ANDA 72929, held by Purepac Pharm. Gemfibrozil.
As of Nov 13, 2026, ANDA 72929 (Gemfibrozil), held by Purepac Pharm, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 4, 1991 | Original application | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gemfibrozil300MG ยท capsule;oral | Gemfibrozil | 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