Vaccines, Blood & Biologics
STN: BL 103914/5574
Proper Name: Influenza Virus Vaccine
Tradename: Fluzone Quadrivalent
Manufacturer: Sanofi Pasteur Inc.
- For active immunization of persons 6 months of age and older for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
June 27, 2014 Approval Letter - Fluzone Quadrivalent
To include the 2014-2015 United States Formulation.
December 11, 2013 Approval Letter - Fluzone Quadivalent
To include a thimerosal preserved multi-dose vial presentation of Fluzone® Quadrivalent formulation.
June 7, 2013 Approval Letter - Fluzone Quadrivalent
For active immunization of persons 6 months of age and older for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
May 28, 2013 - Summary Basis of Regulatory Action - Fluzone Quadrivalent(PDF - 130KB) Statistical Review and Evaluation - Fluzone® Quadrivalent(PDF - 222KB) Clinical Review - Fluzone Quadrivalent(PDF - 970KB)
Fluzone, Fluzone High-Dose and Fluzone Intradermal Sanofi Pasteur, Inc. FDA Online Label Repository
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