Sulfasalazine

ANDA 86184, held by Epic Pharma LLC. Sulfasalazine.

As of Nov 15, 2026, ANDA 86184 (Sulfasalazine), held by Epic Pharma LLC, was first approved by FDA on Sep 16, 1994, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 16, 1994
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 16, 1994	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfasalazine500MG · tablet;oral	Sulfasalazine	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Sep 16, 1994	Original application	Approved	None posted
Jun 27, 1983	Supplement 2Manufacturing	Approved	None posted
Apr 1, 1983	Supplement 1Manufacturing	Approved	None posted
Apr 1, 1983	Supplement 3Manufacturing	Approved	None posted
Apr 1, 1983	Supplement 4Manufacturing	Approved	None posted
Apr 1, 1983	Supplement 5Manufacturing	Approved	None posted

Identifiers

Application: ANDA 86184
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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