ANDA 75846, held by Ivax Sub Teva Pharms. Oxaprozin.
As of Nov 13, 2026, ANDA 75846 (Oxaprozin), held by Ivax Sub Teva Pharms, was first approved by FDA on May 13, 2002, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 13, 2002 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxaprozin600MG ยท tablet;oral | Oxaprozin | 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