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FDA ANDA · ANDA040272

OXYCODONE AND ACETAMINOPHEN

Sponsor: DURAMED PHARMS BARR

APPLICATION
ANDA040272
TYPE
ANDA
ORIGINAL APPROVAL
1998-06-30
LATEST ACTION
2002-08-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

OXYCODONE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2002-08-13Manufacturing (CMC) · Supplement 2AP
2002-08-13Manufacturing (CMC) · Supplement 3AP
1999-06-29Manufacturing (CMC) · Supplement 1AP
1998-06-30Original — Review ↗AP
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.

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