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Product Approval Information - Licensing Action

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Proper name: Immune Globulin Intravenous (Human), 10% by Chromatography Process
Tradename: Gamunex
Manufacturer: Bayer Corporation, Berkeley, CA, License #0008
Indication for Use: In primary humoral immunodeficiency and idiopathic thrombocytopenic purpura
Approval Date: 8/27/2003
Type of submission: Biologics license application

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Approval Letter - (Text)

Label - (PDF)

 

Updated September 8, 2003
 
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