Product Details for: Danyelza
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
40MG/10ML (4MG/ML)
Single-Dose Vial
351(a)
Danyelza
Rx
Proper Name
naxitamab-gqgk
naxitamab-gqgk
BLA Number
761171
761171
Applicant
Y-mABs Therapeutics, Inc
Y-mABs Therapeutics, Inc
Original Approval Date
November 25, 2020
November 25, 2020
Date of First Licensure