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Perjeta

pertuzumab

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Perjeta
Proper name
pertuzumab
Licence type
351(a)
BLA number
125409
Applicant
Genentech, Inc.
Center
CDER
Presentations
1
First licensure
June 8, 2012

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
420MG/14ML Injection Intravenous Single-Dose Vial Rx June 8, 2012

Sources for this page

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