Pentoxifylline

ANDA 74874, held by Pliva. Pentoxifylline.

As of Nov 13, 2026, ANDA 74874 (Pentoxifylline), held by Pliva, was first approved by FDA on May 25, 1999, with 8 approved supplements and 0 published complete response letters.

First approved: May 25, 1999
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
May 25, 1999	Original application	Approved	Letter

Products

1 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 18, 2002	Supplement 3Manufacturing	Approved	None posted
Nov 18, 2002	Supplement 4Manufacturing	Approved	None posted
Nov 18, 2002	Supplement 5Manufacturing	Approved	None posted
Nov 18, 2002	Supplement 6Manufacturing	Approved	None posted
Nov 18, 2002	Supplement 7Manufacturing	Approved	None posted
Nov 18, 2002	Supplement 8Labeling	Approved	None posted
Jul 7, 2000	Supplement 2Manufacturing	Approved	None posted
Jun 21, 1999	Supplement 1Labeling	Approved	None posted
May 25, 1999	Original application	Approved	Letter

Identifiers

Application: ANDA 74874
Drugs@FDA: Overview at FDA
Company: PLIVA

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