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Beovu

brolucizumab-dbll

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Beovu
Proper name
brolucizumab-dbll
Licence type
351(a)
BLA number
761125
Applicant
Novartis Pharmaceuticals Corporation
Center
CDER
Presentations
2
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
6MG/0.05ML Injection Intravitreal Single-Dose Vial Rx October 7, 2019
6MG/0.05ML Injection Intravitreal Pre-Filled Syringe Rx May 27, 2022

Sources for this page

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