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Saphnelo
anifrolumab-fnia
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Saphnelo
Proper name
anifrolumab-fnia
Licence type
351(a)
BLA number
761451
Applicant
AstraZeneca AB
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 120MG/0.8ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | April 24, 2026 |
| 120MG/0.8ML | Injection | Subcutaneous | Autoinjector | Rx | April 24, 2026 |
| 300MG/2ML (150MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | July 30, 2021 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |