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Product Approval Information - Licensing Action

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Proper name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP)
Tradename: DAPTACEL
Manufacturer: Aventis Pasteur Limited, Toronto, Ontario, License #1280
Indication for Use: Active immunization of infants and toddlers at 2, 4, 6, and 17-20 months of age against diphtheria, tetanus and pertussis
Approval Date: 5/14/2002
Type of submission: Biologics license application

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Approval Letter - (PDF), (Text)

Label - (PDF)

Clinical Review - (PDF)

 

Updated January 14, 2004
 
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