U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. Development & Approval Process (CBER)
  4. 2018 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
  1. Vaccines, Blood & Biologics

2018 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals

2018 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. 

2018 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
Tradename Indication for Use NDA Number Applicant Approval Date
Anticoagulant Sodium Citrate Solution Indication: for use only for the anticoagulation of whole blood as part of automated apheresis procedures ANDA 125608/0 TERUMO BCT
10811 W. Collins Ave,
Lakewood, CO 80215

Lic # 1988
6/26/2018