APPLICATION
ANDA204459
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-26
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 13AP
2025-12-31Labeling · Supplement 12 · standardAP
2024-10-31REMS · Supplement 11AP
2024-05-01Labeling · Supplement 9 · standardAP
2024-05-01Labeling · Supplement 7 · standardAP
2024-05-01Labeling · Supplement 10 · standardAP
2024-05-01Labeling · Supplement 8 · standardAP
2021-03-04Labeling · Supplement 5 · standardAP
2021-02-16Labeling · Supplement 3 · standardAP
2021-02-16Labeling · Supplement 1 · standardAP
2021-02-16Labeling · Supplement 4 · standardAP
2018-09-18REMS · Supplement 2AP
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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