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 |