FLURBIPROFEN | N018766 | PHARMACIA AND UPJOHN CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Premier Research International, LLC FDA-2026-P-3166 Premier Research International, LLC filed this citizen petition requesting that the FDA determine the discontinuation of Flurbiprofen Oral Tablet 100 mg and 50 mg under NDA 018766 from Pharmacia and Upjohn Co was not due to safety or efficacy reasons, to enable Premier's client to submit a 505(b)(2) | 505(q) | 2026-03-26 | Granted | Premier Research International, LLC |
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-5490 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 Flurbiprofen Tablets 25 mg, a new strength differing from the Reference Listed Drug ANS | Suitability | 2025-10-20 | Open | Senores Pharmaceuticals, Inc. |
Amendment to Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1277 Senores Pharmaceuticals, Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act seeking FDA authorization to submit an ANDA for Flurbiprofen Tablets 75 mg, which would differ in strength from the reference listed drug ANSAID. The amendment respond | Suitability | 2025-05-28 | Open | Senores Pharmaceuticals, Inc. |
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1277 Senores Pharmaceuticals, Inc. submitted a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application (ANDA) for Flurbiprofen Tablets 75 mg, a new strength that differs from the Reference Listed Dru | Suitability | 2025-05-16 | Open | Senores Pharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.