Product Details for: Uplizna
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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(a)
Uplizna
Rx
Proper Name
inebilizumab-cdon
inebilizumab-cdon
BLA Number
761142
761142
Applicant
Horizon Therapeutics Ireland DAC
Horizon Therapeutics Ireland DAC
Original Approval Date
June 11, 2020
June 11, 2020
Date of First Licensure