ANDA 76841, held by G And W Labs Inc. Mesalamine.
As of Nov 13, 2026, ANDA 76841 (Mesalamine), held by G And W Labs Inc, was first approved by FDA on Sep 30, 2004, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 30, 2004 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesalamine4GM/60ML ยท enema;rectal | Mesalamine | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 31, 2008 | Supplement 5Labeling | Approved | None posted |
| Sep 30, 2004 | 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
