FDA — authorised 26 October 2016
- Application: ANDA206137
- Marketing authorisation holder: PH HEALTH
- Local brand name: OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Losartan, Losartan and HCTZ, Amlodipine , Spironolactone in United States
FDA authorised Losartan, Losartan and HCTZ, Amlodipine , Spironolactone on 26 October 2016
Marketing authorisations
FDA — authorised 26 October 2016
- Application: ANDA203580
- Marketing authorisation holder: TORRENT
- Local brand name: OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 October 2016
- Application: ANDA078276
- Marketing authorisation holder: RISING
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 November 2016
- Application: ANDA202491
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 2017
- Application: ANDA204798
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 2017
- Application: ANDA205482
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 2017
- Application: ANDA206763
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 2017
- Application: ANDA207662
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 2017
- Application: ANDA203012
- Marketing authorisation holder: ALEMBIC
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 2017
- Application: ANDA202375
- Marketing authorisation holder: TORRENT
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 2017
- Application: ANDA204814
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 2017
- Application: ANDA205192
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 May 2017
- Application: ANDA203281
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 January 2019
- Application: ANDA210552
- Marketing authorisation holder: QILU
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 February 2019
- Application: ANDA211049
- Marketing authorisation holder: SUNSHINE
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 July 2019
- Application: ANDA207135
- Marketing authorisation holder: UMEDICA
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 September 2019
- Application: ANDA206372
- Marketing authorisation holder: MICRO LABS
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 April 2020
- Application: ANDA090237
- Marketing authorisation holder: SANDOZ
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 May 2020
- Application: ANDA208659
- Marketing authorisation holder: INVENTIA
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 December 2022
- Application: ANDA206720
- Marketing authorisation holder: PRINSTON INC
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 January 2023
- Application: ANDA217399
- Marketing authorisation holder: MSN
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 July 2023
- Application: ANDA207480
- Marketing authorisation holder: AMNEAL
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 January 2024
- Application: ANDA206227
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 2024
- Application: ANDA205499
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 November 2024
- Application: ANDA210682
- Marketing authorisation holder: CADILA PHARMS LTD
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2025
- Application: ANDA210718
- Marketing authorisation holder: PIRAMAL
- Local brand name: OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 July 2025
- Application: ANDA207088
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 November 2025
- Application: ANDA207437
- Marketing authorisation holder: MICRO LABS
- Local brand name: OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Losartan, Losartan and HCTZ, Amlodipine , Spironolactone 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 Losartan, Losartan and HCTZ, Amlodipine , Spironolactone approved in United States?
Yes. FDA authorised it on 26 October 2016; FDA authorised it on 26 October 2016; FDA authorised it on 26 October 2016.
Who is the marketing authorisation holder for Losartan, Losartan and HCTZ, Amlodipine , Spironolactone in United States?
PH HEALTH holds the US marketing authorisation.