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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