FDA.reportPublic FDA data

Application 210012

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
68382-685NifedipineNifedipineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-685NifedipineNifedipineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-685NifedipineNifedipineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-686NifedipineNifedipineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-686NifedipineNifedipineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-686NifedipineNifedipineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-687NifedipineNifedipineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-687NifedipineNifedipineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-687NifedipineNifedipineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1190NifedipineNifedipineCadila Healthcare LimitedANDACurrent
70771-1190NifedipineNifedipineCadila Healthcare LimitedANDACurrent
70771-1190NifedipineNifedipineCadila Healthcare LimitedANDACurrent
70771-1191NifedipineNifedipineCadila Healthcare LimitedANDACurrent
70771-1191NifedipineNifedipineCadila Healthcare LimitedANDACurrent
70771-1191NifedipineNifedipineCadila Healthcare LimitedANDACurrent
70771-1192NifedipineNifedipineCadila Healthcare LimitedANDACurrent
70771-1192NifedipineNifedipineCadila Healthcare LimitedANDACurrent
70771-1192NifedipineNifedipineCadila Healthcare LimitedANDACurrent