Product Details for: Riabni
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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
Riabni
Rx
002
Injection
Intravenous
500MG/50ML (10MG/ML)
Single-Dose Vial
351(k) Biosimilar
Riabni
Rx
Proper Name
rituximab-arrx
rituximab-arrx
Reference Product Proper Name
rituximab
rituximab
Reference Product Properietary Name
Rituxan
Rituxan
BLA Number
761140
761140
Applicant
Amgen Inc.
Amgen Inc.
Original Approval Date
December 17, 2020
December 17, 2020
Date of First Licensure