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Kadcyla
ado-trastuzumab emtansine
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Kadcyla
Proper name
ado-trastuzumab emtansine
Licence type
351(a)
BLA number
125427
Applicant
Genentech, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100MG | For Injection | Intravenous | Single-Dose Vial | Rx | February 22, 2013 |
| 160MG | For Injection | Intravenous | Single-Dose Vial | Rx | February 22, 2013 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |