Sulfinpyrazone

ANDA 87665, held by Barr. Sulfinpyrazone.

As of Nov 14, 2026, ANDA 87665 (Sulfinpyrazone), held by Barr, was first approved by FDA on Sep 17, 1982, with 15 approved supplements and 0 published complete response letters.

First approved: Sep 17, 1982
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Sep 17, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfinpyrazone100MG · tablet;oral	Sulfinpyrazone	Discontinued

All 16 submissions, including labeling and manufacturing supplements


Jan 2, 2003	Supplement 22Labeling	Approved	None posted
Dec 21, 1999	Supplement 21Manufacturing	Approved	None posted
Aug 27, 1999	Supplement 20Manufacturing	Approved	None posted
May 20, 1999	Supplement 19Manufacturing	Approved	None posted
Dec 1, 1998	Supplement 18Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 17Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 16Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 13Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 15Manufacturing	Approved	None posted
Jun 12, 1991	Supplement 12Labeling	Approved	None posted
Mar 8, 1991	Supplement 11Labeling	Approved	None posted
Jul 14, 1989	Supplement 10Labeling	Approved	None posted
Mar 20, 1987	Supplement 8Manufacturing	Approved	None posted
Oct 22, 1985	Supplement 2Manufacturing	Approved	None posted
Oct 22, 1985	Supplement 3Manufacturing	Approved	None posted
Sep 17, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87665
Drugs@FDA: Overview at FDA
Company: Barr 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