ANDA 212769, held by Hikma. Sucralfate.
As of Nov 15, 2026, ANDA 212769 (Sucralfate), held by Hikma, was first approved by FDA on Jul 23, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 23, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sucralfate1GM/10ML ยท suspension;oral | Sucralfate | Discontinued |
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
