Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.