E.E.S., Eryped

NDA 50297, held by Azurity. Erythromycin Ethylsuccinate.

As of Nov 13, 2026, NDA 50297 (E.E.S., Eryped), held by Azurity, was first approved by FDA on Aug 6, 1970, with 10 approved supplements and 0 published complete response letters.

First approved: Aug 6, 1970
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Aug 6, 1970	Original application	Approved	None posted

Products

2 strengths and forms


E.E.S.EQ 200MG BASE · tablet, chewable;oral	Erythromycin Ethylsuccinate	Discontinued
ErypedEQ 200MG BASE · tablet, chewable;oral	Erythromycin Ethylsuccinate	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Aug 15, 2012	Supplement 31Labeling · Standard review	Approved	Letter Label
Nov 4, 2010	Supplement 29Labeling · Standard review	Approved	Letter
Dec 10, 2008	Supplement 30Labeling · Standard review	Approved	Label Letter
May 22, 2008	Supplement 28Labeling · Standard review	Approved	Letter
Jan 5, 2008	Supplement 27Labeling · Standard review	Approved	Letter Label
Aug 10, 2006	Supplement 21Labeling · Standard review	Approved	Letter Label
Mar 12, 2004	Supplement 24Labeling · Standard review	Approved	Letter
Apr 25, 2002	Supplement 19Labeling · Standard review	Approved	Letter
Feb 4, 2000	Supplement 18Labeling · Standard review	Approved	Review
Apr 14, 1997	Supplement 17Labeling	Approved	None posted
Aug 6, 1970	Original application	Approved	None posted

Identifiers

Application: NDA 50297
Drugs@FDA: Overview at FDA
Company: Azurity 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