FDA.reportPublic FDA data

Application 200483

Type
ANDA
Sponsor
HIKMA

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
0054-0271CapecitabineCapecitabineHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0271CapecitabineCapecitabineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0271CapecitabineCapecitabineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0271CapecitabineCapecitabineHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0271CapecitabineCapecitabineHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0271CapecitabineCapecitabineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0271CapecitabineCapecitabineHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0271CapecitabineCapecitabineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0271CapecitabineCapecitabineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0271CapecitabineCapecitabineHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0272CapecitabineCapecitabineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0272CapecitabineCapecitabineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0272CapecitabineCapecitabineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0272CapecitabineCapecitabineHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0272CapecitabineCapecitabineHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0272CapecitabineCapecitabineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0272CapecitabineCapecitabineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0272CapecitabineCapecitabineHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0272CapecitabineCapecitabineHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0272CapecitabineCapecitabineHikma Pharmaceuticals USA Inc.ANDACurrent
51407-095CapecitabineCapecitabineGolden State Medical Supply, Inc.ANDACurrent
51407-095CapecitabineCapecitabineGolden State Medical Supply, Inc.ANDACurrent
51407-095CapecitabineCapecitabineGolden State Medical Supply, Inc.ANDACurrent
51407-095CapecitabineCapecitabineGolden State Medical SupplyANDACurrent
51407-095CapecitabineCapecitabineGolden State Medical Supply, Inc.ANDACurrent
51407-095CapecitabineCapecitabineGolden State Medical Supply Inc.ANDACurrent
51407-096CapecitabineCapecitabineGolden State Medical Supply Inc.ANDACurrent
51407-096CapecitabineCapecitabineGolden State Medical Supply, Inc.ANDACurrent
51407-096CapecitabineCapecitabineGolden State Medical SupplyANDACurrent
51407-096CapecitabineCapecitabineGolden State Medical Supply, Inc.ANDACurrent
51407-096CapecitabineCapecitabineGolden State Medical Supply, Inc.ANDACurrent
51407-096CapecitabineCapecitabineGolden State Medical Supply, Inc.ANDACurrent