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… Gemfibrozil Tablets USP, 600mg Apotex ANDA 75-034 Lopid (gemfibrozil) Tablets, Pfizer, NDA 18-422/S-043 1/15/03 1/23/03 Lopid (gemfibrozil) Tablets, USP Pfizer, NDA 18-422/S-040 & S041 1/15/03 1/23/03 8/7/01 Lopid (gemfibrozil) Tablets, Pfizer, NDA 18-422/S-043 GEMFIBROZIL Tablet; 600MG GEMFIBROZIL Geneva TECH 074452 GEMFIBROZIL Tablet; 600MG GEMFIBROZIL Mylan 018422 GEMFIBROZIL Tablet; 600MG LOPID PFIZER 074256 GEMFIBROZIL Tablet; 600MG GEMFIBROZIL Teva 075034 GEMFIBROZIL Tablet; 600MG GEMFIBROZIL Torpharm 074442 GEMFIBROZIL Tablet; 600MG GEMFIBROZIL Watson Lopid (gemfibrozil) Tablets, Pfizer   For the latest approval information, locate this drug using this index.