Treats mildly to moderately active ulcerative proctitis. ANDA 207448, held by Rising. Mesalamine.
As of Nov 13, 2026, ANDA 207448 (Mesalamine), held by Rising, was first approved by FDA on Apr 19, 2019, with 0 approved supplements and 0 published complete response letters.
Mesalamine suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 19, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesalamine1GM · suppository;rectal | Mesalamine | Rx |
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
