Application Nr Approved Date Route Status External Links
ANDA077911 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Glimepiride Tablet Usp Are Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus [See Clinical Studies ( 14.1 ) ]. 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. Glimepiride Tablets Usp Are A Sulfonylurea Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus ( 1 ). Important Limitations Of Use: Not For Treating Type 1 Diabetes Mellitus Or Diabetic Ketoacidosis ( 1 ).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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