Product Information

• Package Insert - Adacel (PDF - 267KB)
  Sanofi Pasteur
• Patient Prescribing Information (PPI) Sheet - Adacel (PDF - 21KB)

Supporting Documents

• February 16, 2012 Approval Letter - Adacel
  To include geriatric use language in the label consistent with the geriatric labeling requirements and revise the content and format of the label.
• February 15, 2012 Clinical Review - Adacel (PDF - 310KB)
• January 30, 2012 Summary Basis for Regulatory Action - Adacel (PDF - 114KB)
• February 11, 2011 Approval Letter - Adacel
  Added a Patient Prescribing Information (PPI) sheet to the labeling.
• January 13, 2011 Approval Letter - Adacel
  Revised Package Insert of Latex hypersensitivity
• January 16, 2009 Approval Letter - Adacel
  To revise the package insert to include revision of the placement of infonnalion regarding latex content of the product.
• March 18, 2008 Approval Letter - Adacel
  To include unit dose syringes as an alternate presentation.
• June 10, 2005 Approval Letter - Adacel
  Booster immunization against tetanus, diphtheria and pertussis as a single dose in individuals 11 through 64 years of age.

Related Information

• 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.
• FDA Approves a New Combination Vaccine to Help Protect Both Adolescents and Adults against Whooping Cough
  Press Release: June 10, 2005

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