Sulfasalazine

ANDA 89590, held by Sun Pharm Industries. Sulfasalazine.

As of Nov 15, 2026, ANDA 89590 (Sulfasalazine), held by Sun Pharm Industries, was first approved by FDA on Oct 19, 1987, with 24 approved supplements and 0 published complete response letters.

First approved: Oct 19, 1987
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Oct 19, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfasalazine500MG · tablet;oral	Sulfasalazine	Discontinued

All 25 submissions, including labeling and manufacturing supplements


May 15, 2002	Supplement 27Manufacturing	Approved	None posted
Nov 21, 2001	Supplement 26Manufacturing	Approved	None posted
Aug 21, 2001	Supplement 25Labeling	Approved	None posted
Aug 21, 2001	Supplement 24Manufacturing	Approved	None posted
Aug 21, 2001	Supplement 23Manufacturing	Approved	None posted
Apr 18, 2001	Supplement 22Manufacturing	Approved	None posted
Feb 5, 2001	Supplement 21Manufacturing	Approved	None posted
May 16, 2000	Supplement 19Manufacturing	Approved	None posted
May 16, 2000	Supplement 18Manufacturing	Approved	None posted
Mar 24, 2000	Supplement 20Labeling	Approved	None posted
Dec 23, 1998	Supplement 14Manufacturing	Approved	None posted
Nov 23, 1998	Supplement 17Manufacturing	Approved	None posted
Nov 23, 1998	Supplement 16Manufacturing	Approved	None posted
Mar 25, 1998	Supplement 13Labeling	Approved	None posted
Dec 5, 1997	Supplement 12Manufacturing	Approved	None posted
Feb 24, 1997	Supplement 11Manufacturing	Approved	None posted
Oct 6, 1995	Supplement 10Manufacturing	Approved	None posted
Jun 22, 1995	Supplement 9Manufacturing	Approved	None posted
Jan 12, 1994	Supplement 7Manufacturing	Approved	None posted
Dec 11, 1991	Supplement 1Manufacturing	Approved	None posted
May 21, 1991	Supplement 6Labeling	Approved	None posted
Apr 3, 1991	Supplement 4Manufacturing	Approved	None posted
Feb 11, 1991	Supplement 3Labeling	Approved	None posted
Sep 26, 1990	Supplement 2Labeling	Approved	None posted
Oct 19, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 89590
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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