PREGABALIN | N209501 | UPJOHN US 2 LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from PharmaVector LLC FDA-2026-P-1792 PharmaVector LLC filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA declaration that Pregabalin Extended-Release Tablets in 247.5 mg, 495 mg and 660 mg strengths are suitable for submission as an ANDA, with LYRICA CR Extended-Re | Suitability | 2026-02-19 | Open | PharmaVector LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.