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Product Approval Information - Licensing Action

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Proper name: Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method
Tradename: Advate
Manufacturer: Baxter Healthcare Corp, Westlake Village, CA, License #0140
Indication for Use: Indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes, and in the perioperative management of patients with hemophilia A
Approval Date: 7/25/2003
Type of submission: Biologics license application

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Approval Letter - (Text)

Labeling - (PDF)

Summary Basis for Approval - (PDF), (Text)

Talkpaper

 

Updated August 22, 2003
 
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