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U.S. Department of Health and Human Services

Drugs

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Trastuzumab Product Approval Information - Licensing Action 12/11/01

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)

Label (PDF)