FDA — authorised 5 June 2003
- Application: NDA021532
- Marketing authorisation holder: COSETTE
- Local brand name: BENICAR HCT
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Olmesartan medoxomil and hydrochlorothiazide in United States
FDA authorised Olmesartan medoxomil and hydrochlorothiazide on 5 June 2003
Marketing authorisations
FDA — authorised 26 October 2016
- Application: ANDA078827
- Marketing authorisation holder: NATCO PHARMA USA
- Local brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 2017
- Application: ANDA204233
- Marketing authorisation holder: ALEMBIC
- Local brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 2017
- Application: ANDA205391
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 2017
- Application: ANDA207804
- Marketing authorisation holder: PRINSTON INC
- Local brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 May 2017
- Application: ANDA206515
- Marketing authorisation holder: TORRENT
- Local brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 February 2019
- Application: ANDA209281
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 February 2023
- Application: ANDA206377
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 June 2023
- Application: ANDA204801
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 July 2024
- Application: ANDA207037
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 July 2025
- Application: ANDA209199
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 August 2025
- Application: ANDA214427
- Marketing authorisation holder: HANGZHOU BINJIANG
- Local brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 2025
- Application: ANDA217398
- Marketing authorisation holder: MSN
- Local brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 March 2026
- Application: ANDA208465
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 April 2026
- Application: ANDA206371
- Marketing authorisation holder: MICRO LABS
- Local brand name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved the new drug application (ANDA206371) for Olmesartan medoxomil and hydrochlorothiazide on 13 April 2026. This approval allows Micro Labs to market the combination tablet for oral administration. The drug is indicated for the treatment of hypertension.
FDA
- Status: approved
Olmesartan medoxomil and hydrochlorothiazide in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Olmesartan medoxomil and hydrochlorothiazide approved in United States?
Yes. FDA authorised it on 5 June 2003; FDA authorised it on 26 October 2016; FDA authorised it on 24 April 2017.
Who is the marketing authorisation holder for Olmesartan medoxomil and hydrochlorothiazide in United States?
COSETTE holds the US marketing authorisation.