2001 Biological License Application Supplement Noteworthy 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.
Transfer of Therapeutic Products to CDER
| 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 |
