ANDA 77486, held by Mylan. Glimepiride.
As of Nov 15, 2026, ANDA 77486 (Glimepiride), held by Mylan, was first approved by FDA on Feb 10, 2006, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 10, 2006 | 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
