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  1. Development & Approval Process (CBER)

2016 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. 

2016 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
Tradename/Common Name Indication for Use NDA Number Applicant Approval Date
Cord Blood Sterile Collection Bag, Anticoagulant Citrate Phosphate Dextrose Solution (CPD) The use of Sterile Cord Blood Collection Unit with Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD) For collection up to 250 ml of umbilical cord blood for MSC1207DD and up to 150 ml of umbilical cord blood for MSC1208DD. 125552/0 Macopharma
3675 Crestwood Parkway, Suite 260,
Duluth, GA, 30096
12/21/2016