Treats mildly to moderately active ulcerative colitis. ANDA 216334, held by Annora Pharma. Mesalamine.
As of Nov 13, 2026, ANDA 216334 (Mesalamine), held by Annora Pharma, was first approved by FDA on Feb 5, 2024, with 0 approved supplements and 0 published complete response letters.
Mesalamine delayed-release tablets are indicated for the: · induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. · treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. Mesalamine delayed-release tablet is an aminosalicylate indicated for the:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 5, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesalamine1.2GM · tablet, delayed release;oral | 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
