FDA.reportPublic FDA data

Application 077806

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BALSALAZIDE DISODIUMBALSALAZIDE DISODIUMCAPSULE;ORAL750MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0079Balsalazide DisodiumBalsalazide DisodiumHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0079Balsalazide DisodiumBalsalazide DisodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0079Balsalazide DisodiumBalsalazide DisodiumHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0079Balsalazide DisodiumBalsalazide DisodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0079Balsalazide DisodiumBalsalazide DisodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
60429-952Balsalazide DisodiumBalsalazide DisodiumGSMS, IncorporatedANDACurrent
60429-952Balsalazide DisodiumBalsalazide DisodiumGolden State Medical Supply, Inc.ANDACurrent
60429-952Balsalazide DisodiumBalsalazide DisodiumGolden State Medical Supply, Inc.ANDACurrent
72789-149Balsalazide DisodiumBalsalazide DisodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-149Balsalazide DisodiumBalsalazide DisodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-149Balsalazide DisodiumBalsalazide DisodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-149Balsalazide DisodiumBalsalazide DisodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent