ANDA 219864, held by Annora Pharma. Mesalamine.
As of Nov 13, 2026, ANDA 219864 (Mesalamine), held by Annora Pharma, was first approved by FDA on Aug 13, 2025, with 0 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 |
|---|---|---|---|
| Aug 13, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesalamine375MG · capsule, extended release;oral | Mesalamine | Rx |
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
