FDA BLA · BLA761171

DANYELZA

naxitamab

Sponsor: Y-MABS THERAPEUTICS INC

APPLICATION

BLA761171

TYPE

BLA

ORIGINAL APPROVAL

2020-11-25

LATEST ACTION

2025-08-27

ROUTE

INTRAVENOUS

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

DANYELZAPrescription

NAXITAMAB-GQGK 40MG/10ML · SOLUTION · INTRAVENOUS

2025-08-27Labeling · Supplement 13 · standard — Label ↗AP

2024-03-20Labeling · Supplement 8 · standard — Letter ↗AP

2020-11-25Type 1 - New Molecular Entity · Original · priority — Label ↗AP

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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