NAPROXEN | A074190 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, PC FDA-2018-P-1195 · 13 docket documents Hyman, Phelps & McNamara, PC filed this petition requesting that FDA amend the Orange Book to designate Naproxen Oral Suspension, 25 mg/mL approved under ANDA 074190 as a new Reference Standard, because the current Reference Standard and Reference Listed Drug (NAPROSYN Oral Suspension, 25 mg/mL unde | Other | 2018-03-20 | Denied | Hyman, Phelps & McNamara, PC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.1762
per ml
Lowest NADAC/Unit
$0.1762
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00054363063NAPROXEN 125 MG/5 ML SUSPEN | $0.1762 | 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.