Application 215591

Type
ANDA
Sponsor
ZHEJIANG JIUZHOU

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
35561-355CARBAMAZEPINE ERcarbamazepineAustarPharma LLCANDACurrent
35561-356CARBAMAZEPINE ERcarbamazepineAustarPharma LLCANDACurrent
35561-357CARBAMAZEPINE ERcarbamazepineAustarPharma LLCANDACurrent