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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2001 Biological License Application Supplement Approvals

This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed in order by date of approval.


Tradename/
Proper Name
Indication for Use STN Manufacturer/
License Number
Approval Date
Auszyme Monoclonal
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme Immuno Assay (EIA)/Monoclonal)
Labeling Change:
Include cadaveric serum specimen testing
101250/5006 Abbott Laboratories
D-049C/AP6C/2
100 Abbott Park Road
Abbott Park, IL 60064-3500
License 0043
12/19/2001
Tripedia
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
New Formulation:
A preservative-free, single dose vial presentation(reduced thimerosal)
103922/5001 Aventis Pasteur Inc
Discovery Drive
Swiftwater, PA 18370
License 1277
3/7/2001