Product Details for: Fluad
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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)
Fluad
Disc
002
Injection
Intramuscular
60UG/.5ML
Pre-Filled Syringe
351(a)
Fluad,Fluad Quadrivalent
Rx
Proper Name
Influenza Vaccine, Adjuvanted
Influenza Vaccine, Adjuvanted
BLA Number
125510
125510
Applicant
Seqirus Inc.
Seqirus Inc.
Original Approval Date
November 24, 2015
November 24, 2015
Date of First Licensure