Drug Approval Package: Alteplase

Company:  Genentech
Application No.:  103172-Supplement 1055
Approval Date: 6/18/1996

Proper name: Alteplase
Tradename: Activase
Manufacturer: Genentech, Inc, South San Francisco, CA, License #1048
Indication for Use: Management of acute ischemic stroke in adults, for improving neurological recovery, and reducing the incidence of disability
Approval Date: 6/18/96
Type of submission: Product license supplement

• Approval Letter (PDF)
• SBA (PDF)
• Clinical Review I (PDF)
• Clinical Review II (PDF)

Date updated: July 5, 2017

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