Product Details for: Herceptin Hylecta

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
600MG/5ML;10,000 UNITS/5ML (120MG/2,000UNITS/ML)
Single-Dose Vial
351(a)
Herceptin Hylecta
Rx
Proper Name
trastuzumab and hyaluronidase-oysk
BLA Number
761106
Applicant
Genentech, Inc.
Original Approval Date
February 28, 2019
Date of First Licensure
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