Product Details for: Kadcyla
RETURN TO SEARCH RESULTS
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
For Injection
Intravenous
100MG
Single-Dose Vial
351(a)
Kadcyla
Rx
002
For Injection
Intravenous
160MG
Single-Dose Vial
351(a)
Kadcyla
Rx
Proper Name
ado-trastuzumab emtansine
ado-trastuzumab emtansine
BLA Number
125427
125427
Applicant
Genentech, Inc.
Genentech, Inc.
Original Approval Date
February 22, 2013
February 22, 2013
Date of First Licensure