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Beyfortus
nirsevimab-alip
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Beyfortus
Proper name
nirsevimab-alip
Licence type
351(a)
BLA number
761328
Applicant
Sanofi Vaccines US Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100MG/ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | July 17, 2023 |
| 50MG/0.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | July 17, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |