Application Nr Approved Date Route Status External Links
ANDA077883 None Oral None 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 Patients 5 Years Of Age And Older. Safety And Effectiveness Of Balsalazide Beyond 8 Weeks In Children (Ages 5 To 17 Years) And 12 Weeks In Adults Have Not Been Established. Balsalazide Is A Locally Acting Aminosalicylate Indicated For The Treatment Of Mildly To Moderately Active Ulcerative Colitis In Patients 5 Years Of Age And Older. ( 1 ) Safety And Effectiveness Of Balsalazide Beyond 8 Weeks In Children (Ages 5 To 17 Years) And 12 Weeks In Adults Have Not Been Established. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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