Relieves rheumatoid arthritis. ANDA 74431, held by Genus. Flurbiprofen.
As of Nov 13, 2026, ANDA 74431 (Flurbiprofen), held by Genus, was first approved by FDA on May 31, 1995, with 13 approved supplements and 0 published complete response letters.
Flurbiprofen tablets are indicated: For relief of the signs and symptoms of rheumatoid arthritis. For relief of the signs and symptoms of osteoarthritis. Flurbiprofen tablets are a nonsteroidal anti-inflammatory drug indicated for Relief of the signs and symptoms of rheumatoid arthritis Relief of the signs and symptoms of osteoarthritis
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 31, 1995 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Flurbiprofen100MG · tablet;oral | Flurbiprofen | Rx |
| Aug 7, 2026 | Supplement 26Labeling · Standard review | Approved | None posted |
| Nov 29, 2010 | Supplement 17Labeling | Approved | None posted |
| Apr 25, 2006 | Supplement 15Labeling | Approved | None posted |
| Mar 13, 2006 | Supplement 14Labeling | Approved | None posted |
| Aug 30, 2001 | Supplement 9Manufacturing | Approved | None posted |
| Jul 7, 2000 | Supplement 8Manufacturing | Approved | None posted |
| Aug 27, 1998 | Supplement 7Manufacturing | Approved | None posted |
| Mar 9, 1998 | Supplement 6Manufacturing | Approved | None posted |
| Apr 7, 1997 | Supplement 5Manufacturing | Approved | None posted |
| Apr 7, 1997 | Supplement 4Manufacturing | Approved | None posted |
| Apr 7, 1997 | Supplement 3Manufacturing | Approved | None posted |
| Oct 21, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Feb 22, 1996 | Supplement 1Manufacturing | Approved | None posted |
| May 31, 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
