For type 2 diabetes mellitus. ANDA 77091, held by Dr Reddys Labs Ltd. Glimepiride.
As of Nov 15, 2026, ANDA 77091 (Glimepiride), held by Dr Reddys Labs Ltd, was first approved by FDA on Oct 6, 2005, with 9 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 |
|---|---|---|---|
| Oct 6, 2005 | Original application | Approved |
| Glimepiride1MG · tablet;oral | Glimepiride | Rx |
| Glimepiride2MG · tablet;oral | Glimepiride | Rx |
| Glimepiride4MG · tablet;oral | Glimepiride | Rx |
| May 31, 2019 | Supplement 15Labeling · Standard review | Approved | None posted |
| May 31, 2019 | Supplement 17Labeling · Standard review | Approved | None posted |
| Apr 24, 2015 | Supplement 9Labeling | Approved | None posted |
| Apr 24, 2015 | Supplement 11Labeling · Standard review | Approved | None posted |
| Apr 24, 2015 | Supplement 12Labeling · Standard review | Approved | None posted |
| Nov 30, 2009 | Supplement 6Labeling | Approved | None posted |
| Nov 30, 2009 | Supplement 7Labeling | Approved | None posted |
| Nov 13, 2007 | Supplement 5Labeling | Approved | None posted |
| Aug 15, 2006 | Supplement 1Labeling | Approved | None posted |
| Oct 6, 2005 | Original application | Approved |
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
