Product Details for: Padcev

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
20MG
Single-Dose Vial
351(a)
Padcev
Rx
002
For Injection
Intravenous
30MG
Single-Dose Vial
351(a)
Padcev
Rx
Proper Name
enfortumab vedotin-ejfv
BLA Number
761137
Applicant
Astellas Pharma US, Inc.
Original Approval Date
December 18, 2019
Date of First Licensure
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