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Briumvi

ublituximab-xiiy

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Briumvi
Proper name
ublituximab-xiiy
Licence type
351(a)
BLA number
761238
Applicant
TG 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
150MG/6ML (25MG/ML) Injection Intravenous Single-Dose Vial Rx December 28, 2022

Sources for this page

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