← FDA DRUG APPROVALS

FDA ANDA · ANDA040139

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN

Sponsor: WATSON LABS

APPLICATION
ANDA040139
TYPE
ANDA
ORIGINAL APPROVAL
1996-12-16
LATEST ACTION
2002-03-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 650MG, PROPOXYPHENE HYDROCHLORIDE 65MG · TABLET · ORAL

Approval history

2002-03-27Manufacturing (CMC) · Supplement 7AP
2001-04-18Manufacturing (CMC) · Supplement 5AP
2001-04-18Manufacturing (CMC) · Supplement 4AP
2000-03-21Manufacturing (CMC) · Supplement 6AP
1998-08-21Manufacturing (CMC) · Supplement 3AP
1997-07-08Manufacturing (CMC) · Supplement 1AP
1996-12-16OriginalAP
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 →