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Perjeta
pertuzumab
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Perjeta
Proper name
pertuzumab
Licence type
351(a)
BLA number
125409
Applicant
Genentech, Inc.
Center
CDER
Presentations
1
First licensure
June 8, 2012
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 420MG/14ML | Injection | Intravenous | Single-Dose Vial | Rx | June 8, 2012 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |