Manages known or suspected opioid overdose. ANDA 216007, held by Chengdu Shuode. Nalmefene Hydrochloride.
As of Nov 15, 2026, ANDA 216007 (Nalmefene Hydrochloride), held by Chengdu Shuode, was first approved by FDA on Nov 15, 2023, 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 |
|---|---|---|---|
| Nov 15, 2023 | Original application | Approved | None posted |
| Nalmefene HydrochlorideEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) · solution;intramuscular, intravenous, subcutaneous | Nalmefene Hydrochloride | Rx |
| Nalmefene HydrochlorideEQ 2MG BASE/2ML (EQ 1MG BASE/ML) · solution;intramuscular, intravenous, subcutaneous | Nalmefene Hydrochloride | Rx |
| Nalmefene Hydrochloride2MG BASE/2ML (EQ 1MGBASE/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
