FDA.reportPublic FDA data

Application 216441

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FAMOTIDINEFAMOTIDINETABLET;ORAL20MGNoNo
002FAMOTIDINEFAMOTIDINETABLET;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60760-736FamotidineFamotidineST. MARY'S MEDICAL PARK PHARMACYANDACurrent
68071-2842FamotidineFamotidineNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8269FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-8285FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
70710-1683FamotidineFamotidineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1684FamotidineFamotidineZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1702FamotidineFamotidineZydus Lifesciences LimitedANDACurrent
70771-1702FamotidineFamotidineZydus Lifesciences LimitedANDACurrent
70771-1703FamotidineFamotidineZydus Lifesciences LimitedANDACurrent
70771-1703FamotidineFamotidineZydus Lifesciences LimitedANDACurrent
71335-2190FamotidineFamotidineBryant Ranch PrepackANDACurrent
71335-9615FamotidineFamotidineBryant Ranch PrepackANDACurrent