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FDA ANDA · ANDA062759

ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL

Sponsor: BARR

APPLICATION
ANDA062759
TYPE
ANDA
ORIGINAL APPROVAL
1988-05-20
LATEST ACTION
2015-12-16
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Discontinued

Products

ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYLDiscontinued
ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML, SULFISOXAZOLE ACETYL EQ 600MG BASE/5ML · GRANULE · ORAL

Approval history

2015-12-16Labeling · Supplement 35 · standardAP
1999-12-21Manufacturing (CMC) · Supplement 29AP
1999-05-20Manufacturing (CMC) · Supplement 28AP
1998-12-01Manufacturing (CMC) · Supplement 27AP
1998-01-26Manufacturing (CMC) · Supplement 26AP
1996-02-08Manufacturing (CMC) · Supplement 25AP
1995-02-06Manufacturing (CMC) · Supplement 14AP
1995-02-06Manufacturing (CMC) · Supplement 13AP
1995-02-06Manufacturing (CMC) · Supplement 11AP
1995-02-01Manufacturing (CMC) · Supplement 20AP
1995-02-01Labeling · Supplement 10AP
1994-12-23Manufacturing (CMC) · Supplement 24AP
1994-02-03Manufacturing (CMC) · Supplement 23AP
1993-11-08Labeling · Supplement 21AP
1993-07-28Labeling · Supplement 22AP
1992-04-03Manufacturing (CMC) · Supplement 19AP
1992-04-03Manufacturing (CMC) · Supplement 17AP
1992-01-13Labeling · Supplement 16AP
1990-10-30Manufacturing (CMC) · Supplement 15AP
1989-03-31Manufacturing (CMC) · Supplement 6AP
1989-03-08Manufacturing (CMC) · Supplement 4AP
1989-03-08Manufacturing (CMC) · Supplement 5AP
1988-05-20OriginalAP
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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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