APPLICATION
ANDA061895
TYPE
ANDA
ORIGINAL APPROVAL
1975-01-03
LATEST ACTION
1991-11-13
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued
Products
ILOSONEDiscontinued
ERYTHROMYCIN ESTOLATE EQ 250MG BASE · TABLET, CHEWABLE · ORAL
ILOSONEDiscontinued
ERYTHROMYCIN ESTOLATE EQ 125MG BASE · TABLET, CHEWABLE · ORAL
Approval history
1991-11-13Labeling · Supplement 8AP
1991-11-13Labeling · Supplement 10AP
1991-09-05Labeling · Supplement 9AP
1991-01-14Labeling · Supplement 11AP
1990-04-10Manufacturing (CMC) · Supplement 7AP
1990-04-10Manufacturing (CMC) · Supplement 5AP
1975-01-03OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.