Treats active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis. ANDA 220016, held by Klm Labs Pvt. Mesalamine.
As of Nov 13, 2026, ANDA 220016 (Mesalamine), held by Klm Labs Pvt, was first approved by FDA on Mar 31, 2026, with 0 approved supplements and 0 published complete response letters.
Mesalamine Rectal Suspension is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 31, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mesalamine4GM/60ML · enema;rectal | 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
