ANDA 91221, held by Watson Labs Inc. Pregabalin.
As of Nov 13, 2026, ANDA 91221 (Pregabalin), held by Watson Labs Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 27, 2015 | Original application | Tentative approval | None posted |
| Pregabalin25MG · capsule;oral | Pregabalin | None (tentative approval) |
| Pregabalin50MG · capsule;oral | Pregabalin | None (tentative approval) |
| Pregabalin75MG · capsule;oral | Pregabalin | None (tentative approval) |
| Pregabalin100MG · capsule;oral | Pregabalin | None (tentative approval) |
| Pregabalin150MG · capsule;oral | Pregabalin | None (tentative approval) |
| Pregabalin200MG · capsule;oral | Pregabalin | None (tentative approval) |
| Pregabalin225MG · capsule;oral | Pregabalin | None (tentative approval) |
| Pregabalin300MG · capsule;oral | Pregabalin | None (tentative approval) |
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