Ilosone

NDA 50010, held by Lilly. Erythromycin Estolate.

As of Nov 13, 2026, NDA 50010 (Ilosone), held by Lilly, was first approved by FDA on Apr 13, 1967, with 12 approved supplements and 0 published complete response letters.

First approved: Apr 13, 1967
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Apr 13, 1967	Original application	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
IlosoneEQ 125MG BASE/5ML · suspension;oral	Erythromycin Estolate	Discontinued
IlosoneEQ 250MG BASE/5ML · suspension;oral	Erythromycin Estolate	Discontinued

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 16, 1998	Supplement 24Manufacturing	Approved	None posted
Apr 24, 1997	Supplement 22Labeling	Approved	None posted
Apr 18, 1994	Supplement 18Manufacturing	Approved	None posted
Oct 28, 1993	Supplement 19Labeling	Approved	None posted
Aug 10, 1992	Supplement 16Labeling	Approved	None posted
Apr 3, 1992	Supplement 12Labeling	Approved	None posted
Aug 22, 1991	Supplement 14Manufacturing	Approved	None posted
Jan 7, 1991	Supplement 8Labeling	Approved	None posted
Dec 10, 1990	Supplement 7Labeling	Approved	None posted
Dec 10, 1990	Supplement 6Labeling	Approved	None posted
Apr 16, 1990	Supplement 9Labeling	Approved	None posted
Apr 10, 1990	Supplement 3Manufacturing	Approved	None posted
Apr 13, 1967	Original application	Approved	None posted

Identifiers

Application: NDA 50010
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