APPLICATION
ANDA088743
TYPE
ANDA
ORIGINAL APPROVAL
1985-07-18
LATEST ACTION
1996-10-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEDiscontinued
ACETAMINOPHEN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG · CAPSULE · ORAL
Approval history
1996-10-24Labeling · Supplement 17AP
1996-10-24Labeling · Supplement 16AP
1996-02-16Labeling · Supplement 13AP
1992-03-20Labeling · Supplement 12AP
1989-03-31Labeling · Supplement 2AP
1989-02-07Labeling · Supplement 10AP
1985-07-18OriginalAP
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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