Product Approval Information - New Drug Applications
Product name: 6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection (Voluven® 500 mL freeflex® flexible plastic intravenous solution container)
Manufacturer: Fresenius Kabi Norge A.S., Halden Norway
Intended Use: Treatment and prophylaxis of hypovolemia
Approval Date: 12/27/2007
Type of submission: New Drug Application
NDA Number: BN070012