ANDA 217857, held by Aiping Pharm Inc. Pregabalin.
As of Nov 13, 2026, ANDA 217857 (Pregabalin), held by Aiping Pharm Inc, was first approved by FDA on Jan 28, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 28, 2025 | Original application | Approved | None posted |
| Pregabalin330MG · tablet, extended release;oral | Pregabalin | Rx |
| Pregabalin165MG · 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