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FDA ANDA · ANDA089451

ESGIC-PLUS

Sponsor: MIKART

APPLICATION
ANDA089451
TYPE
ANDA
ORIGINAL APPROVAL
1988-05-23
LATEST ACTION
2002-08-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ESGIC-PLUSDiscontinued
ACETAMINOPHEN 500MG, BUTALBITAL 50MG, CAFFEINE 40MG · TABLET · ORAL

Approval history

2002-08-13Manufacturing (CMC) · Supplement 34AP
2001-03-28Manufacturing (CMC) · Supplement 33AP
2000-09-11Labeling · Supplement 30AP
1998-07-31Manufacturing (CMC) · Supplement 31AP
1998-06-26Manufacturing (CMC) · Supplement 32AP
1998-04-06Manufacturing (CMC) · Supplement 28AP
1998-04-06Manufacturing (CMC) · Supplement 29AP
1997-07-16Manufacturing (CMC) · Supplement 24AP
1997-07-16Manufacturing (CMC) · Supplement 27AP
1997-07-16Manufacturing (CMC) · Supplement 25AP
1997-04-25Labeling · Supplement 26AP
1996-11-20Labeling · Supplement 23AP
1995-10-16Manufacturing (CMC) · Supplement 22AP
1995-10-16Manufacturing (CMC) · Supplement 21AP
1995-08-21Manufacturing (CMC) · Supplement 20AP
1995-02-08Manufacturing (CMC) · Supplement 19AP
1993-08-11Labeling · Supplement 18AP
1993-02-25Manufacturing (CMC) · Supplement 16AP
1993-02-25Labeling · Supplement 14AP
1993-02-25Manufacturing (CMC) · Supplement 12AP
1993-02-25Labeling · Supplement 17AP
1993-02-25Manufacturing (CMC) · Supplement 15AP
1993-02-25Manufacturing (CMC) · Supplement 13AP
1992-04-03Manufacturing (CMC) · Supplement 10AP
1992-01-31Labeling · Supplement 11AP
1992-01-13Manufacturing (CMC) · Supplement 8AP
1992-01-13Manufacturing (CMC) · Supplement 6AP
1992-01-13Labeling · Supplement 9AP
1992-01-13Labeling · Supplement 7AP
1990-03-27Manufacturing (CMC) · Supplement 4AP
1989-10-12Bioequivalence · Supplement 5AP
1988-11-29Manufacturing (CMC) · Supplement 1AP
1988-11-29Manufacturing (CMC) · Supplement 2AP
1988-05-23OriginalAP
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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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