Product Approval Information
Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
Tradename: Pediarix
Manufacturer: GlaxoSmithKline Biologicals, License #1617
Package Insert (PDF - 165 KB) - March, 2007
Date: December 13, 2002
Indication: Active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3
December 13, 2002 Approval Letter
Clinical Review (11/25/2002)
Clinical Review (11/12/2001)
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