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FDA ANDA · ANDA079046

OXYMORPHONE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH

APPLICATION
ANDA079046
TYPE
ANDA
ORIGINAL APPROVAL
2010-12-13
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 30MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 15MG · 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 5MG · TABLET, EXTENDED RELEASE · ORAL
OXYMORPHONE HYDROCHLORIDEDiscontinued
OXYMORPHONE HYDROCHLORIDE 7.5MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-06-18REMS · Supplement 40AP
2026-01-05Labeling · Supplement 39 · standardAP
2025-11-12Labeling · Supplement 36 · standardAP
2024-10-31REMS · Supplement 37AP
2023-12-15Labeling · Supplement 34 · standardAP
2023-12-15Labeling · Supplement 35 · standardAP
2023-12-12Labeling · Supplement 33 · standardAP
2021-03-04Labeling · Supplement 32 · standardAP
2019-10-10Labeling · Supplement 30 · standardAP
2019-10-10Labeling · Supplement 31 · standardAP
2018-09-21Labeling · Supplement 29 · standardAP
2018-09-18REMS · Supplement 28AP
2017-05-26REMS · Supplement 27AP
2016-12-16Labeling · Supplement 26 · standardAP
2016-12-16Labeling · Supplement 24 · standardAP
2016-09-30REMS · Supplement 25AP
2016-04-20REMS · Supplement 23AP
2015-06-26REMS · Supplement 21AP
2014-11-21Manufacturing (CMC) · Supplement 11 · unknownAP
2014-08-19REMS · Supplement 18AP
2014-04-17Manufacturing (CMC) · Supplement 16 · unknownAP
2014-04-16Labeling · Supplement 13 · standard — Label ↗AP
2013-07-11OriginalAP
2013-04-15REMS · Supplement 8AP
2012-07-09REMS · Supplement 4AP
2010-12-13Original — Other ↗AP
VIEW ON DRUGS@FDA ↗

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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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