← FDA DRUG APPROVALS

FDA ANDA · ANDA061897

ILOSONE

Sponsor: LILLY

APPLICATION
ANDA061897
TYPE
ANDA
ORIGINAL APPROVAL
1975-01-06
LATEST ACTION
1997-07-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ILOSONEDiscontinued
ERYTHROMYCIN ESTOLATE EQ 125MG BASE · CAPSULE · ORAL
ILOSONEDiscontinued
ERYTHROMYCIN ESTOLATE EQ 250MG BASE · CAPSULE · ORAL

Approval history

1997-07-22Labeling · Supplement 22AP
1992-01-27Manufacturing (CMC) · Supplement 16AP
1991-10-23Labeling · Supplement 13AP
1991-09-05Labeling · Supplement 14AP
1991-01-14Labeling · Supplement 15AP
1990-04-10Manufacturing (CMC) · Supplement 12AP
1990-04-10Manufacturing (CMC) · Supplement 10AP
1975-01-06OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →