FDA.reportPublic FDA data

Application 208884

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROL SULFATEALBUTEROL SULFATETABLET;ORALEQ 2MG BASENoNo
002ALBUTEROL SULFATEALBUTEROL SULFATETABLET;ORALEQ 4MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70710-1061AlbuterolAlbuterolZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1061AlbuterolAlbuterolZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1062AlbuterolAlbuterolZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1062AlbuterolAlbuterolZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1511AlbuterolAlbuterolCadila Healthcare LimitedANDACurrent
70771-1511AlbuterolAlbuterolZydus Lifesciences LimitedANDACurrent
70771-1512AlbuterolAlbuterolCadila Healthcare LimitedANDACurrent
70771-1512AlbuterolAlbuterolZydus Lifesciences LimitedANDACurrent