Composition
- Active ingredients
- OXYMORPHONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- OXYMORPHONE HYDROCHLORIDE 1MG/ML · InjectableNDA011707-002 · Discontinued
- OXYMORPHONE HYDROCHLORIDE 1.5MG/ML · InjectableNDA011707-001 · Discontinued
- OXYMORPHONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletThis page
- OXYMORPHONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA021611-001 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA021611.
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
- Active substance
- oxymorphone hydrochloride
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Endo Pharms
- Status
- Discontinued
- FDA approval
- 22 Jun 2006
- Application
- NDA021611-002