82644-087_3d44a562-4fde-4867-90e6-433ea752bb3c","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","TABLET, FILM COATED","ORAL","20240119","","ANDA","ANDA061147","Pharmaka Generics Inc.","250","mg/1","","N","20251231"
"9696","TETRACYCLINE HYDROCHLORIDE","Tetracycline Hydrochloride","82644087060","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","82644-870","82644-870-60","82644-870_3d44a562-4fde-4867-90e6-433ea752bb3c","HUMAN PRESCRIPTION DRUG","Tetracycline Hydrochloride","","TABLET, FILM COATED","ORAL","20240119","","ANDA","ANDA061147","Pharmaka Generics Inc.","500","mg/1","","N","20251231"
"9697","DEXAMETHASONE; TOBRAMYCIN","tobramycin / dexamethasone","82667001105","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","82667-011","82667-011-05","82667-011_31ba978f-7bc8-031f-e063-6394a90ae09c","HUMAN PRESCRIPTION DRUG","Tobradex ST","","SUSPENSION/ DROPS","OPHTHALMIC","20250331","","NDA","NDA050818","Harrow Eye, LLC",".5; 3","mg/mL; mg/mL","","N","20261231"
"9698","DEXAMETHASONE; TOBRAMYCIN","tobramycin / dexamethasone","82667001100","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]","82667-011","82667-011-00","82667-011_31ba978f-7bc8-031f-e063-6394a90ae09c","HUMAN PRESCRIPTION DRUG","Tobradex ST","","SUSPENSION/ DROPS","OPHTHALMIC","20250331","","NDA","NDA050818","Harrow Eye, LLC",".5; 3","mg/mL; mg/mL","","N","20261231"
"9699","NATAMYCIN","natamycin","82667001205","Polyene Antimicrobial [EPC], Polyenes [CS]","82667-012","82667-012-05","82667-012_20ed3cfd-08c8-0392-e063-6294a90a7c0b","HUMAN PRESCRIPTION DRUG","NATACYN","","SUSPENSION/ DROPS","OPHTHALMIC","20241101","","NDA","NDA050514","Harrow Eye, LLC","50","mg/mL","","N","20251231"
"9700","DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","neomycin sulfate, polymyxin b sulfate and dexamethasone","82667010005","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","82667-100","82667-100-05","82667-100_27b3b360-0ac4-66d0-e063-6394a90a4c21","HUMAN PRESCRIPTION DRUG","Maxitrol","","SUSPENSION","OPHTHALMIC","19641115","","NDA","NDA050023","Harrow Eye, LLC","1; 3.5; 10000","mg/mL; mg/mL; [USP'U]/mL","","N","20251231"
"9701","MOXIFLOXACIN HYDROCHLORIDE","moxifloxacin hydrochloride","82667070003","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","82667-700","82667-700-03","82667-700_12053b08-7e67-c6f3-e063-6394a90a9cd9","HUMAN PRESCRIPTION DRUG","VIGAMOX","","SOLUTION/ DROPS","OPHTHALMIC","20240701","","NDA","NDA021598","Harrow Eye, LLC","5","mg/mL","","N","20251231"
"9702","CLOTRIMAZOLE","Antifungal Soap","82739001901","Azole Antifungal [EPC], Azoles [CS]","82739-019","82739-019-01","82739-019_1b1225df-9c5a-41a1-e063-6394a90a860f","HUMAN OTC DRUG","RoyceDerm Tea Tree Oil Antifungal Soap.","","SOAP","TOPICAL","20240617","","OTC MONOGRAPH DRUG","M005","Shenzhen Situya Trading Co., Ltd.","1","g/100g","","N","20251231"
"9703","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","82804001712","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","82804-017","82804-017-12","82804-017_e05caabb-b95c-4e54-890e-bbc371a20fc3","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","POWDER, FOR SUSPENSION","ORAL","20111220","","ANDA","ANDA201091","Proficient Rx LP","600; 42.9","mg/5mL; mg/5mL","","N","20251231"
"9704","FLUCONAZOLE","Fluconazole","82804003060","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","82804-030","82804-030-60","82804-030_fc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Proficient Rx LP","200","mg/1","","N","20251231"
"9705","FLUCONAZOLE","Fluconazole","82804003090","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","82804-030","82804-030-90","82804-030_fc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Proficient Rx LP","200","mg/1","","N","20251231"
"9706","FLUCONAZOLE","Fluconazole","82804003030","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","82804-030","82804-030-30","82804-030_fc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Proficient Rx LP","200","mg/1","","N","20251231"
"9707","NYSTATIN","Nystatin","82804004515","Polyene Antifungal [EPC], Polyenes [CS]","82804-045","82804-045-15","82804-045_8566c432-741f-4af7-91d7-1b7668ce5e95","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20190724","","ANDA","ANDA212557","Proficient Rx LP","100000","U/g","","N","20251231"
"9708","NYSTATIN","Nystatin","82804004530","Polyene Antifungal [EPC], Polyenes [CS]","82804-045","82804-045-30","82804-045_8566c432-741f-4af7-91d7-1b7668ce5e95","HUMAN PRESCRIPTION DRUG","Nystatin","","CREAM","TOPICAL","20190724","","ANDA","ANDA212557","Proficient Rx LP","100000","U/g","","N","20251231"
"9709","MOXIFLOXACIN HYDROCHLORIDE","MOXIFLOXACIN","82804005503","Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","82804-055","82804-055-03","82804-055_c38e051f-5765-4066-9953-2d0832481b1e","HUMAN PRESCRIPTION DRUG","MOXIFLOXACIN","","SOLUTION/ DROPS","OPHTHALMIC","20171004","","ANDA","ANDA206242","Proficient Rx LP","5","mg/mL","","N","20251231"
"9710","AMOXICILLIN; CLAVULANATE POTASSIUM","amoxicillin and clavulanate potassium","82804006020","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","82804-060","82804-060-20","82804-060_0d40bc70-8f47-48c2-a7c6-ba7db9cace74","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, COATED","ORAL","20221121","","NDA AUTHORIZED GENERIC","NDA050720","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20251231"
"9711","OFLOXACIN","ofloxacin otic","82804006105","Quinolone Antimicrobial [EPC], Quinolones [CS]","82804-061","82804-061-05","82804-061_54900137-8062-44cc-9505-3d65dedc8a16","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION","AURICULAR (OTIC)","20220715","","ANDA","ANDA216130","Proficient Rx LP","3","mg/mL","","N","20251231"
"9712","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","82804006601","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","82804-066","82804-066-01","82804-066_790279d4-2456-4091-abec-960b78885432","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170630","","ANDA","ANDA203702","Proficient Rx LP","500","mg/1","","N","20251231"
"9713","CEFTRIAXONE SODIUM","Ceftriaxone Sodium","82804006610","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","82804-066","82804-066-10","82804-066_790279d4-2456-4091-abec-960b78885432","HUMAN PRESCRIPTION DRUG","Ceftriaxone Sodium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20170630","","ANDA","ANDA203702","Proficient Rx LP","500","mg/1","","N","20251231"
"9714","CLARITHROMYCIN","Clarithromycin","82804006920","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","82804-069","82804-069-20","82804-069_28f60574-4ecd-441c-aebe-5b1d18033ef6","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","Proficient Rx LP","500","mg/1","","N","20251231"
"9715","CLARITHROMYCIN","Clarithromycin","82804006930","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","82804-069","82804-069-30","82804-069_28f60574-4ecd-441c-aebe-5b1d18033ef6","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","Proficient Rx LP","500","mg/1","","N","20251231"
"9716","CLARITHROMYCIN","Clarithromycin","82804006990","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","82804-069","82804-069-90","82804-069_28f60574-4ecd-441c-aebe-5b1d18033ef6","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","Proficient Rx LP","500","mg/1","","N","20251231"
"9717","CLARITHROMYCIN","Clarithromycin","82804006960","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","82804-069","82804-069-60","82804-069_28f60574-4ecd-441c-aebe-5b1d18033ef6","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET","ORAL","20050825","","ANDA","ANDA065136","Proficient Rx LP","500","mg/1","","N","20251231"
"9718","KETOCONAZOLE","Ketoconazole Cream, 2%","82804009115","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","82804-091","82804-091-15","82804-091_36e0bdcb-845c-452f-ad5a-a116ad657a3a","HUMAN PRESCRIPTION DRUG","Ketoconazole","","CREAM","TOPICAL","20210527","","ANDA","ANDA212443","Proficient Rx LP","20","mg/g","","N","20251231"
"9719","OFLOXACIN","ofloxacin","82804010105","Quinolone Antimicrobial [EPC], Quinolones [CS]","82804-101","82804-101-05","82804-101_0c4e0b81-a344-4678-97d2-b15dc2857882","HUMAN PRESCRIPTION DRUG","ofloxacin","","SOLUTION/ DROPS","OPHTHALMIC","20221207","","ANDA","ANDA215886","Proficient Rx LP","3","mg/mL","","N","20251231"
"9720","CEPHALEXIN","Cephalexin","82804010615","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","82804-106","82804-106-15","82804-106_88347743-e869-4266-835f-599e7c957d00","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Proficient Rx LP","500","mg/1","","N","20251231"
"9721","CEPHALEXIN","Cephalexin","82804010620","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","82804-106","82804-106-20","82804-106_88347743-e869-4266-835f-599e7c957d00","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Proficient Rx LP","500","mg/1","","N","20251231"
"9722","CEPHALEXIN","Cephalexin","82804010628","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","82804-106","82804-106-28","82804-106_88347743-e869-4266-835f-599e7c957d00","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Proficient Rx LP","500","mg/1","","N","20251231"
"9723","CEPHALEXIN","Cephalexin","82804010614","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","82804-106","82804-106-14","82804-106_88347743-e869-4266-835f-599e7c957d00","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Proficient Rx LP","500","mg/1","","N","20251231"
"9724","CEPHALEXIN","Cephalexin","82804010640","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","82804-106","82804-106-40","82804-106_88347743-e869-4266-835f-599e7c957d00","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Proficient Rx LP","500","mg/1","","N","20251231"
"9725","CEPHALEXIN","Cephalexin","82804010630","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","82804-106","82804-106-30","82804-106_88347743-e869-4266-835f-599e7c957d00","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20051116","","ANDA","ANDA065253","Proficient Rx LP","500","mg/1","","N","20251231"
"9726","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","82804011510","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","82804-115","82804-115-10","82804-115_ad3c1b1b-ca8b-4976-aba5-aed2f338dd92","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"9727","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","82804011520","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","82804-115","82804-115-20","82804-115_ad3c1b1b-ca8b-4976-aba5-aed2f338dd92","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"9728","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","82804011514","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","82804-115","82804-115-14","82804-115_ad3c1b1b-ca8b-4976-aba5-aed2f338dd92","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230914","","ANDA","ANDA217357","Proficient Rx LP","25; 75","mg/1; mg/1","","N","20251231"
