← FDA DRUG APPROVALS

FDA ANDA · ANDA040219

OXYCODONE AND ACETAMINOPHEN

Sponsor: MUTUAL PHARM

APPLICATION
ANDA040219
TYPE
ANDA
ORIGINAL APPROVAL
1998-01-22
LATEST ACTION
2002-07-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

OXYCODONE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 500MG, OXYCODONE HYDROCHLORIDE 5MG · CAPSULE · ORAL

Approval history

2002-07-24Manufacturing (CMC) · Supplement 9AP
2002-02-08Manufacturing (CMC) · Supplement 7AP
2001-11-02Manufacturing (CMC) · Supplement 5AP
2001-09-24Manufacturing (CMC) · Supplement 6AP
2000-12-18Manufacturing (CMC) · Supplement 3AP
2000-12-18Manufacturing (CMC) · Supplement 1AP
2000-12-18Manufacturing (CMC) · Supplement 4AP
2000-12-18Manufacturing (CMC) · Supplement 2AP
1998-01-22OriginalAP
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 →