Product Approval Information

Proper Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Tradename: Adacel
Manufacturer: Sanofi Pasteur, Ltd, License #1726

Package Insert (PDF - 343 KB) - Approved: January 16, 2009

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Date: January 16, 2009
To revise the package insert to include revision of the placement of infonnalion regarding latex
content of the product.
January 16, 2009 Approval Letter

Date: March 18, 2008
To include unit dose syringes as an alternate presentation
March 18, 2008 Approval Letter

Date: June 10, 2005
Indication: Booster immunization against tetanus, diphtheria and pertussis as a single dose in individuals 11 through 64 years of age
June 10, 2005 Approval Letter
FDA Approves a New Combination Vaccine to Help Protect Both Adolescents and Adults against Whooping Cough - June 10, 2005