APPLICATION
ANDA061896
TYPE
ANDA
ORIGINAL APPROVAL
1975-01-03
LATEST ACTION
1997-07-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ILOSONEDiscontinued
ERYTHROMYCIN ESTOLATE EQ 500MG BASE · TABLET · ORAL
Approval history
1997-07-22Labeling · Supplement 19AP
1992-01-27Manufacturing (CMC) · Supplement 13AP
1991-10-23Labeling · Supplement 9AP
1991-09-05Labeling · Supplement 10AP
1991-01-14Labeling · Supplement 12AP
1990-04-16Labeling · Supplement 11AP
1990-04-10Manufacturing (CMC) · Supplement 8AP
1990-04-10Manufacturing (CMC) · Supplement 6AP
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.