Product Approval Information - New Drug Applications

Product name: Anticoagulant Citrate Phosphate Dextrose Solution (CPD)
Manufacturer: Gambro BCT Inc, Lakewood, Colorado
Intended Use: The collection set is intended for a single Whole Blood collection of 500 mL ± 10%.
Approval Date: 1/6/2009
Type of submission: Abbreviated New Drug Application
ANDA Number: BA070025

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Updated: January 9, 2009