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GLIMEPIRIDE

 
 
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

Safety Information
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 | 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 | Amaryl, glimepiride, Tablet; Oral, Sanofi Aventis Us, Labeling Revision | Duetact, glimepiride; pioglitazone hydrochloride, Tablet; Oral, Takeda Global, Labeling Revision | Avandaryl, glimepiride; rosiglitazone maleate, Tablet; Oral, Sb Pharmco, Labeling Revision | Glimepiride, glimepiride, Tablet; Oral, Micro Labs Usa, Approval | Glimepiride, glimepiride, Tablet; Oral, Aurobindo Pharma Ltd, Approval | Pioglitazone Hydrochloride and Glimepiride, glimepiride; pioglitazone hydrochloride, Tablet; Oral, Sandoz, Approval | Avandaryl, glimepiride; rosiglitazone maleate, Tablet; Oral, Sb Pharmco, Supplement | Amaryl, glimepiride, Tablet; Oral, Sanofi Aventis Us, Manufacturing Change or Addition | Glimepiride, glimepiride, Tablet; Oral, Indoco Remedies, Approval | Amaryl, glimepiride, Tablet; Oral, Sanofi Aventis Us, Manufacturing Change or Addition | Duetact, glimepiride; pioglitazone hydrochloride, Tablet; Oral, Takeda Pharms Usa, Manufacturing Change or Addition | Amaryl, glimepiride, Tablet; Oral, Sanofi Aventis Us, Labeling Revision | Glimepiride, glimepiride, Tablet; Oral, Hikma Pharms, Approval

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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