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U.S. Department of Health and Human Services

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Botulinum Toxin Type A Product Approval Information - Licensing Action 12/21/00

Proper name: Botulinum Toxin Type A
Tradename: BOTOX
Manufacturer: Allergan, Inc, Irvine, CA, License #1145
Indication for Use: Treatment of cervical dystonia
Approval Date: 12/21/2000
Type of submission: Biologics license supplement

 


Approval Letter (PDF)

12/15/2000 - Clinical Review - Part 2 (PDFs)

11/19/1999 - Clinical Review - Part 6 (PDFs)