ANDA 215705, held by Zydus Lifesciences. Sucralfate.
As of Nov 15, 2026, ANDA 215705 (Sucralfate), held by Zydus Lifesciences, was first approved by FDA on May 3, 2023, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Sucralfate tablets are indicated in: Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 3, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sucralfate1GM · tablet;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
