Trastuzumab
Product Approval Information - Licensing Action
Proper name: Trastuzumab
Tradename: Herceptin
Manufacturer: Genentech, Inc, South San Francisco, CA, License #1048
Indication for Use: Revised package insert to include updated median survival data
Approval Date: 12/11/2001
Type of submission: Biologics license application supplement
Approval Letter
(PDF),
(Text)
Label
(PDF)
Last Updated: 1/23/2002
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Updated: September 25, 2003 |