Pentoxifylline

ANDA 75028, held by Bausch. Pentoxifylline.

As of Nov 13, 2026, ANDA 75028 (Pentoxifylline), held by Bausch, was first approved by FDA on Jul 20, 1998, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 20, 1998
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jul 20, 1998	Original application	Approved	Letter Review

Products

1 strengths and forms

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

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 2, 2017	Supplement 10Labeling · Standard review	Approved	None posted
Feb 2, 2017	Supplement 12Labeling · Standard review	Approved	None posted
Feb 2, 2017	Supplement 13Labeling · Standard review	Approved	None posted
Dec 7, 2006	Supplement 9Labeling	Approved	None posted
Feb 20, 2002	Supplement 6Manufacturing	Approved	None posted
Aug 21, 2001	Supplement 4Manufacturing	Approved	None posted
Aug 21, 2001	Supplement 5Manufacturing	Approved	None posted
Jun 30, 2000	Supplement 3Manufacturing	Approved	None posted
Jun 11, 1999	Supplement 1Manufacturing	Approved	None posted
Jun 11, 1999	Supplement 2Manufacturing	Approved	None posted
Jul 20, 1998	Original application	Approved	Letter Review

Identifiers

Application: ANDA 75028
Drugs@FDA: Overview at FDA
Company: Bausch Health

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