FDA — authorised 5 June 2002
- Application: ANDA089424
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Aldactone in United States
FDA authorised Aldactone on 5 June 2002
Marketing authorisations
FDA — authorised 22 September 2014
- Application: ANDA040750
- Marketing authorisation holder: OXFORD PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 1 May 2015
- Application: NDA012151
- Marketing authorisation holder: PFIZER
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 4 August 2017
- Application: NDA209478
- Marketing authorisation holder: CMP DEV LLC
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 21 February 2025
- Application: ANDA218085
- Marketing authorisation holder: HETERO LABS LTD III
- Status: approved
Aldactone 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 Aldactone approved in United States?
Yes. FDA authorised it on 5 June 2002; FDA authorised it on 22 September 2014; FDA authorised it on 1 May 2015.
Who is the marketing authorisation holder for Aldactone in United States?
SUN PHARM INDUSTRIES holds the US marketing authorisation.