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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2002 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals

This list reflects information 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/
Established Name
Indication for Use NDA/ANDA Number Applicant Approval Date
Citrate Phosphate Double Dextrose / Additive Solution 3
Anticoagulant Citrate Phosphate 2X Dextrose Solution (CP2D)
Use only with automated apheresis devices for collecting human blood and blood components 000127 Haemonetics Corp
400 Wood Road
Braintree, MA 02184
1/18/2002
Anticoagulant Citrate Dextrose Solution Formula A
Anticoagulant Citrate Dextrose Solution (ACD)
For use only with automated apheresis devices 980728 Haemonetics Corp
400 Wood Road
Braintree, MA 02184
2/6/2002
ACD-A Solution
Anticoagulant Citrate Dextrose Solution (ACD)
For use only with automated apheresis devices 010228 Gambro BCT, Inc
10811 W. Collins Ave
Lakewood, CO 80215
2/25/2002
AS3 Nutricel Additive System Additive Solution Formula 3
Anticoagulant Citrate Phosphate 2X Dextrose Solution
To provide the CP2D during collection and add AS3 to the separated Red Blood Cells in order to extend the length of time they can be stored 001214 Gambro BCT, Inc
10811 W. Collins Ave
Lakewood, CO 80215
5/29/2002
Adsol with ACD-A/
Anticoagulant Citrate Dextrose Solution (ACD)
Adsol preservation system combined with ACD-A Anticoagulated Red Cell Products 000922 Baxter Healthcare Corp
Fenwal Division
Route 120 and Wilson Road
Round Lake, IL 60073 US
8/29/2002