APPLICATION
ANDA203601
TYPE
ANDA
ORIGINAL APPROVAL
2013-01-30
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 22AP
2025-12-22Labeling · Supplement 20 · standardAP
2025-01-29Labeling · Supplement 16 · standardAP
2024-10-31REMS · Supplement 17AP
2023-12-15Labeling · Supplement 12 · standardAP
2021-03-04Labeling · Supplement 8 · standardAP
2021-02-19Labeling · Supplement 3 · standardAP
2018-09-18REMS · Supplement 5AP
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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