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FDA ANDA · ANDA060359

ERYTHROCIN STEARATE

Sponsor: AZURITY

APPLICATION
ANDA060359
TYPE
ANDA
ORIGINAL APPROVAL
1964-06-24
LATEST ACTION
2013-12-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ERYTHROCIN STEARATEDiscontinued
ERYTHROMYCIN STEARATE EQ 500MG BASE · TABLET · ORAL
ERYTHROCIN STEARATEDiscontinued
ERYTHROMYCIN STEARATE EQ 250MG BASE · TABLET · ORAL
ERYTHROCIN STEARATEDiscontinued
ERYTHROMYCIN STEARATE EQ 125MG BASE · TABLET · ORAL

Approval history

2013-12-04Labeling · Supplement 28 · standardLabelAP
2013-07-24Labeling · Supplement 29 · standardAP
2009-09-18Labeling · Supplement 27AP
2009-07-02Labeling · Supplement 25AP
2004-03-17Labeling · Supplement 22AP
2003-01-03Manufacturing (CMC) · Supplement 20AP
2001-02-09Labeling · Supplement 19AP
2000-10-26Labeling · Supplement 17AP
2000-07-11Manufacturing (CMC) · Supplement 18AP
1998-04-20Manufacturing (CMC) · Supplement 16AP
1964-06-24OriginalAP
VIEW ON DRUGS@FDA ↗

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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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