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Product Approval Information - Licensing Action

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Proper name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
Tradename: Pediarix
Manufacturer: SmithKline Beecham Biologicals, Rixensart, Belgium, License #1090
Indication for Use: 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
Approval Date: 12/13/2002
Type of submission: Biologics license application

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Approval Letter - (Text)

Label - (PDF)

Talkpaper

 

Updated February 5, 2003
 
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