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2009 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) 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/
Established Name
Indication for Use NDA Number Applicant Approval Date
CPD
Anticoagulant Citrate Phosphate Dextrose Solution (CPD)
The collection set is intended for a single Whole Blood collection of 500 mL ± 10%. BA070025 Gambro BCT, Inc.
10811 West Collins Avenue
Lakewood, CO 80215
01/06/2009
 
Updated: January 8, 2009