CELECOXIB | N211759 | CARWIN PHARMACEUTICAL ASSOCIATES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from McNeely, Hare & War, LLP. FDA-2018-P-1966 · 6 docket documents McNeely, Hare & War, LLP filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine that celecoxib oral capsules in 150 mg and 300 mg strengths are suitable for submission in an ANDA, with Celebrex capsules approved in NDA 20-9 | Suitability | 2018-05-22 | GrantedNo FDA response document on docket | McNeely, Hare & War, LLP. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 12678405Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Sep 17, 2045 | — | — | Yes | — | — |