ANDA 218410, held by Novast Labs. Mesalamine.
As of Nov 13, 2026, ANDA 218410 (Mesalamine), held by Novast Labs, was first approved by FDA on Aug 22, 2024, 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 22, 2024 | Original application | Approved | None posted |
| 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
