APPLICATION
ANDA077290
TYPE
ANDA
ORIGINAL APPROVAL
2005-12-08
LATEST ACTION
2018-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 20MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 10MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 30MG · TABLET · ORAL
OXYCODONE HYDROCHLORIDEDiscontinued
OXYCODONE HYDROCHLORIDE 15MG · TABLET · ORAL
Approval history
2018-09-18REMS · Supplement 24AP
2015-04-27Labeling · Supplement 7 · standardAP
2009-04-29Labeling · Supplement 6AP
2005-12-08OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.