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FDA NDA · NDA020459

REVEX

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APPLICATION
NDA020459
TYPE
NDA
ORIGINAL APPROVAL
1995-04-17
LATEST ACTION
2006-04-11
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

REVEX · ReferenceDiscontinued
NALMEFENE HYDROCHLORIDE EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
REVEX · ReferenceDiscontinued
NALMEFENE HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Approval history

2006-04-11Labeling · Supplement 6 · standard — Letter ↗AP
2000-12-12Labeling · Supplement 2 · standardAP
1996-01-24Manufacturing (CMC) · Supplement 1 · standardAP
1995-04-17Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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