FDA Logo links to FDA home page
Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Biologics Evaluation and Research
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page

horizontal rule
CBER links to product areas Blood Vaccines Cellular/Gene Therapy Tissue Devices
CBER links Products Industry Healthcare Reading Room Meetings What's New
horizontal rule

Product Approval Information - New Drug Applications

horizontal rule

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

horizontal rule

Approval Letter

 

Updated November 25, 2005
 
horizontal rule

CBER Home Page | CBER A-Z Index | CBER Search | Contact CBER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA / Center for Biologics Evaluation and Research