NDA 21723, held by Cp Pharms. Pregabalin.
As of Nov 14, 2026, NDA 21723 (Lyrica), held by Cp Pharms, was first approved by FDA on Dec 30, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 30, 2004 | Original applicationTYPE 6 · Standard review | Approved |
| Lyrica25MG · capsule; oral | Pregabalin | Rx |
| Lyrica50MG · capsule; oral | Pregabalin | Rx |
| Lyrica75MG · capsule; oral | Pregabalin | Rx |
| Lyrica100MG · capsule; oral | Pregabalin | Rx |
| Lyrica150MG · capsule; oral | Pregabalin | Rx |
| Lyrica200MG · capsule; oral | Pregabalin | Rx |
| Lyrica225MG · capsule; oral | Pregabalin | Rx |
| Lyrica300MG · 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