"9729","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","82804013006","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","82804-130","82804-130-06","82804-130_ee0e72c6-18ff-4219-b067-26578a27ce79","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Proficient Rx LP","500","mg/1","","N","20261231"
"9730","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","82804013010","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","82804-130","82804-130-10","82804-130_ee0e72c6-18ff-4219-b067-26578a27ce79","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Proficient Rx LP","500","mg/1","","N","20261231"
"9731","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","82804013020","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","82804-130","82804-130-20","82804-130_ee0e72c6-18ff-4219-b067-26578a27ce79","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Proficient Rx LP","500","mg/1","","N","20261231"
"9732","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","82804013030","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","82804-130","82804-130-30","82804-130_ee0e72c6-18ff-4219-b067-26578a27ce79","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Proficient Rx LP","500","mg/1","","N","20261231"
"9733","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","82804013014","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","82804-130","82804-130-14","82804-130_ee0e72c6-18ff-4219-b067-26578a27ce79","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20231001","","ANDA","ANDA208921","Proficient Rx LP","500","mg/1","","N","20261231"
"9734","NITROFURANTOIN","nitrofurantoin macrocrystals","82804013114","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","82804-131","82804-131-14","82804-131_4eb40c9f-799b-42e9-9979-83461983cb6d","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Proficient Rx LP","100","mg/1","","N","20251231"
"9735","NITROFURANTOIN","nitrofurantoin macrocrystals","82804013120","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","82804-131","82804-131-20","82804-131_4eb40c9f-799b-42e9-9979-83461983cb6d","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Proficient Rx LP","100","mg/1","","N","20251231"
"9736","NITROFURANTOIN","nitrofurantoin macrocrystals","82804013128","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","82804-131","82804-131-28","82804-131_4eb40c9f-799b-42e9-9979-83461983cb6d","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20230321","","ANDA","ANDA217272","Proficient Rx LP","100","mg/1","","N","20251231"
"9737","AMOXICILLIN","Amoxicillin","82804013415","Penicillin-class Antibacterial [EPC], Penicillins [CS]","82804-134","82804-134-15","82804-134_c8e5ad7d-09b7-41d9-8cb0-467b3e8df74f","HUMAN PRESCRIPTION DRUG","Amoxicillin","","POWDER, FOR SUSPENSION","ORAL","20140915","","ANDA","ANDA204030","Proficient Rx LP","250","mg/5mL","","N","20251231"
"9738","CLARITHROMYCIN","Clarithromycin","82804014128","Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]","82804-141","82804-141-28","82804-141_88c7ded8-333c-408d-b693-a72881710f59","HUMAN PRESCRIPTION DRUG","Clarithromycin","","TABLET, FILM COATED","ORAL","20120725","","ANDA","ANDA065489","Proficient Rx LP","500","mg/1","","N","20251231"
"9739","FLUCONAZOLE","Fluconazole","82804014630","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","82804-146","82804-146-30","82804-146_fef2222c-5d61-435e-8761-d8f3d435d6d8","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20081007","","ANDA","ANDA077731","Proficient Rx LP","200","mg/1","","N","20251231"
"9740","AZITHROMYCIN DIHYDRATE","Azithromycin dihydrate","82804015304","Macrolide Antimicrobial [EPC], Macrolides [CS]","82804-153","82804-153-04","82804-153_edecf20d-c681-418b-9c47-02fb32d2b3c0","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208249","Proficient Rx LP","500","mg/1","","N","20251231"
"9741","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","82804017720","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","82804-177","82804-177-20","82804-177_a5253c79-997e-40d9-919b-d2ed8c51daa9","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20261231"
"9742","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","82804017714","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","82804-177","82804-177-14","82804-177_a5253c79-997e-40d9-919b-d2ed8c51daa9","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET","ORAL","20160823","","ANDA","ANDA203824","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20261231"
"9743","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","82804018206","Macrolide Antimicrobial [EPC], Macrolides [CS]","82804-182","82804-182-06","82804-182_a8e106cb-7245-45a5-9aad-bd624b1e011d","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240215","","ANDA","ANDA208250","Proficient Rx LP","250","mg/1","","N","20261231"
"9744","AMOXICILLIN","Amoxicillin","82804020020","Penicillin-class Antibacterial [EPC], Penicillins [CS]","82804-200","82804-200-20","82804-200_577d8a00-c538-4089-b788-01b4b92d22f2","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, COATED","ORAL","20060329","","ANDA","ANDA065255","Proficient Rx LP","875","mg/1","","N","20261231"
"9745","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","82804020120","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","82804-201","82804-201-20","82804-201_c8030539-314f-437d-abe7-415d6e58add7","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20120120","","ANDA","ANDA091568","Proficient Rx LP","875; 125","mg/1; mg/1","","N","20261231"
"9746","AZITHROMYCIN DIHYDRATE","azithromycin","82804021406","Macrolide Antimicrobial [EPC], Macrolides [CS]","82804-214","82804-214-06","82804-214_25bc2e78-9d0d-41c6-a55e-a267d4457967","HUMAN PRESCRIPTION DRUG","azithromycin","","TABLET, FILM COATED","ORAL","20221117","","ANDA","ANDA065398","Proficient Rx LP","250","mg/1","","N","20261231"
"9747","FLUCONAZOLE","Fluconazole","82804021803","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","82804-218","82804-218-03","82804-218_c0193e27-f1a4-4698-a6bb-3df772c16256","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20060125","","ANDA","ANDA077253","Proficient Rx LP","100","mg/1","","N","20261231"
"9748","TERBINAFINE HYDROCHLORIDE","terbinafine hydrochloride","82804022030","Allylamine Antifungal [EPC], Allylamine [CS]","82804-220","82804-220-30","82804-220_53235270-6ffb-44c8-aa55-debf59e1d964","HUMAN PRESCRIPTION DRUG","terbinafine hydrochloride","","TABLET","ORAL","20220128","","ANDA","ANDA078163","Proficient Rx LP","250","mg/1","","N","20261231"
"9749","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","82868000210","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","82868-002","82868-002-10","82868-002_1bceaa46-be92-baa1-e063-6394a90a7b9e","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20230926","","ANDA","ANDA204755","Northwind Pharmaceuticals, LLC","875; 125","mg/1; mg/1","","N","20251231"
"9750","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","82868000214","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","82868-002","82868-002-14","82868-002_1bceaa46-be92-baa1-e063-6394a90a7b9e","HUMAN PRESCRIPTION DRUG","AMOXICILLIN AND CLAVULANATE POTASSIUM","","TABLET, FILM COATED","ORAL","20230926","","ANDA","ANDA204755","Northwind Pharmaceuticals, LLC","875; 125","mg/1; mg/1","","N","20251231"
"9751","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","82868001214","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","82868-012","82868-012-14","82868-012_2a7f8a3c-f8fe-1f80-e063-6394a90a9056","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230920","","ANDA","ANDA077066","Northwind Pharmaceuticals, LLC","25; 75","mg/1; mg/1","","N","20251231"
"9752","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","82868001210","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","82868-012","82868-012-10","82868-012_2a7f8a3c-f8fe-1f80-e063-6394a90a9056","HUMAN PRESCRIPTION DRUG","Nitrofurantoin (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230920","","ANDA","ANDA077066","Northwind Pharmaceuticals, LLC","25; 75","mg/1; mg/1","","N","20251231"
"9753","METRONIDAZOLE","metronidazole","82868001420","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","82868-014","82868-014-20","82868-014_26f56937-43bc-8a75-e063-6394a90ade14","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20230928","","ANDA","ANDA206560","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"9754","METRONIDAZOLE","metronidazole","82868001421","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","82868-014","82868-014-21","82868-014_26f56937-43bc-8a75-e063-6394a90ade14","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20230928","","ANDA","ANDA206560","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"9755","METRONIDAZOLE","metronidazole","82868001428","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","82868-014","82868-014-28","82868-014_26f56937-43bc-8a75-e063-6394a90ade14","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20230928","","ANDA","ANDA206560","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"9756","METRONIDAZOLE","metronidazole","82868001414","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","82868-014","82868-014-14","82868-014_26f56937-43bc-8a75-e063-6394a90ade14","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20230928","","ANDA","ANDA206560","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"9757","METRONIDAZOLE","metronidazole","82868001430","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","82868-014","82868-014-30","82868-014_26f56937-43bc-8a75-e063-6394a90ade14","HUMAN PRESCRIPTION DRUG","metronidazole","","TABLET","ORAL","20230928","","ANDA","ANDA206560","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"9758","NITROFURANTOIN","nitrofurantoin macrocrystals","82868001510","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","82868-015","82868-015-10","82868-015_1ea22ac4-82db-02a8-e063-6294a90a4639","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20231006","","ANDA","ANDA217272","Northwind Pharmaceuticals, LLC","100","mg/1","","N","20251231"
"9759","NITROFURANTOIN","nitrofurantoin macrocrystals","82868001514","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","82868-015","82868-015-14","82868-015_1ea22ac4-82db-02a8-e063-6294a90a4639","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20231006","","ANDA","ANDA217272","Northwind Pharmaceuticals, LLC","100","mg/1","","N","20251231"
