Lowers the risk of NSAID (nonsteroidal anti-inflammatory drugs, including…. ANDA 210201, held by Acq Pharma. Misoprostol.
As of Nov 15, 2026, ANDA 210201 (Misoprostol), held by Acq Pharma, was first approved by FDA on Jul 2, 2019, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Misoprostol tablets are 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 2, 2019 | Original application | Approved | None posted |
| Misoprostol0.1MG · tablet;oral | Misoprostol | Rx |
| Misoprostol0.2MG · tablet;oral | Misoprostol | Rx |
| Sep 5, 2024 | Supplement 2Manufacturing | Approved | None posted |
| Jul 2, 2019 | 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
