Pediazole

NDA 50529, held by Ross Labs. Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl.

As of Nov 13, 2026, NDA 50529 (Pediazole), held by Ross Labs, was first approved by FDA on Nov 29, 1979, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 29, 1979
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below


Sep 29, 1992	Supplement 12Efficacy (new indication or use)	Approved	None posted
Nov 29, 1979	Original applicationTYPE 3/4 · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
PediazoleEQ 200MG BASE/5ML;EQ 600MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · granule;oral	Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Feb 9, 2004	Supplement 33Labeling · Standard review	Approved	Letter
Jun 21, 1994	Supplement 31Manufacturing · Standard review	Approved	None posted
May 6, 1993	Supplement 30Manufacturing · Standard review	Approved	None posted
Sep 29, 1992	Supplement 21Labeling	Approved	None posted
Sep 29, 1992	Supplement 12Efficacy (new indication or use)	Approved	None posted
Mar 11, 1992	Supplement 29Manufacturing · Standard review	Approved	None posted
Apr 16, 1991	Supplement 27Manufacturing · Standard review	Approved	None posted
Nov 29, 1979	Original applicationTYPE 3/4 · Standard review	Approved	None posted

Identifiers

Application: NDA 50529
Drugs@FDA: Overview at FDA
Company: Ross 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