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… Fenofibrate Capsules (Micronized), 67 mg, Novopharm Limited ANDA 75-753 9/3/02 Fenofibrate Capsules (Micronized), 134 & 200 mg, (67 mg, strength remains ) Novopharm Limited ANDA 75-753 4/9/02 4/10/03 Fenofibrate Capsules (Micronized), 67, 134, & 200 mg, Impax, ANDA 75-868 Tricor Micro/Fenfibrate Capsules, 67 mg, Fournier Research/Abbott NDA 019-304/S-001 2/9/98 10/26/98 Tricor Indication: As an adjunctive therapy to diet for the treatment of adult patients with very high elevations of serum triglyceride levels who are at risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Tricor (fenofibrate) Capsules-Micronized, Abbott NDA 19-304/S-005 4/24/00 4/27/00 6/8/01 Tricor Indication: Treatment of Hypercholesterolemia as adjunctive therapy to diet for the reduction of low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides, and apolipoprotein B (Apo B) in adult patients withe primary hypercholesterolemia or mixed dyslipidemia (Frederickson Types IIa and IIb). Tricor (Fenofibrate) Tablets, 54 & 160 mg, Abbott NDA 21-203 Fenofibrate Capsules (Micronized), Impax, FENOFIBRATE Capsule; 134MG FENOFIBRATE (MICRONIZED) Teva 075753 FENOFIBRATE Capsule; 200MG FENOFIBRATE (MICRONIZED) Teva 075753 FENOFIBRATE Capsule; 67MG FENOFIBRATE (MICRONIZED) Teva 021203 FENOFIBRATE Tablet; 160MG TRICOR Abbott 021203 FENOFIBRATE Tablet; 54MG TRICOR Abbott Fenofibrate Tablets, Teva Pharmaceuticals, Fenofibrate Tablets, Impax Pharmaceuticals, Fenofibrate Tablets, Ranbaxy Laboratories,   For the latest approval information, locate this drug using this index.