Treats mildly to moderately active ulcerative colitis. ANDA 219997, held by Sandoz. Mesalamine.
As of Nov 13, 2026, ANDA 219997 (Mesalamine), held by Sandoz, was first approved by FDA on Mar 10, 2026, with 0 approved supplements and 0 published complete response letters.
Mesalamine extended-release capsules are indicated for the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 10, 2026 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesalamine250MG · capsule, extended release;oral | Mesalamine | Rx |
| Mesalamine500MG · capsule, extended 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
