FDA.reportPublic FDA data

Application 205571

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBAMAZEPINECARBAMAZEPINETABLET, EXTENDED RELEASE;ORAL100MGNoNo
002CARBAMAZEPINECARBAMAZEPINETABLET, EXTENDED RELEASE;ORAL200MGNoNo
003CARBAMAZEPINECARBAMAZEPINETABLET, EXTENDED RELEASE;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-063carbamazepinecarbamazepineNorthstar Rx LLCANDACurrent
16714-063carbamazepinecarbamazepineNorthstar Rx LLCANDACurrent
16714-064carbamazepinecarbamazepineNorthstar Rx LLCANDACurrent
16714-064carbamazepinecarbamazepineNorthstar Rx LLCANDACurrent
16714-065carbamazepinecarbamazepineNorthstar Rx LLCANDACurrent
16714-065carbamazepinecarbamazepineNorthstar Rx LLCANDACurrent
68382-555carbamazepinecarbamazepineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-555carbamazepinecarbamazepineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-555carbamazepinecarbamazepineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-556carbamazepinecarbamazepineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-556carbamazepinecarbamazepineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-556carbamazepinecarbamazepineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-557carbamazepinecarbamazepineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-557carbamazepinecarbamazepineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-557carbamazepinecarbamazepineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1468carbamazepinecarbamazepineCadila Healthcare LimitedANDACurrent
70771-1468carbamazepinecarbamazepineCadila Healthcare LimitedANDACurrent
70771-1468carbamazepinecarbamazepineCadila Healthcare LimitedANDACurrent
70771-1469carbamazepinecarbamazepineCadila Healthcare LimitedANDACurrent
70771-1469carbamazepinecarbamazepineCadila Healthcare LimitedANDACurrent
70771-1469carbamazepinecarbamazepineCadila Healthcare LimitedANDACurrent
70771-1470carbamazepinecarbamazepineCadila Healthcare LimitedANDACurrent
70771-1470carbamazepinecarbamazepineCadila Healthcare LimitedANDACurrent
70771-1470carbamazepinecarbamazepineCadila Healthcare LimitedANDACurrent