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 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

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