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Vaccines, Blood & Biologics
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Resources for You
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Pediarix
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
Indications:
- 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.
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Supporting Documents
- December 13, 2002 Approval Letter - Pediarix
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. - Clinical Review - November 25, 2002 - Pediarix
- Clinical Review - November 12, 2001 - Pediarix (PDF - 943KB)
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Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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