Treats moderately active ulcerative colitis. ANDA 203286, held by Zydus Pharms. Mesalamine.
As of Nov 13, 2026, ANDA 203286 (Mesalamine), held by Zydus Pharms, was first approved by FDA on Jul 21, 2017, with 11 approved supplements 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 |
|---|---|---|---|
| Jul 21, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesalamine800MG · tablet, delayed release;oral | Mesalamine | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 2026 | Supplement 18Labeling · Standard review | Approved | None posted |
| Nov 7, 2023 | Supplement 14Labeling · Standard review | Approved | None posted |
| Mar 1, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| Mar 1, 2023 | Supplement 10Labeling · Standard review | Approved | None posted |
| Mar 1, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| Mar 1, 2023 | Supplement 12Labeling · Standard review | Approved | None posted |
| Nov 18, 2021 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 18, 2021 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 18, 2021 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jun 26, 2018 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 26, 2018 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 21, 2017 | Original application | Approved |
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
