← FDA DRUG APPROVALS

FDA ANDA · ANDA061904

ERYTHROMYCIN ETHYLSUCCINATE

Sponsor: CARNEGIE

APPLICATION
ANDA061904
TYPE
ANDA
ORIGINAL APPROVAL
1975-03-03
LATEST ACTION
2020-01-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ERYTHROMYCIN ETHYLSUCCINATEPrescription
ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE · TABLET · ORAL

Approval history

2020-01-17Labeling · Supplement 25 · standardAP
2020-01-17Labeling · Supplement 23 · standardAP
2013-12-04Labeling · Supplement 21 · standard — Label ↗AP
2013-07-24Labeling · Supplement 22 · standardAP
2009-09-18Labeling · Supplement 18AP
2007-03-15Labeling · Supplement 14AP
2003-01-03Manufacturing (CMC) · Supplement 12AP
2001-05-24Labeling · Supplement 11AP
1998-04-20Manufacturing (CMC) · Supplement 10AP
1989-07-18Manufacturing (CMC) · Supplement 5AP
1988-08-29Manufacturing (CMC) · Supplement 8AP
1975-03-03OriginalAP
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 →