FDA — authorised 5 May 1959
- Application: NDA011878
- Marketing authorisation holder: NOVARTIS
- Local brand name: SERPASIL-ESIDRIX #1
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 amlodipine and olmesartan in United States
FDA authorised amlodipine and olmesartan on 5 May 1959 · 119 US adverse-event reports
Marketing authorisations
FDA — authorised 27 January 1961
- Application: NDA012616
- Marketing authorisation holder: PFIZER
- Local brand name: ALDACTAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 December 1962
- Application: NDA013402
- Marketing authorisation holder: MERCK
- Local brand name: ALDORIL D30
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 December 1965
- Application: NDA016042
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Local brand name: DYAZIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 October 1974
- Application: ANDA083972
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 1975
- Application: ANDA084580
- Marketing authorisation holder: BARR
- Local brand name: RESERPINE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 1975
- Application: ANDA084658
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 1975
- Application: ANDA084579
- Marketing authorisation holder: BARR
- Local brand name: RESERPINE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 March 1977
- Application: ANDA083965
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 June 1977
- Application: ANDA085672
- Marketing authorisation holder: ABC HOLDING
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 July 1977
- Application: ANDA085098
- Marketing authorisation holder: IMPAX LABS
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 August 1977
- Application: ANDA085683
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 August 1977
- Application: ANDA083607
- Marketing authorisation holder: IMPAX LABS
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 September 1977
- Application: ANDA085022
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 January 1978
- Application: ANDA085182
- Marketing authorisation holder: HERITAGE
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 1978
- Application: ANDA085004
- Marketing authorisation holder: ROXANE
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 1978
- Application: ANDA085005
- Marketing authorisation holder: ROXANE
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 July 1978
- Application: ANDA086087
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 October 1978
- Application: ANDA086594
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 October 1978
- Application: ANDA086597
- Marketing authorisation holder: PVT FORM
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 June 1979
- Application: NDA018031
- Marketing authorisation holder: WYETH PHARMS INC
- Local brand name: INDERIDE-80/25
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 August 1979
- Application: ANDA086513
- Marketing authorisation holder: MYLAN
- Local brand name: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 November 1979
- Application: ANDA084714
- Marketing authorisation holder: ABC HOLDING
- Local brand name: HYDRO-RESERP
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 November 1980
- Application: ANDA087068
- Marketing authorisation holder: OXFORD PHARMS
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 November 1980
- Application: ANDA087059
- Marketing authorisation holder: OXFORD PHARMS
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 November 1980
- Application: ANDA087060
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 1981
- Application: ANDA085213
- Marketing authorisation holder: SANDOZ
- Local brand name: HYDRO-SERP "50"
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 1981
- Application: ANDA087267
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 August 1981
- Application: ANDA085054
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 August 1981
- Application: ANDA085208
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 December 1981
- Application: ANDA087610
- Marketing authorisation holder: VANGARD
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 December 1981
- Application: NDA018061
- Marketing authorisation holder: MERCK
- Local brand name: TIMOLIDE 10-25
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 December 1981
- Application: ANDA087655
- Marketing authorisation holder: VANGARD
- Local brand name: SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 March 1982
- Application: ANDA087565
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 July 1982
- Application: ANDA086369
- Marketing authorisation holder: ALRA
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 July 1982
- Application: ANDA083554
- Marketing authorisation holder: ALRA
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 1983
- Application: ANDA087511
- Marketing authorisation holder: LEDERLE
- Local brand name: SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 April 1983
- Application: ANDA086026
- Marketing authorisation holder: WATSON LABS
- Local brand name: SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 May 1984
- Application: ANDA088200
- Marketing authorisation holder: SANDOZ
- Local brand name: RESERPINE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 1984
- Application: ANDA088588
- Marketing authorisation holder: ROXANE
- Local brand name: HYDROCHLOROTHIAZIDE INTENSOL
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 22 October 1984
- Application: NDA019129
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: MAXZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 December 1984
- Application: ANDA088829
- Marketing authorisation holder: SUPERPHARM
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 December 1984
- Application: ANDA088828
- Marketing authorisation holder: SUPERPHARM
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 December 1984
- Application: ANDA088827
- Marketing authorisation holder: SUPERPHARM
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 December 1984
- Application: NDA018303
- Marketing authorisation holder: VALIDUS PHARMS
- Local brand name: LOPRESSOR HCT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 February 1985
- Application: ANDA088924
- Marketing authorisation holder: TEVA
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 February 1985
- Application: ANDA088923
- Marketing authorisation holder: TEVA
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 November 1985
- Application: ANDA087999
