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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2003 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
triCitrasol
Anticoagulant Sodium Citrate Conc. 46.7% Trisodium Citrate, 30mL
triCitrasol, after dilution of a rouleaux agent is an anticoagulant used in granulocytapheresis procedures BN010409 Cytosol Laboratories, Inc
55 Messina Drive
Braintree, MA 02184-6783
7/10/2003
Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P., (ACD-A), 50 mL, PN 6053 Use for the extracorporeal processing of blood with Autologous PRP systems in production of platelet rich plasma (PRP) for in vitro use BN020037 Cytosol Laboratories, Inc
55 Messina Drive
Braintree, MA 02184-6783
8/26/2003