Product Approval Information
Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Tradename: Tripedia
Manufacturer: Sanofi Pasteur, Inc. License #1725
Package Insert (PDF - 3.2 MB) - Approved: March 7, 2001
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Date: March 7, 2001
Indication: Preservative-free, single dose vial presentation
March 7, 2001 Approval Letter
Date: August 24, 2000
Indication: 5th dose at 4-6 years of age after 4 prior doses of Tripedia
August 24, 2000 Approval Letter
Date: September 27, 1996
Indication: 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
September 27, 1996 Approval Letter
Summary for Basis of Approval (ActHIB combined with Tripedia (PDF - 1 MB)
Date: July 31, 1996
Indication: Additional indication as primary series in infants and children
July 31, 1996 Approval Letter