CELECOXIB | N212157 | SCILEX PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2025-P-1533 · 7 docket documents 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 | Granted | Senores Pharmaceuticals, Inc |
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 | Granted | McNeely, Hare & War, LLP. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$30.53
per ml
Lowest NADAC/Unit
$30.53
per ml
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 69557033301ELYXYB 120 MG/4.8 ML SOLUTION | $30.53 | ML | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.