Application Nr Approved Date Route Status External Links
ANDA211858 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Mesalamine Delayed-Release Tablets Are Indicated For The: • Induction And Maintenance Of Remission In Adult Patients With Mildly To Moderately Active Ulcerative Colitis. • Treatment Of Mildly To Moderately Active Ulcerative Colitis In Pediatric Patients Weighing At Least 24 Kg. Mesalamine Delayed-Release Tablets Are An Aminosalicylate Indicated For The: • Induction And Maintenance Of Remission In Adult Patients With Mildly To Moderately Active Ulcerative Colitis. (1) • Treatment Of Mildly To Moderately Active Ulcerative Colitis In Pediatric Patients Weighing At Least 24 Kg. (1)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Mesalamine MESALAMINE ZINC1688

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