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FDA ANDA · ANDA040289

OXYCODONE AND ACETAMINOPHEN

Sponsor: DURAMED PHARMS BARR

APPLICATION
ANDA040289
TYPE
ANDA
ORIGINAL APPROVAL
1999-03-16
LATEST ACTION
2002-04-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2002-04-12Manufacturing (CMC) · Supplement 5AP
2002-04-12Manufacturing (CMC) · Supplement 3AP
2002-04-12Manufacturing (CMC) · Supplement 6AP
2002-04-12Manufacturing (CMC) · Supplement 4AP
2001-08-31Manufacturing (CMC) · Supplement 2AP
1999-05-20Manufacturing (CMC) · Supplement 1AP
1999-03-16Original — Letter ↗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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