Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020459
Company: HIKMA

Products on NDA 020459

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REVEX	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HYDROCHLORIDE	EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Discontinued	None	Yes	No
REVEX	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HYDROCHLORIDE	EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020459

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/17/1995	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020459Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/11/2006	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020459s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020459s006ltr.pdf
12/12/2000	SUPPL-2	Labeling		Label is not available on this site.
01/24/1996	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020459

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/11/2006	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020459s006lbl.pdf