ANDA 210585, held by Somerset Theraps LLC. Pregabalin.
As of Nov 13, 2026, ANDA 210585 (Pregabalin), held by Somerset Theraps LLC, was first approved by FDA on Dec 26, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 26, 2019 | Original application | Approved | None posted |
| 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 |
| 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
