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Afluria, Afluria Quadrivalent
Influenza Vaccine
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Afluria, Afluria Quadrivalent
Proper name
Influenza Vaccine
Licence type
351(a)
BLA number
125254
Applicant
Seqirus Pty Ltd.
Center
CBER
Presentations
5
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 225UG | Injection | Intramuscular | Multi-Dose Vial | Disc | September 28, 2007 |
| 30UG/.25ML | Injection | Intramuscular | Pre-Filled Syringe | Disc | October 4, 2018 |
| 45UG/.5ML | Injection | Intramuscular | Syringe | Disc | September 28, 2007 |
| 60UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Disc | August 26, 2016 |
| 60UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Disc | August 26, 2016 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |