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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 | Leflunomide Tablets, Teva Pharma, Approval | Leflunomide Tablets, Sandoz, Approval | Leflunomide Tablets, Barr Labs, Approval | Leflunomide Tablets, Kali Labs, Approval | Leflunomide Tablets, Sandoz, Approval | Leflunomide Tablets, Apotex, Approval | Arava (leflunomide tablets), Sanofi-Aventis, Labeling Revision | Arava (leflunomide) Tablets, Sanofi-Aventis, Labeling Revision | Arava (leflunomide) Tablets, Sanofi Aventis, Labeling Revision | Leflunomide Tablets, Alembic Pharmaceuticals Limited, Approval
  
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