Sulfisoxazole

ANDA 80379, held by Hikma. Sulfisoxazole.

As of Nov 15, 2026, ANDA 80379 (Sulfisoxazole), held by Hikma, was first approved by FDA on Feb 13, 1973, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 13, 1973
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Feb 13, 1973	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfisoxazole500MG · tablet;oral	Sulfisoxazole	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Feb 21, 1991	Supplement 17Manufacturing	Approved	None posted
Apr 3, 1984	Supplement 12Manufacturing	Approved	None posted
Apr 3, 1984	Supplement 13Manufacturing	Approved	None posted
Feb 13, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 80379
Drugs@FDA: Overview at FDA
Company: Hikma

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