2019 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/Common Name||Indication for Use||NDA/ANDA Number||Applicant||Approval Date|
Platelet Additive Solution 3
|This Prior Approval sNDA provides for the use of InterSol Solution with the Terumo Trima Accel Device.||080041/75||Fresenius Kabi
Three Corporate Drive,
Lake Zurich, IL 60047
Lic. # 1966