APPLICATION
ANDA089067
TYPE
ANDA
ORIGINAL APPROVAL
1985-04-19
LATEST ACTION
1994-04-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEDiscontinued
ACETAMINOPHEN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG · CAPSULE · ORAL
Approval history
1994-04-13Labeling · Supplement 19AP
1994-04-13Labeling · Supplement 20AP
1993-05-17Labeling · Supplement 16AP
1992-04-08Labeling · Supplement 17AP
1990-04-05Labeling · Supplement 13AP
1989-09-11Labeling · Supplement 12AP
1989-03-31Labeling · Supplement 5AP
1985-04-19OriginalAP
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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