Product Details for: Unituxin
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
17.5MG/5ML (3.5MG/ML)
Single-Dose Vial
351(a)
Unituxin
Rx
Proper Name
dinutuximab
dinutuximab
BLA Number
125516
125516
Applicant
United Therapeutics Corporation
United Therapeutics Corporation
Original Approval Date
March 10, 2015
March 10, 2015
Date of First Licensure