Application Nr Approved Date Route Status External Links
NDA022205 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Giazo 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 Giazo In The Treatment Of Female Patients Was Not Demonstrated In Clinical Trials [See Clinical Trials ( 14.1 )]. • Safety And Effectiveness Of Giazo Therapy Beyond 8 Weeks Have Not Been Established. Giazo 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 Giazo Beyond 8 Weeks 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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