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

horizonal rule
CBER links to product areas
CBER links
horizonal rule

Product Approval Information - New Drug Applications

horizonal rule

Product name: Anticoagulant Citrate Dextrose Solution Formula A
Manufacturer: Gambro BCT Inc, Lakewood, Colorado
Intended Use: Only with automated apheresis devices
Approval Date: 2/25/2002
Type of submission: Abbreviated New Drug application


Approval Letter - (Text), (PDF)

SBA - (Text), (PDF)

 

 
horizonal rule