Drug Approval Package

 Comtan (Entacapone) Tablets
Company:  Orion Corporation
Application No.:  NDA 20-796
Approval Date: 12/30/1999

• Approval Letter(s) (PDF) 

• Printed Labeling (PDF)

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) 
  Part 1 (PDF)
  Part 2 (PDF)

• Statistical Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Correspondence (PDF)

• Addendum to Study Report (PDF)

• Clinical Review of NDA (PDF)

• Memorandums (PDF)

• Safety Review of Clinical Data (PDF)

• Unified Parkinson's Disease Rating Scale (PDF)

November 21, 2002

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