ANDA 75851, held by Pharmobedient. Oxaprozin.
As of Nov 13, 2026, ANDA 75851 (Oxaprozin), held by Pharmobedient, was first approved by FDA on Aug 17, 2001, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 17, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxaprozin600MG ยท tablet;oral | Oxaprozin | Discontinued |
| Dec 10, 2003 | Supplement 2Labeling | Approved | None posted |
| Mar 13, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Aug 17, 2001 | Original application | Approved |
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
