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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: 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),
(Text)
Label
(PDF),
(Text)
Last Updated: 12/10/2001
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Updated: September 25, 2003 |
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