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General MedicationsINTRAMUSCULARStandard

MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)

MIDAZOLAM HYDROCHLORIDE

Standard Dose
EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Prescription
Summary

Approval overview MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) is listed in Drugs@FDA under application 216359 (NDA).

Review priority: N/A Marketing status: Prescription Active ingredient MIDAZOLAM HYDROCHLORIDE Form and strength SOLUTION;INTRAMUSCULAR - EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML) Sponsor RAFA LABS LTD Submission history Latest submission status date: 2024-05-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) is listed in Drugs@FDA under application 216359 (NDA). Review priority: N/A Marketing status: Prescription Active ingredient MIDAZOLAM HYDROCHLORIDE Form and strength SOLUTION;INTRAMUSCULAR - EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML) Sponsor RAFA LABS LTD Submission history Latest submission status date: 2024-05-02 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: N/A

Interaction Notes

  • No interaction notes stored yet.