ANDA 74560, held by Theragen. Flurbiprofen.
As of Nov 13, 2026, ANDA 74560 (Flurbiprofen), held by Theragen, was first approved by FDA on May 16, 1997, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 16, 1997 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Flurbiprofen100MG ยท tablet;oral | Flurbiprofen | 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
