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FDA BLA · BLA761172

EBANGA

ansuvimab

Sponsor: RIDGEBACK BIOTHERAPEUTICS

APPLICATION
BLA761172
TYPE
BLA
ORIGINAL APPROVAL
2020-12-21
LATEST ACTION
2026-02-18
ROUTE
INTRAVENOUS, IV (INFUSION)
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

EBANGAPrescription
ANSUVIMAB-ZYKL 400MG/VIAL · POWDER · IV (INFUSION)

Approval history

2026-02-18Labeling · Supplement 11 · standard — Letter ↗AP
2024-12-26Labeling · Supplement 8 · standard — Label ↗AP
2022-05-19Labeling · Supplement 4 · standard — Letter ↗AP
2021-12-07Labeling · Supplement 2 · standard — Label ↗AP
2020-12-21Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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