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 |