🇺🇸 Aggressive Blood Pressure control in United States

FDA authorised Aggressive Blood Pressure control on 12 February 1959

Marketing authorisations

FDA — authorised 12 February 1959

  • Application: NDA011793
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: ESIDRIX
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 5 May 1959

  • Application: NDA011878
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: SERPASIL-ESIDRIX #1
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 6 July 1959

  • Application: NDA011971
  • Marketing authorisation holder: ABBVIE
  • Local brand name: ORETIC
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 27 January 1961

  • Application: NDA012616
  • Marketing authorisation holder: PFIZER
  • Local brand name: ALDACTAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 20 December 1962

  • Application: NDA013402
  • Marketing authorisation holder: MERCK
  • Local brand name: ALDORIL D30
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 2 December 1965

  • Application: NDA016042
  • Marketing authorisation holder: GLAXOSMITHKLINE LLC
  • Local brand name: DYAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 12 January 1973

  • Application: ANDA083177
  • Marketing authorisation holder: IVAX SUB TEVA PHARMS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 16 May 1974

  • Application: NDA011958
  • Marketing authorisation holder: MERCK
  • Local brand name: HYDROPRES 50
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 2 July 1974

  • Application: ANDA083809
  • Marketing authorisation holder: WHITEWORTH TOWN PLSN
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 3 October 1974

  • Application: ANDA083972
  • Marketing authorisation holder: SUN PHARM INDUSTRIES
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 24 January 1975

  • Application: ANDA083232
  • Marketing authorisation holder: WATSON LABS TEVA
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 30 May 1975

  • Application: ANDA084580
  • Marketing authorisation holder: BARR
  • Local brand name: RESERPINE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 24 September 1975

  • Application: ANDA084658
  • Marketing authorisation holder: IVAX SUB TEVA PHARMS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 30 September 1975

  • Application: ANDA084579
  • Marketing authorisation holder: BARR
  • Local brand name: RESERPINE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 24 June 1976

  • Application: ANDA084324
  • Marketing authorisation holder: LANNETT CO INC
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 24 June 1976

  • Application: ANDA084325
  • Marketing authorisation holder: LANNETT CO INC
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 21 September 1976

  • Application: ANDA084776
  • Marketing authorisation holder: INWOOD LABS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 17 December 1976

  • Application: ANDA084912
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 31 January 1977

  • Application: ANDA084878
  • Marketing authorisation holder: HIKMA INTL PHARMS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 21 March 1977

  • Application: ANDA083965
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 1 April 1977

  • Application: ANDA084771
  • Marketing authorisation holder: BARR
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 27 April 1977

  • Application: ANDA085233
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 3 May 1977

  • Application: ANDA085232
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 1 June 1977

  • Application: ANDA085323
  • Marketing authorisation holder: SOLVAY
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 2 June 1977

  • Application: ANDA085672
  • Marketing authorisation holder: ABC HOLDING
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 15 July 1977

  • Application: ANDA085098
  • Marketing authorisation holder: IMPAX LABS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 17 August 1977

  • Application: ANDA085683
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 19 August 1977

  • Application: ANDA083607
  • Marketing authorisation holder: IMPAX LABS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 1 September 1977

  • Application: ANDA085022
  • Marketing authorisation holder: IVAX SUB TEVA PHARMS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 20 January 1978

  • Application: ANDA085182
  • Marketing authorisation holder: HERITAGE
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 26 January 1978

  • Application: ANDA085347
  • Marketing authorisation holder: WHITEWORTH TOWN PLSN
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 10 April 1978

  • Application: ANDA085338
  • Marketing authorisation holder: WHITEWORTH TOWN PLSN
  • Local brand name: H.R.-50
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 13 July 1978

  • Application: ANDA085005
  • Marketing authorisation holder: ROXANE
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 13 July 1978

  • Application: ANDA085004
  • Marketing authorisation holder: ROXANE
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 17 July 1978

  • Application: ANDA086087
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 5 October 1978

  • Application: ANDA086594
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 11 October 1978

