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.
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, HESPAN (6% Hetastarch in 0.9% Sodium Chloride injection) B. Braun Medical, Inc. Anticoagulant Sodium Citrate 4% w/v Solution, USP Haemonetics Corp HEXTEND (6% Hetastarch in Lactated Electrolyte Injection) BioTime, Inc. 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. Isoplate Solution in 500mL EXCEL containers; Multi-Electrolyte Injection B. Braun Medical, Inc. SOLX® System Hemerus Medical, LLC