← FDA DRUG APPROVALS

FDA ANDA · ANDA088765

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Sponsor: GRAHAM DM

APPLICATION
ANDA088765
TYPE
ANDA
ORIGINAL APPROVAL
1985-03-27
LATEST ACTION
1992-07-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

1992-07-15Labeling · Supplement 16AP
1992-07-15Labeling · Supplement 15AP
1990-03-23Labeling · Supplement 14AP
1989-06-20Labeling · Supplement 12AP
1985-03-27OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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