Application Nr Approved Date Route Status External Links
ANDA203286 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 Aminosalicylate Indicated For The Treatment Of Moderately Active Ulcerative Colitis In Adults. ( 1 ) Limitation Of Use Safety And Effectiveness Of Mesalamine Delayed-Release Tablets Beyond 6 Weeks Have Not Been Established ( 1 ) Mesalamine Delayed-Release Tablets Are Indicated For The Treatment Of Moderately Active Ulcerative Colitis In Adults. Limitations Of Use: Safety And Effectiveness Of Mesalamine Delayed-Release Tablets Beyond 6 Weeks Have Not Been Established.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

Comments