  • Application: ANDA086597
  • Marketing authorisation holder: PVT FORM
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 12 March 1979

  • Application: ANDA085219
  • Marketing authorisation holder: AUROLIFE PHARMA LLC
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 15 June 1979

  • Application: NDA018031
  • Marketing authorisation holder: WYETH PHARMS INC
  • Local brand name: INDERIDE-80/25
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 3 August 1979

  • Application: ANDA086513
  • Marketing authorisation holder: MYLAN
  • Local brand name: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 20 November 1979

  • Application: ANDA084714
  • Marketing authorisation holder: ABC HOLDING
  • Local brand name: HYDRO-RESERP
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 10 July 1980

  • Application: ANDA086881
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 5 November 1980

  • Application: ANDA087068
  • Marketing authorisation holder: OXFORD PHARMS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 5 November 1980

  • Application: ANDA087060
  • Marketing authorisation holder: DAVA PHARMS INC
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 5 November 1980

  • Application: ANDA087059
  • Marketing authorisation holder: OXFORD PHARMS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 16 April 1981

  • Application: ANDA087267
  • Marketing authorisation holder: MUTUAL PHARM
  • Local brand name: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 16 April 1981

  • Application: ANDA084827
  • Marketing authorisation holder: SANDOZ
  • Local brand name: HYDRO-SERP "25"
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 16 April 1981

  • Application: ANDA085213
  • Marketing authorisation holder: SANDOZ
  • Local brand name: HYDRO-SERP "50"
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 20 August 1981

  • Application: ANDA085208
  • Marketing authorisation holder: ACTAVIS ELIZABETH
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 20 August 1981

  • Application: ANDA085054
  • Marketing authorisation holder: ACTAVIS ELIZABETH
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 24 November 1981

  • Application: ANDA087398
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 7 December 1981

  • Application: ANDA087610
  • Marketing authorisation holder: VANGARD
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 11 December 1981

  • Application: NDA018061
  • Marketing authorisation holder: MERCK
  • Local brand name: TIMOLIDE 10-25
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 14 December 1981

  • Application: ANDA087655
  • Marketing authorisation holder: VANGARD
  • Local brand name: SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 9 March 1982

  • Application: ANDA087565
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 19 April 1982

  • Application: ANDA087752
  • Marketing authorisation holder: USL PHARMA
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 21 July 1982

  • Application: ANDA086369
  • Marketing authorisation holder: ALRA
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 21 July 1982

  • Application: ANDA083554
  • Marketing authorisation holder: ALRA
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 30 March 1983

  • Application: ANDA087511
  • Marketing authorisation holder: LEDERLE
  • Local brand name: SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 8 April 1983

  • Application: ANDA086026
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 1 May 1984

  • Application: ANDA088200
  • Marketing authorisation holder: SANDOZ
  • Local brand name: RESERPINE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 2 July 1984

  • Application: ANDA088588
  • Marketing authorisation holder: ROXANE
  • Local brand name: HYDROCHLOROTHIAZIDE INTENSOL
  • Indication: SOLUTION — ORAL
  • Status: approved

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FDA — authorised 2 July 1984

  • Application: ANDA088587
  • Marketing authorisation holder: ROXANE
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: SOLUTION — ORAL
  • Status: approved

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FDA — authorised 22 October 1984

  • Application: NDA019129
  • Marketing authorisation holder: AUROBINDO PHARMA USA
  • Local brand name: MAXZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 28 December 1984

  • Application: ANDA088829
  • Marketing authorisation holder: SUPERPHARM
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 28 December 1984

  • Application: ANDA088828
  • Marketing authorisation holder: SUPERPHARM
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 28 December 1984

  • Application: ANDA088827
  • Marketing authorisation holder: SUPERPHARM
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 31 December 1984

  • Application: NDA018303
  • Marketing authorisation holder: VALIDUS PHARMS
  • Local brand name: LOPRESSOR HCT
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 7 February 1985

  • Application: ANDA088923
  • Marketing authorisation holder: TEVA
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 7 February 1985

  • Application: ANDA088924
  • Marketing authorisation holder: TEVA
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 26 August 1985

