ANDA 74452, held by Pharmobedient. Gemfibrozil.
As of Nov 13, 2026, ANDA 74452 (Gemfibrozil), held by Pharmobedient, was first approved by FDA on Feb 16, 1995, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 16, 1995 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gemfibrozil600MG ยท tablet;oral | Gemfibrozil | Discontinued |
| Mar 13, 1998 | Supplement 2Manufacturing | Approved | None posted |
| Apr 29, 1996 | Supplement 1Manufacturing | Approved | None posted |
| Feb 16, 1995 | 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
