ANDA 78952, held by Hikma Pharms. Glimepiride.
As of Nov 15, 2026, ANDA 78952 (Glimepiride), held by Hikma Pharms, was first approved by FDA on Aug 1, 2013, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 1, 2013 | 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
