Revex

NDA 20459, held by Hikma. Nalmefene Hydrochloride.

As of Nov 13, 2026, NDA 20459 (Revex), held by Hikma, was first approved by FDA on Apr 17, 1995, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 17, 1995
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Apr 17, 1995	Original applicationNew molecular entity · Standard review	Approved	Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
RevexEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;intramuscular, intravenous, subcutaneous	Nalmefene Hydrochloride	DiscontinuedReference drug
RevexEQ 2MG BASE/2ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;intramuscular, intravenous, subcutaneous	Nalmefene Hydrochloride	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 11, 2006	Supplement 6Labeling · Standard review	Approved	Letter Label
Dec 12, 2000	Supplement 2Labeling · Standard review	Approved	None posted
Jan 24, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 17, 1995	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20459
Drugs@FDA: Overview at FDA
Company: Hikma

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