Treats active duodenal ulcer. ANDA 212141, held by Glenmark Pharms Ltd. Sucralfate.
As of Nov 15, 2026, ANDA 212141 (Sucralfate), held by Glenmark Pharms Ltd, was first approved by FDA on Jan 5, 2026, 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 |
|---|---|---|---|
| Jan 5, 2026 | 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
