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General MedicationsPOWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDERStandard

BESPONSA

INOTUZUMAB OZOGAMICIN

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

Approval overview BESPONSA is listed in Drugs@FDA under application 761040 (BLA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient INOTUZUMAB OZOGAMICIN Form and strength POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER - 0.9/MG/VIAL Sponsor WYETH PHARMS INC Submission history Latest submission status date: 2024-03-06 00:00:00.

Structured Monograph

Clinical summary

Approval overview BESPONSA is listed in Drugs@FDA under application 761040 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient INOTUZUMAB OZOGAMICIN Form and strength POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER - 0.9/MG/VIAL Sponsor WYETH PHARMS INC Submission history Latest submission status date: 2024-03-06 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.