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General MedicationsINJECTIONStandard

VORAXAZE

GLUCARPIDASE

Standard Dose
1000 UNITS PER VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview VORAXAZE is listed in Drugs@FDA under application 125327 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient GLUCARPIDASE Form and strength INJECTABLE; INJECTION - 1000 UNITS PER VIAL Sponsor BTG INTERNATIONAL INC Submission history Latest submission status date: 2019-08-13 00:00:00.

Structured Monograph

Clinical summary

Approval overview VORAXAZE is listed in Drugs@FDA under application 125327 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient GLUCARPIDASE Form and strength INJECTABLE; INJECTION - 1000 UNITS PER VIAL Sponsor BTG INTERNATIONAL INC Submission history Latest submission status date: 2019-08-13 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.