Treats active duodenal ulcer. ANDA 216726, held by Abon Pharms LLC. Sucralfate.
As of Nov 15, 2026, ANDA 216726 (Sucralfate), held by Abon Pharms LLC, was first approved by FDA on Mar 21, 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 |
|---|---|---|---|
| Mar 21, 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
