STN: BL 125111
Proper Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Tradename: Adacel
Manufacturer: Sanofi Pasteur, Ltd
Indication: 

• Immunization for prevention of tetanus, diphtheria and pertussis as a single dose in persons 10 through 64 years of age. 

Product Information

• Package Insert - Adacel
• Patient Prescribing Information (PPI) Sheet - Adacel

Supporting Documents

• December 28, 2020 Approval Letter - Adacel
• January 11, 2019 Summary Basis for Regulatory Action - Adacel
• January 11, 2019 Approval Letter - Adacel
  To include re-administration in adolescents and adults following a previous pose.
• September 29, 2017 Approval Letter - Adacel
• Supporting Documents older than three years - Adacel

Related Information

• FDA Approves a New Combination Vaccine to Help Protect Both Adolescents and Adults against Whooping Cough - ARCHIVED