Treats active duodenal ulcer. ANDA 216474, held by Strides Pharma. Sucralfate.
As of Nov 15, 2026, ANDA 216474 (Sucralfate), held by Strides Pharma, was first approved by FDA on May 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 |
|---|---|---|---|
| May 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
