FDA — authorised 29 December 1986
- Status: approved
🇺🇸 Atrovent in United States
FDA authorised Atrovent on 29 December 1986
Marketing authorisations
FDA — authorised 5 November 2003
- Application: ANDA076598
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 20 May 2013
- Application: ANDA075693
- Marketing authorisation holder: RITEDOSE CORP
- Indication: Labeling
- Status: approved
FDA — authorised 27 October 2016
- Application: ANDA206543
- Marketing authorisation holder: LUOXIN AUROVITAS
- Status: approved
FDA — authorised 9 July 2020
- Application: ANDA206532
- Marketing authorisation holder: LUOXIN AUROVITAS
- Status: approved
FDA — authorised 23 February 2026
- Application: ANDA217953
- Marketing authorisation holder: ARMSTRONG PHARMS
- Status: approved
Atrovent in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Atrovent approved in United States?
Yes. FDA authorised it on 29 December 1986; FDA authorised it on 5 November 2003; FDA authorised it on 20 May 2013.
Who is the marketing authorisation holder for Atrovent in United States?
Marketing authorisation holder not available in our data.