Product Details for: Arzerra

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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
Single-Dose Vial
351(a)
Arzerra
Disc
002
Injection
Intravenous
1,000MG/50ML
Single-Dose Vial
351(a)
Arzerra
Disc
003
Injection
Subcutaneous
20MG/0.4ML
Autoinjector
351(a)
Kesimpta
Rx
004
Injection
Subcutaneous
20MG/0.4ML
Pre-Filled Syringe
351(a)
Kesimpta
Disc
Proper Name
ofatumumab
BLA Number
125326
Applicant
Novartis Pharmaceuticals Corporation
Original Approval Date
October 26, 2009
Date of First Licensure
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