FDA — authorised 30 March 2012
- Application: ANDA077369
- Marketing authorisation holder: TEVA
- Local brand name: IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Irbesartan and Hydrochlorothiazide in United States
FDA authorised Irbesartan and Hydrochlorothiazide on 30 March 2012 · 507 US adverse-event reports
Marketing authorisations
FDA — authorised 27 September 2012
- Application: ANDA202414
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: supplemented
FDA — authorised 27 September 2012
- Application: ANDA077969
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2012
- Application: ANDA077446
- Marketing authorisation holder: SANDOZ
- Local brand name: IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2012
- Application: ANDA201505
- Marketing authorisation holder: APOTEX INC
- Local brand name: IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2012
- Application: ANDA090351
- Marketing authorisation holder: HIKMA
- Local brand name: IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2012
- Application: ANDA091370
- Marketing authorisation holder: ALEMBIC
- Status: supplemented
FDA — authorised 22 October 2012
- Application: ANDA091539
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 February 2013
- Application: ANDA203630
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 2013
- Application: ANDA201524
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 May 2014
- Application: ANDA203072
- Marketing authorisation holder: PRINSTON INC
- Local brand name: IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2016
- Application: ANDA203036
- Marketing authorisation holder: ATLAS PHARMS LLC
- Local brand name: IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 October 2016
- Application: ANDA207896
- Marketing authorisation holder: HISUN PHARM HANGZHOU
- Local brand name: IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 September 2017
- Application: ANDA207018
- Marketing authorisation holder: UNICHEM
- Status: supplemented
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 507
Most-reported reactions
- Dizziness — 69 reports (13.61%)
- Hyponatraemia — 61 reports (12.03%)
- Fatigue — 60 reports (11.83%)
- Nausea — 51 reports (10.06%)
- Malaise — 48 reports (9.47%)
- Drug Ineffective — 45 reports (8.88%)
- Vomiting — 45 reports (8.88%)
- Dyspnoea — 44 reports (8.68%)
- Fall — 43 reports (8.48%)
- Asthenia — 41 reports (8.09%)
Irbesartan 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 Irbesartan and Hydrochlorothiazide 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 Irbesartan and Hydrochlorothiazide in United States?
TEVA holds the US marketing authorisation.