ANDA 70848, held by Teva. Sucralfate.
As of Nov 15, 2026, ANDA 70848 (Sucralfate), held by Teva, was first approved by FDA on Mar 29, 1996, with 20 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Sucralfate tablets, USP 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 |
|---|---|---|---|
| Mar 29, 1996 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sucralfate1GM · tablet;oral | Sucralfate | Rx |
| Aug 27, 2015 | Supplement 35Labeling · Standard review | Approved | None posted |
| Sep 12, 2008 | Supplement 31Labeling | Approved | None posted |
| Oct 23, 2007 | Supplement 27Labeling | Approved | None posted |
| Oct 23, 2002 | Supplement 18Manufacturing | Approved | None posted |
| Oct 23, 2002 | Supplement 17Manufacturing | Approved | None posted |
| Oct 23, 2002 | Supplement 16Manufacturing | Approved | None posted |
| May 15, 2002 | Supplement 15Manufacturing | Approved | None posted |
| Nov 13, 2001 | Supplement 14Manufacturing | Approved | None posted |
| Nov 13, 2001 | Supplement 13Manufacturing | Approved | None posted |
| Aug 30, 2001 | Supplement 12Manufacturing | Approved | None posted |
| May 29, 2001 | Supplement 10Manufacturing | Approved | None posted |
| Aug 24, 2000 | Supplement 9Manufacturing | Approved | None posted |
| Jul 7, 2000 | Supplement 8Manufacturing | Approved | None posted |
| Mar 31, 2000 | Supplement 7Manufacturing | Approved | None posted |
| Feb 16, 2000 | Supplement 6Manufacturing | Approved | None posted |
| Mar 26, 1999 | Supplement 5Manufacturing | Approved | None posted |
| Mar 12, 1999 | Supplement 4Manufacturing | Approved | None posted |
| Jun 18, 1997 | Supplement 3Manufacturing | Approved | None posted |
| Nov 8, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Nov 8, 1996 | Supplement 1Manufacturing | Approved | None posted |
| Mar 29, 1996 | 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