  • Application: ANDA089137
  • Marketing authorisation holder: SUPERPHARM
  • Local brand name: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 6 November 1985

  • Application: ANDA087999
  • Marketing authorisation holder: PUREPAC PHARM
  • Local brand name: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 15 January 1986

  • Application: ANDA070183
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 15 January 1986

  • Application: ANDA070543
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 15 January 1986

  • Application: ANDA070544
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 15 January 1986

  • Application: ANDA070182
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 18 April 1986

  • Application: ANDA070301
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 18 April 1986

  • Application: ANDA070305
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 15 May 1986

  • Application: ANDA070852
  • Marketing authorisation holder: ACTAVIS ELIZABETH
  • Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 15 May 1986

  • Application: ANDA070851
  • Marketing authorisation holder: ACTAVIS ELIZABETH
  • Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 1 October 1986

  • Application: ANDA070705
  • Marketing authorisation holder: ANI PHARMS
  • Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 2 February 1987

  • Application: ANDA070614
  • Marketing authorisation holder: STRIDES PHARMA INTL
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 2 March 1987

  • Application: ANDA071127
  • Marketing authorisation holder: DURAMED PHARMS BARR
  • Local brand name: PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 2 March 1987

  • Application: ANDA071126
  • Marketing authorisation holder: DURAMED PHARMS BARR
  • Local brand name: PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 1 April 1987

  • Application: ANDA070947
  • Marketing authorisation holder: RISING
  • Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 6 April 1987

  • Application: NDA019046
  • Marketing authorisation holder: SCHERING
  • Local brand name: NORMOZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 26 August 1987

  • Application: ANDA071060
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 26 August 1987

  • Application: ANDA071061
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 8 December 1987

  • Application: ANDA071251
  • Marketing authorisation holder: APOTEX INC
  • Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 26 January 1988

  • Application: ANDA071771
  • Marketing authorisation holder: WARNER CHILCOTT
  • Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 14 March 1988

  • Application: ANDA072043
  • Marketing authorisation holder: ANI PHARMS
  • Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 8 April 1988

  • Application: ANDA071821
  • Marketing authorisation holder: TEVA
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 8 April 1988

  • Application: ANDA071819
  • Marketing authorisation holder: TEVA
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 8 April 1988

  • Application: ANDA071820
  • Marketing authorisation holder: TEVA
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 8 April 1988

  • Application: ANDA071822
  • Marketing authorisation holder: TEVA
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 30 November 1988

  • Application: ANDA071851
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 19 January 1989

  • Application: ANDA071069
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 19 January 1989

  • Application: ANDA070959
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 6 February 1989

  • Application: ANDA070958
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 6 February 1989

  • Application: ANDA070960
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 16 February 1989

  • Application: NDA019778
  • Marketing authorisation holder: MERCK
  • Local brand name: PRINZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 2 June 1989

  • Application: ANDA072510
  • Marketing authorisation holder: DAVA PHARMS INC
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 2 June 1989

  • Application: ANDA072507
  • Marketing authorisation holder: DAVA PHARMS INC
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 2 June 1989

  • Application: ANDA072509
  • Marketing authorisation holder: DAVA PHARMS INC
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 2 June 1989

  • Application: ANDA072508
  • Marketing authorisation holder: DAVA PHARMS INC
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 20 July 1989

  • Application: NDA019888
  • Marketing authorisation holder: ALMATICA
  • Local brand name: ZESTORETIC
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 18 December 1991

  • Application: ANDA071498
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 18 December 1991

  • Application: ANDA071501
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 24 January 1992

  • Application: ANDA081189
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 24 January 1992

  • Application: ANDA081190
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 23 September 1993

  • Application: ANDA073449
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 30 March 1995

  • Application: ANDA074259
  • Marketing authorisation holder: ANI PHARMS
  • Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 31 January 1996

  • Application: ANDA073467
  • Marketing authorisation holder: ANI PHARMS
  • Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 26 April 1996

  • Application: ANDA074026
  • Marketing authorisation holder: PLIVA
  • Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 7 June 1996

