FDA.reportPublic FDA data

Application 210184

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL30MGNoNo
002NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL60MGNoNo
003NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL90MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-688NIFEDIPINENIFEDIPINEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-688NIFEDIPINENIFEDIPINEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-688NIFEDIPINENIFEDIPINEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-689NIFEDIPINENIFEDIPINEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-689NIFEDIPINENIFEDIPINEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-689NIFEDIPINENIFEDIPINEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-690NIFEDIPINENIFEDIPINEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-690NIFEDIPINENIFEDIPINEZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-690NIFEDIPINENIFEDIPINEZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1365NIFEDIPINENIFEDIPINEZydus Lifesciences LimitedANDACurrent
70771-1365NIFEDIPINENIFEDIPINECadila Healthcare LimitedANDACurrent
70771-1365NIFEDIPINENIFEDIPINECadila Healthcare LimitedANDACurrent
70771-1366NIFEDIPINENIFEDIPINEZydus Lifesciences LimitedANDACurrent
70771-1366NIFEDIPINENIFEDIPINECadila Healthcare LimitedANDACurrent
70771-1366NIFEDIPINENIFEDIPINECadila Healthcare LimitedANDACurrent
70771-1367NIFEDIPINENIFEDIPINEZydus Lifesciences LimitedANDACurrent
70771-1367NIFEDIPINENIFEDIPINECadila Healthcare LimitedANDACurrent
70771-1367NIFEDIPINENIFEDIPINECadila Healthcare LimitedANDACurrent