Treats mildly to moderately active ulcerative proctitis. ANDA 208362, held by J Molner. Mesalamine.
As of Nov 13, 2026, ANDA 208362 (Mesalamine), held by J Molner, was first approved by FDA on Jun 21, 2019, with 0 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE Mesalamine Rectal Suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. Mesalamine Rectal Suppositories are an aminosalicylate
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 21, 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
