Product Details for: Flucelvax, Flucelvax Quadrivalent
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
45UG/.5ML
Pre-Filled Syringe
351(a)
Flucelvax, Flucelvax Quadrivalent
Disc
002
Injection
Intramuscular
60UG/.5ML
Pre-Filled Syringe
351(a)
Flucelvax, Flucelvax Quadrivalent
Disc
003
Injection
Intramuscular
60UG/.5ML
Multi-Dose Vial
351(a)
Flucelvax, Flucelvax Quadrivalent
Disc
004
Injection
Intramuscular
45UG/.5ML
Multi-Dose Vial
351(a)
Flucelvax, Flucelvax Quadrivalent
Disc
005
Injection
Intramuscular
45UG/.5ML
Pre-Filled Syringe
351(a)
Flucelvax, Flucelvax Quadrivalent
Rx
Proper Name
Influenza Vaccine
Influenza Vaccine
BLA Number
125408
125408
Applicant
Seqirus Inc.
Seqirus Inc.
Original Approval Date
November 20, 2012
November 20, 2012
Date of First Licensure