ANDA 217533, held by Amta. Mesalamine.
As of Nov 13, 2026, ANDA 217533 (Mesalamine), held by Amta, was first approved by FDA on Jun 6, 2023, with 1 approved supplement 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 |
|---|---|---|---|
| Jun 6, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesalamine375MG · capsule, extended release;oral | Mesalamine | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 11, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jun 6, 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
