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FDA NDA · NDA021611

OPANA

Sponsor: ENDO PHARMS

APPLICATION
NDA021611
TYPE
NDA
ORIGINAL APPROVAL
2006-06-22
LATEST ACTION
2019-10-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

OPANA · ReferenceDiscontinued
OXYMORPHONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
OPANA · ReferenceDiscontinued
OXYMORPHONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2019-10-25Efficacy · Supplement 16 · standard — Label ↗AP
2019-10-07Labeling · Supplement 17 · standard — Label ↗AP
2018-09-18Labeling · Supplement 15 · standard — Letter ↗AP
2018-09-18REMS · Supplement 13 — Letter ↗AP
2016-12-22Manufacturing (CMC) · Supplement 11 · standardAP
2016-12-16Labeling · Supplement 10 · standard — Letter ↗AP
2013-09-17Manufacturing (CMC) · Supplement 8 · standardAP
2012-07-09Labeling · Supplement 7 · standard — Letter ↗AP
2011-02-03Labeling · Supplement 5 · standard — Label ↗AP
2010-04-15Labeling · Supplement 4 · standard — Letter ↗AP
2006-08-02Labeling · Supplement 1 · standard — Letter ↗AP
2006-06-22Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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