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Purple Book
Database of Licensed Biological Products

Product Details for: Herceptin Hylecta
Product Label Grayed out Product Label links indicate that there is no product label available for the product.

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001InjectionSubcutaneous600MG/5ML;10,000 UNITS/5ML (120MG/2,000UNITS/ML)Single-Dose Vial351(a)Herceptin HylectaRx

Proper Name
trastuzumab and hyaluronidase-oysk

BLA Number
761106

Applicant
Genentech, Inc.

Original Approval Date
February 28, 2019

Date of First Licensure