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 April 1986
- Application: ANDA070301
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 April 1986
- Application: ANDA070305
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 October 1986
- Application: ANDA070705
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 February 1987
- Application: ANDA070614
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 April 1987
- Application: ANDA070947
- Marketing authorisation holder: RISING
- Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 1987
- Application: ANDA071060
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 1987
- Application: ANDA071061
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 December 1987
- Application: ANDA071251
- Marketing authorisation holder: APOTEX INC
- Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 January 1988
- Application: ANDA071771
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 March 1988
- Application: ANDA072043
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 April 1988
- Application: ANDA071821
- Marketing authorisation holder: TEVA
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 April 1988
- Application: ANDA071822
- Marketing authorisation holder: TEVA
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 April 1988
- Application: ANDA071820
- Marketing authorisation holder: TEVA
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 April 1988
- Application: ANDA071819
- Marketing authorisation holder: TEVA
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 November 1988
- Application: ANDA071851
- Marketing authorisation holder: WATSON LABS
- Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 January 1989
- Application: ANDA070959
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 January 1989
- Application: ANDA071069
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 February 1989
- Application: ANDA070960
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 February 1989
- Application: ANDA070958
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 February 1989
- Application: NDA019778
- Marketing authorisation holder: MERCK
- Local brand name: PRINZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 June 1989
- Application: ANDA072509
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 June 1989
- Application: ANDA072508
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 June 1989
- Application: ANDA072507
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 June 1989
- Application: ANDA072510
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 July 1989
- Application: NDA019888
- Marketing authorisation holder: ALMATICA
- Local brand name: ZESTORETIC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 January 1992
- Application: ANDA081190
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 January 1992
- Application: ANDA081189
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 September 1993
- Application: ANDA073449
- Marketing authorisation holder: WATSON LABS
- Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 1995
- Application: ANDA074259
- Marketing authorisation holder: ANI PHARMS
- Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 January 1996
- Application: ANDA073467
- Marketing authorisation holder: ANI PHARMS
- Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 June 1997
- Application: ANDA074821
- Marketing authorisation holder: SANDOZ
- Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 January 1998
- Application: ANDA074970
- Marketing authorisation holder: ANI PHARMS
- Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 March 1998
- Application: NDA020818
- Marketing authorisation holder: NOVARTIS
- Local brand name: DIOVAN HCT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 December 1999
- Application: NDA020125
- Marketing authorisation holder: PFIZER PHARMS
- Local brand name: ACCURETIC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 November 2000
- Application: NDA021162
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: MICARDIS HCT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 August 2004
- Application: ANDA076792
- Marketing authorisation holder: MYLAN
- Local brand name: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 March 2005
- Application: ANDA077093
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2007
- Application: ANDA040810
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 July 2007
- Application: ANDA040807
- Marketing authorisation holder: IPCA LABS LTD
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 September 2007
- Application: ANDA040809
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 2007
- Application: NDA022100
- Marketing authorisation holder: COSETTE
- Local brand name: AZOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 August 2008
- Application: ANDA040907
- Marketing authorisation holder: UNICHEM
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 September 2008
- Application: ANDA090096
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 April 2009
- Application: ANDA079237
- Marketing authorisation holder: IPCA LABS LTD
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 January 2010
- Application: ANDA090510
- Marketing authorisation holder: UNICHEM
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 April 2010
- Application: ANDA077157
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 April 2010
- Application: ANDA077732
- Marketing authorisation holder: HIKMA
- Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 April 2010
- Application: ANDA090528
- Marketing authorisation holder: TORRENT PHARMS
- Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 May 2010
- Application: ANDA078245
- Marketing authorisation holder: LUPIN LTD
- Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 August 2010
- Application: ANDA077948
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 January 2011
- Application: ANDA200180
- Marketing authorisation holder: WATSON LABS
- Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 August 2012
- Application: ANDA202289
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 September 2012
- Application: ANDA201845
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 September 2012
- Application: ANDA078020
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 2012
- Application: ANDA202556
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 March 2013
- Application: ANDA201682
- Marketing authorisation holder: IPCA LABS LTD
- Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 March 2013
