Approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) with Supporting Documents for CBER-Regulated Products
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.
Products
- Anticoagulant Citrate Phosphate Dextrose Solution (CPD)
- Anticoagulant Citrate Dextrose Solution Formula A
- 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
- Anticoagulant Citrate Phosphate Double Dextrose (CP2D) & Additive Solution 3 (AS-3)
- Anticoagulant Sodium Citrate 4% w/v Solution, USP
- ANTICOAGULANT SODIUM CITRATE 4% w/v SOLUTION, USP (STN 125697)
- ANTICOAGULANT SODIUM CITRATE 4% W/V SOLUTION USP - BA 125750
- HESPAN (6% Hetastarch in 0.9% Sodium Chloride injection)
- HEXTEND (6% Hetastarch in Lactated Electrolyte Injection)
- Hextend, High Molecular Weight Hydroxyethyl Starch 6% (Hetastarch) in Buffered Electrolyte Dextrose Solution
- InterSol Solution/ Platelet Additive Solution 3
- 6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection (Voluven 500 mL freeflex flexible plastic intravenous solution container)
- Isoplate Solution in 500mL EXCEL containers; Multi-Electrolyte Injection
- 0.9% Sodium Chloride Injection USP
- SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP
- SOLX System
- Sterile Cord Blood Collection Unit with Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD)
Related Information
- Complete List of Currently Approved NDA and ANDA Application Submissions
- Biologics Products & Establishments
- New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products