APPLICATION
ANDA077822
TYPE
ANDA
ORIGINAL APPROVAL
2008-07-24
LATEST ACTION
2008-07-24
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)
Products
OXYCODONE HYDROCHLORIDENone (Tentative Approval)
OXYCODONE HYDROCHLORIDE 40MG · TABLET, EXTENDED RELEASE · ORAL
OXYCODONE HYDROCHLORIDENone (Tentative Approval)
OXYCODONE HYDROCHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
OXYCODONE HYDROCHLORIDENone (Tentative Approval)
OXYCODONE HYDROCHLORIDE 80MG · TABLET, EXTENDED RELEASE · ORAL
OXYCODONE HYDROCHLORIDENone (Tentative Approval)
OXYCODONE HYDROCHLORIDE 20MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2008-07-24OriginalAP
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.