Vaccines, Blood & Biologics
Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Manufacturer: Sanofi Pasteur, Inc. License #1725
Indications: For active immunization against diphtheria, tetanus, and pertussis (whooping cough) as a five-dose series in infants and children 6 weeks to 7 years of age (prior to seventh birthday).
March 7, 2001 Approval Letter - Tripedia
Preservative-free, single dose vial presentation.
August 24, 2000 Approval Letter - Tripedia
5th dose at 4-6 years of age after 4 prior doses of Tripedia.
September 27, 1996 Approval Letter - Tripedia
For the reconstitution of Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), manufactured by Pasteur Merieux Serums et Vaccins, S.A., for immunization of 15-18 month old children.
Summary for Basis of Approval (ActHIB combined with Tripedia) - Tripedia(PDF - 1000KB) July 31, 1996 Approval Letter - Tripedia
Additional indication as primary series in infants and children.
Summary Basis for Approval - Tripedia(PDF - 1.2MB)