FDA — authorised 23 July 2012
- Application: NDA202450
- Marketing authorisation holder: AZURITY
- Local brand name: TUDORZA PRESSAIR
- Indication: POWDER, METERED — INHALATION
- Status: approved
🇺🇸 Tudorza Pressair in United States
FDA authorised Tudorza Pressair on 23 July 2012
Marketing authorisations
FDA — authorised 29 March 2019
- Application: NDA210595
- Marketing authorisation holder: AZURITY
- Indication: Type 4 - New Combination
- Status: approved
Tudorza Pressair 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 Tudorza Pressair approved in United States?
Yes. FDA authorised it on 23 July 2012; FDA authorised it on 29 March 2019.
Who is the marketing authorisation holder for Tudorza Pressair in United States?
AZURITY holds the US marketing authorisation.