NDA 020459

EUROHLTH INTL SARL

FDA Drug Application

Application #020459

Documents

• Letter: 2006-04-13
• Label: 2006-04-12
• Review: 2019-02-15

Application Sponsors

NDA 020459

EUROHLTH INTL SARL

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 0.1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	REVEX	NALMEFENE HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	REVEX	NALMEFENE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1995-04-17	STANDARD
LABELING; Labeling	SUPPL	2	AP	2000-12-12	STANDARD
LABELING; Labeling	SUPPL	6	AP	2006-04-11	STANDARD

Submissions Property Types

SUPPL

1

Null

0

CDER Filings

EUROHLTH INTL SARL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20459
            [companyName] => EUROHLTH INTL SARL
            [docInserts] => ["",""]
            [products] => [{"drugName":"REVEX","activeIngredients":"NALMEFENE HYDROCHLORIDE","strength":"EQ 0.1MG BASE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"REVEX","activeIngredients":"NALMEFENE HYDROCHLORIDE","strength":"EQ 1MG BASE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/11\/2006","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020459s006lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"REVEX","submission":"NALMEFENE HYDROCHLORIDE","actionType":"EQ 0.1MG BASE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"REVEX","submission":"NALMEFENE HYDROCHLORIDE","actionType":"EQ 1MG BASE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2006-04-11
        )

)