"9760","NITROFURANTOIN","nitrofurantoin macrocrystals","82868001520","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","82868-015","82868-015-20","82868-015_1ea22ac4-82db-02a8-e063-6294a90a4639","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20231006","","ANDA","ANDA217272","Northwind Pharmaceuticals, LLC","100","mg/1","","N","20251231"
"9761","NITROFURANTOIN","nitrofurantoin macrocrystals","82868001528","Nitrofuran Antibacterial [EPC], Nitrofurans [CS]","82868-015","82868-015-28","82868-015_1ea22ac4-82db-02a8-e063-6294a90a4639","HUMAN PRESCRIPTION DRUG","nitrofurantoin macrocrystals","","CAPSULE","ORAL","20231006","","ANDA","ANDA217272","Northwind Pharmaceuticals, LLC","100","mg/1","","N","20251231"
"9762","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","82868002110","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","82868-021","82868-021-10","82868-021_08676fab-a5b6-94a8-e063-6294a90aa861","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20231023","","ANDA","ANDA207372","Northwind Pharmaceuticals, LLC","25; 75","mg/1; mg/1","","N","20251231"
"9763","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin monohydrate/macrocrystals","82868002114","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","82868-021","82868-021-14","82868-021_08676fab-a5b6-94a8-e063-6294a90aa861","HUMAN PRESCRIPTION DRUG","Nitrofurantoin","(monohydrate/macrocrystals)","CAPSULE","ORAL","20231023","","ANDA","ANDA207372","Northwind Pharmaceuticals, LLC","25; 75","mg/1; mg/1","","N","20251231"
"9764","FLUCONAZOLE","Fluconazole","82868003386","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","82868-033","82868-033-86","82868-033_1bf4724d-a360-3e58-e063-6394a90ab188","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20231214","","ANDA","ANDA077253","Northwind Pharmaceuticals, LLC","150","mg/1","","N","20251231"
"9765","AMOXICILLIN","Amoxicillin","82868005620","Penicillin-class Antibacterial [EPC], Penicillins [CS]","82868-056","82868-056-20","82868-056_26f58c54-98b2-cdbd-e063-6294a90ae4e6","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20240530","","ANDA","ANDA065271","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"9766","AMOXICILLIN","Amoxicillin","82868005614","Penicillin-class Antibacterial [EPC], Penicillins [CS]","82868-056","82868-056-14","82868-056_26f58c54-98b2-cdbd-e063-6294a90ae4e6","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20240530","","ANDA","ANDA065271","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"9767","CEPHALEXIN","Cephalexin","82868005714","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","82868-057","82868-057-14","82868-057_26e47091-dc5c-f97a-e063-6394a90a28d7","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20240611","","ANDA","ANDA065253","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"9768","CEPHALEXIN","Cephalexin","82868005720","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","82868-057","82868-057-20","82868-057_26e47091-dc5c-f97a-e063-6394a90a28d7","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20240611","","ANDA","ANDA065253","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"9769","CEPHALEXIN","Cephalexin","82868005730","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","82868-057","82868-057-30","82868-057_26e47091-dc5c-f97a-e063-6394a90a28d7","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20240611","","ANDA","ANDA065253","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"9770","CEPHALEXIN","Cephalexin","82868005710","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","82868-057","82868-057-10","82868-057_26e47091-dc5c-f97a-e063-6394a90a28d7","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20240611","","ANDA","ANDA065253","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"9771","CEFDINIR","Cefdinir","82868005920","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","82868-059","82868-059-20","82868-059_1d0d4339-4148-4479-e063-6294a90a0bd6","HUMAN PRESCRIPTION DRUG","Cefdinir","","CAPSULE","ORAL","20240625","","ANDA","ANDA210220","Northwind Pharmaceuticals, LLC","300","mg/1","","N","20251231"
"9772","AMOXICILLIN","Amoxicillin","82868006330","Penicillin-class Antibacterial [EPC], Penicillins [CS]","82868-063","82868-063-30","82868-063_26e252dc-4e3f-1989-e063-6394a90a9aed","HUMAN PRESCRIPTION DRUG","Amoxicillin","","TABLET, CHEWABLE","ORAL","20240718","","ANDA","ANDA064013","Northwind Pharmaceuticals, LLC","250","mg/1","","N","20251231"
"9773","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","82868006514","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","82868-065","82868-065-14","82868-065_25171da5-7488-db90-e063-6394a90a29b7","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20241016","","ANDA","ANDA211013","Northwind Pharmaceuticals, LLC","25; 75","mg/1; mg/1","","N","20251231"
"9774","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","82868006614","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","82868-066","82868-066-14","82868-066_2516e2a4-59d2-39ad-e063-6394a90a4889","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20241022","","ANDA","ANDA075593","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"9775","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin","82868006630","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","82868-066","82868-066-30","82868-066_2516e2a4-59d2-39ad-e063-6394a90a4889","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20241022","","ANDA","ANDA075593","Northwind Pharmaceuticals, LLC","500","mg/1","","N","20251231"
"9776","AMOXICILLIN; CLAVULANATE POTASSIUM","Amoxicillin and Clavulanate Potassium","82868006714","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","82868-067","82868-067-14","82868-067_26e1e354-11a0-ae5e-e063-6394a90a3929","HUMAN PRESCRIPTION DRUG","Amoxicillin and Clavulanate Potassium","","TABLET, FILM COATED","ORAL","20241017","","ANDA","ANDA091568","Northwind Pharmaceuticals, LLC","875; 125","mg/1; mg/1","","N","20251231"
"9777","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, POLYMYXIN B","82942100201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","82942-1002","82942-1002-1","82942-1002_369d6dd7-ae55-e456-e063-6294a90ab143","HUMAN OTC DRUG","Triple Antibiotic","","CREAM","TOPICAL","20221001","","OTC MONOGRAPH DRUG","M004","J&A Digital Inc.","400; 3.5; 5000","[CFU]/g; mg/g; [CFU]/g","","N","20261231"
"9778","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin Zinc, Neomycin sulfate, Polymyxin B sulfate","82953001301","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","82953-013","82953-013-01","82953-013_0e1b75c1-96b6-e939-e063-6394a90abffc","HUMAN OTC DRUG","triple antibiotic","01","OINTMENT","TOPICAL","20240104","","OTC MONOGRAPH DRUG","M004","Cosmuses Cosmetics (Ningbo) Co., Ltd.","400; 3.5; 5000","U/g; mg/g; U/g","","N","20251231"
"9779","CHLORAMPHENICOL; LOBELIA ERINUS; STREPTOMYCES GRISEUS; SUS SCROFA PITUITARY GLAND; UREA","Chloremphenicol, Hypophysis, Lobelia Erenus, Streptomycin, Urea","82969206401","Allergens [CS], Amphenicol-class Antibacterial [EPC], Amphenicols [EXT], Bacterial Proteins [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Bacterial Allergenic Extract [EPC]","82969-2064","82969-2064-1","82969-2064_2ceaa0c4-3af3-432f-e063-6294a90af645","HUMAN OTC DRUG","Bestmade Natural Products BM64","","LIQUID","ORAL","20150101","","UNAPPROVED HOMEOPATHIC","","Bestmade Natural Products","200; 200; 200; 200; 200","[hp_C]/200[hp_C]; [hp_C]/200[hp_C]; [hp_C]/200[hp_C]; [hp_C]/200[hp_C]; [hp_C]/200[hp_C]","","N","20261231"
"9780","ALLYLTHIOUREA; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; BLACK COHOSH; FERRIC PICRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; QUININE SULFATE; SODIUM SALICYLATE","Baryta Carb, Baryta Mur, Calc Carb, China Sulph, Cimicifuga, Ferrum Picricum, Natrum Salicylicum, Thiosinaminum","82969207101","Antimalarial [EPC], Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]","82969-2071","82969-2071-1","82969-2071_2cedd523-000a-a39e-e063-6394a90aa81e","HUMAN OTC DRUG","Bestmade Natural Products BM71","","LIQUID","ORAL","20150101","","UNAPPROVED HOMEOPATHIC","","Bestmade Natural Products","30; 30; 30; 30; 30; 30; 30; 30","[hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]","","N","20261231"
"9781","CALCIUM FLUORIDE; DYSPHANIA AMBROSIOIDES WHOLE; ERYSIMUM CHEIRI SEED; HYACINTHOIDES NON-SCRIPTA WHOLE; POTASSIUM CHLORIDE; QUININE SULFATE; ROSA X DAMASCENA FLOWERING TOP; VERBASCUM THAPSUS WHOLE","Agraphis nutans, Calc fluor, Chenopodium, Cherianthus cheiri, China sulph, Kali mur, Rosa damascus, Verbascum","82969211701","Antimalarial [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]","82969-2117","82969-2117-1","82969-2117_2d905563-249c-dacf-e063-6394a90a48b3","HUMAN OTC DRUG","Bestmade Natural Products BM117","","LIQUID","ORAL","20250207","","UNAPPROVED HOMEOPATHIC","","Bestmade Natural Products","30; 30; 30; 30; 30; 30; 30; 30","[hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]","","N","20261231"
"9782","PENICILLIN V POTASSIUM","Penicillin V Potassium","82982001220","Penicillin-class Antibacterial [EPC], Penicillins [CS]","82982-012","82982-012-20","82982-012_198d1d13-e423-3543-e063-6394a90a957b","HUMAN PRESCRIPTION DRUG","Penicillin V Potassium","","TABLET, FILM COATED","ORAL","20221219","20250831","ANDA","ANDA065435","Pharmasource Meds LLC","500","mg/1","","N",""
"9783","AMOXICILLIN","Amoxicillin","82982002220","Penicillin-class Antibacterial [EPC], Penicillins [CS]","82982-022","82982-022-20","82982-022_198cdc87-f7b3-0a31-e063-6394a90a7e77","HUMAN PRESCRIPTION DRUG","Amoxicillin","","CAPSULE","ORAL","20230217","20260630","ANDA","ANDA065271","Pharmasource Meds, LLC","500","mg/1","","N",""
"9784","CEPHALEXIN","Cephalexin","82982002420","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","82982-024","82982-024-20","82982-024_198d06e8-115d-8ac3-e063-6394a90a978e","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20230109","20260731","ANDA","ANDA090836","Pharmasource Meds, LLC","500","mg/1","","N",""
"9785","CLINDAMYCIN HYDROCHLORIDE","Clindamycin hydrochloride","82982002830","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]","82982-028","82982-028-30","82982-028_198ccc85-8300-0a2b-e063-6394a90a249f","HUMAN PRESCRIPTION DRUG","Clindamycin hydrochloride","","CAPSULE","ORAL","20230217","20250630","ANDA","ANDA065061","Pharmasource Meds, LLC","300","mg/1","","N",""
