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General MedicationsSINGLE-DOSEStandard

MYLOTARG

GEMTUZUMAB OZOGAMICIN

Standard Dose
4.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview MYLOTARG is listed in Drugs@FDA under application 761060 (BLA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient GEMTUZUMAB OZOGAMICIN Form and strength VIAL;SINGLE-DOSE - 4.5MG Sponsor WYETH PHARMS INC Submission history Latest submission status date: 2020-06-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview MYLOTARG is listed in Drugs@FDA under application 761060 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient GEMTUZUMAB OZOGAMICIN Form and strength VIAL;SINGLE-DOSE - 4.5MG Sponsor WYETH PHARMS INC Submission history Latest submission status date: 2020-06-16 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.