2002 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/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 |