ANDA 211593, held by Alvogen. Pregabalin.
As of Nov 13, 2026, ANDA 211593 (Pregabalin), held by Alvogen, was first approved by FDA on Apr 13, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 13, 2021 | Original application | Approved |
| Pregabalin82.5MG · tablet, extended release;oral | Pregabalin | Discontinued |
| Pregabalin165MG · tablet, extended release;oral | Pregabalin | Discontinued |
| Pregabalin330MG · tablet, extended release;oral | Pregabalin | 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
