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Zinbryta

daclizumab

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Zinbryta
Proper name
daclizumab
Licence type
351(a)
BLA number
761029
Applicant
Biogen Inc.
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
150MG/ML Injection Subcutaneous Pre-Filled Syringe Disc May 27, 2016
150MG/ML Injection Subcutaneous Autoinjector Disc May 26, 2017

Sources for this page

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