FDA — authorised 22 June 2021
- Application: ANDA207306
- Marketing authorisation holder: CIPLA
- Status: approved
🇺🇸 Brovana in United States
FDA authorised Brovana on 22 June 2021
Marketing authorisations
FDA — authorised 22 June 2021
- Application: ANDA213762
- Marketing authorisation holder: SLATE RUN PHARMA
- Status: approved
FDA — authorised 9 November 2021
- Application: ANDA200293
- Marketing authorisation holder: TEVA PHARMS USA
- Indication: Not Applicable
- Status: approved
FDA — authorised 26 May 2022
- Application: ANDA215385
- Marketing authorisation holder: SUN PHARM
- Status: approved
FDA — authorised 7 March 2025
- Application: ANDA218555
- Marketing authorisation holder: MICRO LABS
- Status: approved
Brovana in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Brovana approved in United States?
Yes. FDA authorised it on 22 June 2021; FDA authorised it on 22 June 2021; FDA authorised it on 9 November 2021.
Who is the marketing authorisation holder for Brovana in United States?
CIPLA holds the US marketing authorisation.