Product Approval Information - New Drug Applications

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

Approval Letter
Summary of Basis for Approval (PDF - 121 KB)

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Updated: July 30, 2008