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U.S. Department of Health and Human Services

Drugs

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Trastuzumab Product Approval Information - Licensing Action 2/9/00

Proper name: Trastuzumab
Tradename: Herceptin
Manufacturer: Genentech, Inc, South San Francisco, CA, License #1048
Indication for Use: Label changes to the package insert, product container, and package to clarify the instructions for reconstitution
Approval Date: 2/9/2000
Type of submission: Biologics license application supplement

 


Approval Letter (PDF)

Label (PDF)