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Danyelza

naxitamab-gqgk

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Danyelza

Proper name

naxitamab-gqgk

Licence type

351(a)

BLA number

761171

Applicant

Y-mABs Therapeutics, Inc

Center

CDER

Presentations

1

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
40MG/10ML (4MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	November 25, 2020

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	November 25, 2027

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity