Treats active duodenal ulcer. ANDA 211884, held by Vistapharm LLC. Sucralfate.
As of Nov 15, 2026, ANDA 211884 (Sucralfate), held by Vistapharm LLC, was first approved by FDA on Mar 15, 2022, 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 15, 2022 | Original application | Approved |
| 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
