ANDA 91229, held by Sandoz Inc. Pregabalin.
As of Nov 13, 2026, ANDA 91229 (Pregabalin), held by Sandoz Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 31, 2012 | 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
