For type 2 diabetes mellitus. ANDA 91220, held by Micro Labs. Glimepiride.
As of Nov 15, 2026, ANDA 91220 (Glimepiride), held by Micro Labs, was first approved by FDA on Jun 29, 2012, with 5 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 |
|---|---|---|---|
| Jun 29, 2012 | Original application | Approved | None posted |
| Glimepiride1MG · tablet;oral | Glimepiride | Rx |
| Glimepiride2MG · tablet;oral | Glimepiride | Rx |
| Glimepiride3MG · tablet;oral | Glimepiride | Rx |
| Glimepiride4MG · tablet;oral | Glimepiride | Rx |
| Glimepiride6MG · tablet;oral | Glimepiride | Rx |
| Glimepiride8MG · tablet;oral | Glimepiride | Rx |
| Sep 15, 2020 | Supplement 15Labeling · Standard review | Approved | None posted |
| Apr 7, 2020 | Supplement 14Labeling · Standard review | Approved | None posted |
| Aug 25, 2017 | Supplement 10Labeling · Standard review | Approved | None posted |
| Dec 3, 2014 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 3, 2014 | Supplement 3Manufacturing | Approved | None posted |
| Jun 29, 2012 | 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
