Eryc

Treats infections caused by susceptible strains of the designated organisms in the…. NDA 50536, held by Dr Reddys Labs SA. Erythromycin.

As of Nov 14, 2026, NDA 50536 (Eryc), held by Dr Reddys Labs SA, was first approved by FDA on Jan 26, 1981, with 23 approved supplements and 0 published complete response letters.

First approved: Jan 26, 1981
Review: Standard
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Erythromycin is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below: Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved) (see appropriate sulfonamide labeling for prescribing information). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Jan 26, 1981	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Eryc250MG · capsule, delayed rel pellets;oral	Erythromycin	RxReference drug

All 24 submissions, including labeling and manufacturing supplements


Apr 23, 2018	Supplement 26Labeling · Standard review	Approved	Label Letter
Dec 19, 2013	Supplement 23Manufacturing · Standard review	Approved	None posted
Dec 19, 2013	Supplement 24Manufacturing · Standard review	Approved	None posted
Mar 21, 2013	Supplement 21Labeling · Standard review	Approved	Label Letter
Feb 14, 2012	Supplement 22Labeling · Standard review	Approved	Letter Label
Feb 21, 2008	Supplement 20Labeling · Standard review	Approved	Letter Label
Jan 12, 2006	Supplement 19Labeling · Standard review	Approved	Letter Label
Feb 2, 2004	Supplement 16Labeling · Standard review	Approved	Letter
Dec 18, 2003	Supplement 18Labeling · Standard review	Approved	Letter
Sep 22, 2000	Supplement 13Labeling · Standard review	Approved	None posted
Aug 5, 1999	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 21, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 16, 1986	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 30, 1982	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 28, 1982	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 7, 1981	Supplement 10Labeling	Approved	None posted
Jun 15, 1981	Supplement 9Labeling	Approved	None posted
Jun 5, 1981	Supplement 6Labeling	Approved	None posted
Jun 5, 1981	Supplement 8Manufacturing · Standard review	Approved	None posted
May 21, 1981	Supplement 3Labeling	Approved	None posted
May 20, 1981	Supplement 5Manufacturing · Standard review	Approved	None posted
May 18, 1981	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 22, 1981	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 26, 1981	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50536
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's 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