← FDA DRUG APPROVALS

FDA ANDA · ANDA089007

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA089007
TYPE
ANDA
ORIGINAL APPROVAL
1986-03-17
LATEST ACTION
2013-10-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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

Approval history

2013-10-18Labeling · Supplement 44 · standardAP
2011-06-22Labeling · Supplement 43AP
2003-05-08Labeling · Supplement 38AP
2002-08-13Manufacturing (CMC) · Supplement 37AP
2001-03-28Manufacturing (CMC) · Supplement 36AP
2001-03-23Labeling · Supplement 31AP
1998-07-31Manufacturing (CMC) · Supplement 35AP
1998-04-06Manufacturing (CMC) · Supplement 34AP
1998-04-06Manufacturing (CMC) · Supplement 32AP
1998-04-06Manufacturing (CMC) · Supplement 30AP
1998-04-06Manufacturing (CMC) · Supplement 33AP
1996-03-22Labeling · Supplement 29AP
1995-09-15Manufacturing (CMC) · Supplement 28AP
1995-02-08Manufacturing (CMC) · Supplement 27AP
1993-10-15Labeling · Supplement 26AP
1992-06-04Manufacturing (CMC) · Supplement 12AP
1991-12-03Labeling · Supplement 24AP
1990-12-31Manufacturing (CMC) · Supplement 22AP
1990-12-31Manufacturing (CMC) · Supplement 20AP
1990-12-31Labeling · Supplement 23AP
1990-12-31Manufacturing (CMC) · Supplement 21AP
1989-04-14Manufacturing (CMC) · Supplement 19AP
1988-11-03Manufacturing (CMC) · Supplement 18AP
1988-11-03Manufacturing (CMC) · Supplement 10AP
1988-11-03Manufacturing (CMC) · Supplement 17AP
1988-10-26Labeling · Supplement 16AP
1988-10-26Labeling · Supplement 15AP
1988-09-20Labeling · Supplement 14AP
1988-03-29Manufacturing (CMC) · Supplement 9AP
1988-03-29Manufacturing (CMC) · Supplement 7AP
1988-03-29Manufacturing (CMC) · Supplement 5AP
1988-03-29Manufacturing (CMC) · Supplement 3AP
1988-03-29Manufacturing (CMC) · Supplement 8AP
1988-03-29Manufacturing (CMC) · Supplement 6AP
1988-03-29Manufacturing (CMC) · Supplement 13AP
1987-06-02Manufacturing (CMC) · Supplement 11AP
1986-05-19Manufacturing (CMC) · Supplement 1AP
1986-05-19Manufacturing (CMC) · Supplement 2AP
1986-03-17OriginalAP
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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