FDA — authorised 25 April 2002
- Marketing authorisation holder: DAIICHI SANKYO
- Status: approved
🇺🇸 Benicar in United States
FDA authorised Benicar on 25 April 2002
Marketing authorisations
FDA — authorised 26 October 2016
- Application: ANDA078276
- Marketing authorisation holder: RISING
- Local brand name: OLMESARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
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 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: ANDA204814
- Marketing authorisation holder: MACLEODS PHARMS LTD
- 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: ANDA205192
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: OLMESARTAN MEDOXOMIL
- 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: ANDA206763
- Marketing authorisation holder: ALKEM LABS LTD
- 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 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 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
The FDA approved the new drug application (ANDA207437) for OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE (Benicar) on 24 November 2025. This approval allows Micro Labs to market the combination tablet for oral use in the United States. The approval was granted through the standard expedited pathway.
Benicar 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 Benicar approved in United States?
Yes. FDA authorised it on 25 April 2002; FDA authorised it on 26 October 2016; FDA authorised it on 26 October 2016.
Who is the marketing authorisation holder for Benicar in United States?
DAIICHI SANKYO holds the US marketing authorisation.