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