"9786","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","82982004414","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","82982-044","82982-044-14","82982-044_198ccc85-82fd-0a2b-e063-6394a90a249f","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20230228","20271130","ANDA","ANDA090624","Pharmasource Meds, LLC","800; 160","mg/1; mg/1","","N",""
"9787","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","82982004420","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","82982-044","82982-044-20","82982-044_198ccc85-82fd-0a2b-e063-6394a90a249f","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20230228","20271130","ANDA","ANDA090624","Pharmasource Meds, LLC","800; 160","mg/1; mg/1","","N",""
"9788","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","82982005020","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","82982-050","82982-050-20","82982-050_198d06e8-115c-8ac3-e063-6394a90a978e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20230123","20260731","ANDA","ANDA077859","Pharmasource Meds, LLC","500","mg/1","","N",""
"9789","CIPROFLOXACIN HYDROCHLORIDE","Ciprofloxacin Hydrochloride","82982005014","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","82982-050","82982-050-14","82982-050_198d06e8-115c-8ac3-e063-6394a90a978e","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET, FILM COATED","ORAL","20230123","20260731","ANDA","ANDA077859","Pharmasource Meds, LLC","500","mg/1","","N",""
"9790","FLUCONAZOLE","Fluconazole","82982007002","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]","82982-070","82982-070-02","82982-070_198ba216-39a2-3d98-e063-6394a90a9f0b","HUMAN PRESCRIPTION DRUG","Fluconazole","","TABLET","ORAL","20230613","20270630","ANDA","ANDA077731","Pharmasource Meds, LLC","150","mg/1","","N",""
"9791","METRONIDAZOLE","Metronidazole","82982007214","Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","82982-072","82982-072-14","82982-072_198b5fb0-dd50-b1c0-e063-6394a90a1d83","HUMAN PRESCRIPTION DRUG","Metronidazole","","TABLET","ORAL","20231103","20260731","ANDA","ANDA203974","Pharmasource Meds, LLC","500","mg/1","","N",""
"9792","CEPHALEXIN","Cephalexin","82982007320","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","82982-073","82982-073-20","82982-073_198b8446-8758-eb8d-e063-6394a90a1a3a","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20231103","20250630","ANDA","ANDA065253","Pharmasource Meds, LLC","500","mg/1","","N",""
"9793","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","82996000101","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","82996-001","82996-001-01","82996-001_2434694e-cf1d-49bc-e063-6294a90a05d3","HUMAN OTC DRUG","First Aid Antibiotic","","GEL","TOPICAL","20221101","20270401","OTC MONOGRAPH DRUG","M004","Hubei Changjian Medical Products Co., Ltd.","400; 35; 5000","[iU]/g; mg/g; [iU]/g","","N",""
"9794","MICONAZOLE NITRATE","Miconazole Nitrate","83004001401","Azole Antifungal [EPC], Azoles [CS]","83004-014","83004-014-01","83004-014_2fae9a58-8790-5e78-e063-6394a90a7df2","HUMAN OTC DRUG","Athletes Foot","","CREAM","TOPICAL","20250227","","OTC MONOGRAPH DRUG","M005","Rida LLC","2","g/100mL","","N","20261231"
"9795","BUTENAFINE HYDROCHLORIDE","Butenafine Hydrochloride","83004001601","Benzylamine Antifungal [EPC], Benzylamines [CS]","83004-016","83004-016-01","83004-016_2fae9415-875b-58bc-e063-6394a90a3612","HUMAN OTC DRUG","Antifungal Foot Treatment","","GEL","TOPICAL","20250227","","UNAPPROVED HOMEOPATHIC","","Rida LLC","10","mg/g","","N","20261231"
"9796","MICONAZOLE NITRATE","Miconazole Nitrate","83004002001","Azole Antifungal [EPC], Azoles [CS]","83004-020","83004-020-01","83004-020_2fae7bae-0ca7-5443-e063-6394a90a8e76","HUMAN OTC DRUG","Terramed Just Think Comfort Jock Itch Antifungal Treatment","","LIQUID","TOPICAL","20250301","","OTC MONOGRAPH DRUG","M005","Rida LLC","2","g/100mL","","N","20261231"
"9797","MICONAZOLE NITRATE","Miconazole Nitrate","83004002501","Azole Antifungal [EPC], Azoles [CS]","83004-025","83004-025-01","83004-025_3632e06d-9a9b-ca67-e063-6394a90ab6e8","HUMAN OTC DRUG","Fungazol Athlete Foot","","CREAM","TOPICAL","20250523","","OTC MONOGRAPH DRUG","M005","Rida LLC","2","g/100mL","","N","20261231"
"9798","NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE","Nitrofurantoin (monohydrate/macrocrystals)","83008003214","Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]","83008-032","83008-032-14","83008-032_90be5cfe-fcc5-4e8a-a748-a6f3d2511079","HUMAN PRESCRIPTION DRUG","NITROFURANTOIN (monohydrate/macrocrystals)","","CAPSULE","ORAL","20230628","20260331","ANDA","ANDA211013","Quality Care Products, LLC","25; 75","mg/1; mg/1","","N",""
"9799","CIPROFLOXACIN HYDROCHLORIDE","Ciprofolxacin","83008007820","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","83008-078","83008-078-20","83008-078_d6e43461-8fb9-44e4-998b-b501bbabf58b","HUMAN PRESCRIPTION DRUG","Ciprofloxacin","","TABLET","ORAL","20240821","20260831","ANDA","ANDA208921","Quality Care Products, LLC","500","mg/1","","N",""
"9800","AZITHROMYCIN DIHYDRATE","Azithromycin Dihydrate","83008008106","Macrolide Antimicrobial [EPC], Macrolides [CS]","83008-081","83008-081-06","83008-081_ba400da0-efae-451a-91d4-b9f5ad4dc773","HUMAN PRESCRIPTION DRUG","Azithromycin Dihydrate","","TABLET, FILM COATED","ORAL","20240828","20270102","ANDA","ANDA208250","Quality Care Products, LLC","250","mg/1","","N",""
"9801","BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CEANOTHUS AMERICANUS LEAF; CINCHONA OFFICINALIS BARK; HELIANTHUS ANNUUS FLOWERING TOP; QUERCUS ROBUR NUT; QUININE ARSENITE; SODIUM CHLORIDE","Cinchona Officinalis, Quercus Glandium Spiritus, Ceanothus Americanus, Spleen (Bovine), Thymus (Bovine), Chininum Arsenicosum, Natrum Muriaticum, Helianthus Annuus","83027002001","Antimalarial [EPC]","83027-0020","83027-0020-1","83027-0020_0835d6a7-9650-4a22-b46f-8bdb0e6f49ed","HUMAN OTC DRUG","Spleen Thymus Liquescence","","LIQUID","ORAL","20230324","","UNAPPROVED HOMEOPATHIC","","Nutritional Specialties, Inc.","6; 6; 6; 4; 16; 4; 12; 12","[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL","","N","20251231"
"9802","CLOTRIMAZOLE","Clotrimazole 1%","83035106203","Azole Antifungal [EPC], Azoles [CS]","83035-1062","83035-1062-3","83035-1062_23e80332-b3d5-6877-e063-6394a90ac195","HUMAN OTC DRUG","TM-Clotrimazole","","CREAM","TOPICAL","20230403","","OTC MONOGRAPH DRUG","M005","Singular Dreamer, Ltd dba True Marker","1","g/100g","","N","20251231"
"9803","DAPTOMYCIN","daptomycin","83090001101","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","83090-011","83090-011-01","83090-011_5ef48d1a-eecc-4782-b347-7930a733e603","HUMAN PRESCRIPTION DRUG","daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION","INTRAVENOUS","20231105","","ANDA","ANDA215890","Sintetica US LLC","500","mg/20mL","","N","20261231"
"9804","MICONAZOLE NITRATE","MICONAZOLE NITRATE","83099000000","Azole Antifungal [EPC], Azoles [CS]","83099-000","83099-000-00","83099-000_089fd7d6-e589-daec-e063-6294a90ab9b6","HUMAN OTC DRUG","Evercare Antifungal Treatment Super Absorbent Powder","","POWDER","TOPICAL","20221128","","OTC MONOGRAPH DRUG","M005","PANEFFORT, LLC","20","mg/g","","N","20251231"
"9805","AMOXICILLIN","Amoxicillin","83112003121","Penicillin-class Antibacterial [EPC], Penicillins [CS]","83112-031","83112-031-21","83112-031_2bb1b5c0-cc63-e2b8-e063-6394a90aeaeb","HUMAN PRESCRIPTION DRUG","Amoxicillin 500 mg","","CAPSULE","ORAL","20230101","","ANDA","ANDA065271","Health Department, Oklahoma State","500","mg/1","","N","20261231"
"9806","AMOXICILLIN","Amoxicillin","83112003130","Penicillin-class Antibacterial [EPC], Penicillins [CS]","83112-031","83112-031-30","83112-031_2bb1b5c0-cc63-e2b8-e063-6394a90aeaeb","HUMAN PRESCRIPTION DRUG","Amoxicillin 500 mg","","CAPSULE","ORAL","20230101","","ANDA","ANDA065271","Health Department, Oklahoma State","500","mg/1","","N","20261231"
"9807","CEFIXIME","Cefixime","83112058450","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","83112-584","83112-584-50","83112-584_2a95979e-4e79-0007-e063-6394a90a80e0","HUMAN PRESCRIPTION DRUG","Cefixime 400 mg UD","","CAPSULE","ORAL","20230101","","ANDA","ANDA210574","Health Department, Oklahoma State","400","mg/1","","N","20251231"
"9808","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","83165000500","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","83165-005","83165-005-00","83165-005_09ce7749-d5e6-8dc4-e063-6394a90a5296","HUMAN OTC DRUG","First Aid Antibiotic","","LIQUID","TOPICAL","20230101","","OTC MONOGRAPH DRUG","M004","Hubei Fanjian Medical Product Co.,Ltd","400; 3.5; 5000","U/g; mg/g; U/g","","N","20251231"
"9809","AMIKACIN SULFATE","Amikacin Sulfate","83301002202","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","83301-0022","83301-0022-2","83301-0022_151983fd-599d-4c3c-8895-6acf80cb3ac6","HUMAN PRESCRIPTION DRUG","Amikacin Sulfate","","INJECTION","INTRAMUSCULAR; INTRAVENOUS","20250404","","ANDA","ANDA218146","Mullan Pharmaceutical Inc.","250","mg/mL","","N","20261231"
"9810","AMIKACIN SULFATE","Amikacin Sulfate","83301002302","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]","83301-0023","83301-0023-2","83301-0023_151983fd-599d-4c3c-8895-6acf80cb3ac6","HUMAN PRESCRIPTION DRUG","Amikacin Sulfate","","INJECTION","INTRAMUSCULAR; INTRAVENOUS","20250404","","ANDA","ANDA218146","Mullan Pharmaceutical Inc.","250","mg/mL","","N","20261231"
"9811","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate","83324003601","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","83324-036","83324-036-01","83324-036_12779daa-01fe-aa1b-e063-6394a90a4d30","HUMAN OTC DRUG","Triple Antibiotic Plus Pain Relief","","OINTMENT","TOPICAL","20240228","","OTC MONOGRAPH DRUG","M004","Chain Drug Marketing Association Inc.","500; 3.5; 10000; 10","[USP'U]/g; mg/g; [USP'U]/g; mg/g","","N","20251231"
"9812","CLOTRIMAZOLE","Clotrimazole","83324004101","Azole Antifungal [EPC], Azoles [CS]","83324-041","83324-041-01","83324-041_24ff6316-4ab4-b860-e063-6394a90ace42","HUMAN OTC DRUG","Clotrimazole 1%","","CREAM","TOPICAL","20240813","","OTC MONOGRAPH DRUG","M005","Chain Drug Marketing Association Inc.","1","g/100g","","N","20251231"
