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Drugs

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)

Label (PDF)

Reviews

  •       Statistical Review - (PDF)
  •       Clinical Pharmacology and Toxicology Review - (PDF)
  •       Clinical Review - (PDF)

Page Last Updated: 09/30/2016
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