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.