2022 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
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Mon, 05/16/2022 – 11:45
Detailed Description
This page lists the 2022 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
Center
Center for Biologics Evaluation and Research
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
Short Title
2022 Biological NDA and ANDA Approvals
Source Organization
FDA
Content Owner
Office of the Center Director
Publish Date
Mon, 05/16/2022 – 11:48
Review Date
Tue, 05/16/2023 – 00:00
Last Reviewed Date
Mon, 05/16/2022 – 00:00
Site Structure
Development & Approval Process (CBER)
Next Review Date
1 Year
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First Publish Date
Mon, 05/16/2022 – 11:48
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Language
English
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