NALOXONE HYDROCHLORIDE | A072076 | INTERNATIONAL MEDICATION SYSTEM
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from BPI Labs, LLC FDA-2021-P-0477 BPI Labs, LLC submitted this citizen petition on May 19, 2021 pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting FDA determination that its proposed Naloxone Hydrochloride Injection 2 mg/2 mL (1 mg/mL) formulation is suitable for submission as an Abbreviated New | Other | 2021-05-21 | Open | BPI Labs |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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