← FDA DRUG APPROVALS

FDA ANDA · ANDA061905

E.E.S 400

erythromycin ethylsuccinate

Sponsor: CARNEGIE

APPLICATION
ANDA061905
TYPE
ANDA
ORIGINAL APPROVAL
1982-08-12
LATEST ACTION
2015-09-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

E.E.S. 400Discontinued
ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE · TABLET · ORAL
E.E.S. 400Prescription
ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE · TABLET · ORAL

Approval history

2015-09-01Labeling · Supplement 50 · standardAP
2013-10-31Labeling · Supplement 49 · standard — Label ↗AP
2009-02-25Labeling · Supplement 44AP
2009-02-25Labeling · Supplement 45AP
2006-07-21Labeling · Supplement 43AP
2003-01-03Manufacturing (CMC) · Supplement 38AP
2002-12-09Manufacturing (CMC) · Supplement 40AP
2002-12-09Manufacturing (CMC) · Supplement 39AP
2001-01-17Labeling · Supplement 37AP
2000-11-16Labeling · Supplement 35AP
1998-04-20Manufacturing (CMC) · Supplement 36AP
1994-07-29Labeling · Supplement 34AP
1994-07-29Manufacturing (CMC) · Supplement 33AP
1992-08-18Manufacturing (CMC) · Supplement 31AP
1992-08-18Labeling · Supplement 32AP
1989-04-03Manufacturing (CMC) · Supplement 28AP
1982-08-12OriginalAP
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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.

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