Pentoxifylline

ANDA 74877, held by Heritage. Pentoxifylline.

As of Nov 13, 2026, ANDA 74877 (Pentoxifylline), held by Heritage, was first approved by FDA on Jul 8, 1997, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 8, 1997
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 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	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 5, 2000	Supplement 5Manufacturing	Approved	None posted
Jul 16, 1998	Supplement 3Labeling	Approved	None posted
Jun 16, 1998	Supplement 2Manufacturing	Approved	None posted
Jan 29, 1998	Supplement 1Manufacturing	Approved	None posted
Jan 29, 1998	Supplement 4Manufacturing	Approved	None posted
Jul 8, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74877
Drugs@FDA: Overview at FDA
Company: Heritage 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