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Flublok
Influenza Vaccine
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Flublok
Proper name
Influenza Vaccine
Licence type
351(a)
BLA number
125285
Applicant
Protein Sciences Corporation
Center
CBER
Presentations
3
First licensure
January 16, 2013
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 135UG/.5ML | Injection | Intramuscular | Single-Dose Vial | Rx | January 16, 2013 |
| 135UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | March 4, 2024 |
| 180UG/.5ML | Injection | Intramuscular | Pre-Filled Syringe | Rx | October 7, 2016 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |