Lowers the risk of NSAID (nonsteroidal anti-inflammatory drugs, including…. ANDA 91667, held by Novel Labs Inc. Misoprostol.
As of Nov 15, 2026, ANDA 91667 (Misoprostol), held by Novel Labs Inc, was first approved by FDA on Jul 25, 2012, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND 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 Tablet has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol Tablets should be taken for the duration of NSAID therapy. Misoprostol Tablets has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 25, 2012 | Original application | Approved | None posted |
| Misoprostol0.1MG · tablet;oral | Misoprostol | Discontinued |
| Misoprostol0.2MG · tablet;oral | Misoprostol | Discontinued |
| Apr 13, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 13, 2020 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jul 25, 2012 | Original application | Approved | None posted |
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
