← FDA DRUG APPROVALS

FDA ANDA · ANDA089067

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Sponsor: GRAHAM DM

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
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →