2018 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 Use | NDA Number | Applicant | Approval Date |
---|---|---|---|---|
Anticoagulant Sodium Citrate Solution | Indication: for use only for the anticoagulation of whole blood as part of automated apheresis procedures | ANDA 125608/0 | TERUMO BCT 10811 W. Collins Ave, Lakewood, CO 80215 Lic # 1988 |
6/26/2018 |