Product Approval Information
Proper Name: Influenza Virus Vaccine
Tradename: Fluzone
Manufacturer: Sanofi Pasteur, Inc, License #1725
Package Insert (PDF - 116 KB) - Approved: July 14, 2008
Date: July 14, 2008
Revisions to the Package Insert: To Comply with Physician's Labeling Rule Guidelines
July 14, 2008 Approval Letter
Date: July 14, 2008
New Formulation: 2008-2009 United States formulation
July 14, 2008 Approval Letter
Date: July 13, 2007
New Formulation: 2007-2008 United States formulation
July 13, 2007 Approval Letter
Date: July 10, 2006
New Formulation: 2006-2007 United States formulation
July 10, 2006 Approval Letter
Date: July 14, 2005
New Formulation: 2005-2006 United States formulation
July 14, 2005 Approval Letter
Date: July 14, 2005
New Dosage Form: Preservative free single dose presentation in a unit dose vial
July 14, 2005 Approval Letter
Date: December 23, 2004
New Dosage Form: Single dose formulation without thimerosal for the 0.25 mL and 0.5 mL syringes
December 23, 2004 Approval Letter
Date: September 4, 2002
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
September 4, 2002 Approval Letter