Fluzone Quadrivalent
STN: BL 103914
Proper Name: Influenza Virus Vaccine
Tradename: Fluzone Quadrivalent
Manufacturer: Sanofi Pasteur Inc.
Indication:
- 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.
- Fluzone Intradermal Quadrivalent: For active immunization of persons 18 through 64 years of age for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine
Product Information
Supporting Documents
February 9, 2017 Approval Letter -Fluzone Quadrivalent - Southern Hemisphere (PDF - 33KB)
To include the 2017 Southern Hemisphere Formulation and Associated Labeling Revisions.July 1, 2016 Approval Letter - Fluzone Quadrivalent (PDF - 43KB)
To include the 2016-2017 United States formulation and associated labeling revisions.May 5, 2016 Approval Letter - Fluzone Quadrivalent (PDF - 29KB)
To update the Fluzone Quadrivalent package insert with relevant information from the Fluzone Trivalent package insert.March 24, 2016 Approval Letter - Fluzone Quadrivalent (PDF - 27KB)
To include 2016 Southern Hemisphere formulation.September 29, 2015 Approval Letter - Fluzone Quadrivalent (PDF - 39KB)
To include the correct NDC number for the Fluzone Quadrivalent multi-dose vial formulation in the 2015-2016 Fluzone Quadrivalent package insert.June 26, 2015 Approval Letter - Fluzone Quadrivalent (PDF - 27KB)
To include the 2015 - 2016 United States formulation.February 18, 2015 Approval Letter - Fluzone Quadrivalent
To include changes to the Fluzone Quadrivalent Package insert.December 11, 2014 Approval Letter - Fluzone Intradermal Quadrivalent
To include a quadrivalent intradermal formulation of influenza vaccine (Fluzone Intradermal Quadrivalent) for use in persons 18 through 64 years of age.December 10, 2014 Summary Basis for Regulatory Action - Fluzone Intradermal Quadrivalent (PDF - 146KB)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)
Related Information
Fluzone, Fluzone High-Dose and Fluzone Intradermal Sanofi Pasteur, Inc. FDA Online Label Repository
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