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… Amaryl (glimepiride Tablets, 1mg 2mg and 4mg, Aventis NDA 20-496/S-007 4/15/02 4/22/02 Amaryl (glimepiride Tablets, 1mg 2mg and 4mg, Metabolic and Endocrine Drug Products NDA 20-496/S-005 9/27/00 6/8/01 Amaryl (glimepiride Tablets, 1mg 2mg and 4mg, Hoechst Marion Roussel NDA 20-496/S-002 Amaryl (glimepiride tablets), Aventis Pharmaceuticals, Labeling Revision   For the latest approval information, locate this drug using this index.