- Application: ANDA091524
- Marketing authorisation holder: APOTEX
- Local brand name: QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 March 2013
- Application: ANDA078946
- Marketing authorisation holder: LUPIN LTD
- Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 March 2013
- Application: ANDA091519
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 March 2013
- Application: ANDA202519
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 March 2013
- Application: ANDA201662
- Marketing authorisation holder: ALEMBIC
- Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 November 2013
- Application: ANDA202870
- Marketing authorisation holder: ALEMBIC
- Local brand name: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 March 2014
- Application: ANDA202150
- Marketing authorisation holder: HERITAGE
- Local brand name: MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 October 2016
- Application: ANDA206884
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: supplemented
FDA — authorised 15 May 2017
- Application: ANDA206906
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
FDA — authorised 5 July 2017
- Application: ANDA207807
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Status: approved
FDA — authorised 21 July 2017
- Application: ANDA204832
- Marketing authorisation holder: UNICHEM
- Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 November 2017
- Application: ANDA207435
- Marketing authorisation holder: MICRO LABS
- Status: approved
FDA — authorised 29 June 2018
- Application: ANDA208360
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 January 2019
- Application: ANDA203561
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 February 2019
- Application: ANDA208358
- Marketing authorisation holder: CADILA
- Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 February 2022
- Application: ANDA216211
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 August 2023
- Application: ANDA204382
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 February 2025
- Application: ANDA209591
- Marketing authorisation holder: HETERO LABS LTD V
- Status: approved
FDA — authorised 23 April 2026
- Application: ANDA204687
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved a new drug application (ANDA204687) from SCIEGEN PHARMS for amlodipine and olmesartan tablets on 23 April 2026. This approval allows SCIEGEN PHARMS to market the drug in the United States. The approved indication is for oral administration, but the specific local brand name is not provided in the FDA database.
FDA
- Application: ANDA085152
- Marketing authorisation holder: ELKINS SINN
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087638
- Marketing authorisation holder: VANGARD
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA074857
- Marketing authorisation holder: NOVARTIS
- Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA087651
- Marketing authorisation holder: USL PHARMA
- Local brand name: SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA018872
- Marketing authorisation holder: NOVARTIS
- Local brand name: VISKAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087540
- Marketing authorisation holder: ASCOT
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071772
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087539
- Marketing authorisation holder: ASCOT
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087553
- Marketing authorisation holder: UPSHER SMITH
- Local brand name: SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084135
- Marketing authorisation holder: HEATHER
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070368
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085112
- Marketing authorisation holder: MYLAN
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070688
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084029
- Marketing authorisation holder: IMPAX LABS
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088025
- Marketing authorisation holder: ASCOT
- Local brand name: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070366
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085974
- Marketing authorisation holder: WATSON LABS
- Local brand name: SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070689
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070367
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070365
- Marketing authorisation holder: WATSON LABS
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087948
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087587
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087586
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071459
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085099
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084536
- Marketing authorisation holder: ROXANE
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071458
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086504
- Marketing authorisation holder: HALSEY
- Local brand name: HYDRO-D
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071460
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071461
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089661
- Marketing authorisation holder: MORTON GROVE
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA071737
- Marketing authorisation holder: VITARINE
- Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA083458
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083456
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA201616
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: HYDROCHLOROTHIAZIDE; IRBESARTAN
- Indication: TABLET — ORAL
- 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: 119
Most-reported reactions
- Drug Ineffective — 22 reports (18.49%)
- Dizziness — 13 reports (10.92%)
- Hypertension — 12 reports (10.08%)
- Hypotension — 12 reports (10.08%)
- Diarrhoea — 11 reports (9.24%)
- Fatigue — 11 reports (9.24%)
- Toxicity To Various Agents — 11 reports (9.24%)
- Acute Kidney Injury — 9 reports (7.56%)
- Blood Pressure Increased — 9 reports (7.56%)
- Drug Interaction — 9 reports (7.56%)
amlodipine and olmesartan 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 amlodipine and olmesartan approved in United States?
Yes. FDA authorised it on 5 May 1959; FDA authorised it on 27 January 1961; FDA authorised it on 20 December 1962.
Who is the marketing authorisation holder for amlodipine and olmesartan in United States?
NOVARTIS holds the US marketing authorisation.