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FDA ANDA · ANDA088758

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Sponsor: MALLINCKRODT

APPLICATION
ANDA088758
TYPE
ANDA
ORIGINAL APPROVAL
1985-03-27
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 25AP
1992-03-20Labeling · Supplement 23AP
1988-06-03Labeling · Supplement 19AP
1985-03-27OriginalAP
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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