APPLICATION
ANDA079087
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-14
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
OXYMORPHONE HYDROCHLORIDEPrescription
OXYMORPHONE HYDROCHLORIDE 30MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEPrescription
OXYMORPHONE HYDROCHLORIDE 15MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEPrescription
OXYMORPHONE HYDROCHLORIDE 7.5MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEPrescription
OXYMORPHONE HYDROCHLORIDE 40MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEPrescription
OXYMORPHONE HYDROCHLORIDE 20MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEPrescription
OXYMORPHONE HYDROCHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEPrescription
OXYMORPHONE HYDROCHLORIDE 5MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-06-18REMS · Supplement 52AP
2025-12-29Labeling · Supplement 50 · standardAP
2025-10-17Labeling · Supplement 47 · standardAP
2024-10-31REMS · Supplement 48AP
2023-12-15Labeling · Supplement 46 · standardAP
2023-12-15Labeling · Supplement 44 · standardAP
2023-12-15Labeling · Supplement 45 · standardAP
2023-12-15Labeling · Supplement 43 · standardAP
2021-03-04Labeling · Supplement 42 · standardAP
2019-10-11Labeling · Supplement 38 · standardAP
2018-09-28Labeling · Supplement 28 · standardAP
2018-09-20Labeling · Supplement 35 · standardAP
2018-09-18REMS · Supplement 32AP
2017-05-26REMS · Supplement 29AP
2016-12-16Labeling · Supplement 24 · standardAP
2016-12-16Labeling · Supplement 27 · standardAP
2016-12-15Labeling · Supplement 21 · standardAP
2016-09-30REMS · Supplement 26AP
2016-04-20REMS · Supplement 20AP
2015-06-26REMS · Supplement 18AP
2014-08-19REMS · Supplement 17AP
2014-04-16Labeling · Supplement 12 · standardAP
2013-04-15REMS · Supplement 6AP
2012-10-12REMS · Supplement 5AP
2012-10-12REMS · Supplement 4AP
2012-05-22Labeling · Supplement 1AP
2010-12-21OriginalAP
2010-07-22OriginalAP
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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