FDA.reportPublic FDA data

Application 088875

Type
ANDA
Sponsor
WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDESYRUP;ORAL10MG/5ML;6.25MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0605Promethazine with Codeinepromethazine hydrochloride and codeine phosphateATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0605Promethazine with Codeinepromethazine hydrochloride and codeine phosphateATLANTIC BIOLOGICALS CORP.ANDACurrent
50090-4127Promethazine with Codeinepromethazine hydrochloride and codeine phosphateA-S Medication SolutionsANDACurrent
52959-118PROMETHAZINE WITH CODEINEPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEH.J. Harkins Company,Inc.ANDACurrent
60432-606Promethazine with Codeinepromethazine hydrochloride and codeine phosphateMorton Grove Pharmaceuticals, Inc.ANDACurrent
60432-606Promethazine with Codeinepromethazine hydrochloride and codeine phosphateMorton Grove Pharmaceuticals, Inc.ANDACurrent
60432-606Promethazine with Codeinepromethazine hydrochloride and codeine phosphateMorton Grove Pharmaceuticals, Inc.ANDACurrent
67296-0516Promethazine with Codeinepromethazine hydrochloride and codeine phosphateRedPharm Drug, Inc.ANDACurrent
70166-555Promethazine with Codeinepromethazine hydrochloride and codeine phosphateLohxaANDACurrent