CELECOXIB | N020998 | UPJOHN US 2 LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2025-P-1532 Senores Pharmaceuticals, Inc. filed this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Celecoxib Capsules, 25 mg, a new strength of the Reference Listed Drug Celebrex that is | Suitability | 2025-06-03 | Open | Senores Pharmaceuticals |
Attachment 3 Celebrex PI- re Suitability Petition from McNeely, Hare & War, LLP. FDA-2018-P-1966 I cannot provide a summary of this petition because the attachment content provided contains only a title and file reference without the substantive details of the petition itself. To accurately summarize who filed it, which drug or product is involved, and what regulatory action was requested, I wo | Suitability | 2018-05-22 | Open | McNeely |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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