Sulfinpyrazone

ANDA 87666, held by Barr. Sulfinpyrazone.

As of Nov 14, 2026, ANDA 87666 (Sulfinpyrazone), held by Barr, was first approved by FDA on Sep 17, 1982, with 19 approved supplements and 0 published complete response letters.

First approved: Sep 17, 1982
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfinpyrazone200MG · capsule;oral	Sulfinpyrazone	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Jan 2, 2003	Supplement 25Labeling	Approved	None posted
Dec 21, 1999	Supplement 24Manufacturing	Approved	None posted
May 20, 1999	Supplement 23Manufacturing	Approved	None posted
Mar 18, 1999	Supplement 22Manufacturing	Approved	None posted
Dec 1, 1998	Supplement 21Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 20Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 19Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 16Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 18Manufacturing	Approved	None posted
Jun 12, 1991	Supplement 15Labeling	Approved	None posted
Mar 8, 1991	Supplement 14Labeling	Approved	None posted
Jul 14, 1989	Supplement 13Labeling	Approved	None posted
May 16, 1988	Supplement 9Manufacturing	Approved	None posted
May 16, 1988	Supplement 10Manufacturing	Approved	None posted
May 16, 1988	Supplement 11Manufacturing	Approved	None posted
Mar 20, 1987	Supplement 8Manufacturing	Approved	None posted
Oct 22, 1985	Supplement 5Manufacturing	Approved	None posted
Oct 22, 1985	Supplement 6Manufacturing	Approved	None posted
Jun 27, 1983	Supplement 2Manufacturing	Approved	None posted
Sep 17, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87666
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