Product Approval Information
Proper Name: Anthrax Vaccine Adsorbed
Tradename: Biothrax
Manufacturer: Emergent BioDefense Operations Lansing Inc., License #1755
Date: December 11, 2008
Revised Package Insert To include a change in schedule from 0, 2, 4 weeks and 6, 12 and 18 months to 0, 4 weeks, and 6, 12, and 18 months, and a change in route of administration from subcutaneous to intramuscular.
December 11, 2008 Approval Letter
Date: April 27, 2005
Indication: Extension of dating to 36 months
April 27, 2005 Approval Letter
Date: January 31, 2002
Manufacturing change: Hollister-Stier as contract manufacturer for filling
January 31, 2002 Approval Letter
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