ANDA 214496, held by Epic Pharma LLC. Pregabalin.
As of Nov 14, 2026, ANDA 214496 (Pregabalin), held by Epic Pharma LLC, was first approved by FDA on Jun 1, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 1, 2023 | Original application | Approved | None posted |
| Pregabalin82.5MG · tablet, extended release;oral | Pregabalin | Rx |
| Pregabalin165MG · tablet, extended release;oral | Pregabalin | Rx |
| Pregabalin330MG · tablet, extended release;oral | Pregabalin | Rx |
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
