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 4, 2019 Approval Letter - Fluzone Quadrivalent -Sourthern Hemisphere (PDF - 33KB)
To include the 2019 Southern Hemisphere FluzoneQuadrivalent formulation and associated labeling revisions.January 23, 2019 Approval Letter - Fluzone Quadrivalent (PDF - 104KB)
To include the use of a 0.5 mL single dose presentation of Fluzone Quadrivalent formulation in children 6 to ‹36 months of age.January 18, 2019 Summary Basis of Regulatory Action (PDF - 375KB)Clinical Review Template - Fluzone Quadrivalent (PDF - 686KB)Statistical Review and Evaluation - Fluzone Quadrivalent (PDF - 316KB)- June 29, 2018 Approval Letter- Fluzone-Quadrivalent (PDF - 96KB)
To include the 2018-2019 Northern Hemisphere formulation and associated labeling revisions. January 10, 2018 Approval Letter - Fluzone Quadrivalent - Southern Hemisphere (PDF - 33KB)
To include the 2018 Southern Hemisphere Formulation and Associated Labeling Revisions.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)Supporting Documents older than three years - Fluzone Quadrivalent
Related Information
Fluzone, Fluzone High-Dose and Fluzone Intradermal Sanofi Pasteur, Inc. FDA Online Label Repository
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