Drug Approval Package: Botulinum Toxin Type A
Company: Allergan
Application No.:103000/1004
Approval Date: 12/21/2000
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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)
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
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