APPLICATION
ANDA087804
TYPE
ANDA
ORIGINAL APPROVAL
1985-01-24
LATEST ACTION
2013-10-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEDiscontinued
ACETAMINOPHEN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG · TABLET · ORAL
Approval history
2013-10-18Labeling · Supplement 39 · standardAP
2012-01-20Labeling · Supplement 38AP
2006-10-10Labeling · Supplement 34AP
2002-10-21Labeling · Supplement 30AP
2002-08-26Manufacturing (CMC) · Supplement 29AP
2002-08-26Manufacturing (CMC) · Supplement 28AP
2000-07-26Manufacturing (CMC) · Supplement 27AP
1998-11-23Manufacturing (CMC) · Supplement 24AP
1998-11-23Labeling · Supplement 25AP
1998-08-19Labeling · Supplement 26AP
1996-06-20Manufacturing (CMC) · Supplement 7AP
1994-09-29Manufacturing (CMC) · Supplement 21AP
1994-06-13Labeling · Supplement 20AP
1994-03-16Labeling · Supplement 19AP
1993-05-27Labeling · Supplement 18AP
1992-09-03Manufacturing (CMC) · Supplement 6AP
1992-09-03Manufacturing (CMC) · Supplement 10AP
1992-07-16Labeling · Supplement 16AP
1989-11-21Labeling · Supplement 12AP
1988-08-24Labeling · Supplement 11AP
1988-05-18Labeling · Supplement 9AP
1985-01-24OriginalAP
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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