FDA.reportPublic FDA data

Application 209365

Type
ANDA
Sponsor
MSN

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
69097-948CapecitabineCapecitabineCipla USA Inc.ANDACurrent
69097-948CapecitabineCapecitabineCipla USA Inc.ANDACurrent
69097-949CapecitabineCapecitabineCipla USA Inc.ANDACurrent
69097-949CapecitabineCapecitabineCipla USA Inc.ANDACurrent
69539-019CapecitabineCapecitabineMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-019CapecitabineCapecitabineMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-019CapecitabineCapecitabineMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-020CapecitabineCapecitabineMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-020CapecitabineCapecitabineMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-020CapecitabineCapecitabineMSN LABORATORIES PRIVATE LIMITEDANDACurrent
72205-006CapecitabineCapecitabineNovadoz Pharmaceuticals LLCANDACurrent
72205-006CapecitabineCapecitabineNovadoz Pharmaceuticals LLCANDACurrent
72205-006CapecitabineCapecitabineNovadoz Pharmaceuticals LLCANDACurrent
72205-007CapecitabineCapecitabineNovadoz Pharmaceuticals LLCANDACurrent
72205-007CapecitabineCapecitabineNovadoz Pharmaceuticals LLCANDACurrent
72205-007CapecitabineCapecitabineNovadoz Pharmaceuticals LLCANDACurrent