Treats mildly to moderately active ulcerative proctitis. ANDA 208953, held by Zydus Pharms. Mesalamine.
As of Nov 13, 2026, ANDA 208953 (Mesalamine), held by Zydus Pharms, was first approved by FDA on Feb 12, 2020, with 4 approved supplements and 0 published complete response letters.
Mesalamine is an aminosalicylate indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 12, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesalamine1GM · suppository;rectal | Mesalamine | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 28, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Nov 27, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 28, 2022 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 28, 2022 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 12, 2020 | 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
