Tenecteplase
Product Approval Information - Licensing Action
Proper name: Tenecteplase
Tradename: TNKase
Manufacturer: Genentech, Inc, South San Francisco, CA, License #1048
Indication for Use: Reduction of mortality associated with acute myocardial infarction (AMI)
Approval Date: 6/2/2000
Type of submission: Biologics license application
Approval Letter (PDF),
(Text)
Label
(PDF),
(Text)
Reviews
Statistical Review - (PDF)
Clinical Pharmacology and Toxicology Review -
(PDF),
(Text)
Clinical Review - (PDF)
Last Updated: 12/10/2001
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Updated: September 25, 2003 |