Pentoxifylline

Treats intermittent claudication on the basis of chronic occlusive arterial disease of…. ANDA 74425, held by Rising. Pentoxifylline.

As of Nov 13, 2026, ANDA 74425 (Pentoxifylline), held by Rising, was first approved by FDA on Jul 8, 1997, with 16 approved supplements and 0 published complete response letters.

First approved: Jul 8, 1997
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS & USAGE Pentoxifylline extended-release tablets are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline extended-release tablets 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jul 8, 1997	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pentoxifylline400MG · tablet, extended release;oral	Pentoxifylline	Rx

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 2, 2020	Supplement 24Labeling · Standard review	Approved	None posted
Jan 21, 2016	Supplement 21Labeling · Standard review	Approved	None posted
Jan 21, 2016	Supplement 22Labeling · Standard review	Approved	None posted
Jan 12, 2007	Supplement 13Manufacturing	Approved	None posted
Dec 12, 2005	Supplement 14Labeling	Approved	None posted
Jan 21, 2004	Supplement 11Labeling	Approved	None posted
Apr 19, 2000	Supplement 10Manufacturing	Approved	None posted
Nov 15, 1999	Supplement 9Manufacturing	Approved	None posted
Nov 3, 1999	Supplement 6Manufacturing	Approved	None posted
Nov 3, 1999	Supplement 7Labeling	Approved	None posted
Nov 3, 1999	Supplement 8Manufacturing	Approved	None posted
Jul 22, 1999	Supplement 5Manufacturing	Approved	None posted
Aug 25, 1998	Supplement 4Labeling	Approved	None posted
Apr 7, 1998	Supplement 2Manufacturing	Approved	None posted
Apr 7, 1998	Supplement 3Manufacturing	Approved	None posted
Feb 26, 1998	Supplement 1Manufacturing	Approved	None posted
Jul 8, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74425
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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