Treats mildly to moderately active ulcerative colitis. ANDA 217337, held by Sinotherapeutics Inc. Mesalamine.
As of Nov 13, 2026, ANDA 217337 (Mesalamine), held by Sinotherapeutics Inc, was first approved by FDA on May 12, 2023, with 1 approved supplement 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 12, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesalamine1.2GM · tablet, delayed release;oral | Mesalamine | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 29, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| May 12, 2023 | Original application | Approved | None posted |
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
