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General MedicationsINTRAMUSCULAR, SUBCUTANEOUSStandard

ZIMHI

NALOXONE HYDROCHLORIDE

Standard Dose
5MG/0.5ML (5MG/0.5ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ZIMHI is listed in Drugs@FDA under application 212854 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient NALOXONE HYDROCHLORIDE Form and strength SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 5MG/0.5ML (5MG/0.5ML) Sponsor ZMI PHARMA Submission history Latest submission status date: 2021-10-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview ZIMHI is listed in Drugs@FDA under application 212854 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NALOXONE HYDROCHLORIDE Form and strength SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 5MG/0.5ML (5MG/0.5ML) Sponsor ZMI PHARMA Submission history Latest submission status date: 2021-10-15 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
ZIMHI (NALOXONE HYDROCHLORIDE) | Drug Monograph | MedicHelpline