NAPROXEN | N018965 | ATNAHS PHARMA US LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Drug Device Consulting LLC FDA-2021-P-0340 · 6 docket documents Drug Device Consulting LLC filed this suitability petition under section 502(j)(2)(C) of the FD&C Act requesting FDA approval to submit an ANDA for Naproxen Suspension at a new 50mg/mL strength, which would be an additional strength to the already-approved 25mg/mL reference listed drug Naprosyn, all | Suitability | 2021-03-30 | Granted | Drug Device Consulting LLC |
Citizen Petition from Novitium Pharma LLC FDA-2017-P-6689 · 14 docket documents Novitium Pharma LLC, a specialty pharmaceutical company developing generic drugs, submitted a citizen petition pursuant to 21 CFR 10.25(a), 10.30, and 314.122 requesting that the FDA designate West Ward Pharmaceuticals International Limited's approved generic Naproxen Oral Suspension 25 mg/mL (ANDA | 505(q) | 2017-11-30 | Denied | Novitium Pharma LLC |
Petition for Stay of Action from Elan Pharmaceuticals FDA-1998-P-0829 · 9 docket documents 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
$0.1135
per ml
Lowest NADAC/Unit
$0.1135
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 42192061916NAPROXEN 125 MG/5 ML SUSPEN | $0.1135 | ML | Generic | — | 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.