Product Details for: Uplizna Product Label Grayed out Product Label links indicate that there is no product label available for the product.
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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
BLA Number
761142
Applicant
Horizon Therapeutics Ireland DAC
Original Approval Date
June 11, 2020
Date of First Licensure