FDA — authorised 30 March 2012
- Application: ANDA077159
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Any antihypertensive medication alone or in combination in United States
FDA authorised Any antihypertensive medication alone or in combination on 30 March 2012
Marketing authorisations
FDA — authorised 27 September 2012
- Application: ANDA077466
- Marketing authorisation holder: SANDOZ
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2012
- Application: ANDA203161
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2012
- Application: ANDA079213
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2012
- Application: ANDA202910
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 October 2012
- Application: ANDA202254
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2012
- Application: ANDA201531
- Marketing authorisation holder: LUPIN LTD
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2012
- Application: ANDA200832
- Marketing authorisation holder: APOTEX INC
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2012
- Application: ANDA091236
- Marketing authorisation holder: ALEMBIC PHARMS LTD
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2012
- Application: ANDA090201
- Marketing authorisation holder: HIKMA
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
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: 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 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 7 December 2015
- Application: ANDA204774
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 2015
- Application: ANDA203685
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: IRBESARTAN
- 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 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 22 May 2024
- Application: ANDA211056
- Marketing authorisation holder: IPCA LABS LTD
- Local brand name: IRBESARTAN
- 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 — authorised 4 November 2025
- Application: ANDA219539
- Marketing authorisation holder: MSN
- Local brand name: IRBESARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Any antihypertensive medication alone or in combination 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 Any antihypertensive medication alone or in combination approved in United States?
Yes. FDA authorised it on 30 March 2012; FDA authorised it on 27 September 2012; FDA authorised it on 27 September 2012.
Who is the marketing authorisation holder for Any antihypertensive medication alone or in combination in United States?
TEVA PHARMS holds the US marketing authorisation.