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 Botulinum Toxin Type A

Product Approval Information - Licensing Action

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), (Text)

12/15/200 - Clinical Review - Part 1, Part 2

11/19/1999 - Clinical Review - Part 1, Part 2, Part 3, Part 4, Part 5, Part 6

Last Updated: 4/25/2002


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Date created: September 16, 2003

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