FDA — authorised 2 April 1959
- Application: NDA011707
- Marketing authorisation holder: ENDO PHARMS
- Local brand name: OPANA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Oxymorphone ER in United States
FDA authorised Oxymorphone ER on 2 April 1959
Marketing authorisations
FDA — authorised 22 June 2006
- Application: NDA021610
- Marketing authorisation holder: ENDO OPERATIONS
- Local brand name: OPANA ER
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 June 2006
- Application: NDA021611
- Marketing authorisation holder: ENDO PHARMS
- Local brand name: OPANA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 December 2011
- Application: NDA201655
- Marketing authorisation holder: ENDO PHARMS
- Local brand name: OPANA ER
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
Oxymorphone ER in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Oxymorphone ER approved in United States?
Yes. FDA authorised it on 2 April 1959; FDA authorised it on 22 June 2006; FDA authorised it on 22 June 2006.
Who is the marketing authorisation holder for Oxymorphone ER in United States?
ENDO PHARMS holds the US marketing authorisation.