Manages known or suspected opioid overdose. ANDA 212955, held by Knoa Pharma. Nalmefene Hydrochloride.
As of Nov 15, 2026, ANDA 212955 (Nalmefene Hydrochloride), held by Knoa Pharma, was first approved by FDA on Feb 8, 2022, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nalmefene hydrochloride injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. Nalmefene hydrochloride injection is indicated in the management of known or suspected opioid overdose.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 8, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nalmefene HydrochlorideEQ 2MG BASE/2ML (EQ 1MG BASE/ML) · solution;intramuscular, intravenous, subcutaneous | Nalmefene Hydrochloride | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
