FDA Approval Activities for this Drug…

Arava (leflunomide) Tablets, 10 mg, 20 mg, and 100 mg, Aventis NDA 20-905/S6/S7 6/13/03 7/8/03 7/8/03 Arava (leflunomide) Tablets, 10 mg, 20 mg, and 100 mg, Hoechst Marion Roussel NDA 20-905 9/10/98 9/17/98 9/17/98 5/25/01 Arava Indication: Arava is indicated in adults for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms and to retard structural damage as evidenced by X-ray erosions and joint space narrowing. Arava (leflunomide) Tablets, Aventis Pharmaceuticals | Arava (leflunomide) tablets, Aventis Pharma, Labeling Revision

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