Application Nr Approved Date Route Status External Links
ANDA077911 2009-09-22 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Glimepiride Tablet, Usp Is Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus [see Clinical Studies ( 14.1) ]. Glimepiride Tablet Usp Is A Sulfonylurea Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus ( 1.1). Important Limitations Of Use: Not For Treating Type 1 Diabetes Mellitus Or Diabetic Ketoacidosis ( 1.1). 1.1 Important Limitations Of Use Glimepiride Should Not Be Used For The Treatment Of Type 1 Diabetes Mellitus Or Diabetic Ketoacidosis, As It Would Not Be Effective In These Settings.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Povidones POVIDONES Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Glimepiride GLIMEPIRIDE ZINC100001976

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