FDA — authorised 2 November 1990
- Marketing authorisation holder: PFIZER
- Status: approved
🇺🇸 Cardura in United States
FDA authorised Cardura on 2 November 1990
Marketing authorisations
FDA — authorised 8 July 2011
- Application: ANDA075509
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Indication: Labeling
- Status: approved
FDA — authorised 28 July 2014
- Application: NDA019668
- Marketing authorisation holder: VIATRIS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 22 June 2021
- Application: NDA021269
- Marketing authorisation holder: VIATRIS
- Indication: Labeling
- Status: approved
FDA — authorised 15 March 2022
- Application: ANDA212727
- Marketing authorisation holder: RISING
- Status: approved
FDA — authorised 10 January 2024
- Application: ANDA212329
- Marketing authorisation holder: UNICHEM
- Status: approved
Cardura 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 Cardura approved in United States?
Yes. FDA authorised it on 2 November 1990; FDA authorised it on 8 July 2011; FDA authorised it on 28 July 2014.
Who is the marketing authorisation holder for Cardura in United States?
PFIZER holds the US marketing authorisation.