← FDA Drug Approvals (Drugs@FDA)
OPANA ER
NDA · New Drug Application · Sponsor: ENDO OPERATIONS · Approved 2006-06-22
Drug application
- FDA Application #
NDA021610
- 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 OPERATIONS
- First approval
- 2006-06-22
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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