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  1. Development & Approval Process (CBER)

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. 

2019 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
Tradename/Common Name Indication for Use NDA/ANDA Number Applicant Approval Date
InterSol Solution
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
5/22/2019