FDA.reportPublic FDA data

Application 207652

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAPECITABINECAPECITABINETABLET;ORAL150MGNoNo
002CAPECITABINECAPECITABINETABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-458CapecitabineCapecitabineAscend Laboratories, LLCANDACurrent
67877-458CapecitabineCapecitabineAscend Laboratories, LLCANDACurrent
67877-458CapecitabineCapecitabineAscend Laboratories, LLCANDACurrent
67877-458CapecitabineCapecitabineAscend Laboratories, LLCANDACurrent
67877-459CapecitabineCapecitabineAscend Laboratories, LLCANDACurrent
67877-459CapecitabineCapecitabineAscend Laboratories, LLCANDACurrent
67877-459CapecitabineCapecitabineAscend Laboratories, LLCANDACurrent
67877-459CapecitabineCapecitabineAscend Laboratories, LLCANDACurrent