Application Nr Approved Date Route Status External Links
ANDA206336 2015-09-08 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & Usage Balsalazide Disodium Tablets Is Indicated For The Treatment Of Mildly To Moderately Active Ulcerative Colitis In Male Patients 18 Years Of Age And Older. Limitations Of Use: Effectiveness Of Balsalazide Disodium Tablets In The Treatment Of Female Patients Was Not Demonstrated In Clinical Trials [see Clinical Trials (14.1 )]. Safety And Effectiveness Of Balsalazide Disodium Tablets Therapy Beyond 8 Weeks Have Not Been Established. Balsalazide Disodium Tablets Is A Locally Acting Aminosalicylate Indicated For The Treatment Of Mildly To Moderately Active Ulcerative Colitis In Male Patients 18 Years Of Age And Older. (1) Limitations Of Use Effectiveness In Female Patients Was Not Demonstrated In Clinical Trials. (1) Safety And Effectiveness Of Balsalazide Disodium Tablets Beyond 8 Weeks Have Not Been Established. (1)

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. 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.
3. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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