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Padcev
enfortumab vedotin-ejfv
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Padcev
Proper name
enfortumab vedotin-ejfv
Licence type
351(a)
BLA number
761137
Applicant
Astellas Pharma US, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 20MG | For Injection | Intravenous | Single-Dose Vial | Rx | December 18, 2019 |
| 30MG | For Injection | Intravenous | Single-Dose Vial | Rx | December 18, 2019 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |