APPLICATION
ANDA091443
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-15
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OXYMORPHONE HYDROCHLORIDEPrescription
OXYMORPHONE HYDROCHLORIDE 10MG · TABLET · ORAL
OXYMORPHONE HYDROCHLORIDEPrescription
OXYMORPHONE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 19AP
2025-12-29Labeling · Supplement 18 · standardAP
2025-10-10Labeling · Supplement 16 · standardAP
2024-10-31REMS · Supplement 17AP
2023-12-15Labeling · Supplement 14 · standardAP
2023-12-15Labeling · Supplement 15 · standardAP
2023-12-13Labeling · Supplement 11 · standardAP
2021-04-01Labeling · Supplement 10 · standardAP
2021-04-01Labeling · Supplement 7 · standardAP
2018-09-18REMS · Supplement 9AP
2014-05-16Labeling · Supplement 3 · standardAP
2011-05-11Labeling · Supplement 1AP
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.