"9813","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.","83324005005","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","83324-050","83324-050-05","83324-050_1a14f49a-8fbc-4b14-e063-6394a90a817b","HUMAN OTC DRUG","QC Triple Antibiotic","","OINTMENT","TOPICAL","20240315","","OTC MONOGRAPH DRUG","M004","Chain Drug Marketing Association","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"9814","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate.","83324005001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","83324-050","83324-050-01","83324-050_1a14f49a-8fbc-4b14-e063-6394a90a817b","HUMAN OTC DRUG","QC Triple Antibiotic","","OINTMENT","TOPICAL","20240315","","OTC MONOGRAPH DRUG","M004","Chain Drug Marketing Association","400; 3.5; 5000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"9815","CLOTRIMAZOLE","Clotrimazole","83324015415","Azole Antifungal [EPC], Azoles [CS]","83324-154","83324-154-15","83324-154_81dcf354-b177-4acf-89f9-06653b184450","HUMAN OTC DRUG","Clotrimazole","","CREAM","VAGINAL","20240731","","ANDA","ANDA074165","QUALITY CHOICE (Chain Drug Marketing Association)","10","mg/g","","N","20251231"
"9816","MICONAZOLE NITRATE","Miconazole Nitrate","83324016015","Azole Antifungal [EPC], Azoles [CS]","83324-160","83324-160-15","83324-160_b9d43020-9b44-4306-8bd8-0b8419c8e22d","HUMAN OTC DRUG","Miconazole 7","","CREAM","VAGINAL","20240731","","ANDA","ANDA074164","QUALITY CHOICE (Chain Drug Marketing Association)","20","mg/g","","N","20251231"
"9817","MICONAZOLE NITRATE","Athletes Foot Powder Spray Talc Free","83324023346","Azole Antifungal [EPC], Azoles [CS]","83324-233","83324-233-46","83324-233_3300da55-68e6-c262-e063-6294a90a3011","HUMAN OTC DRUG","Miconazole Nitrate","","AEROSOL, POWDER","TOPICAL","20250410","","OTC MONOGRAPH DRUG","M005","Chain Drug Marketing Association","20","mg/g","","N","20261231"
"9818","MENTHOL, UNSPECIFIED FORM; MICONAZOLE; SILVER","Menthol,Colloidal Silver,Miconazole","83364000301","Azole Antifungal [EPC], Azoles [CS]","83364-003","83364-003-01","83364-003_13b6bd75-7750-f4b1-e063-6294a90a10f4","HUMAN OTC DRUG","FungiFree Antifungal Ringworm Cream","","CREAM","TOPICAL","20240225","","UNAPPROVED DRUG OTHER","","YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD","8; .1; .1","g/100g; g/100g; g/100g","","N","20251231"
"9819","KETOCONAZOLE; TOLNAFTATE","Ketoconazole, Tolnaftate","83364000501","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","83364-005","83364-005-01","83364-005_186e7e21-b3f6-1c94-e063-6394a90adaeb","HUMAN OTC DRUG","FungiFree Nail Fungus Treatment","","SOLUTION","TOPICAL","20240516","","UNAPPROVED DRUG OTHER","","YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD","1.7; 1","g/100g; g/100g","","N","20251231"
"9820","MICONAZOLE NITRATE","MICONAZOLE NITRATE","83364001401","Azole Antifungal [EPC], Azoles [CS]","83364-014","83364-014-01","83364-014_28a00fbf-7336-85dc-e063-6294a90ab620","HUMAN OTC DRUG","FUNGIFREE Jock Itch Psoriasis Treatment Cream","","CREAM","TOPICAL","20241209","","OTC MONOGRAPH DRUG","M005","YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD","2","g/100g","","N","20251231"
"9821","CLOTRIMAZOLE","Clotrimazole","83474000334","Azole Antifungal [EPC], Azoles [CS]","83474-003","83474-003-34","83474-003_e7a22b39-82a1-46ff-8690-4d9e8b04413f","HUMAN OTC DRUG","Clotrimazole (Topical Solution), 1%","","SOLUTION","TOPICAL","20240415","","OTC MONOGRAPH DRUG","M005","Puro Pharma Inc.","10","mg/mL","","N","20251231"
"9822","MICONAZOLE NITRATE","Miconazole Nitrate","83520096121","Azole Antifungal [EPC], Azoles [CS]","83520-961","83520-961-21","83520-961_12eef049-76c8-1450-e063-6394a90a00ea","HUMAN OTC DRUG","Dermachange Jock","","POWDER","TOPICAL","20231025","","OTC MONOGRAPH DRUG","M005","Private label Beauty and Wellness","2","g/100g","","N","20251231"
"9823","MICONAZOLE NITRATE","Miconazole Nitrate","83520096102","Azole Antifungal [EPC], Azoles [CS]","83520-961","83520-961-02","83520-961_12eef049-76c8-1450-e063-6394a90a00ea","HUMAN OTC DRUG","Dermachange Jock","","POWDER","TOPICAL","20231025","","OTC MONOGRAPH DRUG","M005","Private label Beauty and Wellness","2","g/100g","","N","20251231"
"9824","AMPICILLIN SODIUM","ampicillin sodium","83634010099","Penicillin-class Antibacterial [EPC], Penicillins [CS]","83634-100","83634-100-99","83634-100_d6776ddf-b79b-4e34-9741-5b8b4275283a","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20250201","","ANDA","ANDA201404","Avenacy Inc.","10","g/100mL","","N","20251231"
"9825","NAFCILLIN SODIUM","Nafcillin Sodium","83634010199","Penicillin-class Antibacterial [EPC], Penicillins [CS]","83634-101","83634-101-99","83634-101_7a4b6e14-65c7-456d-999a-eb8dacaaeece","HUMAN PRESCRIPTION DRUG","Nafcillin","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20250201","","ANDA","ANDA090005","Avenacy Inc.","10","g/100mL","","N","20251231"
"9826","PENICILLIN G POTASSIUM","penicillin g potassium","83634010220","Penicillin-class Antibacterial [EPC], Penicillins [CS]","83634-102","83634-102-20","83634-102_727994cd-436d-4347-a023-5a861abd3264","HUMAN PRESCRIPTION DRUG","Penicillin G Potassium","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20250201","","ANDA","ANDA065448","Avenacy Inc.","5000000","[iU]/1","","N","20251231"
"9827","PENICILLIN G POTASSIUM","penicillin g potassium","83634010351","Penicillin-class Antibacterial [EPC], Penicillins [CS]","83634-103","83634-103-51","83634-103_727994cd-436d-4347-a023-5a861abd3264","HUMAN PRESCRIPTION DRUG","Penicillin G Potassium","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20250201","","ANDA","ANDA065448","Avenacy Inc.","20000000","[iU]/1","","N","20251231"
"9828","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin and tazobactam","83634010420","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","83634-104","83634-104-20","83634-104_21b0bb97-b453-45a0-95d6-4930c4f70027","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20250201","","ANDA","ANDA065523","Avenacy Inc.","2; .25","g/10mL; g/10mL","","N","20251231"
"9829","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin and tazobactam","83634010530","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","83634-105","83634-105-30","83634-105_21b0bb97-b453-45a0-95d6-4930c4f70027","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20250201","","ANDA","ANDA065523","Avenacy Inc.","3; .375","g/15mL; g/15mL","","N","20251231"
"9830","PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","piperacillin and tazobactam","83634010650","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","83634-106","83634-106-50","83634-106_21b0bb97-b453-45a0-95d6-4930c4f70027","HUMAN PRESCRIPTION DRUG","Piperacillin and Tazobactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20250201","","ANDA","ANDA065523","Avenacy Inc.","4; .5","g/20mL; g/20mL","","N","20251231"
"9831","DAPTOMYCIN","daptomycin","83634010720","Lipopeptide Antibacterial [EPC], Lipopeptides [CS]","83634-107","83634-107-20","83634-107_8a125f13-b3f1-4802-af5e-10b8f23a97cf","HUMAN PRESCRIPTION DRUG","Daptomycin","","INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","INTRAVENOUS","20250115","","ANDA","ANDA212022","Avenacy Inc.","500","mg/10mL","","N","20251231"
"9832","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin and sulbactam","83634010899","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","83634-108","83634-108-99","83634-108_2facc8c4-46fb-4562-a621-a856ec473567","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAVENOUS","20250201","","ANDA","ANDA065314","Avenacy, LLC","10; 5","g/1; g/1","","N","20261231"
"9833","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin and sulbactam","83634010920","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","83634-109","83634-109-20","83634-109_defc86ea-aea6-4978-b547-2473933197ef","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20250201","","ANDA","ANDA065222","Avenacy, LLC","1; .5","g/1; g/1","","N","20261231"
"9834","AMPICILLIN SODIUM; SULBACTAM SODIUM","ampicillin and sulbactam","83634011020","Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]","83634-110","83634-110-20","83634-110_defc86ea-aea6-4978-b547-2473933197ef","HUMAN PRESCRIPTION DRUG","Ampicillin and Sulbactam","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20250201","","ANDA","ANDA065222","Avenacy, LLC","2; 1","g/1; g/1","","N","20261231"
"9835","PYRIMETHAMINE","pyrimethamine","83649033001","Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]","83649-330","83649-330-01","83649-330_c7c0666e-57ea-45e4-b3b4-e3950a173011","HUMAN PRESCRIPTION DRUG","Daraprim","","TABLET","ORAL","19530123","","NDA","NDA008578","TILDE Sciences LLC","25","mg/1","","N","20251231"
"9836","PYRIMETHAMINE","pyrimethamine","83649033003","Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]","83649-330","83649-330-03","83649-330_c7c0666e-57ea-45e4-b3b4-e3950a173011","HUMAN PRESCRIPTION DRUG","Daraprim","","TABLET","ORAL","19530123","","NDA","NDA008578","TILDE Sciences LLC","25","mg/1","","N","20251231"
"9837","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate","83807000201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","83807-002","83807-002-01","83807-002_0a292232-ca12-12be-e063-6394a90a9857","HUMAN OTC DRUG","EVERLIT CARE Triple Antibiotic","","OINTMENT","TOPICAL","20231114","","OTC MONOGRAPH DRUG","M004","EVERLIT GLOBAL INC.","400; .0035; 5000","[USP'U]/g; g/g; [USP'U]/g","","N","20251231"
"9838","KETOCONAZOLE","Pureskin Scalp Protection anti dandruff shampoo","83887000401","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","83887-004","83887-004-01","83887-004_2d38d7f4-6c9a-182d-e063-6294a90a7b33","HUMAN OTC DRUG","Pureskin Scalp Protection anti dandruff shampoo.","","SHAMPOO","TOPICAL","20250203","","OTC MONOGRAPH DRUG","M032","Changsha Beiliang E-commerce Co., Ltd",".5","g/100mL","","N","20261231"
"9839","KETOCONAZOLE; SOPHORA FLAVESCENS ROOT","Advanced Scalp Shampoo","83887000501","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","83887-005","83887-005-01","83887-005_2e89c938-e6a0-1323-e063-6294a90aebdb","HUMAN OTC DRUG","DERPHEA Advanced Scalp Shampoo.","","SHAMPOO","TOPICAL","20250220","","OTC MONOGRAPH DRUG","M032","Changsha Beiliang E-commerce Co., Ltd","1; 2","g/100mL; g/100mL","","N","20261231"
"9840","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","83980000101","Antimalarial [EPC], Antirheumatic Agent [EPC]","83980-001","83980-001-01","83980-001_31f4188d-1c26-4aab-aa12-354329160a39","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20240603","","ANDA","ANDA040766","Ipca Laboratories Limited","200","mg/1","","N","20251231"
"9841","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","83980000110","Antimalarial [EPC], Antirheumatic Agent [EPC]","83980-001","83980-001-10","83980-001_31f4188d-1c26-4aab-aa12-354329160a39","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20240603","","ANDA","ANDA040766","Ipca Laboratories Limited","200","mg/1","","N","20251231"
"9842","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","83980000197","Antimalarial [EPC], Antirheumatic Agent [EPC]","83980-001","83980-001-97","83980-001_31f4188d-1c26-4aab-aa12-354329160a39","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20240603","","ANDA","ANDA040766","Ipca Laboratories Limited","200","mg/1","","N","20251231"
