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General MedicationsINJECTIONStandard

UPLIZNA

INEBILIZUMAB-CDON

Standard Dose
100MG/10ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview UPLIZNA is listed in Drugs@FDA under application 761142 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient INEBILIZUMAB-CDON Form and strength INJECTABLE;INJECTION - 100MG/10ML Sponsor VIELA BIO Submission history Latest submission status date: 2025-12-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview UPLIZNA is listed in Drugs@FDA under application 761142 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient INEBILIZUMAB-CDON Form and strength INJECTABLE;INJECTION - 100MG/10ML Sponsor VIELA BIO Submission history Latest submission status date: 2025-12-11 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.