APPLICATION
ANDA201187
TYPE
ANDA
ORIGINAL APPROVAL
2014-12-15
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OXYMORPHONE HYDROCHLORIDEPrescription
OXYMORPHONE HYDROCHLORIDE 5MG · TABLET · ORAL
OXYMORPHONE HYDROCHLORIDEPrescription
OXYMORPHONE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 16AP
2025-12-23Labeling · Supplement 15 · standardAP
2025-11-17Labeling · Supplement 14 · standardAP
2024-10-31REMS · Supplement 13AP
2023-12-15Labeling · Supplement 12 · standardAP
2023-12-13Labeling · Supplement 11 · standardAP
2021-03-04Labeling · Supplement 10 · standardAP
2021-02-16Labeling · Supplement 2 · standardAP
2021-02-16Labeling · Supplement 7 · standardAP
2021-02-16Labeling · Supplement 5 · standardAP
2018-09-18REMS · Supplement 4AP
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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