← FDA DRUG APPROVALS

FDA ANDA · ANDA040143

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: VINTAGE PHARMS

APPLICATION
ANDA040143
TYPE
ANDA
ORIGINAL APPROVAL
1996-02-22
LATEST ACTION
2002-11-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 650MG, HYDROCODONE BITARTRATE 10MG · TABLET · ORAL

Approval history

2002-11-18Labeling · Supplement 8AP
1997-04-25Manufacturing (CMC) · Supplement 1AP
1996-02-22OriginalAP
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 →