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Product Approval Information - Licensing Action

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Proper name: Immune Globulin Intravenous (Human)
Tradename: OCTAGAM
Manufacturer: OCTAPHARMA Pharmazeutika Produktionsges m.b.H., Vienna, Austria, License #1646
Indication for Use: Treatment of primary immune deficient diseases
Approval Date: 5/21/2004
Type of submission: Biologics license application

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Approval Letter - (Text)

Labeling - (PDF)

 

Updated June 9, 2004
 
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