NAPROXEN SODIUM | N020353 | TWI PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Petition for Stay of Action from Elan Pharmaceuticals FDA-1998-P-0829 Elan Pharmaceuticals submitted this petition on December 15, 1998, requesting that the Food and Drug Administration stay approval of any abbreviated new drug application referencing Naprelan, a controlled release naproxen sodium product, pending FDA action on a companion citizen petition requiring A | 505(q) Stay Request | 2016-12-02 | Denied | — |
Citizen Petition from Elan Pharmaceuticals FDA-1998-P-0829 Elan Pharmaceuticals filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act on December 15, 1998, requesting that the FDA require abbreviated new drug applications (ANDAs) for controlled release naproxen sodium products referencing Naprelan include additional ph | 505(q) | 2016-12-01 | Denied | Elan Pharmaceuticals |
Citizen Petition From Almatica Pharma, Inc. FDA-2014-P-0407 Almatica Pharma, Inc. filed this citizen petition under Section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require applicants seeking to file ANDAs referencing Naprelan (naproxen sodium extended release tablets), approved under NDA No. 020353, to establish bioequivale | 505(q) | 2014-04-10 | Denied | Almatica Pharma, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$8.78
per ea
Lowest NADAC/Unit
$8.78
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 47781015475NAPROXEN SOD CR 500 MG TABLET | $8.78 | EA | Generic | — | 2026-10-21 |
| 24979025368NAPROXEN SOD CR 500 MG TABLET | $8.78 | EA | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.