NALOXONE HYDROCHLORIDE | A209522 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Adapt Pharma Operations Lts FDA-2016-P-4094 · 3 docket documents Adapt Pharma Operations Ltd filed this citizen petition on November 23, 2016, requesting that the FDA not approve any abbreviated new drug application (ANDA) for generic intranasal naloxone products until the agency establishes a product-specific bioequivalence guidance requiring specific pharmacoki | 505(q) | 2016-11-30 | Partially Denied | Adapt Pharma Operations Lts |
Citizen Petition from Adapt Pharma Operations Ltd. FDA-2016-P-3912 · 3 docket documents Adapt Pharma Operations Ltd filed this citizen petition on November 9, 2016, requesting that the FDA not approve any abbreviated new drug applications (ANDAs) for generic intranasal naloxone products intended for community use until the agency issues formal guidance establishing specific pharmacokin | 505(q) | 2016-11-17 | Withdrawn | Adapt Pharma Operations Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$15.46
per ea
Lowest NADAC/Unit
$15.46
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00480347868NALOXONE HCL 4 MG NASAL SPRAY | $15.46 | EA | 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.