Treats mildly to moderately active ulcerative colitis. ANDA 211858, held by Sun Pharm. Mesalamine.
As of Nov 13, 2026, ANDA 211858 (Mesalamine), held by Sun Pharm, was first approved by FDA on Jan 25, 2019, with 7 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 25, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesalamine1.2GM · tablet, delayed release;oral | Mesalamine | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 25, 2023 | Supplement 16Labeling · Standard review | Approved | None posted |
| Aug 25, 2023 | Supplement 12Labeling · Standard review | Approved | None posted |
| Aug 25, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| Mar 22, 2021 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 22, 2021 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 22, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 19, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 25, 2019 | 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
