ANDA 74314, held by Roxane. Alprazolam.
As of Nov 15, 2026, ANDA 74314 (Alprazolam), held by Roxane, was first approved by FDA on Oct 31, 1993, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 31, 1993 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Alprazolam0.5MG/5ML ยท solution;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
