Product Details for: Lynozyfic

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
5MG/2.5ML (2MG/ML)
Single-Dose Vial
351(a)
Lynozyfic
Rx
002
Injection
Intravenous
200MG/10ML (20MG/ML)
Single-Dose Vial
351(a)
Lynozyfic
Rx
Proper Name
linvoseltamab-gcpt
BLA Number
761400
Applicant
Regeneron Pharmaceuticals, Inc.
Original Approval Date
July 2, 2025
Date of First Licensure