Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020459
Company: EUROHLTH INTL SARL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REVEX NALMEFENE HYDROCHLORIDE EQ 0.1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
REVEX NALMEFENE HYDROCHLORIDE EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
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.

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

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