← FDA DRUG APPROVALS

FDA ANDA · ANDA089175

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Sponsor: MIKART

APPLICATION
ANDA089175
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-21
LATEST ACTION
2013-10-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BUTALBITAL, ACETAMINOPHEN AND CAFFEINEPrescription
ACETAMINOPHEN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG · TABLET · ORAL

Approval history

2013-10-18Labeling · Supplement 45 · standardAP
2011-06-22Labeling · Supplement 44AP
2009-06-22Labeling · Supplement 42AP
2002-11-20Labeling · Supplement 35AP
2002-08-13Manufacturing (CMC) · Supplement 34AP
2001-03-28Manufacturing (CMC) · Supplement 33AP
1998-07-31Manufacturing (CMC) · Supplement 31AP
1998-06-26Manufacturing (CMC) · Supplement 32AP
1997-06-27Manufacturing (CMC) · Supplement 27AP
1997-06-27Manufacturing (CMC) · Supplement 25AP
1997-06-27Labeling · Supplement 28AP
1997-06-27Manufacturing (CMC) · Supplement 26AP
1997-06-27Manufacturing (CMC) · Supplement 24AP
1997-01-15Manufacturing (CMC) · Supplement 30AP
1997-01-15Manufacturing (CMC) · Supplement 29AP
1996-03-25Manufacturing (CMC) · Supplement 20AP
1996-03-25Manufacturing (CMC) · Supplement 19AP
1995-10-16Manufacturing (CMC) · Supplement 22AP
1995-10-16Manufacturing (CMC) · Supplement 23AP
1995-08-18Manufacturing (CMC) · Supplement 21AP
1995-02-08Manufacturing (CMC) · Supplement 18AP
1993-11-17Labeling · Supplement 16AP
1993-11-17Labeling · Supplement 17AP
1993-11-17Manufacturing (CMC) · Supplement 15AP
1992-01-31Labeling · Supplement 13AP
1991-08-02Manufacturing (CMC) · Supplement 7AP
1991-08-02Labeling · Supplement 8AP
1989-07-14Labeling · Supplement 12AP
1989-07-14Labeling · Supplement 11AP
1989-06-02Manufacturing (CMC) · Supplement 10AP
1988-12-30Manufacturing (CMC) · Supplement 9AP
1988-07-12Labeling · Supplement 6AP
1988-05-20Manufacturing (CMC) · Supplement 5AP
1988-05-20Manufacturing (CMC) · Supplement 3AP
1988-05-20Manufacturing (CMC) · Supplement 4AP
1988-05-20Manufacturing (CMC) · Supplement 2AP
1987-11-02Manufacturing (CMC) · Supplement 1AP
1987-01-21OriginalAP
VIEW ON DRUGS@FDA ↗

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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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