ANDA 207271, held by Mylan. Mesalamine.
As of Nov 13, 2026, ANDA 207271 (Mesalamine), held by Mylan, was first approved by FDA on Nov 20, 2019, with 4 approved supplements and 0 published complete response letters.
Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 20, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesalamine375MG · capsule, extended release;oral | Mesalamine | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 1, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 1, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jun 3, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 3, 2022 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 20, 2019 | Original application | Approved |
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
