CELECOXIB | N212157 | SCILEX PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2025-P-1533 Senores Pharmaceuticals, Inc. filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Celecoxib capsules in 60 mg and 120 mg strengths suitable for submission of an Abbreviated New Drug Application (ANDA), with the Reference | Suitability | 2025-06-03 | Open | Senores Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.