FDA.reportPublic FDA data

Application 211623

Type
ANDA
Sponsor
UNIQUE PHARM

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
16571-680CARBAMAZEPINECARBAMAZEPINERising Pharma Holdings, Inc.ANDACurrent
16571-681CARBAMAZEPINECARBAMAZEPINERising Pharma Holdings, Inc.ANDACurrent
16571-682CARBAMAZEPINECARBAMAZEPINERising Pharma Holdings, Inc.ANDACurrent
60687-583CARBAMAZEPINECARBAMAZEPINEAmerican Health PackagingANDACurrent
60687-594CARBAMAZEPINECARBAMAZEPINEAmerican Health PackagingANDACurrent
70518-3174CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-3174CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-3335CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent
70518-3591CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.ANDACurrent