Product Details for: Gazyva
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
1,000MG/40ML (25MG/ML)
Single-Dose Vial
351(a)
Gazyva
Rx
Proper Name
obinutuzumab
obinutuzumab
BLA Number
125486
125486
Applicant
Genentech, Inc.
Genentech, Inc.
Original Approval Date
November 1, 2013
November 1, 2013
Date of First Licensure