"9843","HYDROXYCHLOROQUINE SULFATE","Hydroxychloroquine Sulfate","83980000105","Antimalarial [EPC], Antirheumatic Agent [EPC]","83980-001","83980-001-05","83980-001_31f4188d-1c26-4aab-aa12-354329160a39","HUMAN PRESCRIPTION DRUG","Hydroxychloroquine Sulfate","","TABLET, FILM COATED","ORAL","20240603","","ANDA","ANDA040766","Ipca Laboratories Limited","200","mg/1","","N","20251231"
"9844","MICONAZOLE NITRATE","Antifungal Cream","84010000901","Azole Antifungal [EPC], Azoles [CS]","84010-009","84010-009-01","84010-009_15b74e48-6ca3-2688-e063-6294a90aa887","HUMAN OTC DRUG","Charmpoo Antifungal Cream","","CREAM","TOPICAL","20240409","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","2","g/100g","","N","20251231"
"9845","CLOTRIMAZOLE; MICONAZOLE","Clotrimazole1%, Miconazole1%Clotrimazole","84010001401","Azole Antifungal [EPC], Azole Antifungal [EPC], Azoles [CS], Azoles [CS]","84010-014","84010-014-01","84010-014_1739fa38-35ae-2f18-e063-6394a90af6f4","HUMAN OTC DRUG","HEALMUSZ Clotrimazole","","CREAM","TOPICAL","20240429","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","1; 1","g/100g; g/100g","","N","20251231"
"9846","CLOTRIMAZOLE; MICONAZOLE","Clotrimazole1%, Miconazole1%Clotrimazole","84010003001","Azole Antifungal [EPC], Azole Antifungal [EPC], Azoles [CS], Azoles [CS]","84010-030","84010-030-01","84010-030_21fc5ec9-c832-2a8b-e063-6394a90abe0c","HUMAN OTC DRUG","Nekvnro Clotrimazole","","OINTMENT","TOPICAL","20240913","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","1; 1","g/100g; g/100g","","N","20251231"
"9847","CLOTRIMAZOLE; MICONAZOLE","Clotrimazole1%, Miconazole1%Clotrimazole","84010003002","Azole Antifungal [EPC], Azole Antifungal [EPC], Azoles [CS], Azoles [CS]","84010-030","84010-030-02","84010-030_21fc5ec9-c832-2a8b-e063-6394a90abe0c","HUMAN OTC DRUG","Nekvnro Clotrimazole","","OINTMENT","TOPICAL","20240913","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","1; 1","g/100g; g/100g","","N","20251231"
"9848","CLOTRIMAZOLE; MICONAZOLE","Clotrimazole1%, Miconazole1%Clotrimazole","84010003003","Azole Antifungal [EPC], Azole Antifungal [EPC], Azoles [CS], Azoles [CS]","84010-030","84010-030-03","84010-030_21fc5ec9-c832-2a8b-e063-6394a90abe0c","HUMAN OTC DRUG","Nekvnro Clotrimazole","","OINTMENT","TOPICAL","20240913","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","1; 1","g/100g; g/100g","","N","20251231"
"9849","CLOTRIMAZOLE; MICONAZOLE","Clotrimazole1%, Miconazole1%Clotrimazole","84010003004","Azole Antifungal [EPC], Azole Antifungal [EPC], Azoles [CS], Azoles [CS]","84010-030","84010-030-04","84010-030_21fc5ec9-c832-2a8b-e063-6394a90abe0c","HUMAN OTC DRUG","Nekvnro Clotrimazole","","OINTMENT","TOPICAL","20240913","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","1; 1","g/100g; g/100g","","N","20251231"
"9850","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B","Triple Antibiotic","84010003901","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","84010-039","84010-039-01","84010-039_2547cfaf-edb7-7b05-e063-6394a90a5345","HUMAN OTC DRUG","DERMFREE Triple Antibiotic","","OINTMENT","TOPICAL","20241025","","OTC MONOGRAPH DRUG","M004","Jiangxi Hemei Pharmaceutical Co., Ltd","500; 3.5; 10000","[USP'U]/g; mg/g; [USP'U]/g","","N","20251231"
"9851","MICONAZOLE NITRATE","Antifungal Cream","84010004602","Azole Antifungal [EPC], Azoles [CS]","84010-046","84010-046-02","84010-046_275333aa-bac8-5618-e063-6394a90ae5ad","HUMAN OTC DRUG","Charmpoo Antifungal Cream","","CREAM","TOPICAL","20241120","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","2","g/100g","","N","20251231"
"9852","MICONAZOLE NITRATE","Antifungal Cream","84010004601","Azole Antifungal [EPC], Azoles [CS]","84010-046","84010-046-01","84010-046_275333aa-bac8-5618-e063-6394a90ae5ad","HUMAN OTC DRUG","Charmpoo Antifungal Cream","","CREAM","TOPICAL","20241120","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","2","g/100g","","N","20251231"
"9853","MICONAZOLE NITRATE","Miconazole nitrate 1% ANTIFUNGAL","84010006701","Azole Antifungal [EPC], Azoles [CS]","84010-067","84010-067-01","84010-067_2b42b4af-5d3c-559a-e063-6394a90a7ff7","HUMAN OTC DRUG","Charmpoo ANTIFUNGAL","","SOAP","CUTANEOUS","20250106","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","1","g/100g","","N","20261231"
"9854","MICONAZOLE NITRATE","Miconazole nitrate 2% Antifungal Cream","84010006901","Azole Antifungal [EPC], Azoles [CS]","84010-069","84010-069-01","84010-069_2dc0f61e-331e-d8b4-e063-6294a90a9152","HUMAN OTC DRUG","Charmpoo Antifungal Cream","","CREAM","TOPICAL","20250210","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","2","g/100g","","N","20261231"
"9855","CLOTRIMAZOLE; MICONAZOLE","Clotrimazole1%, Miconazole1%Clotrimazole","84010008501","Azole Antifungal [EPC], Azole Antifungal [EPC], Azoles [CS], Azoles [CS]","84010-085","84010-085-01","84010-085_300e0106-b743-5d31-e063-6394a90ae2b9","HUMAN OTC DRUG","HEALSURE Clotrimazole","","CREAM","TOPICAL","20250311","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","1; 1","g/100g; g/100g","","N","20261231"
"9856","CLOTRIMAZOLE; MICONAZOLE","Clotrimazole1%, Miconazole1%Clotrimazole","84010008502","Azole Antifungal [EPC], Azole Antifungal [EPC], Azoles [CS], Azoles [CS]","84010-085","84010-085-02","84010-085_300e0106-b743-5d31-e063-6394a90ae2b9","HUMAN OTC DRUG","HEALSURE Clotrimazole","","CREAM","TOPICAL","20250311","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","1; 1","g/100g; g/100g","","N","20261231"
"9857","CLOTRIMAZOLE; MICONAZOLE","Clotrimazole1%, Miconazole1% Clotrimazole","84010010401","Azole Antifungal [EPC], Azole Antifungal [EPC], Azoles [CS], Azoles [CS]","84010-104","84010-104-01","84010-104_347428e0-3f4f-da26-e063-6294a90a8727","HUMAN OTC DRUG","NATUHEAL Clotrimazole","","CREAM","TOPICAL","20250506","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","1; 1","g/100g; g/100g","","N","20261231"
"9858","CLOTRIMAZOLE; MICONAZOLE","Clotrimazole1%, Miconazole1% Clotrimazole","84010010402","Azole Antifungal [EPC], Azole Antifungal [EPC], Azoles [CS], Azoles [CS]","84010-104","84010-104-02","84010-104_347428e0-3f4f-da26-e063-6294a90a8727","HUMAN OTC DRUG","NATUHEAL Clotrimazole","","CREAM","TOPICAL","20250506","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","1; 1","g/100g; g/100g","","N","20261231"
"9859","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B","Triple Antibiotic","84010011501","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","84010-115","84010-115-01","84010-115_35a3d89b-8763-9a48-e063-6294a90a2b02","HUMAN OTC DRUG","WELLREME Triple Antibiotic","","OINTMENT","TOPICAL","20250521","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","500; 3.5; 10000","[USP'U]/g; mg/g; [USP'U]/g","","N","20261231"
"9860","CLOTRIMAZOLE","Clotrimazole1% Clotrimazole","84010012901","Azole Antifungal [EPC], Azoles [CS]","84010-129","84010-129-01","84010-129_3643697f-2872-5d0f-e063-6294a90aacb5","HUMAN OTC DRUG","WELLREME Clotrimazole","","CREAM","TOPICAL","20250529","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","1","g/100g","","N","20261231"
"9861","CLOTRIMAZOLE","Clotrimazole1% Clotrimazole","84010013401","Azole Antifungal [EPC], Azoles [CS]","84010-134","84010-134-01","84010-134_3749103c-dc4b-8ddd-e063-6394a90a4917","HUMAN OTC DRUG","DERMFREE Clotrimazole","","CREAM","TOPICAL","20250611","","OTC MONOGRAPH DRUG","M005","Jiangxi Hemei Pharmaceutical Co., Ltd","1","g/100g","","N","20261231"
"9862","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE","84219000100","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","84219-001","84219-001-00","84219-001_15081208-e9bb-be2f-e063-6394a90a5bc6","HUMAN OTC DRUG","First Aid Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate","","GEL","TOPICAL","20240515","","OTC MONOGRAPH DRUG","M004","M-star (Hubei) Health&Care Products Co., Ltd.","400; 3.5; 5000","U/g; mg/g; U/g","","N","20251231"
"9863","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","bacitracin zinc, neomycin sulfate, polymyxin b sulfate","84269450001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","84269-4500","84269-4500-1","84269-4500_1f96393b-0fde-fb5e-e063-6294a90aa5fe","HUMAN OTC DRUG","Triple Antibiotic","","OINTMENT","TOPICAL","20240901","","OTC MONOGRAPH DRUG","M004","Wildeman Business Group","400; 3.5; 5000","[iU]/g; mg/g; [iU]/g","","N","20251231"
"9864","CLINDAMYCIN HYDROCHLORIDE; METRONIDAZOLE","Acnil Clindamycin Hydrochloride and Metronidazole Liniment","84277564701","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]","84277-5647","84277-5647-1","84277-5647_2e5af775-2563-cb6c-e063-6294a90a6411","HUMAN OTC DRUG","Acnil","","LINIMENT","TOPICAL","20240501","","UNAPPROVED DRUG OTHER","","Jiangsu Chenpai Bond Pharmaceutical Co.,Ltd.","10; 8","mg/30mL; mg/30mL","","N","20261231"
"9865","CLOBETASOL PROPIONATE; KETOCONAZOLE","Danil compound ketoconazole solution for scalp disorders.","84277566503","Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","84277-5665","84277-5665-3","84277-5665_2e5ad164-898f-f276-e063-6394a90ade14","HUMAN OTC DRUG","Danil","","SOLUTION","TOPICAL","20240501","","UNAPPROVED DRUG OTHER","","Jiangsu Chenpai Bond Pharmaceutical Co.,Ltd.",".25; 15","mg/g; mg/g","","N","20261231"
"9866","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","FIRST AID ANTIBIOTIC","84289011840","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","84289-118","84289-118-40","84289-118_30a685a4-c6ab-46b1-e063-6394a90a8835","HUMAN OTC DRUG","PROSKI TRIPLE ANTIBIIOTIC","","OINTMENT","TOPICAL","20250401","","OTC MONOGRAPH DRUG","M004","PHARMAMED USA INC","400; 5; 5000","[iU]/g; mg/g; [iU]/g","","N","20261231"
"9867","KETOCONAZOLE","lanimpress1%ketoconazoleantidandruffshampoo","84372003701","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","84372-037","84372-037-01","84372-037_2120e631-d475-7830-e063-6394a90a7ab0","HUMAN OTC DRUG","lanimpress1%ketoconazoleantidandruffshampoo","","LOTION","TOPICAL","20240902","","OTC MONOGRAPH DRUG","M016","Shenzhen Zhumeng Times Technology Co., Ltd.","5","g/125mL","","N","20251231"
"9868","KETOCONAZOLE","lanimpress1%ketoconazoleantidandruffshampoo","84372003801","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","84372-038","84372-038-01","84372-038_21241055-d65c-ba69-e063-6394a90a19cc","HUMAN OTC DRUG","lanimpress1%ketoconazoleantidandruffshampoo","","LOTION","TOPICAL","20240902","","OTC MONOGRAPH DRUG","M016","Shenzhen Zhumeng Times Technology Co., Ltd.","5","g/125mL","","N","20251231"
