ANDA 76995, held by Actavis Labs Fl Inc. Glimepiride.
As of Nov 15, 2026, ANDA 76995 (Glimepiride), held by Actavis Labs Fl Inc, was first approved by FDA on Apr 26, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 26, 2010 | Original application | Approved | None posted |
| Glimepiride1MG · tablet;oral | Glimepiride | Discontinued |
| Glimepiride2MG · tablet;oral | Glimepiride | Discontinued |
| Glimepiride4MG · tablet;oral | Glimepiride | Discontinued |
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
