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Flucelvax, Flucelvax Quadrivalent
Influenza Vaccine
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Flucelvax, Flucelvax Quadrivalent
Proper name
Influenza Vaccine
Licence type
351(a)
BLA number
125408
Applicant
Seqirus Inc.
Center
CBER
Presentations
5
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 45UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Disc | November 20, 2012 |
| 45UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Disc | March 4, 2024 |
| 45UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | March 4, 2024 |
| 60UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Disc | May 23, 2016 |
| 60UG/.5ML | Injection | Intramuscular | Multi-Dose Vial | Disc | March 3, 2017 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |