FDA.reportPublic FDA data

Application 090943

Type
ANDA
Sponsor
MYLAN

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
0378-2511CapecitabinecapecitabineMylan Pharmaceuticals Inc.ANDACurrent
0378-2511CapecitabinecapecitabineMylan Pharmaceuticals Inc.ANDACurrent
0378-2511CapecitabinecapecitabineMylan Pharmaceuticals Inc.ANDACurrent
0378-2511CapecitabinecapecitabineMylan Pharmaceuticals Inc.ANDACurrent
0378-2512CapecitabinecapecitabineMylan Pharmaceuticals Inc.ANDACurrent
0378-2512CapecitabinecapecitabineMylan Pharmaceuticals Inc.ANDACurrent
0378-2512CapecitabinecapecitabineMylan Pharmaceuticals Inc.ANDACurrent
0378-2512CapecitabinecapecitabineMylan Pharmaceuticals Inc.ANDACurrent
51079-510CapecitabinecapecitabineMylan Institutional Inc.ANDACurrent
51079-510CapecitabinecapecitabineMylan Institutional Inc.ANDACurrent
51079-510CapecitabinecapecitabineMylan Institutional Inc.ANDACurrent