Erythromycin

As of Nov 13, 2026, NDA 50532 (Erythromycin), held by Lilly, was first approved by FDA on Jun 3, 1980, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 3, 1980
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 3, 1980	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Erythromycin2% · solution;topical	Erythromycin	Discontinued

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 7, 1990	Supplement 5Labeling	Approved	None posted
Dec 7, 1990	Supplement 6Labeling	Approved	None posted
Jun 3, 1981	Supplement 10Labeling	Approved	None posted
Nov 14, 1980	Supplement 9Labeling	Approved	None posted
Jun 3, 1980	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50532
Drugs@FDA: Overview at FDA
Company: Lilly

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