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Drugs@FDA: FDA-Approved Drugs

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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HYDROCHLORIDE EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued None Yes No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HYDROCHLORIDE EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Discontinued None Yes No
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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