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Product Approval Information - Licensing Action

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Proper name: Hepatitis B Vaccine (Recombinant)
Tradename: Recombivax
Manufacturer: Merck & Co, Inc, West Point, PA, License #0002
Labeling Supplement: Addition of two doses of the 10 mcg formulation (1.0 mL) administered at 0 and 4 to 6 months as an alternate regimen for the routine vaccination of healthy adolescents 11 to 15 years of age
Approval Date: 9/23/99
Type of submission: Product license application supplement

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Approval Letter - (Text), (PDF)

 

Updated March 5, 2001
 
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