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General MedicationsSUBCUTANEOUSStandard

ANDEMBRY

GARADACIMAB-GXII

Standard Dose
200MG/1.2ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ANDEMBRY is listed in Drugs@FDA under application 761367 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient GARADACIMAB-GXII Form and strength INJECTABLE;SUBCUTANEOUS - 200MG/1.2ML Sponsor CSL BEHRING LLC Submission history Latest submission status date: 2025-06-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview ANDEMBRY is listed in Drugs@FDA under application 761367 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient GARADACIMAB-GXII Form and strength INJECTABLE;SUBCUTANEOUS - 200MG/1.2ML Sponsor CSL BEHRING LLC Submission history Latest submission status date: 2025-06-16 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.