Product Details for: Ruxience

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
100MG/10ML (10MG/ML)
Single-Dose Vial
351(k) Biosimilar
Ruxience
Rx
002
Injection
Intravenous
500MG/50ML (10MG/ML)
Single-Dose Vial
351(k) Biosimilar
Ruxience
Rx
Proper Name
rituximab-pvvr
Reference Product Proper Name
rituximab
Reference Product Properietary Name
Rituxan
BLA Number
761103
Applicant
Pfizer Ireland Pharmaceuticals Unlimited Company
Original Approval Date
July 23, 2019
Date of First Licensure
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