FDA.reportPublic FDA data

Application 212948

Type
ANDA
Sponsor
ANBISON LAB

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
71930-072CarbamazepineCarbamazepineEywa Pharma IncANDACurrent
71930-073CarbamazepineCarbamazepineEywa Pharma IncANDACurrent
71930-074CarbamazepineCarbamazepineEywa Pharma IncANDACurrent