Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.


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)


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

Page Last Updated: 09/30/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English