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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
Anticoagulant Sodium Citrate 4% w/v Solution, USP Intended for use only with automated apheresis devices in the collection of human plasma or in performing therapeutic plasma exchange procedures. It is not to be infused directly into the donor. 125697/0 Laboratorios Grifols, S.A.
Grifols Shared Services North America, Inc.
8368 U.S. Highway 70 West
Clayton, NC 27520
10/25/2019
0.9% Sodium Chloride Injection USP Solution A pre-attached subassembly component of the Fresenius Kabi apheresis kit for apheresis kit priming and/or for use as a replenishment fluid to maintain isovolemia in subjects undergoing an apheresis procedure. 125695/0 Fresenius Kabi AG
Else-Kroner Strasse 1
D-61352
Bad Homburg
Baden-Wurttemberg
61352 Germany
 
09/05/2019
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
5/22/2019