APPLICATION
ANDA089536
TYPE
ANDA
ORIGINAL APPROVAL
1988-02-16
LATEST ACTION
2015-11-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEDiscontinued
ACETAMINOPHEN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG · TABLET · ORAL
Approval history
2015-11-03Labeling · Supplement 25AP
2003-09-29Labeling · Supplement 24AP
2002-09-05Manufacturing (CMC) · Supplement 22AP
2002-07-24Manufacturing (CMC) · Supplement 20AP
2002-07-24Manufacturing (CMC) · Supplement 23AP
2002-05-03Manufacturing (CMC) · Supplement 21AP
2002-02-08Manufacturing (CMC) · Supplement 18AP
2002-02-08Manufacturing (CMC) · Supplement 17AP
2001-11-02Manufacturing (CMC) · Supplement 15AP
2001-09-24Manufacturing (CMC) · Supplement 16AP
2000-12-18Manufacturing (CMC) · Supplement 14AP
2000-12-18Manufacturing (CMC) · Supplement 12AP
2000-12-18Manufacturing (CMC) · Supplement 13AP
2000-12-18Manufacturing (CMC) · Supplement 11AP
2000-08-08Manufacturing (CMC) · Supplement 10AP
1997-06-02Manufacturing (CMC) · Supplement 5AP
1997-02-04Manufacturing (CMC) · Supplement 9AP
1994-08-16Labeling · Supplement 8AP
1992-05-08Labeling · Supplement 7AP
1991-08-16Labeling · Supplement 6AP
1988-02-16OriginalAP
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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