APPLICATION
ANDA200822
TYPE
ANDA
ORIGINAL APPROVAL
2013-07-15
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 15MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 7.5MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 40MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 20MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 5MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 30MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-06-18REMS · Supplement 22AP
2025-12-22Labeling · Supplement 21 · standardAP
2025-10-21Labeling · Supplement 19 · standardAP
2024-10-31REMS · Supplement 20AP
2023-12-15Labeling · Supplement 18 · standardAP
2023-12-12Labeling · Supplement 17 · standardAP
2023-12-12Labeling · Supplement 16 · standardAP
2021-03-04Labeling · Supplement 15 · standardAP
2019-10-09Labeling · Supplement 14 · standardAP
2018-09-21Labeling · Supplement 13 · standardAP
2018-09-18REMS · Supplement 12AP
2017-05-26REMS · Supplement 11AP
2017-03-10Labeling · Supplement 8 · standardAP
2017-03-10Labeling · Supplement 9 · standardAP
2016-09-30REMS · Supplement 10AP
2016-04-20REMS · Supplement 6AP
2015-06-26REMS · Supplement 4AP
2014-08-19REMS · Supplement 3AP
2014-04-16Labeling · Supplement 1 · standardAP
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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