FDA — authorised 8 January 2014
- Application: ANDA078710
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: TELMISARTAN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 High dose of Micardis®, once daily in United States
FDA authorised High dose of Micardis®, once daily on 8 January 2014
Marketing authorisations
FDA — authorised 7 July 2014
- Application: ANDA203171
- Marketing authorisation holder: TORRENT
- Local brand name: TELMISARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 2014
- Application: ANDA090032
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: TELMISARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 2014
- Application: ANDA202130
- Marketing authorisation holder: ALEMBIC
- Local brand name: TELMISARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 2014
- Application: ANDA203325
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: TELMISARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 September 2015
- Application: ANDA206511
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: TELMISARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 September 2015
- Application: ANDA204415
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: TELMISARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 October 2015
- Application: ANDA205150
- Marketing authorisation holder: INVENTIA
- Local brand name: TELMISARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 April 2016
- Application: ANDA205901
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: TELMISARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 August 2016
- Application: ANDA204164
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: TELMISARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 May 2017
- Application: ANDA207882
- Marketing authorisation holder: PRINSTON INC
- Local brand name: TELMISARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 July 2017
- Application: ANDA208605
- Marketing authorisation holder: CADILA PHARMS LTD
- Local brand name: TELMISARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 February 2019
- Application: ANDA207843
- Marketing authorisation holder: HISUN PHARM HANGZHOU
- Local brand name: TELMISARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2024
- Application: ANDA218157
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: TELMISARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2025
- Application: ANDA203986
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: TELMISARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
High dose of Micardis®, once daily 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 High dose of Micardis®, once daily approved in United States?
Yes. FDA authorised it on 8 January 2014; FDA authorised it on 7 July 2014; FDA authorised it on 7 July 2014.
Who is the marketing authorisation holder for High dose of Micardis®, once daily in United States?
CHARTWELL RX holds the US marketing authorisation.