Treats intermittent claudication on the basis of chronic occlusive arterial disease of…. NDA 18631, held by Validus Pharms. Pentoxifylline.
As of Nov 14, 2026, NDA 18631 (Trental), held by Validus Pharms, was first approved by FDA on Aug 30, 1984, with 32 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Pentoxifylline extended-release tablet is indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline extended-release tablet can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 1984 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trental400MG · tablet, extended release;oral | Pentoxifylline | RxReference drug |
| Jan 15, 2016 | Supplement 41Labeling · Standard review | Approved | |
| Feb 13, 2015 | Supplement 40Labeling · Standard review | Approved | |
| Apr 17, 2014 | Supplement 36Labeling · Standard review | Approved | |
| Jul 5, 2012 | Supplement 39Labeling | Approved | |
| Apr 7, 2005 | Supplement 34Labeling · Standard review | Approved | |
| Sep 30, 2003 | Supplement 33Labeling · Standard review | Approved | |
| Nov 3, 1997 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Apr 29, 1997 | Supplement 30Labeling · Standard review | Approved | |
| Jun 18, 1996 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Feb 9, 1996 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Jan 2, 1996 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Jul 28, 1995 | Supplement 23Labeling · Standard review | Approved | None posted |
| Apr 10, 1995 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Apr 4, 1995 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Nov 4, 1994 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Jul 25, 1994 | Supplement 22Labeling · Standard review | Approved | None posted |
| Nov 24, 1993 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Feb 11, 1993 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Dec 16, 1991 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Nov 7, 1991 | Supplement 14Labeling | Approved | None posted |
| Nov 7, 1991 | Supplement 12Labeling | Approved | None posted |
| Apr 30, 1991 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Mar 27, 1991 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Oct 30, 1990 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Feb 23, 1990 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Jul 28, 1989 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Jan 27, 1988 | Supplement 7Labeling | Approved | None posted |
| Sep 3, 1987 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| May 27, 1986 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Apr 24, 1986 | Supplement 3Labeling | Approved | None posted |
| Oct 4, 1985 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| May 13, 1985 | Supplement 1Labeling | Approved | None posted |
| Aug 30, 1984 | Original applicationNew molecular entity · Priority review | 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
