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Product Approval Information - Licensing Action

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Proper names: Tetanus Toxoid Concentrate (For Further Manufacturing Use) and
                       Diphtheria Toxoid Concentrate (For Further Manufacturing Use)
Tradename: None
Manufacturer: Statens Seruminstitut, Copenhagen, Denmark, License #1255
Indication for Use: For further manufacture to Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed under a shared manufacturing arrangement with North American Vaccine, Inc
Approval Date: 7/29/98
Type of submission: Biologics license application

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Approval Letter - (PDF), (Text)

 

Updated March 6, 2001
 
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