  • Application: ANDA074701
  • Marketing authorisation holder: PHARMOBEDIENT
  • Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 5 June 1997

  • Application: ANDA074821
  • Marketing authorisation holder: SANDOZ
  • Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 27 June 1997

  • Application: NDA020729
  • Marketing authorisation holder: UCB INC
  • Local brand name: UNIRETIC
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 6 January 1998

  • Application: ANDA074970
  • Marketing authorisation holder: ANI PHARMS
  • Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 6 March 1998

  • Application: NDA020818
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: DIOVAN HCT
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 18 June 1999

  • Application: ANDA075052
  • Marketing authorisation holder: DURAMED PHARMS BARR
  • Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 28 December 1999

  • Application: NDA020125
  • Marketing authorisation holder: PFIZER PHARMS
  • Local brand name: ACCURETIC
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 28 January 2000

  • Application: ANDA075640
  • Marketing authorisation holder: QUAGEN
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 17 November 2000

  • Application: NDA021162
  • Marketing authorisation holder: BOEHRINGER INGELHEIM
  • Local brand name: MICARDIS HCT
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 29 March 2002

  • Application: ANDA040412
  • Marketing authorisation holder: PRINSTON INC
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 17 September 2002

  • Application: ANDA075907
  • Marketing authorisation holder: PRINSTON INC
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 31 March 2004

  • Application: ANDA076374
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 20 August 2004

  • Application: ANDA076792
  • Marketing authorisation holder: MYLAN
  • Local brand name: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 28 March 2005

  • Application: ANDA077093
  • Marketing authorisation holder: PHARMOBEDIENT
  • Local brand name: QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 28 August 2006

  • Application: NDA021956
  • Marketing authorisation holder: CONCORDIA
  • Local brand name: DUTOPROL
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 23 January 2007

  • Application: ANDA040735
  • Marketing authorisation holder: PHARMOBEDIENT
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 27 February 2007

  • Application: ANDA040707
  • Marketing authorisation holder: ACTAVIS ELIZABETH
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 16 March 2007

  • Application: ANDA040702
  • Marketing authorisation holder: LEADING
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 27 March 2007

  • Application: ANDA040810
  • Marketing authorisation holder: SUN PHARM INDS INC
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 20 July 2007

  • Application: ANDA040807
  • Marketing authorisation holder: IPCA LABS LTD
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 24 August 2007

  • Application: ANDA078450
  • Marketing authorisation holder: AUROBINDO PHARMA
  • Local brand name: QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 4 September 2007

  • Application: ANDA040809
  • Marketing authorisation holder: JUBILANT CADISTA
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 19 September 2007

  • Application: ANDA078164
  • Marketing authorisation holder: AUROBINDO PHARMA
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 11 February 2008

  • Application: ANDA078391
  • Marketing authorisation holder: JUBILANT CADISTA
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 16 May 2008

  • Application: ANDA078389
  • Marketing authorisation holder: APOTEX
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 30 May 2008

  • Application: ANDA040857
  • Marketing authorisation holder: SUN PHARM INDS INC
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 15 August 2008

  • Application: ANDA040907
  • Marketing authorisation holder: UNICHEM
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 25 September 2008

  • Application: ANDA090096
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 2 April 2009

  • Application: ANDA079237
  • Marketing authorisation holder: IPCA LABS LTD
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 19 January 2010

  • Application: ANDA090510
  • Marketing authorisation holder: UNICHEM
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 6 April 2010

  • Application: ANDA090528
  • Marketing authorisation holder: TORRENT PHARMS
  • Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA — authorised 6 April 2010

  • Application: ANDA077732
  • Marketing authorisation holder: HIKMA
  • Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 6 April 2010

  • Application: ANDA077157
  • Marketing authorisation holder: TEVA PHARMS
  • Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 6 April 2010

  • Application: ANDA091652
  • Marketing authorisation holder: MYLAN
  • Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 21 May 2010

  • Application: ANDA078245
  • Marketing authorisation holder: LUPIN LTD
  • Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 11 August 2010

