FDA — authorised 13 July 2005
- Application: NDA021286
- Marketing authorisation holder: COSETTE
- Indication: Labeling
- Status: approved
🇺🇸 olmesartan medoxomil-hydrochlorothiazide in United States
FDA authorised olmesartan medoxomil-hydrochlorothiazide on 13 July 2005
Marketing authorisations
FDA — authorised 28 September 2012
- Application: NDA200175
- Marketing authorisation holder: COSETTE
- Indication: Labeling
- Status: approved
FDA — authorised 26 October 2016
- Application: ANDA206884
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
FDA — authorised 28 December 2020
- Application: ANDA206906
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 27 June 2022
- Application: ANDA203012
- Marketing authorisation holder: ALEMBIC
- Indication: Labeling
- Status: approved
FDA
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
olmesartan medoxomil-hydrochlorothiazide in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is olmesartan medoxomil-hydrochlorothiazide approved in United States?
Yes. FDA authorised it on 13 July 2005; FDA authorised it on 28 September 2012; FDA authorised it on 26 October 2016.
Who is the marketing authorisation holder for olmesartan medoxomil-hydrochlorothiazide in United States?
COSETTE holds the US marketing authorisation.