Treats infections caused by susceptible strains of the designated organisms in the…. NDA 50207, held by Carnegie. Erythromycin Ethylsuccinate.
As of Nov 13, 2026, NDA 50207 (E.E.S., Eryped), held by Carnegie, was first approved by FDA on Apr 2, 1965, with 18 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ery-Ped and other antibacterial drugs, Ery-Ped should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 2, 1965 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| E.E.S.EQ 200MG BASE/5ML · granule;oral | Erythromycin Ethylsuccinate | RxReference drug |
| ErypedEQ 400MG BASE/5ML · granule;oral | Erythromycin Ethylsuccinate | RxReference drug |
| ErypedEQ 200MG BASE/5ML · granule;oral | Erythromycin Ethylsuccinate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 23, 2018 | Supplement 74Labeling · Standard review | Approved | |
| Aug 17, 2017 | Supplement 73Labeling · Standard review | Approved | |
| Feb 2, 2012 | Supplement 71Labeling · Standard review | Approved | |
| Jan 26, 2011 | Supplement 64Labeling · Standard review | Approved | |
| Nov 4, 2010 | Supplement 67Labeling · Standard review | Approved | |
| Dec 10, 2008 | Supplement 68Labeling · Standard review | Approved | |
| May 22, 2008 | Supplement 66Labeling · Standard review | Approved | |
| Jan 5, 2008 | Supplement 65Labeling · Standard review | Approved | |
| Aug 10, 2006 | Supplement 58Labeling · Standard review | Approved | |
| Mar 12, 2004 | Supplement 61Labeling · Standard review | Approved | |
| Apr 25, 2002 | Supplement 57Labeling · Standard review | Approved | |
| Feb 4, 2000 | Supplement 55Labeling · Standard review | Approved | |
| Feb 4, 2000 | Supplement 54Labeling · Standard review | Approved | |
| Nov 24, 1999 | Supplement 56Manufacturing | Approved | None posted |
| May 9, 1997 | Supplement 53Manufacturing | Approved | None posted |
| Apr 29, 1997 | Supplement 52Manufacturing | Approved | None posted |
| Apr 14, 1997 | Supplement 51Labeling | Approved | None posted |
| Apr 14, 1997 | Supplement 50Labeling | Approved | None posted |
| Apr 2, 1965 | Original application | Approved | None posted |
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