ANDA 77366, held by Ranbaxy. Glimepiride.
As of Nov 15, 2026, ANDA 77366 (Glimepiride), held by Ranbaxy, was first approved by FDA on Oct 6, 2005, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 6, 2005 | Original application | Approved |
| Glimepiride3MG · tablet;oral | Glimepiride | Discontinued |
| Glimepiride6MG · 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
