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 |
---|---|---|---|---|
Gambro BCT 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 |