Treats active duodenal ulcer.in the short-term (up to 8 weeks) treatment of active…. ANDA 213549, held by Pd Partners. Sucralfate.
As of Nov 15, 2026, ANDA 213549 (Sucralfate), held by Pd Partners, was first approved by FDA on Jan 17, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Sucralfate Oral Suspension is Sucralfate oral suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 17, 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
