NALOXONE HYDROCHLORIDE | N212045 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2021-P-0514 · 5 docket documents Hyman, Phelps & McNamara, P.C. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Naloxone HCl Nasal Spray, 8 mg/Spray, suitable for submission as an ANDA, with NARCAN Nasal Spray (NDA 208411) as the reference listed dru | Suitability | 2021-05-27 | Open | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$59.74
per ea
Lowest NADAC/Unit
$59.74
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 59467067901KLOXXADO 8 MG NASAL SPRAY | $59.74 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.