Sulfinpyrazone

ANDA 87770, held by Ivax Pharms. Sulfinpyrazone.

As of Nov 14, 2026, ANDA 87770 (Sulfinpyrazone), held by Ivax Pharms, was first approved by FDA on Nov 19, 1982, with 12 approved supplements and 0 published complete response letters.

First approved: Nov 19, 1982
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Nov 19, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfinpyrazone200MG · capsule;oral	Sulfinpyrazone	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Jan 28, 2000	Supplement 15Manufacturing	Approved	None posted
Nov 23, 1999	Supplement 14Manufacturing	Approved	None posted
Aug 20, 1999	Supplement 13Manufacturing	Approved	None posted
Dec 9, 1998	Supplement 12Manufacturing	Approved	None posted
May 30, 1997	Supplement 11Manufacturing	Approved	None posted
Apr 12, 1996	Supplement 9Manufacturing	Approved	None posted
Jan 6, 1995	Supplement 10Labeling	Approved	None posted
Apr 28, 1993	Supplement 8Manufacturing	Approved	None posted
Sep 16, 1991	Supplement 7Labeling	Approved	None posted
Jan 25, 1991	Supplement 5Manufacturing	Approved	None posted
Jan 25, 1991	Supplement 6Manufacturing	Approved	None posted
Jan 26, 1988	Supplement 4Manufacturing	Approved	None posted
Nov 19, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87770
Drugs@FDA: Overview at FDA
Company: IVAX 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