  • Application: ANDA090150
  • Marketing authorisation holder: APOTEX
  • Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 19 August 2010

  • Application: ANDA077948
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 6 October 2010

  • Application: ANDA091629
  • Marketing authorisation holder: AUROBINDO PHARMA
  • Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 6 October 2010

  • Application: ANDA078385
  • Marketing authorisation holder: ZYDUS PHARMS USA INC
  • Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 12 January 2011

  • Application: ANDA200180
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 20 April 2011

  • Application: ANDA201356
  • Marketing authorisation holder: INVAGEN PHARMS
  • Local brand name: QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 19 January 2012

  • Application: ANDA090654
  • Marketing authorisation holder: SUN PHARM INDS
  • Local brand name: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 27 January 2012

  • Application: ANDA091662
  • Marketing authorisation holder: CHARTWELL MOLECULAR
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 17 February 2012

  • Application: ANDA091617
  • Marketing authorisation holder: ALEMBIC PHARMS LTD
  • Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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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

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FDA — authorised 18 September 2012

  • Application: ANDA201845
  • Marketing authorisation holder: JUBILANT CADISTA
  • Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 21 September 2012

  • Application: ANDA078020
  • Marketing authorisation holder: MYLAN PHARMS INC
  • Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 24 September 2012

  • Application: ANDA202556
  • Marketing authorisation holder: ACCORD HLTHCARE
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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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

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FDA — authorised 12 March 2013

  • Application: ANDA091524
  • Marketing authorisation holder: APOTEX
  • Local brand name: QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA — authorised 21 March 2013

  • Application: ANDA202519
  • Marketing authorisation holder: AUROBINDO PHARMA LTD
  • Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 21 March 2013

  • Application: ANDA201662
  • Marketing authorisation holder: ALEMBIC
  • Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 21 March 2013

  • Application: ANDA091519
  • Marketing authorisation holder: WATSON LABS TEVA
  • Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 21 March 2013

  • Application: ANDA078946
  • Marketing authorisation holder: LUPIN LTD
  • Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 21 March 2013

  • Application: ANDA203026
  • Marketing authorisation holder: APOTEX INC
  • Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 6 November 2013

  • Application: ANDA202870
  • Marketing authorisation holder: ALEMBIC
  • Local brand name: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA — authorised 7 March 2014

  • Application: ANDA202150
  • Marketing authorisation holder: HERITAGE
  • Local brand name: MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 7 April 2014

  • Application: ANDA090651
  • Marketing authorisation holder: SUN PHARM INDS INC
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA — authorised 23 July 2014

  • Application: ANDA203018
  • Marketing authorisation holder: SCIEGEN PHARMS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA — authorised 8 February 2016

  • Application: ANDA206083
  • Marketing authorisation holder: PRINSTON INC
  • Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA — authorised 21 July 2017

  • Application: ANDA204832
  • Marketing authorisation holder: UNICHEM
  • Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA — authorised 6 November 2017

  • Application: ANDA204901
  • Marketing authorisation holder: PRINSTON INC
  • Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA — authorised 29 June 2018

  • Application: ANDA208360
  • Marketing authorisation holder: ZYDUS PHARMS
  • Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA — authorised 14 January 2019

  • Application: ANDA203561
  • Marketing authorisation holder: SCIEGEN PHARMS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

Read official source →

FDA — authorised 11 February 2019

  • Application: ANDA208358
  • Marketing authorisation holder: CADILA
  • Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

Read official source →

FDA — authorised 15 March 2019

  • Application: ANDA203000
  • Marketing authorisation holder: ZYDUS LIFESCIENCES
  • Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 23 February 2022

  • Application: ANDA216211
  • Marketing authorisation holder: RUBICON RESEARCH
  • Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA — authorised 11 August 2023

  • Application: ANDA204382
  • Marketing authorisation holder: AMNEAL PHARMS
  • Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 29 September 2023

  • Application: ANDA218015
  • Marketing authorisation holder: GRANULES
  • Local brand name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA — authorised 8 January 2025

  • Application: ANDA215789
  • Marketing authorisation holder: SENORES PHARMS
  • Local brand name: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA — authorised 28 January 2025

