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Product Approval Information - Licensing Action

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Proper name: Hepatitis B Immune Globulin (Human)
Tradename: Nabi-HB
Manufacturer: Nabi, Boca Raton, FL, License #1022
Indication for Use: For the treatment of acute exposure to HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure of infants to persons with acute HBV infection
Approval Date: 3/24/99
Type of submission: Biologics license application

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Approval Letter - (Text), (PDF)

Label - (PDF)

SBA - (PDF)

 

Updated March 5, 2001
 
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