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General MedicationsIV (INFUSION)Standard

EBANGA

ANSUVIMAB-ZYKL

Standard Dose
400MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview EBANGA is listed in Drugs@FDA under application 761172 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ANSUVIMAB-ZYKL Form and strength POWDER;IV (INFUSION) - 400MG/VIAL Sponsor RIDGEBACK BIOTHERAPEUTICS Submission history Latest submission status date: 2026-02-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview EBANGA is listed in Drugs@FDA under application 761172 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient ANSUVIMAB-ZYKL Form and strength POWDER;IV (INFUSION) - 400MG/VIAL Sponsor RIDGEBACK BIOTHERAPEUTICS Submission history Latest submission status date: 2026-02-18 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.