FDA — authorised 25 February 2011
- Application: NDA200796
- Marketing authorisation holder: AZURITY
- Local brand name: EDARBI
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Azilsartan medoxomil and chlorthalidone in United States
FDA authorised Azilsartan medoxomil and chlorthalidone on 25 February 2011 · 1 US adverse-event reports
Marketing authorisations
FDA — authorised 20 July 2022
- Application: ANDA214489
- Marketing authorisation holder: LUPIN
- Local brand name: AZILSARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 January 2025
- Application: ANDA217490
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA219062
- Marketing authorisation holder: HETERO LABS LIMITED
- Local brand name: AZILSARTAN MEDOXOMIL
- Indication: TABLET
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 1
Most-reported reactions
- Constipation — 1 report (100%)
Other Cardiovascular approved in United States
Frequently asked questions
Is Azilsartan medoxomil and chlorthalidone approved in United States?
Yes. FDA authorised it on 25 February 2011; FDA authorised it on 20 July 2022; FDA authorised it on 21 January 2025.
Who is the marketing authorisation holder for Azilsartan medoxomil and chlorthalidone in United States?
AZURITY holds the US marketing authorisation.