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FDA ANDA · ANDA061461

ERYTHROMYCIN STEARATE

Sponsor: ANI PHARMS

APPLICATION
ANDA061461
TYPE
ANDA
ORIGINAL APPROVAL
1980-04-11
LATEST ACTION
1999-08-20
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

1999-08-20Manufacturing (CMC) · Supplement 26AP
1998-12-09Manufacturing (CMC) · Supplement 25AP
1997-05-30Manufacturing (CMC) · Supplement 24AP
1993-07-01Labeling · Supplement 23AP
1993-05-14Labeling · Supplement 22AP
1993-03-23Manufacturing (CMC) · Supplement 20AP
1993-03-23Manufacturing (CMC) · Supplement 21AP
1992-09-03Manufacturing (CMC) · Supplement 19AP
1992-08-20Labeling · Supplement 16AP
1992-08-20Manufacturing (CMC) · Supplement 17AP
1992-06-23Manufacturing (CMC) · Supplement 15AP
1988-09-26Manufacturing (CMC) · Supplement 14AP
1980-04-11OriginalAP
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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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