Vaccines, Blood & Biologics
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New Drug Applications with Supporting Documents
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.
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Products
Anticoagulant Citrate Phosphate Dextrose Solution (CPD) Gambro BCT Inc Anticoagulant Citrate Dextrose Solution Formula A Gambro BCT Inc 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 MacoProductions S.A.S., Anticoagulant Citrate Phosphate Double Dextrose (CP2D) & Additive Solution 3 (AS-3) Haemonetics Corp, Anticoagulant Sodium Citrate 4% w/v Solution, USP Haemonetics Corp Hextend, High Molecular Weight Hydroxyethyl Starch 6% (Hetastarch) in Buffered Electrolyte Dextrose Solution BioTime, Inc InterSol Solution/Platelet Additive Solution 3 Fenwal, Inc. 6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection (Voluven® 500 mL freeflex® flexible plastic intravenous solution container) Fresenius Kabi Norge A.S.
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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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