ANDA 77725, held by Ani Pharms. Alprazolam.
As of Nov 15, 2026, ANDA 77725 (Alprazolam), held by Ani Pharms, was first approved by FDA on Jul 31, 2006, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 31, 2006 | Original application | Approved | None posted |
| Alprazolam0.5MG · tablet, extended release;oral | Alprazolam | Discontinued |
| Alprazolam1MG · tablet, extended release;oral | Alprazolam | Discontinued |
| Alprazolam3MG · tablet, extended release;oral | Alprazolam | Discontinued |
| Alprazolam2MG · tablet, extended release;oral | Alprazolam | 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
