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… 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 | Glimepiride Tablets, Andrx Pharma, Tentative Approval | Glimepiride Tablets, Ranbaxy Labs, Tentative Approval | Glimepiride Tablets, Ranbaxy Labs, Tentative Approval | Glimepiride Tablets, Dr. Reddy's Labs, Tentative Approval | Glimepiride Tablets, InvaGen Pharma, Tentative Approval | Amaryl (glimepiride) Tablets, Aventis Pharma, Labeling Revision | Glimepiride Tablets, Ranbaxy, Approval | Glimepiride Tablets, Ranbaxy, Approval | Glimepiride Tablets, InvaGen Pharma, Approval | Glimepiride Tablets, CorePharma, Approval | Glimepiride Tablets, Teva Pharma, Approval | Glimepiride Tablets, Dr. Reddy’s, Approval | Amaryl (glimepiride) Tablets, Aventis Pharma, Patient Population Altered | Avandaryl (rosiglitazone maleate and glimepiride) Tablets, GlaxoSmithKline, Approval | Glimepiride Tablets, Mylan Pharma, Approval | Glimepiride Tablets, Par Pharma, Approval | Glimepiride Tablets, Cobalt Pharma, Approval | Glimepiride Tablets, Genpharm, Approval | Avandaryl (rosiglitazone maleate and glimepiride) Tablets, GlaxoSmithKline, Labeling Revision | Duetact (Pioglitazone HCI, Glimepiride) Combination Tablets, Takeda Global, Approval | Avandaryl (rosiglitazone maleate and glimepiride) Tablets, SB Pharmco, Manufacturing Change or Addition | Avandaryl (rosiglitazone maleate and glimepiride) Tablets, SB Pharmco, Labeling Revision | Glimepiride Tablets, Accord Healthcare, Approval | Duetact (pioglitazone HCl + glimepiride) Fixed-dose Combination Tablets, Takeda Global, Package Change | DUETACT (pioglitazone HCl plus glimepiride) fixed-dose combination Tablets, Takeda Global, Labeling Revision | Duetact (pioglitazone HCl plus glimepiride) Fixed-dose Combination Tablets, Takeda Global, Formulation 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