Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com