ANDA 211431, held by Pharmobedient. Pregabalin.
As of Nov 14, 2026, ANDA 211431 (Pregabalin), held by Pharmobedient, was first approved by FDA on Jul 2, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 2, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pregabalin330MG ยท 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
