Treats active duodenal ulcer. ANDA 211780, held by Chartwell Rx. Sucralfate.
As of Nov 15, 2026, ANDA 211780 (Sucralfate), held by Chartwell Rx, was first approved by FDA on Apr 14, 2025, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Sucralfate oral suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 14, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sucralfate1GM/10ML · suspension;oral | Sucralfate | 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
