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General MedicationsSYRINGEStandard

XOLAIR

OMALIZUMAB

Standard Dose
300MG/2ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview XOLAIR is listed in Drugs@FDA under application 103976 (BLA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient OMALIZUMAB Form and strength SYRINGE - 300MG/2ML Sponsor GENENTECH Submission history Latest submission status date: 2024-02-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview XOLAIR is listed in Drugs@FDA under application 103976 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient OMALIZUMAB Form and strength SYRINGE - 300MG/2ML Sponsor GENENTECH Submission history Latest submission status date: 2024-02-16 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.