Treats active duodenal ulcer. ANDA 217126, held by Cosette Pharms Nc. Sucralfate.
As of Nov 15, 2026, ANDA 217126 (Sucralfate), held by Cosette Pharms Nc, was first approved by FDA on Nov 13, 2024, 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 |
|---|---|---|---|
| Nov 13, 2024 | 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
