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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 4/12/02

Proper name: Botulinum Toxin Type A
Tradename: BOTOX COSMETIC
Manufacturer: Allergan, Inc, Irvine, CA, License #1145
Indication for Use: Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients < 65 years of age
Approval Date: 4/12/2002
Type of submission: Biologics license supplement

 


Approval Letter (PDF)

Label - (PDF)

Approval Memo - (PDF)

Medical Officer's Review - Part 3 (PDF)

Statistical Review - (PDF)