glimepiride
Drug Details
- Generic Name
- glimepiride
- Brand Names
- Glimepiride
- Application Number
- ANDA077370
- Sponsor
- Solco Healthcare U.S., LLC
- NDC Codes
- 3
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- GLIMEPIRIDE
Indications and Usage
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.