APPLICATION
ANDA062847
TYPE
ANDA
ORIGINAL APPROVAL
1988-09-14
LATEST ACTION
2001-12-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ERYTHROMYCIN ETHYLSUCCINATEDiscontinued
ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE · TABLET · ORAL
Approval history
2001-12-10Labeling · Supplement 17AP
2000-02-23Manufacturing (CMC) · Supplement 16AP
1998-02-25Manufacturing (CMC) · Supplement 14AP
1998-02-05Manufacturing (CMC) · Supplement 15AP
1997-05-21Manufacturing (CMC) · Supplement 13AP
1995-06-05Manufacturing (CMC) · Supplement 12AP
1993-12-22Manufacturing (CMC) · Supplement 11AP
1993-04-08Labeling · Supplement 9AP
1992-02-03Manufacturing (CMC) · Supplement 4AP
1991-12-09Labeling · Supplement 7AP
1991-12-09Manufacturing (CMC) · Supplement 5AP
1991-12-09Labeling · Supplement 8AP
1991-08-06Labeling · Supplement 6AP
1991-05-17Labeling · Supplement 2AP
1990-01-31Manufacturing (CMC) · Supplement 3AP
1988-09-14OriginalAP
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.