Lowers the risk of NSAID (nonsteroidal anti-inflammatory drugs, including…. ANDA 76095, held by Ani Pharms. Misoprostol.
As of Nov 15, 2026, ANDA 76095 (Misoprostol), held by Ani Pharms, was first approved by FDA on Jul 10, 2002, with 5 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 10, 2002 | Original application | Approved |
| Misoprostol0.1MG · tablet;oral | Misoprostol | Rx |
| Misoprostol0.2MG · tablet;oral | Misoprostol | Rx |
| Jul 14, 2022 | Supplement 15Manufacturing | Approved | None posted |
| Jan 27, 2010 | Supplement 12Labeling | Approved | None posted |
| Dec 27, 2007 | Supplement 4Labeling | Approved | None posted |
| Nov 20, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Nov 20, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Jul 10, 2002 | 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
