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)