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OPANA ER

NDA · New Drug Application · Sponsor: ENDO PHARMS · Approved 2011-12-09

Drug application

FDA Application #

NDA201655

Application type

New Drug Application

Brand name

OPANA ER

Generic name

Oxymorphone Hydrochloride

Active ingredients

OXYMORPHONE HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Discontinued

Sponsor

ENDO PHARMS

First approval

2011-12-09

Source

Authoritative

Drugs@FDA application overview

Machine

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