NALMEFENE HYDROCHLORIDE | N218590 | KNOA PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Nirsum Pharmaceuticals, LLC FDA-2017-P-2044 · 16 docket documents Nirsum Pharmaceuticals, LLC filed this petition under 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner determine whether Revex (nalmefene hydrochloride injection) in strengths of 0.1 mg base/ml and 1.0 mg base/ml, subject of NDA 020-459, was withdrawn fro | 505(q) | 2017-04-04 | Denied | Nirsum Pharmaceuticals, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.