Product Details for: Vyloy

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
100MG
Single-Dose Vial
351(a)
Vyloy
Rx
002
For Injection
Intravenous
300MG
Single-Dose Vial
351(a)
Vyloy
Rx
Proper Name
zolbetuximab-clzb
BLA Number
761365
Applicant
Astellas Pharma US, Inc.
Original Approval Date
October 18, 2024
Date of First Licensure