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Herceptin
trastuzumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Herceptin
Proper name
trastuzumab
Licence type
351(a)
BLA number
103792
Applicant
Genentech, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 150MG | For Injection | Intravenous | Single-Dose Vial | Rx | February 10, 2017 |
| 420MG | For Injection | Intravenous | Multi-Dose Vial | Disc* | September 25, 1998 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | October 20, 2017 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |