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Flulaval, Flulaval Quadrivalent
Influenza Vaccine
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Flulaval, Flulaval Quadrivalent
Proper name
Influenza Vaccine
Licence type
351(a)
BLA number
125163
Applicant
ID Biomedical Corporation of Quebec
Center
CBER
Presentations
5
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 15UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Disc | November 10, 2009 |
| 45UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Rx | October 5, 2006 |
| 45UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | September 27, 2013 |
| 60UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Disc | August 15, 2013 |
| 60UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Disc | September 27, 2013 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |