FDA — authorised 24 September 2014
- Application: NDA021936
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: SPIRIVA RESPIMAT
- Indication: SPRAY, METERED — INHALATION
- Status: approved
🇺🇸 Spiriva® Respimat® in United States
FDA authorised Spiriva® Respimat® on 24 September 2014
Marketing authorisations
FDA — authorised 15 September 2015
- Application: NDA207070
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: SPIRIVA RESPIMAT
- Indication: SPRAY — INHALATION
- Status: approved
FDA
- Status: approved
Spiriva® Respimat® 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 Spiriva® Respimat® approved in United States?
Yes. FDA authorised it on 24 September 2014; FDA authorised it on 15 September 2015; FDA has authorised it.
Who is the marketing authorisation holder for Spiriva® Respimat® in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.