Product Details for: Afluria, Afluria Quadrivalent

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
225UG
Multi-Dose Vial
351(a)
Afluria, Afluria Quadrivalent
Rx
002
Injection
Intramuscular
45UG/.5ML
Syringe
351(a)
Afluria, Afluria Quadrivalent
Rx
003
Injection
Intramuscular
60UG/.5ML
Pre-Filled Syringe
351(a)
Afluria, Afluria Quadrivalent
Disc
004
Injection
Intramuscular
60UG/.5ML
Multi-Dose Vial
351(a)
Afluria, Afluria Quadrivalent
Disc
005
Injection
Intramuscular
30UG/.25ML
Pre-Filled Syringe
351(a)
Afluria, Afluria Quadrivalent
Disc
Proper Name
Influenza Vaccine
BLA Number
125254
Applicant
Seqirus Pty Ltd.
Original Approval Date
September 28, 2007
Date of First Licensure