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Herceptin Hylecta

trastuzumab and hyaluronidase-oysk

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Herceptin Hylecta
Proper name
trastuzumab and hyaluronidase-oysk
Licence type
351(a)
BLA number
761106
Applicant
Genentech, 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
600MG/5ML;10,000 UNITS/5ML (120MG/2,000UNITS/ML) Injection Subcutaneous Single-Dose Vial Rx February 28, 2019

Sources for this page

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