Sulfasalazine

ANDA 87197, held by Watson Labs. Sulfasalazine.

As of Nov 15, 2026, ANDA 87197 (Sulfasalazine), held by Watson Labs, was first approved by FDA on Apr 2, 1981, with 6 approved supplements and 0 published complete response letters.

First approved: Apr 2, 1981
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Apr 2, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfasalazine500MG · tablet;oral	Sulfasalazine	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Oct 6, 1992	Supplement 13Labeling	Approved	None posted
Aug 12, 1991	Supplement 12Manufacturing	Approved	None posted
Aug 7, 1991	Supplement 10Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 11Manufacturing	Approved	None posted
May 3, 1984	Supplement 9Manufacturing	Approved	None posted
Apr 27, 1983	Supplement 7Manufacturing	Approved	None posted
Apr 2, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87197
Drugs@FDA: Overview at FDA
Company: Watson 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