FDA — authorised 30 January 2004
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Status: approved
🇺🇸 Spiriva in United States
FDA authorised Spiriva on 30 January 2004
Marketing authorisations
FDA — authorised 17 December 2009
- Application: NDA021395
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Efficacy
- Status: approved
FDA — authorised 16 June 2015
- Application: NDA206756
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Labeling
- Status: approved
FDA — authorised 15 September 2015
- Application: NDA207070
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval
- Status: approved
FDA — authorised 15 February 2017
- Application: NDA021936
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Efficacy
- Status: approved
FDA — authorised 20 June 2023
- Application: ANDA211287
- Marketing authorisation holder: LUPIN
- Status: approved
Spiriva 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 Spiriva approved in United States?
Yes. FDA authorised it on 30 January 2004; FDA authorised it on 17 December 2009; FDA authorised it on 16 June 2015.
Who is the marketing authorisation holder for Spiriva in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.