← FDA DRUG APPROVALS

FDA ANDA · ANDA089971

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: VINTAGE PHARMS

APPLICATION
ANDA089971
TYPE
ANDA
ORIGINAL APPROVAL
1988-12-02
LATEST ACTION
2002-11-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL

Approval history

2002-11-18Labeling · Supplement 14AP
1997-05-30Labeling · Supplement 4AP
1997-05-30Manufacturing (CMC) · Supplement 12AP
1997-05-30Manufacturing (CMC) · Supplement 10AP
1997-05-30Manufacturing (CMC) · Supplement 9AP
1997-05-30Manufacturing (CMC) · Supplement 7AP
1997-05-30Manufacturing (CMC) · Supplement 5AP
1997-05-30Manufacturing (CMC) · Supplement 11AP
1997-05-30Manufacturing (CMC) · Supplement 8AP
1997-05-30Manufacturing (CMC) · Supplement 6AP
1996-09-13Labeling · Supplement 3AP
1992-06-25Labeling · Supplement 2AP
1988-12-02OriginalAP
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 →