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Phesgo

pertuzumab, trastuzumab, and hyaluronidase-zzxf

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Phesgo
Proper name
pertuzumab, trastuzumab, and hyaluronidase-zzxf
Licence type
351(a)
BLA number
761170
Applicant
Genentech, 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
1,200MG, 600MG, 30,000UNITS/15ML (80MG, 40MG, 2,000UNITS/ML) Injection Subcutaneous Single-Dose Vial Rx June 29, 2020
600MG, 600MG, 20,000UNITS/10ML (60MG, 60MG, 2,000UNITS/ML) Injection Subcutaneous Single-Dose Vial Rx June 29, 2020

Sources for this page

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