Product Approval Information - New Drug Applications

This list includes applications for which we have approval documents available, and reflects the information as of the approval date. It is not updated with regard to applicant or application status changes.

Applications are listed in alphabetical order by product name.


Anticoagulant Citrate Phosphate Dextrose Solution (CPD)

Product Name: Anticoagulant Citrate Phosphate Dextrose Solution (CPD)
Manufacturer: Gambro BCT Inc, Lakewood, CO
Indication for Use: Single Whole Blood collection of 500 mL ± 10%
Approval Date: 01/06/2009
Type of Submission: Abbreviated New Drug application
NDA / ANDA Number: BA070025/0


Anticoagulant Citrate Dextrose Solution Formula A

Product Name: Anticoagulant Citrate Dextrose Solution Formula A
Manufacturer: Gambro BCT Inc, Lakewood, CO
Indication for Use: Only with automated apheresis devices
Approval Date: 2/25/2002
Type of Submission: Abbreviated New Drug application
NDA / ANDA Number: ANDA 010228


Anticoagulant Citrate Phosphate Dextrose Solution (CPD) with an integral container of Additive Solution (AS-1) and an integral Leukoflex MTL1-WB Leukocyte Reduction Filter for Whole Blood

Product Name: Anticoagulant Citrate Phosphate Dextrose Solution (CPD) with an integral container of Additive Solution (AS-1) and an integral Leukoflex MTL1-WB Leukocyte Reduction Filter for Whole Blood
Manufacturer: MacoProductions S.A.S., Decatur, GA
Indication for Use: For pre-storage leukocyte reduction of whole blood initiated between 4 and 7 hours after collection if whole blood is stored at ambient temperature, or between 4 and 8 hours of storage at 1 to 6°C
Approval Date: 11/21/2005
Type of Submission: New Drug application
NDA / ANDA Number: BN 040083


Anticoagulant Citrate Phosphate Double Dextrose (CP2D) & Additive Solution 3 (AS-3)

Product Name:Anticoagulant Citrate Phosphate Double Dextrose (CP2D) & Additive Solution 3 (AS-3)
Manufacturer: Haemonetics Corp, Union, SC
Indication for Use: To be used only with automated apheresis devices for collecting human blood and blood componenets
Approval Date: 1/18/2002
Type of Submission: New Drug Application
NDA / ANDA Number: NDA 000127


Anticoagulant Sodium Citrate 4% w/v Solution, USP

Product Name: Anticoagulant Sodium Citrate 4% w/v Solution, U.S.P.
Manufacturer: Haemonetics Corp, Braintree, MA
Indication for Use: Only with automated apheresis devices in the collection of human plasma or in performing therapeutic plasma exchange procedures
Approval Date: 3/3/2000
Type of Submission: New Drug Application
NDA / ANDA Number: OB-NDA 98-0123


Hextend, High Molecular Weight Hydroxyethyl Starch 6% (Hetastarch) in Buffered Electrolyte Dextrose Solution

Product Name: Hextend, High Molecular Weight Hydroxyethyl Starch 6% (Hetastarch) in Buffered Electrolyte Dextrose Solution
Manufacturer: BioTime, Inc, Berkeley, CA
Indication for Use: Plasma volume expander for treatment of hypovolemia during surgery
Approval Date: 3/31/1999
Type of Submission: New Drug Application
NDA / ANDA Number: OB-NDA 20-0952


6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection

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

 
Updated: January 8, 2009