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Generated: December 11, 2018

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Details for New Drug Application (NDA): 020459

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NDA 020459 describes REVEX, which is a drug marketed by Eurohlth Intl Sarl and is included in one NDA. Additional details are available on the REVEX profile page.

The generic ingredient in REVEX is nalmefene hydrochloride. There are four drug master file entries for this compound. Additional details are available on the nalmefene hydrochloride profile page.
Summary for 020459
Tradename:REVEX
Applicant:Eurohlth Intl Sarl
Ingredient:nalmefene hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 0.1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 17, 1995TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 17, 1995TE:RLD:Yes

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