Pentoxifylline

Treats intermittent claudication on the basis of chronic occlusive arterial disease of…. ANDA 74878, held by Ani Pharms. Pentoxifylline.

As of Nov 13, 2026, ANDA 74878 (Pentoxifylline), held by Ani Pharms, was first approved by FDA on Jul 9, 1997, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 9, 1997
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND 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 11 submissions below

Date	Submission	Status	Documents
Jul 9, 1997	Original application	Approved	None posted

Products

1 strengths and forms

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

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 2, 2001	Supplement 10Manufacturing	Approved	None posted
Mar 30, 2001	Supplement 9Manufacturing	Approved	None posted
Aug 28, 2000	Supplement 4Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 8Manufacturing	Approved	None posted
Feb 16, 2000	Supplement 7Manufacturing	Approved	None posted
Feb 16, 2000	Supplement 6Manufacturing	Approved	None posted
Feb 16, 2000	Supplement 5Manufacturing	Approved	None posted
Sep 21, 1998	Supplement 3Manufacturing	Approved	None posted
Mar 2, 1998	Supplement 1Manufacturing	Approved	None posted
Feb 6, 1998	Supplement 2Labeling	Approved	None posted
Jul 9, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74878
Drugs@FDA: Overview at FDA
Company: ANI 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