ANDA 209530, held by Jubilant Generics. Pregabalin.
As of Nov 14, 2026, ANDA 209530 (Pregabalin), held by Jubilant Generics, was first approved by FDA on May 20, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 20, 2025 | Original application | Approved | None posted |
| Pregabalin25MG · capsule;oral | Pregabalin | Rx |
| Pregabalin50MG · capsule;oral | Pregabalin | Rx |
| Pregabalin75MG · capsule;oral | Pregabalin | Rx |
| Pregabalin100MG · capsule;oral | Pregabalin | Rx |
| Pregabalin150MG · capsule;oral | Pregabalin | Rx |
| Pregabalin200MG · capsule;oral | Pregabalin | Rx |
| Pregabalin225MG · capsule;oral | Pregabalin | Rx |
| Pregabalin300MG · capsule;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
