Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.


Botulinum Toxin Type A Product Approval Information - Licensing Action 4/12/02

Proper name: Botulinum Toxin Type A
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)

Page Last Updated: 09/30/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English