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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 | Avandaryl (rosiglitazone maleate and glimepiride), Tablets, SB Pharmco Puerto Rico, Inc, Labeling Revision | Duetact (pioglitazone hydrochloride and glimepiride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision | Amaryl (glimepiride) Tablets, Sanofi-Aventis U.S. LLC, Labeling Revision | Amaryl (glimepiride) Tablets, Sanofi-Aventis U.S., LLC, Labeling Revision | Glimepiride Tablets, Carlsbad Technology, Inc., Approval | Rosiglitazone Maleate and Glimepiride Tablets, Teva Pharmaceuticals, Tentative Approval | Avandaryl (rosiglitazone maleate and glimepiride) Tablets, SB Pharmco Puerto Rico, Inc., Labeling Revision | Glimepiride Tablets, Watson Laboratories, Inc., Approval | Duetact (glimepiride and pioglitazone hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision
  
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