NALOXONE HYDROCHLORIDE | N016636 | ADAPT PHARMA OPERATIONS LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 - NARCAN PI re Suitability Petition from Hyman, Phelps & McNamar... FDA-2021-P-0514 The law firm Hyman, Phelps & McNamara P.C. filed a petition regarding NARCAN (naloxone) and its prescribing information suitability. The petition seeks FDA action on matters related to NARCAN's product information and labeling, though the specific requested regulatory action is not detailed in this | Suitability | 2021-05-27 | Open | Hyman |
Attachment 1 - Narcan re Suitability Petition from Hyman, Phelps & McNamara P.C. FDA-2021-P-0514 Hyman, Phelps & McNamara P.C. filed a citizen petition regarding Narcan requesting that the FDA determine the suitability of the drug product for over-the-counter use, which involves evaluating whether the product can be safely and effectively used by consumers without professional supervision. | Suitability | 2021-05-27 | Open | Hyman |
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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