ANDA 214477, held by Aurobindo Pharma Ltd. Mesalamine.
As of Nov 13, 2026, ANDA 214477 (Mesalamine), held by Aurobindo Pharma Ltd, was first approved by FDA on Mar 31, 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 |
|---|---|---|---|
| Mar 31, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesalamine375MG · capsule, extended release;oral | Mesalamine | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 27, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 31, 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
