Product Information

• Patient Information Sheet - Fluzone and Fluzone High Dose (PDF - 21KB)
• Package Insert - Fluzone (PDF - 239KB)
• Package Insert - Fluzone - High Dose (PDF - 164KB)
• Package Insert - Fluzone-Intradermal (PDF - 253KB)

Supporting Documents

• July 2, 2012 Approval Letter - Fluzone
  To include the 2012 - 2013 United States formulation
• May 15, 2012 Approval Letter-Fluzone, Fluzone High-Dose and Fluzone Intradermal
  To include separate United States prescription information’s (USPI) for Fluzone®, Fluzone High-Dose® and Fluzone Intradermal® formulations, for use in final packaged product beginning in the 2012-2013 season.
• April 10, 2012 Approval Letter - Fluzone
  To include the additional syringe label design for Fluzone 0.25mL, Fluzone 0.5mL and Fluzone High-Dose syringe presentations with a detachable portion for patient records.
• June 27, 2011 Approval Letter (103914/5440)- Fluzone
  To revise labeling to update Section 6.2 Post-Marketing Experience of the prescribing information for Fluzone High-Dose and to update the Octylphenol Ethoxylate (Triton X-100) quantity per dose in Section 11.
• June 27, 2011 Approval Letter (103914/5449) - Fluzone
  To include the 2011 - 2012 United States formulation.
• May 9, 2011 Summary Basis for Regulatory Action - Fluzone Intradermal (PDF - 147KB)
• May 9, 2011 Approval Letter - Fluzone Intradermal
  To include a formulation for intradermal administration.
• February 17, 2011 Approval Letter - Fluzone/Fluzone High-Dose
  Approved request to supplement biologics license application to include a Patient Package Insert.
• July 23, 2010 Approval Letter - Fluzone/Fluzone High-Dose
  2010-2011 United States Formulation
• December 23, 2009 Approval Letter - Fluzone High-Dose
  New High-Dose Formulation.
• Summary Basis for Regulatory Action - Fluzone High-Dose (PDF - 70KB)
  December 23, 2009
• July 10, 2009 Approval Letter - Fluzone
  2009/2010 Season Formulation
• May 6, 2009 Approval Letter - Fluzone
  Update: New Influenza Vaccine Manufacturing Facility (NIVMF), Building.
• July 14, 2008 Approval Letter (1) - Fluzone
  Revisions to the Package Insert: To Comply with Physician's Labeling Rule Guidelines.
• July 14, 2008 Approval Letter (2) - Fluzone
  New Formulation: 2008-2009 United States formulation.
• July 13, 2007 Approval Letter - Fluzone
  New Formulation: 2007-2008 United States formulation.
• July 10, 2006 Approval Letter - Fluzone
  New Formulation: 2006-2007 United States formulation.
• July 14, 2005 Approval Letter (1) - Fluzone
  New Formulation: 2005-2006 United States formulation.
• July 14, 2005 Approval Letter (2) - Fluzone
  New Dosage Form: Preservative free single dose presentation in a unit dose vial.
• December 23, 2004 Approval Letter - Fluzone
  New Dosage Form: Single dose formulation without thimerosal for the 0.25 mL and 0.5 mL syringes.
• September 4, 2002 Approval Letter - Fluzone
  New Formulation: Preservative free formulation in a single dose presentation in 0.25 ml syringes for pediatric use and 0.5 ml syringes for adults and children.

Related Information

• Fluzone Vaccine Safety
  FDA and CDC Update on Fluzone Influenza Vaccine and VAERS Reports of Febrile Seizures in Children
• FDA Approves A High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older
  Press Release: December 23, 2009 (Fluzone High-Dose)
• FDA Approves New Influenza Vaccine Production Facility
  Press Release: May 6, 2009 (Fluzone)

Contact FDA