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Medicines · US (FDA)
Opioids

FDA 2011

Natural opium alkaloids

Opana ER

Approved 9 Dec 2011OralTablet, extended release

The FDA lists this product in 14 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: OXYMORPHONE HYDROCHLORIDE 30MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

OXYMORPHONE HYDROCHLORIDE 40MG · Tablet, extended releaseNDA201655-007 · Discontinued
OXYMORPHONE HYDROCHLORIDE 20MG · Tablet, extended releaseNDA201655-005 · Discontinued
OXYMORPHONE HYDROCHLORIDE 10MG · Tablet, extended releaseNDA201655-003 · Discontinued
OXYMORPHONE HYDROCHLORIDE 5MG · Tablet, extended releaseNDA201655-001 · Discontinued
OXYMORPHONE HYDROCHLORIDE 30MG · Tablet, extended releaseThis page
OXYMORPHONE HYDROCHLORIDE 15MG · Tablet, extended releaseNDA201655-004 · Discontinued
OXYMORPHONE HYDROCHLORIDE 7.5MG · Tablet, extended releaseNDA201655-002 · Discontinued
OXYMORPHONE HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, extended releaseNDA021610-007 · Discontinued
OXYMORPHONE HYDROCHLORIDE 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, extended releaseNDA021610-005 · Discontinued

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OXYMORPHONE HYDROCHLORIDE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, extended releaseNDA021610-003 · Discontinued

OXYMORPHONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, extended releaseNDA021610-001 · Discontinued

OXYMORPHONE HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, extended releaseNDA021610-006 · Discontinued

OXYMORPHONE HYDROCHLORIDE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, extended releaseNDA021610-004 · Discontinued

OXYMORPHONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Tablet, extended releaseNDA021610-002 · Discontinued

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application NDA201655.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Opana ER
Active substance: oxymorphone hydrochloride
Drug class: Natural opium alkaloids
Group: Opioids
Route: Oral
Dosage form: Tablet, extended release
Applicant: Endo Pharms
Status: Discontinued
FDA approval: 9 Dec 2011
Application: NDA201655-006
RxCUI: 82064

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