ANDA 74415, held by Chartwell Rx. Sucralfate.
As of Nov 15, 2026, ANDA 74415 (Sucralfate), held by Chartwell Rx, was first approved by FDA on Jun 8, 1998, with 5 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 |
|---|---|---|---|
| Jun 8, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sucralfate1GM · tablet;oral | Sucralfate | Rx |
| Oct 30, 2015 | Supplement 19Labeling · Standard review | Approved | None posted |
| Jan 16, 2008 | Supplement 8Labeling | Approved | None posted |
| Sep 19, 2007 | Supplement 6Labeling | Approved | None posted |
| Feb 2, 2000 | Supplement 1Manufacturing | Approved | None posted |
| Feb 2, 2000 | Supplement 2Manufacturing | Approved | None posted |
| Jun 8, 1998 | Original application | Approved |
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
