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FDA ANDA · ANDA061505

ERYTHROMYCIN STEARATE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA061505
TYPE
ANDA
ORIGINAL APPROVAL
1973-01-16
LATEST ACTION
2014-08-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2014-08-15Labeling · Supplement 34 · standardAP
2003-09-22Labeling · Supplement 33AP
1998-02-25Manufacturing (CMC) · Supplement 30AP
1998-02-05Manufacturing (CMC) · Supplement 31AP
1993-03-12Labeling · Supplement 26AP
1992-06-24Labeling · Supplement 25AP
1992-06-24Manufacturing (CMC) · Supplement 17AP
1991-10-01Bioequivalence · Supplement 24AP
1990-01-31Manufacturing (CMC) · Supplement 20AP
1990-01-31Manufacturing (CMC) · Supplement 19AP
1973-01-16OriginalAP
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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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