FDA — authorised 31 July 2014
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Status: approved
🇺🇸 Striverdi Respimat in United States
FDA authorised Striverdi Respimat on 31 July 2014
Marketing authorisations
FDA — authorised 31 July 2014
- Application: NDA203108
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Type 1 - New Molecular Entity
- Status: approved
FDA — authorised 16 June 2015
- Application: NDA206756
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Labeling
- Status: approved
Striverdi Respimat in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in United States
Frequently asked questions
Is Striverdi Respimat approved in United States?
Yes. FDA authorised it on 31 July 2014; FDA authorised it on 31 July 2014; FDA authorised it on 16 June 2015.
Who is the marketing authorisation holder for Striverdi Respimat in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.