Product Details for: Sylvant
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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)
Sylvant
Rx
002
For Injection
Intravenous
400MG
Single-Dose Vial
351(a)
Sylvant
Rx
Proper Name
siltuximab
siltuximab
BLA Number
125496
125496
Applicant
Recordati Rare Diseases, Inc.
Recordati Rare Diseases, Inc.
Original Approval Date
April 23, 2014
April 23, 2014
Date of First Licensure