← FDA DRUG APPROVALS

FDA ANDA · ANDA040601

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA040601
TYPE
ANDA
ORIGINAL APPROVAL
2005-07-29
LATEST ACTION
2013-10-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2013-10-18Labeling · Supplement 5 · standardAP
2011-06-27Labeling · Supplement 4AP
2005-07-29OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →