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Product Approval Information - Licensing Action

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Proper name: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Tradename: ActHIB
Manufacturer: Pasteur Merieux Serums et Vaccins, S.A., Lyon, France, License #0384
Indication for Use: Reconstitution with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, manufactured by Connaught Laboratories, Inc, for immunization of 15-18 month old children
Approval Date: 9/27/96
Type of submission: Product license supplement

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Approval Letter - (PDF), (Text)

SBA - (PDF)

 

Updated March 5, 2001
 
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