ANDA 216872, held by Micro Labs. Misoprostol.
As of Nov 15, 2026, ANDA 216872 (Misoprostol), held by Micro Labs, was first approved by FDA on Oct 17, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 17, 2022 | Original application | Approved | None posted |
| Misoprostol0.1MG · tablet;oral | Misoprostol | Discontinued |
| Misoprostol0.2MG · tablet;oral | Misoprostol | Discontinued |
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
