Drug Approval Package

 Tyzeka (Telbivudine) Film Coated Tablets
Company: Idenix Pharmaceuticals, Inc.
Application No.:  022011
Approval Date: 10/25/2006

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: December 22, 2006; Last updated December 15, 2011

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.