Sulfisoxazole

ANDA 84385, held by Pharmeral. Sulfisoxazole.

As of Nov 15, 2026, ANDA 84385 (Sulfisoxazole), held by Pharmeral, was first approved by FDA on Nov 5, 1980, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 5, 1980
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 5, 1980	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sulfisoxazole500MG · tablet;oral	Sulfisoxazole	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Feb 8, 1989	Supplement 55Manufacturing	Approved	None posted
Nov 5, 1980	Original application	Approved	None posted

Identifiers

Application: ANDA 84385
Drugs@FDA: Overview at FDA
Company: Pharmeral

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