Sulfisoxazole

ANDA 80142, held by Ani Pharms. Sulfisoxazole.

As of Nov 15, 2026, ANDA 80142 (Sulfisoxazole), held by Ani Pharms, was first approved by FDA on Mar 6, 1974, with 14 approved supplements and 0 published complete response letters.

First approved: Mar 6, 1974
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Mar 6, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfisoxazole500MG · tablet;oral	Sulfisoxazole	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Jul 29, 2002	Supplement 72Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 71Manufacturing	Approved	None posted
Jan 28, 2000	Supplement 69Manufacturing	Approved	None posted
Nov 23, 1999	Supplement 68Manufacturing	Approved	None posted
Nov 5, 1999	Supplement 64Manufacturing	Approved	None posted
Nov 5, 1999	Supplement 65Manufacturing	Approved	None posted
Nov 5, 1999	Supplement 66Manufacturing	Approved	None posted
Nov 5, 1999	Supplement 67Manufacturing	Approved	None posted
Aug 20, 1999	Supplement 63Manufacturing	Approved	None posted
Dec 9, 1998	Supplement 62Manufacturing	Approved	None posted
May 30, 1997	Supplement 61Manufacturing	Approved	None posted
Apr 17, 1996	Supplement 60Labeling	Approved	None posted
Jan 5, 1993	Supplement 59Manufacturing	Approved	None posted
Aug 14, 1992	Supplement 58Manufacturing	Approved	None posted
Mar 6, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 80142
Drugs@FDA: Overview at FDA
Company: ANI 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