Sulfinpyrazone

ANDA 88934, held by Par Pharm. Sulfinpyrazone.

As of Nov 14, 2026, ANDA 88934 (Sulfinpyrazone), held by Par Pharm, was first approved by FDA on Sep 6, 1985, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 6, 1985
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
Sep 6, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfinpyrazone200MG · capsule;oral	Sulfinpyrazone	Discontinued

All 6 submissions, including labeling and manufacturing supplements


May 8, 1989	Supplement 8Labeling	Approved	None posted
Jan 5, 1988	Supplement 7Manufacturing	Approved	None posted
Sep 3, 1986	Supplement 2Manufacturing	Approved	None posted
Sep 3, 1986	Supplement 3Manufacturing	Approved	None posted
Mar 13, 1986	Supplement 1Manufacturing	Approved	None posted
Sep 6, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 88934
Drugs@FDA: Overview at FDA
Company: Par Pharmaceutical

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