FDA ANDA · ANDA061591

ERYTHROMYCIN STEARATE

Sponsor: ANI PHARMS

APPLICATION

ANDA061591

TYPE

ANDA

ORIGINAL APPROVAL

1972-09-08

LATEST ACTION

2014-05-29

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

ERYTHROMYCIN STEARATEDiscontinued

ERYTHROMYCIN STEARATE EQ 250MG BASE · TABLET · ORAL

2014-05-29Labeling · Supplement 23 · standardAP

1998-12-01Manufacturing (CMC) · Supplement 22AP

1994-12-23Manufacturing (CMC) · Supplement 21AP

1994-10-11Manufacturing (CMC) · Supplement 20AP

1993-07-16Labeling · Supplement 19AP

1992-05-01Manufacturing (CMC) · Supplement 14AP

1992-04-03Manufacturing (CMC) · Supplement 18AP

1992-04-03Manufacturing (CMC) · Supplement 16AP

1991-05-22Labeling · Supplement 12AP

1991-05-22Labeling · Supplement 15AP

1990-11-26Manufacturing (CMC) · Supplement 13AP

1972-09-08OriginalAP

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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