ANDA 73673, held by Teva. Diflunisal.
As of Nov 15, 2026, ANDA 73673 (Diflunisal), held by Teva, was first approved by FDA on Jul 31, 1992, with 24 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diflunisal tablets are indicated for acute or long-term use for symptomatic treatment of the following: Mild to moderate pain Osteoarthritis Rheumatoid arthritis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 31, 1992 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diflunisal500MG · tablet;oral | Diflunisal | Rx |
| Nov 21, 2024 | Supplement 35Labeling · Standard review | Approved | None posted |
| Oct 18, 2024 | Supplement 34Labeling · Standard review | Approved | None posted |
| Apr 28, 2021 | Supplement 32Labeling · Standard review | Approved | None posted |
| May 9, 2016 | Supplement 28Labeling · Standard review | Approved | None posted |
| Dec 14, 2006 | Supplement 26Labeling | Approved | None posted |
| Apr 25, 2006 | Supplement 25Labeling | Approved | None posted |
| Mar 8, 2006 | Supplement 24Labeling | Approved | None posted |
| Mar 8, 2002 | Supplement 22Manufacturing | Approved | None posted |
| Mar 8, 2001 | Supplement 21Manufacturing | Approved | None posted |
| Mar 8, 2001 | Supplement 20Manufacturing | Approved | None posted |
| Dec 2, 1999 | Supplement 19Manufacturing | Approved | None posted |
| Dec 2, 1999 | Supplement 18Manufacturing | Approved | None posted |
| Feb 12, 1999 | Supplement 12Manufacturing | Approved | None posted |
| Feb 12, 1999 | Supplement 11Manufacturing | Approved | None posted |
| Mar 9, 1998 | Supplement 10Labeling | Approved | None posted |
| Jun 16, 1997 | Supplement 9Manufacturing | Approved | None posted |
| Jan 31, 1997 | Supplement 8Manufacturing | Approved | None posted |
| Aug 16, 1996 | Supplement 7Manufacturing | Approved | None posted |
| Jul 24, 1996 | Supplement 6Manufacturing | Approved | None posted |
| Aug 23, 1995 | Supplement 4Manufacturing | Approved | None posted |
| May 4, 1995 | Supplement 5Labeling | Approved | None posted |
| May 4, 1995 | Supplement 2Labeling | Approved | None posted |
| Oct 20, 1994 | Supplement 3Manufacturing | Approved | None posted |
| Aug 18, 1992 | Supplement 1Labeling | Approved | None posted |
| Jul 31, 1992 | 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
