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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection (Voluven® 500 mL freeflex® flexible plastic intravenous solution container)

NDA Number: BN070012
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
Indication:

  • Treatment and prophylaxis of hypovolemia in adults and children
     
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Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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