Application Nr Approved Date Route Status External Links
ANDA077806 2007-12-28 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Balsalazide Disodium Capsules Are Indicated For The Treatment Of Mildly To Moderately Active Ulcerative Colitis In Adults. Safety And Effectiveness Of Balsalazide Disodium Capsules Beyond 12 Weeks In Adults Have Not Been Established. Balsalazide Disodium Capsules Are A Locally Acting Aminosalicylate Indicated For The Treatment Of Mildly To Moderately Active Ulcerative Colitis In Adults. (1) Safety And Effectiveness Of Balsalazide Disodium Capsules Beyond 12 Weeks In Adults Have Not Been Established. (1)

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Gelatin GELATIN Unresolved
3. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
4. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
5. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Butyl Alcohol BUTYL ALCOHOL Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
8. Shellac SHELLAC Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Balsalazide Disodium BALSALAZIDE DISODIUM ZINC3952881

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