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Product Approval Information - Licensing Action

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Proper name: Digoxin Immune Fab (Ovine)
Tradename: DigiFab
Manufacturer: Protherics Inc, Nashville, TN , License #1545
Indication for Use: Treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose
Approval Date: 8/31/2001
Type of submission: Biologics license application

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Approval Letter - (Text)

Label - (PDF)

SBA - (PDF)

 

Updated November 16, 2001
 
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