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