← FDA Drug Approvals (Drugs@FDA)

DANYELZA

BLA · Biologics License Application · Sponsor: Y-MABS THERAPEUTICS INC · Approved 2020-11-25

Drug application

FDA Application #

BLA761171

Application type

Biologics License Application

Brand name

DANYELZA

Generic name

NAXITAMAB

Active ingredients

NAXITAMAB-GQGK

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

Y-MABS THERAPEUTICS INC

Manufacturer

Y-mAbs Therapeutics, Inc.

First approval

2020-11-25

Source

Authoritative

Drugs@FDA application overview

Machine

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