NAPROXEN | N020067 | ATNAHS PHARMA US LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 Draft Label for Naproxen Suspension 50mg/mL re Suitability Petit... FDA-2021-P-0340 Drug Device Consulting LLC filed a citizen petition requesting that the FDA determine the suitability of a draft label for naproxen suspension 50 mg/mL formulation. The petition seeks FDA review and approval of the proposed labeling for this over-the-counter or prescription naproxen suspension produ | Suitability | 2021-03-30 | Granted | Drug Device Consulting LLC |
Attachment 3 RLD Label for Naproxen Suspension 25mg/mL re Suitability Petitio... FDA-2021-P-0340 Drug Device Consulting LLC filed a citizen petition regarding the suitability of the reference listed drug (RLD) label for Naproxen Suspension 25 mg/mL. The petition appears to challenge or question the appropriateness of the existing RLD labeling for this naproxen suspension formulation. | Suitability | 2021-03-30 | Granted | Drug Device Consulting LLC |
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 | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.95
per ea
Lowest NADAC/Unit
$1.95
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 90096016101NAPROXEN DR 500 MG TABLET | $1.95 | 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.