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Product Approval Information - Licensing Action

 


Proper name: Smallpox Vaccine, Dried, Calf Lymph Type
Tradename: Dryvax
Manufacturer: Wyeth Laboratories, Inc, Marietta, PA, License #0003
Indication for Use: Active immunization against smallpox disease
Approval Date: 10/25/2002
Type of submission: Biologics license application supplement

 


Approval Letter (Text)

Label (PDF)

 


Last Updated: 10/25/2002

 

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ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.