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In this section: Development & Approval Process (CBER)

2022 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.

2022 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
Tradename	Indication for Use	NDA Number	Applicant	Approval Date
Anticoagulant Sodium Citrate 4% Solution	Is indicated for use only for the anticoagulation of whole blood as part of automated apheresis procedures	125750/0	CSL Plasma, Inc. 155 Medical Sciences Drive Union, SC 29379	04/25/2022

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