← FDA DRUG APPROVALS

FDA NDA · NDA021610

OPANA ER

Sponsor: ENDO OPERATIONS

APPLICATION
NDA021610
TYPE
NDA
ORIGINAL APPROVAL
2006-06-22
LATEST ACTION
2024-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

OPANA ER · ReferenceDiscontinued
OXYMORPHONE HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
OPANA ER · ReferenceDiscontinued
OXYMORPHONE HYDROCHLORIDE 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
OPANA ER · ReferenceDiscontinued
OXYMORPHONE HYDROCHLORIDE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
OPANA ER · ReferenceDiscontinued
OXYMORPHONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
OPANA ER · ReferenceDiscontinued
OXYMORPHONE HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
OPANA ER · ReferenceDiscontinued
OXYMORPHONE HYDROCHLORIDE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
OPANA ER · ReferenceDiscontinued
OXYMORPHONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-10-31REMS · Supplement 32 — Letter ↗AP
2023-12-15Labeling · Supplement 31 · standard — Label ↗AP
2022-04-28Labeling · Supplement 30 · standard — Label ↗AP
2021-03-04Labeling · Supplement 28 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 27 · standard — Label ↗AP
2018-09-18REMS · Supplement 25 — Letter ↗AP
2018-09-18Labeling · Supplement 26 · standard — Letter ↗AP
2017-05-26REMS · Supplement 24 — Letter ↗AP
2016-12-16Labeling · Supplement 22 · standard — Letter ↗AP
2016-09-30REMS · Supplement 23 — Letter ↗AP
2016-04-20REMS · Supplement 21 — Letter ↗AP
2015-06-26REMS · Supplement 20 — Letter ↗AP
2014-08-19REMS · Supplement 19 — Letter ↗AP
2014-04-16Labeling · Supplement 18 · 901 required — Label ↗AP
2014-02-23Manufacturing (CMC) · Supplement 17 · standardAP
2013-04-15REMS · Supplement 14 — Letter ↗AP
2012-07-09REMS · Supplement 12 — Letter ↗AP
2012-07-09Labeling · Supplement 13 · unknown — Label ↗AP
2010-10-04Labeling · Supplement 9 · standard — Label ↗AP
2008-02-29Manufacturing (CMC) · Supplement 6 — Letter ↗AP
2008-01-10Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2007-07-09Labeling · Supplement 3 · standard — Label ↗AP
2006-08-02Labeling · Supplement 1 · standard — Letter ↗AP
2006-06-22Type 3 - New Dosage Form · Original · standard — 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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