For type 2 diabetes mellitus. ANDA 78181, held by Accord Hlthcare. Glimepiride.
As of Nov 15, 2026, ANDA 78181 (Glimepiride), held by Accord Hlthcare, was first approved by FDA on Aug 23, 2007, with 7 approved supplements and 0 published complete response letters.
Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 23, 2007 | Original application | Approved | None posted |
| Glimepiride1MG · tablet;oral | Glimepiride | Rx |
| Glimepiride2MG · tablet;oral | Glimepiride | Rx |
| Glimepiride4MG · tablet;oral | Glimepiride | Rx |
| May 31, 2019 | Supplement 14Labeling · Standard review | Approved | None posted |
| Aug 25, 2017 | Supplement 11Labeling · Standard review | Approved | None posted |
| Nov 3, 2014 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 1, 2014 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jun 1, 2012 | Supplement 5Labeling | Approved | None posted |
| Dec 30, 2009 | Supplement 3Labeling | Approved | None posted |
| Dec 30, 2009 | Supplement 2Labeling | Approved | None posted |
| Aug 23, 2007 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
