Pentoxil

ANDA 74962, held by Upsher Smith Labs. Pentoxifylline.

As of Nov 13, 2026, ANDA 74962 (Pentoxil), held by Upsher Smith Labs, was first approved by FDA on Mar 31, 1999, with 5 approved supplements and 0 published complete response letters.

First approved: Mar 31, 1999
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
Mar 31, 1999	Original application	Approved	Label Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pentoxil400MG · tablet, extended release;oral	Pentoxifylline	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 30, 2005	Supplement 8Labeling	Approved	None posted
Oct 29, 2004	Supplement 5Labeling	Approved	None posted
Dec 19, 2002	Supplement 3Manufacturing	Approved	None posted
Apr 21, 2000	Supplement 1Manufacturing	Approved	None posted
Apr 21, 2000	Supplement 2Manufacturing	Approved	None posted
Mar 31, 1999	Original application	Approved	Label Review Letter

Identifiers

Application: ANDA 74962
Drugs@FDA: Overview at FDA
Company: Upsher-Smith Laboratories

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