Treats active duodenal ulcer. ANDA 209356, held by Amneal. Sucralfate.
As of Nov 15, 2026, ANDA 209356 (Sucralfate), held by Amneal, was first approved by FDA on Dec 2, 2019, with 1 approved supplement 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 |
|---|---|---|---|
| Dec 2, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sucralfate1GM/10ML · suspension;oral | Sucralfate | Rx |
| Sep 18, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| Dec 2, 2019 | 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
