Drug Approval Package

Arava (leflunomide tablet) Tablets, 10 mg, 20 mg, and 100 mg
Company:  Hoechst Marion Roussel
Application No.:  20905
Approval Date: 9/10/1998

• Approval Letter(s) (PDF)

• Medical Review (Part 1) (PDF) ( 1.6 MB)

• Medical Review (Part 2) (PDF) ( 1.9 MB)

• Chemistry Review(s) (PDF) ( 61 KB)

• Pharmacology Review (Part 1) (PDF) ( 2.2 MB)

• Pharmacology Review (Part 2) (PDF) (2.2  MB)

• Pharmacology Review (Part 3) (PDF) ( 1.9 MB)

• Statistical Review(s) (PDF) ( 1.6 MB)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) ( 1.8 MB)

• Administrative Documents (PDF) ( 2.2 MB)

• Correspondence (PDF) (2.1 MB)

Date created: October 02, 2003

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