FDA — authorised 29 October 2010
- Application: NDA021879
- Marketing authorisation holder: AVANIR PHARMS
- Status: supplemented
🇺🇸 Nuedexta in United States
FDA authorised Nuedexta on 29 October 2010
Marketing authorisations
FDA — authorised 10 October 2017
- Application: ANDA202934
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA202993
- Marketing authorisation holder: PAR PHARM INC
- Local brand name: DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
- Indication: CAPSULE — ORAL
- Status: approved
Nuedexta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Nuedexta approved in United States?
Yes. FDA authorised it on 29 October 2010; FDA authorised it on 10 October 2017; FDA has authorised it.
Who is the marketing authorisation holder for Nuedexta in United States?
AVANIR PHARMS holds the US marketing authorisation.