FDA — authorised 18 December 2002
- Application: ANDA075424
- Marketing authorisation holder: TARO
- Indication: Labeling
- Status: approved
🇺🇸 Cordarone in United States
FDA authorised Cordarone on 18 December 2002
Marketing authorisations
FDA — authorised 3 May 2005
- Application: ANDA075389
- Marketing authorisation holder: DR REDDYS LABS SA
- Indication: Labeling
- Status: approved
FDA — authorised 15 January 2009
- Application: ANDA077161
- Marketing authorisation holder: GLAND PHARMA LTD
- Indication: Labeling
- Status: approved
FDA — authorised 31 May 2013
- Application: ANDA076362
- Marketing authorisation holder: TARO
- Indication: Labeling
- Status: approved
FDA — authorised 25 October 2017
- Application: ANDA204550
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
Cordarone 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 Cordarone approved in United States?
Yes. FDA authorised it on 18 December 2002; FDA authorised it on 3 May 2005; FDA authorised it on 15 January 2009.
Who is the marketing authorisation holder for Cordarone in United States?
TARO holds the US marketing authorisation.