CELECOXIB | N020998 | UPJOHN US 2 LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2025-P-1532 · 7 docket documents 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, 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
$15.65
per ea
Lowest NADAC/Unit
$9.53
per ea
Brand NDCs
6
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 58151008401CELEBREX 200 MG CAPSULE | $15.65 | EA | Brand | $0.0807 | 2026-06-17 |
| 58151008405CELEBREX 200 MG CAPSULE | $15.65 | EA | Brand | $0.0807 | 2026-06-17 |
| 58151008488CELEBREX 200 MG CAPSULE | $15.65 | EA | Brand | $0.0807 | 2026-06-17 |
| 58151008301CELEBREX 100 MG CAPSULE | $9.53 | EA | Brand | $0.0693 | 2026-06-17 |
| 58151008305CELEBREX 100 MG CAPSULE | $9.53 | EA | Brand | $0.0693 | 2026-06-17 |
| 58151008388CELEBREX 100 MG CAPSULE | $9.53 | EA | Brand | $0.0693 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.