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
- 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
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.