← FDA DRUG APPROVALS

FDA ANDA · ANDA040109

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE

Sponsor: MIKART

APPLICATION
ANDA040109
TYPE
ANDA
ORIGINAL APPROVAL
1997-08-26
LATEST ACTION
2002-08-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATEDiscontinued
ACETAMINOPHEN 356.4MG, CAFFEINE 30MG, DIHYDROCODEINE BITARTRATE 16MG · CAPSULE · ORAL

Approval history

2002-08-13Manufacturing (CMC) · Supplement 4AP
2000-07-14Labeling · Supplement 3AP
1998-07-31Manufacturing (CMC) · Supplement 2AP
1998-03-31Manufacturing (CMC) · Supplement 1AP
1997-08-26OriginalAP
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 →