"9869","KETOCONAZOLE","lanimpress1%ketoconazoleantidandruffshampoo","84372003901","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","84372-039","84372-039-01","84372-039_212442d5-da5d-73ae-e063-6294a90accae","HUMAN OTC DRUG","lanimpress1%ketoconazoleantidandruffshampoo","","LOTION","TOPICAL","20240902","","OTC MONOGRAPH DRUG","M016","Shenzhen Zhumeng Times Technology Co., Ltd.","5","g/125mL","","N","20251231"
"9870","KETOCONAZOLE","lanimpress1%ketoconazoleantidandruffshampoo","84372004001","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","84372-040","84372-040-01","84372-040_212489be-4eba-77e0-e063-6294a90a1db5","HUMAN OTC DRUG","lanimpress1%ketoconazoleantidandruffshampoo","","LOTION","TOPICAL","20240902","","OTC MONOGRAPH DRUG","M016","Shenzhen Zhumeng Times Technology Co., Ltd.","5","g/125mL","","N","20251231"
"9871","KETOCONAZOLE","lanimpress1%ketoconazoleantidandruffshampoo","84372004101","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","84372-041","84372-041-01","84372-041_2124c561-37ec-9088-e063-6394a90a2af3","HUMAN OTC DRUG","lanimpress1%ketoconazoleantidandruffshampoo","","LOTION","TOPICAL","20240902","","OTC MONOGRAPH DRUG","M016","Shenzhen Zhumeng Times Technology Co., Ltd.","5","g/125mL","","N","20251231"
"9872","KETOCONAZOLE","lanimpress1%ketoconazoleantidandruffshampoo","84372004201","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","84372-042","84372-042-01","84372-042_2124faae-f3c0-fe02-e063-6394a90aa34f","HUMAN OTC DRUG","lanimpress1%ketoconazoleantidandruffshampoo","","LOTION","TOPICAL","20240902","","OTC MONOGRAPH DRUG","M016","Shenzhen Zhumeng Times Technology Co., Ltd.","5","g/125mL","","N","20251231"
"9873","PENICILLIN G BENZATHINE","Penicillin G Benzathin","84383011001","Penicillin-class Antibacterial [EPC], Penicillins [CS]","84383-110","84383-110-01","84383-110_1a4e5124-618c-ce44-e063-6394a90a43e3","HUMAN PRESCRIPTION DRUG","Lentocilin","","INJECTION, POWDER, FOR SUSPENSION","INTRAMUSCULAR","20240601","","UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE","","LABORATÓRIOS ATRAL, S.A.","1200000","U/4mL","","N","20251231"
"9874","MICONAZOLE NITRATE","MICONAZOLE NITRATE","84387000301","Azole Antifungal [EPC], Azoles [CS]","84387-003","84387-003-01","84387-003_26bc78a5-3755-5f69-e063-6394a90a11a8","HUMAN OTC DRUG","MICONAZOLE NITRATE","","OINTMENT","TOPICAL","20241025","","OTC MONOGRAPH DRUG","M005","ALLIED TRADE LINK LLC","20","mg/g","","N","20251231"
"9875","CLOTRIMAZOLE","CLOTRIMAZOLE","84387000401","Azole Antifungal [EPC], Azoles [CS]","84387-004","84387-004-01","84387-004_266d7b94-2955-4831-e063-6394a90a3f33","HUMAN OTC DRUG","CLOTRIMAZOLE","","CREAM","TOPICAL","20241108","","OTC MONOGRAPH DRUG","M005","ALLIED TRADE LINK LLC","10","mg/g","","N","20251231"
"9876","BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","TRIPLET ANTIBIOTIC","84387000601","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","84387-006","84387-006-01","84387-006_26bd5ba4-264c-2a28-e063-6394a90ada80","HUMAN OTC DRUG","TRIPLET ANTIBIOTIC","","OINTMENT","TOPICAL","20241112","","OTC MONOGRAPH DRUG","M004","ALLIED TRADE LINK LLC","400; 5; 5000","[USP'U]/g; mg/g; [iU]/g","","N","20251231"
"9877","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","84485360701","Allylamine Antifungal [EPC], Allylamine [CS]","84485-3607","84485-3607-1","84485-3607_dc1dfa6d-7d6d-43cf-a25a-8497e3430bcd","HUMAN OTC DRUG","Lamisil AT Cream","","CREAM","TOPICAL","20250120","","NDA","NDA020980","Karo Healthcare Inc.","1","g/100g","","N","20261231"
"9878","TERBINAFINE HYDROCHLORIDE","Terbinafine Hydrochloride","84485374803","Allylamine Antifungal [EPC], Allylamine [CS]","84485-3748","84485-3748-3","84485-3748_58726dc3-45ee-4543-8863-3949940fb64e","HUMAN OTC DRUG","Lamisil AT Cream","","CREAM","TOPICAL","20241101","","NDA","NDA020980","Karo Healthcare Inc.","1","g/100g","","N","20261231"
"9879","AMPICILLIN SODIUM","Ampicillin Sodium","84549011310","Penicillin-class Antibacterial [EPC], Penicillins [CS]","84549-113","84549-113-10","84549-113_364b1db9-e522-7bae-e063-6294a90a651d","HUMAN PRESCRIPTION DRUG","Ampicillin","","INJECTION, POWDER, FOR SOLUTION","INTRAMUSCULAR; INTRAVENOUS","20120201","","ANDA","ANDA065499","ProPharma Distribution","1","g/1","","N","20261231"
"9880","KETOCONAZOLE","1% ketoconazole anti dandruff shampoo","84558000501","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","84558-005","84558-005-01","84558-005_286c5b25-54b2-6fc8-e063-6394a90a90d1","HUMAN OTC DRUG","1% ketoconazole anti dandruff","","SHAMPOO","CUTANEOUS","20241204","","OTC MONOGRAPH DRUG","505G(a)(3)","GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd","1","g/100mL","","N","20251231"
"9881","CLOBETASOL PROPIONATE; KETOCONAZOLE; NEOMYCIN SULFATE","Vixa Skineal Compound ketoconazole","84659904001","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","84659-9040","84659-9040-1","84659-9040_2d6ab2de-0d12-38c5-e063-6394a90ac943","HUMAN PRESCRIPTION DRUG","Vixa Skineal","","CREAM","TOPICAL","20240601","","UNAPPROVED DRUG OTHER","","Yunnan Yuyao Bio-pharmaceutical Co.,Ltd.",".25; 10; 5000","mg/g; mg/g; [iU]/g","","N","20261231"
"9882","BACITRACIN; NEOMYCIN; POLYMYXIN B","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate","84722303200","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","84722-3032","84722-3032-0","84722-3032_286041f9-f87a-b9a5-e063-6394a90a4200","HUMAN OTC DRUG","TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20240920","","OTC MONOGRAPH DRUG","M004","Vive Health LLC","400; 3.5; 5000","[USP'U]/1; mg/1; [USP'U]/1","","N","20251231"
"9883","BACITRACIN; NEOMYCIN; POLYMYXIN B","Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate","84722303201","Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]","84722-3032","84722-3032-1","84722-3032_286041f9-f87a-b9a5-e063-6394a90a4200","HUMAN OTC DRUG","TRIPLE ANTIBIOTIC","","OINTMENT","TOPICAL","20240920","","OTC MONOGRAPH DRUG","M004","Vive Health LLC","400; 3.5; 5000","[USP'U]/1; mg/1; [USP'U]/1","","N","20251231"
"9884","MICONAZOLE","MICONAZOLE","84722305700","Azole Antifungal [EPC], Azoles [CS]","84722-3057","84722-3057-0","84722-3057_30dca43e-e6c5-8107-e063-6394a90a2b97","HUMAN OTC DRUG","ANTIFUNGAL","","POWDER","TOPICAL","20250321","","OTC MONOGRAPH DRUG","M005","VIVE HEALTH LLC","2","g/100g","","N","20261231"
"9885","CLOTRIMAZOLE","CLOTRIMAZOLE","84722305900","Azole Antifungal [EPC], Azoles [CS]","84722-3059","84722-3059-0","84722-3059_33db98f5-f6da-742a-e063-6394a90a2a03","HUMAN OTC DRUG","ANTIFUNGAL","","CREAM","TOPICAL","20250428","","OTC MONOGRAPH DRUG","M005","VIVE HEALTH LLC","1","g/100g","","N","20261231"
"9886","MICONAZOLE","MICONAZOLE","84722306000","Azole Antifungal [EPC], Azoles [CS]","84722-3060","84722-3060-0","84722-3060_33d9c724-d4c5-2597-e063-6294a90aa5f3","HUMAN OTC DRUG","ANTIFUNGAL","","OINTMENT","TOPICAL","20250428","","OTC MONOGRAPH DRUG","M005","VIVE HEALTH LLC","2","g/100g","","N","20261231"
"9887","KETOCONAZOLE","Ketoconazole","84745000201","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","84745-002","84745-002-01","84745-002_2435001f-82a9-a781-e063-6394a90a9628","HUMAN OTC DRUG","POAGCI Ketoconazole VCP-KAD001","","LIQUID","TOPICAL","20241011","","OTC MONOGRAPH DRUG","M032","Vince (Guangzhou) Cosmetics Co., Ltd.","1","g/100mL","","N","20251231"
"9888","MICONAZOLE","Roycederm Tinea Treatment Cream","84746000301","Azole Antifungal [EPC], Azoles [CS]","84746-003","84746-003-01","84746-003_22756ed8-5e39-784a-e063-6394a90a7c02","HUMAN OTC DRUG","Roycederm Tinea Treatment Cream","","CREAM","TOPICAL","20240919","","OTC MONOGRAPH DRUG","M005","Shandong Yuyaotang Pharmaceutical Co., Ltd","2","g/100g","","N","20251231"
"9889","MICONAZOLE NITRATE","Hermon Jock Itch Ringworm and athlete s foot cream","84746000801","Azole Antifungal [EPC], Azoles [CS]","84746-008","84746-008-01","84746-008_31c92743-d3e3-a4ca-e063-6294a90aa481","HUMAN OTC DRUG","Hermon Jock Itch Ringworm and athlete s foot cream","","CREAM","TOPICAL","20250402","","OTC MONOGRAPH DRUG","M005","Shandong Yuyaotang Pharmaceutical Co., Ltd","2","g/100g","","N","20261231"
"9890","MENTHOL, UNSPECIFIED FORM; MICONAZOLE","menthol, Miconazole","85248000701","Azole Antifungal [EPC], Azoles [CS]","85248-007","85248-007-01","85248-007_3637187f-70bd-eb31-e063-6294a90ad3cb","HUMAN OTC DRUG","Antifungal Ringworm Cream","","CREAM","TOPICAL","20250528","","OTC MONOGRAPH DRUG","M005","Jiangxi Yudexi Pharmaceutical Co., LTD","8; .1","g/100g; g/100g","","N","20261231"
"9891","CLOTRIMAZOLE","Clotrimazole","85261031101","Azole Antifungal [EPC], Azoles [CS]","85261-311","85261-311-01","85261-311_2fc7544d-29bf-1f07-e063-6294a90a5e44","HUMAN OTC DRUG","Roycederm Tinea Versicolor Relief Soap.","","SOAP","TOPICAL","20250325","","OTC MONOGRAPH DRUG","M005","Haikou Pucao Trading Co.,Ltd","1","g/100g","","N","20261231"
"9892","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","85293000201","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","85293-002","85293-002-01","85293-002_2fc39084-df93-4b13-e063-6394a90a38a8","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20250305","","ANDA","ANDA076639","Umasuto, LLC","250","mg/1","","N","20261231"
"9893","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","85293000301","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","85293-003","85293-003-01","85293-003_2fc39084-df93-4b13-e063-6394a90a38a8","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20250305","","ANDA","ANDA076639","Umasuto, LLC","500","mg/1","","N","20261231"
"9894","CIPROFLOXACIN HYDROCHLORIDE","ciprofloxacin","85293000401","Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]","85293-004","85293-004-01","85293-004_2fc39084-df93-4b13-e063-6394a90a38a8","HUMAN PRESCRIPTION DRUG","ciprofloxacin","","TABLET","ORAL","20250305","","ANDA","ANDA076639","Umasuto, LLC","750","mg/1","","N","20261231"
"9895","KETOCONAZOLE","Ketoconazole","85384000101","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","85384-0001","85384-0001-1","85384-0001_30b75584-3a1f-c125-e063-6294a90acaa7","HUMAN OTC DRUG","1% ketoconazole","","SHAMPOO","TOPICAL","20250331","","OTC MONOGRAPH DRUG","M005","TAGRID LLC","10","mg/mL","","N","20261231"
"9896","KETOCONAZOLE","Ketoconazole","85384000201","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","85384-0002","85384-0002-1","85384-0002_315a8832-c430-c07a-e063-6394a90a8218","HUMAN OTC DRUG","Tagrit Antifungal Treament Ketoconazole 1%","","CREAM","TOPICAL","20250418","","OTC MONOGRAPH DRUG","M005","TAGRID LLC","10","mg/1000g","","N","20261231"
"9897","MICONAZOLE NITRATE","Miconazole Nitrate","85384000301","Azole Antifungal [EPC], Azoles [CS]","85384-0003","85384-0003-1","85384-0003_31abdc68-5028-15e7-e063-6394a90ac4e6","HUMAN OTC DRUG","Tagri Jock Itck Cream Miconazole Nitrate 2%","","CREAM","TOPICAL","20250422","","OTC MONOGRAPH DRUG","M005","TAGRID LLC","20","mg/g","","N","20261231"
"9898","MICONAZOLE NITRATE","Miconazole Nitrate","85384000401","Azole Antifungal [EPC], Azoles [CS]","85384-0004","85384-0004-1","85384-0004_32396be0-f74b-5483-e063-6294a90ab3ae","HUMAN OTC DRUG","Folliculitis Treatment Cream","","CREAM","TOPICAL","20250422","","OTC MONOGRAPH DRUG","M005","TAGRID LLC","15","mg/g","","N","20261231"
"9899","CLOTRIMAZOLE","Clotrimazole","85384000601","Azole Antifungal [EPC], Azoles [CS]","85384-0006","85384-0006-1","85384-0006_34aeef66-7bc3-e932-e063-6394a90ad684","HUMAN OTC DRUG","Tagrid Antifungal Ringworm Treatment 1% CLOTRIMAZOLE","","CREAM","TOPICAL","20250520","","OTC MONOGRAPH DRUG","M005","TAGRID LLC","1","g/100g","","N","20261231"
"9900","CLOTRIMAZOLE","Clotrimazole","85398000201","Azole Antifungal [EPC], Azoles [CS]","85398-002","85398-002-01","85398-002_32d71d7e-3c79-6b63-e063-6294a90adaed","HUMAN OTC DRUG","Tinea Versicolor Treatment Cream","","CREAM","TOPICAL","20250512","","OTC MONOGRAPH DRUG","M005","Beautivity LLC","10","mg/g","","N","20261231"
"9901","CLOTRIMAZOLE","Clotrimazole","85398000301","Azole Antifungal [EPC], Azoles [CS]","85398-003","85398-003-01","85398-003_33612382-2f13-e9f6-e063-6394a90aaee4","HUMAN OTC DRUG","Tinea Versicolor Treatment Bar","","SOAP","TOPICAL","20250512","","OTC MONOGRAPH DRUG","M005","Beautivity LLC","10","mg/g","","N","20261231"
"9902","TETRACYCLINE HYDROCHLORIDE","TETRACYCLINE HYDROCHLORIDE","85494000001","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","85494-000","85494-000-01","85494-000_3232354b-e9ee-d93a-e063-6394a90ac4a8","HUMAN OTC DRUG","Honestly Battleborn First Aid for Real Man","","SPRAY","TOPICAL","20250303","","OTC MONOGRAPH DRUG","M004","HONESTLY LLC","30","mg/mL","","N","20261231"
"9903","TETRACYCLINE HYDROCHLORIDE","TETRACYCLINE HYDROCHLORIDE","85494000101","Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]","85494-001","85494-001-01","85494-001_3232119a-e6ca-be64-e063-6394a90aa659","HUMAN OTC DRUG","Honestly Battleborn First Aid for Real Man","","OINTMENT","TOPICAL","20250303","","OTC MONOGRAPH DRUG","M004","HONESTLY LLC","30","mg/g","","N","20261231"
"9904","KETOCONAZOLE","dandRX 1% Ketoconazole Anti-Dandruff Shampoo","85521000101","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]","85521-001","85521-001-01","85521-001_324fb7bb-4b8f-e6e6-e063-6394a90adae1","HUMAN OTC DRUG","dandRX 1% Ketoconazole Anti-Dandruff","","LIQUID","TOPICAL","20250409","","OTC MONOGRAPH DRUG","M016","dandRX LLC","1","g/100mL","","N","20261231"
"9905","CLOTRIMAZOLE","Clotrimazole","85633000401","Azole Antifungal [EPC], Azoles [CS]","85633-004","85633-004-01","85633-004_34f3fc13-7334-c93a-e063-6394a90abe12","HUMAN OTC DRUG","Clotrimazole Cream, 1%","","CREAM","TOPICAL","20250519","","OTC MONOGRAPH DRUG","M005","Estiva Generics Corporation","1","g/100g","","N","20261231"
"9906","CEPHALEXIN","Cephalexin","85766000420","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","85766-004","85766-004-20","85766-004_37d27292-b5cb-471d-e063-6394a90a0b34","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210721","","ANDA","ANDA065229","Sportpharm, Inc. dba Sportpharm","500","mg/1","","N","20261231"
"9907","CEPHALEXIN","Cephalexin","85766000421","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","85766-004","85766-004-21","85766-004_37d27292-b5cb-471d-e063-6394a90a0b34","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210721","","ANDA","ANDA065229","Sportpharm, Inc. dba Sportpharm","500","mg/1","","N","20261231"
"9908","CEPHALEXIN","Cephalexin","85766000428","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","85766-004","85766-004-28","85766-004_37d27292-b5cb-471d-e063-6394a90a0b34","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210721","","ANDA","ANDA065229","Sportpharm, Inc. dba Sportpharm","500","mg/1","","N","20261231"
"9909","CEPHALEXIN","Cephalexin","85766000414","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","85766-004","85766-004-14","85766-004_37d27292-b5cb-471d-e063-6394a90a0b34","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210721","","ANDA","ANDA065229","Sportpharm, Inc. dba Sportpharm","500","mg/1","","N","20261231"
"9910","CEPHALEXIN","Cephalexin","85766000430","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","85766-004","85766-004-30","85766-004_37d27292-b5cb-471d-e063-6394a90a0b34","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20210721","","ANDA","ANDA065229","Sportpharm, Inc. dba Sportpharm","500","mg/1","","N","20261231"
"9911","CEPHALEXIN","Cephalexin","85766000528","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","85766-005","85766-005-28","85766-005_37d27e3e-5cd5-b1b5-e063-6294a90a8db6","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20190819","","ANDA","ANDA090836","Sportpharm, Inc. dba Sportpharm","250","mg/1","","N","20261231"
"9912","CEPHALEXIN","Cephalexin","85766000530","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","85766-005","85766-005-30","85766-005_37d27e3e-5cd5-b1b5-e063-6294a90a8db6","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20190819","","ANDA","ANDA090836","Sportpharm, Inc. dba Sportpharm","250","mg/1","","N","20261231"
"9913","CEPHALEXIN","Cephalexin","85766000540","Cephalosporin Antibacterial [EPC], Cephalosporins [CS]","85766-005","85766-005-40","85766-005_37d27e3e-5cd5-b1b5-e063-6294a90a8db6","HUMAN PRESCRIPTION DRUG","Cephalexin","","CAPSULE","ORAL","20190819","","ANDA","ANDA090836","Sportpharm, Inc. dba Sportpharm","250","mg/1","","N","20261231"
"9914","AZITHROMYCIN MONOHYDRATE","Azithromycin","85766000706","Macrolide Antimicrobial [EPC], Macrolides [CS]","85766-007","85766-007-06","85766-007_37d2d33d-962c-86b4-e063-6394a90a6060","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20060106","","ANDA","ANDA065225","Sportpharm, Inc. dba Sportpharm","250","mg/1","","N","20261231"
"9915","AZITHROMYCIN DIHYDRATE","Azithromycin","85766000806","Macrolide Antimicrobial [EPC], Macrolides [CS]","85766-008","85766-008-06","85766-008_37d30779-9bf0-0e10-e063-6294a90aff5b","HUMAN PRESCRIPTION DRUG","Azithromycin","","TABLET, FILM COATED","ORAL","20051114","","ANDA","ANDA065211","Sportpharm, Inc. dba Sportpharm","250","mg/1","","N","20261231"
"9916","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","85766001505","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","85766-015","85766-015-05","85766-015_37fa5d2d-5b6b-ae18-e063-6394a90a2ba4","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Sportpharm, Inc. dba Sportpharm","800; 160","mg/1; mg/1","","N","20261231"
"9917","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","85766001506","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","85766-015","85766-015-06","85766-015_37fa5d2d-5b6b-ae18-e063-6394a90a2ba4","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Sportpharm, Inc. dba Sportpharm","800; 160","mg/1; mg/1","","N","20261231"
"9918","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","85766001510","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","85766-015","85766-015-10","85766-015_37fa5d2d-5b6b-ae18-e063-6394a90a2ba4","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Sportpharm, Inc. dba Sportpharm","800; 160","mg/1; mg/1","","N","20261231"
"9919","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","85766001514","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","85766-015","85766-015-14","85766-015_37fa5d2d-5b6b-ae18-e063-6394a90a2ba4","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Sportpharm, Inc. dba Sportpharm","800; 160","mg/1; mg/1","","N","20261231"
"9920","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","85766001520","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","85766-015","85766-015-20","85766-015_37fa5d2d-5b6b-ae18-e063-6394a90a2ba4","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Sportpharm, Inc. dba Sportpharm","800; 160","mg/1; mg/1","","N","20261231"
"9921","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","85766001528","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","85766-015","85766-015-28","85766-015_37fa5d2d-5b6b-ae18-e063-6394a90a2ba4","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Sportpharm, Inc. dba Sportpharm","800; 160","mg/1; mg/1","","N","20261231"
"9922","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","85766001530","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","85766-015","85766-015-30","85766-015_37fa5d2d-5b6b-ae18-e063-6394a90a2ba4","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Sportpharm, Inc. dba Sportpharm","800; 160","mg/1; mg/1","","N","20261231"
"9923","SULFAMETHOXAZOLE; TRIMETHOPRIM","Sulfamethoxazole and Trimethoprim","85766001501","Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]","85766-015","85766-015-01","85766-015_37fa5d2d-5b6b-ae18-e063-6394a90a2ba4","HUMAN PRESCRIPTION DRUG","Sulfamethoxazole and Trimethoprim","","TABLET","ORAL","20100216","","ANDA","ANDA090624","Sportpharm, Inc. dba Sportpharm","800; 160","mg/1; mg/1","","N","20261231"
"9924","CLINDAMYCIN PHOSPHATE; TRETINOIN","clindamycin phosphate and tretinoin","99207030030","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Retinoid [EPC], Retinoids [CS]","99207-300","99207-300-30","99207-300_4b7e1338-0ec2-4a3f-acbd-8605c74d5d40","HUMAN PRESCRIPTION DRUG","ZIANA","","GEL","TOPICAL","20061201","","NDA","NDA050802","Bausch Health US, LLC","12; .25","mg/g; mg/g","","N","20251231"
"9925","CLINDAMYCIN PHOSPHATE; TRETINOIN","clindamycin phosphate and tretinoin","99207030060","Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Retinoid [EPC], Retinoids [CS]","99207-300","99207-300-60","99207-300_4b7e1338-0ec2-4a3f-acbd-8605c74d5d40","HUMAN PRESCRIPTION DRUG","ZIANA","","GEL","TOPICAL","20061201","","NDA","NDA050802","Bausch Health US, LLC","12; .25","mg/g; mg/g","","N","20251231"
"9926","LULICONAZOLE","LULICONAZOLE","99207085002","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA]","99207-850","99207-850-02","99207-850_e52ec481-1114-4f09-9be0-311e5eb52fa1","HUMAN PRESCRIPTION DRUG","Luzu","","CREAM","TOPICAL","20131114","","NDA","NDA204153","Bausch Health US, LLC","10","mg/g","","N","20251231"
"9927","LULICONAZOLE","LULICONAZOLE","99207085060","Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA]","99207-850","99207-850-60","99207-850_e52ec481-1114-4f09-9be0-311e5eb52fa1","HUMAN PRESCRIPTION DRUG","Luzu","","CREAM","TOPICAL","20131114","","NDA","NDA204153","Bausch Health US, LLC","10","mg/g","","N","20251231"
