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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2012 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals

This list reflects information regarding the applications as of the approval date.  It is not updated with regard to applicant or application status changes.

Tradename
 
Indication for UseNDA NumberApplicantApproval Date
Anticoagulant Citrate Dextrose Solution, USP    (ACD-A)For the extracorporeal processing of blood with Autologous PRP systems in production of platelet rich plasma (PRP) for in vitro use.
 
BA110057Arteriocyte Medical Systems, Inc.
45 South Street, Suite 3
Hopkinton, MA 01748
5/11/2012