Drug Approval Package

Tekturna HCT (aliskiren/hydrochlorothiazide) 150/12.5 mg, 150/25 mg, 300/12.5 mg and 300/25 mg Tablets
Company: Novartis Pharmaceuticals Corporation
NDA: 022107
Approval Date: 1/18/2008

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

Approval Letter(s)(PDF)
• Printed Labeling(PDF) [note for vision impaired users]
• Summary Review(PDF)
• Officer/Employee List  (PDF)
• Medical Review(s)
  • Part 1(PDF)  
  • Part 2(PDF)  
  • Part 3(PDF)  
  • Part 4(PDF)  
  • Part 5(PDF)  
  • Part 6(PDF)  
• Chemistry Review(s)(PDF)
• Pharmacology Review(s)(PDF)
• Statistical Review(s)(PDF)
• Clinical Pharmacology Biopharmaceutics Review(s)
  • Part 1(PDF)  
  • Part 2(PDF)  
• Risk Assessment and Risk Mitigation Review(s)(PDF)
• Proprietary Name Review(s)(PDF)
• Administrative Document(s) and Correspondence (PDF)
  • Part 1(PDF)
  • Part 2

Date created: October 27, 2008

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