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U.S. Department of Health and Human Services

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Alteplase Product Approval Information - Licensing Action 9/4/01

Proper name: Alteplase
Tradename: Cathflo Activase
Manufacturer: Genentech Inc, South San Francisco, CA, License #1048
Indication for Use: Restoration of function to central venous access devices
Approval Date: 9/4/2001
Type of submission: Biologics license application supplement

 


Approval Letter (PDF)

Labeling (PDF)