Treats moderately active ulcerative colitis. ANDA 213191, held by Teva Pharms Inc. Mesalamine.
As of Nov 13, 2026, ANDA 213191 (Mesalamine), held by Teva Pharms Inc, was first approved by FDA on Aug 22, 2024, with 1 approved supplement and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 22, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesalamine800MG · tablet, delayed release;oral | Mesalamine | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 22, 2024 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
