FDA.reportPublic FDA data

Application 211383

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEFERASIROXDEFERASIROXTABLET;ORAL90MGNoNo
002DEFERASIROXDEFERASIROXTABLET;ORAL360MGNoNo
003DEFERASIROXDEFERASIROXTABLET;ORAL180MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-993deferasiroxdeferasiroxNorthstar Rx LLC.ANDACurrent
16714-993deferasiroxdeferasiroxNorthstar Rx LLC.ANDACurrent
16714-993deferasiroxdeferasiroxNorthstar Rx LLC.ANDACurrent
16714-993deferasiroxdeferasiroxNorthstar Rx LLC.ANDACurrent
16714-993deferasiroxdeferasiroxNorthstar Rx LLC.ANDACurrent
16714-994deferasiroxdeferasiroxNorthstar Rx LLC.ANDACurrent
16714-994deferasiroxdeferasiroxNorthstar Rx LLC.ANDACurrent
16714-994deferasiroxdeferasiroxNorthstar Rx LLC.ANDACurrent
16714-994deferasiroxdeferasiroxNorthstar Rx LLC.ANDACurrent
16714-995deferasiroxdeferasiroxNorthstar Rx LLC.ANDACurrent
16714-995deferasiroxdeferasiroxNorthstar Rx LLC.ANDACurrent
16714-995deferasiroxdeferasiroxNorthstar Rx LLC.ANDACurrent
16714-995deferasiroxdeferasiroxNorthstar Rx LLC.ANDACurrent
16714-995deferasiroxdeferasiroxNorthstar Rx LLC.ANDACurrent
70710-1275deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1275deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1275deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1275deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1275deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1275deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1275deferasiroxdeferasiroxZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1275deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1276deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1276deferasiroxdeferasiroxZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1276deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1276deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1276deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1276deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1277deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1277deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1277deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1277deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1277deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1277deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1277deferasiroxdeferasiroxZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1277deferasiroxdeferasiroxZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1471deferasiroxdeferasiroxCadila Healthcare LimitedANDACurrent
70771-1471deferasiroxdeferasiroxCadila Healthcare LimitedANDACurrent
70771-1471deferasiroxdeferasiroxCadila Healthcare LimitedANDACurrent
70771-1471deferasiroxdeferasiroxZydus Lifesciences LimitedANDACurrent
70771-1472deferasiroxdeferasiroxCadila Healthcare LimitedANDACurrent
70771-1472deferasiroxdeferasiroxZydus Lifesciences LimitedANDACurrent
70771-1472deferasiroxdeferasiroxCadila Healthcare LimitedANDACurrent
70771-1473deferasiroxdeferasiroxCadila Healthcare LimitedANDACurrent
70771-1473deferasiroxdeferasiroxZydus Lifesciences LimitedANDACurrent
70771-1473deferasiroxdeferasiroxCadila Healthcare LimitedANDACurrent
70771-1473deferasiroxdeferasiroxCadila Healthcare LimitedANDACurrent