Product Details for: Sarclisa

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
100MG/5ML (20MG/ML)
Single-Dose Vial
351(a)
Sarclisa
Rx
002
Injection
Intravenous
500MG/25ML (20MG/ML)
Single-Dose Vial
351(a)
Sarclisa
Rx
Proper Name
isatuximab-irfc
BLA Number
761113
Applicant
Sanofi-Aventis U.S. LLC
Original Approval Date
March 2, 2020
Date of First Licensure
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