STN: BL 125111
Proper Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Manufacturer: Sanofi Pasteur, Ltd, License #1726
- Booster immunization against tetanus, diphtheria and pertussis as a single dose in individuals 10 through 64 years of age
March 24, 2014 Summary Basis for Regulatory Action - Adacel(PDF - 74KB) March 28, 2014 Approval Letter-Adacel
To lower the age indication for Adacel administration from 11 to 10 years of age.
July 23, 2013 Approval Letter - Adacel
To include revisions to the NDC, 2D barcode on the detachable portion of the label and a new logo.
May 29, 2013 Approval Letter - Adacel
To include the addition of an expiration date "(E)" on the detachable portion of the vial label.
April 16, 2013 Approval Letter - Adacel
To include detachable syringe labels designed with a 2D Barcode.
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.
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[ARCHIVED]
Press Release: June 10, 2005