← FDA DRUG APPROVALS

FDA NDA · NDA020932

ROXICODONE

Sponsor: ROXANE

APPLICATION
NDA020932
TYPE
NDA
ORIGINAL APPROVAL
1998-10-26
LATEST ACTION
1998-10-26
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ROXICODONEDiscontinued
OXYCODONE HYDROCHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
ROXICODONEDiscontinued
OXYCODONE HYDROCHLORIDE 30MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

1998-10-26Type 3 - New Dosage Form · Original · standard — 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.

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 →