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General MedicationsINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSGeneric

REVEX

NALMEFENE HYDROCHLORIDE

Standard Dose
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview REVEX is listed in Drugs@FDA under application 020459 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient NALMEFENE HYDROCHLORIDE Form and strength SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor HIKMA Submission history Latest submission status date: 2006-04-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview REVEX is listed in Drugs@FDA under application 020459 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient NALMEFENE HYDROCHLORIDE Form and strength SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS - EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor HIKMA Submission history Latest submission status date: 2006-04-11 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Discontinued
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.