  • Application: ANDA214611
  • Marketing authorisation holder: MACLEODS PHARMS LTD
  • Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

Read official source →

FDA — authorised 23 April 2026

  • Application: ANDA204687
  • Marketing authorisation holder: SCIEGEN PHARMS
  • Local brand name: VALSARTAN AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA085067
  • Marketing authorisation holder: INWOOD LABS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA085112
  • Marketing authorisation holder: MYLAN
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA084899
  • Marketing authorisation holder: WEST WARD
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA070688
  • Marketing authorisation holder: PUREPAC PHARM
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA070366
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA070365
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA070689
  • Marketing authorisation holder: PUREPAC PHARM
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA070367
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA070854
  • Marketing authorisation holder: PUREPAC PHARM
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA070853
  • Marketing authorisation holder: PUREPAC PHARM
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA087587
  • Marketing authorisation holder: WARNER CHILCOTT
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA087586
  • Marketing authorisation holder: WARNER CHILCOTT
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA084880
  • Marketing authorisation holder: MYLAN
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA085099
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA086504
  • Marketing authorisation holder: HALSEY
  • Local brand name: HYDRO-D
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA089661
  • Marketing authorisation holder: MORTON GROVE
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: SOLUTION — ORAL
  • Status: approved

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FDA

  • Application: ANDA071737
  • Marketing authorisation holder: VITARINE
  • Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA

  • Status: approved

FDA

  • Application: ANDA083458
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA083456
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA071897
  • Marketing authorisation holder: PARKE DAVIS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA071922
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA071898
  • Marketing authorisation holder: PARKE DAVIS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA071899
  • Marketing authorisation holder: PARKE DAVIS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA201616
  • Marketing authorisation holder: CIPLA LIMITED
  • Local brand name: HYDROCHLOROTHIAZIDE; IRBESARTAN
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA071900
  • Marketing authorisation holder: PARKE DAVIS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA086192
  • Marketing authorisation holder: MAST MM
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA071923
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA087553
  • Marketing authorisation holder: UPSHER SMITH
  • Local brand name: SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA087540
  • Marketing authorisation holder: ASCOT
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA087539
  • Marketing authorisation holder: ASCOT
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA084029
  • Marketing authorisation holder: IMPAX LABS
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA074857
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA

  • Application: ANDA087948
  • Marketing authorisation holder: PARKE DAVIS
  • Local brand name: SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA071920
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA084536
  • Marketing authorisation holder: ROXANE
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA070829
  • Marketing authorisation holder: SANDOZ
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA071921
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA088025
  • Marketing authorisation holder: ASCOT
  • Local brand name: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA071553
  • Marketing authorisation holder: IVAX SUB TEVA PHARMS
  • Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA087651
  • Marketing authorisation holder: USL PHARMA
  • Local brand name: SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA071458
  • Marketing authorisation holder: IVAX SUB TEVA PHARMS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Application: ANDA070830
  • Marketing authorisation holder: SANDOZ
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA071459
  • Marketing authorisation holder: IVAX SUB TEVA PHARMS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA071460
  • Marketing authorisation holder: IVAX SUB TEVA PHARMS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA071461
  • Marketing authorisation holder: IVAX SUB TEVA PHARMS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA071552
  • Marketing authorisation holder: IVAX SUB TEVA PHARMS
  • Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA087638
  • Marketing authorisation holder: VANGARD
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA085152
  • Marketing authorisation holder: ELKINS SINN
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: NDA018872
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: VISKAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA088054
  • Marketing authorisation holder: PUREPAC PHARM
  • Local brand name: SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA071772
  • Marketing authorisation holder: WARNER CHILCOTT
  • Local brand name: PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA084135
  • Marketing authorisation holder: HEATHER
  • Local brand name: HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA070368
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: METHYLDOPA AND HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA085974
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

Aggressive Blood Pressure control 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 Aggressive Blood Pressure control approved in United States?

Yes. FDA authorised it on 12 February 1959; FDA authorised it on 5 May 1959; FDA authorised it on 6 July 1959.

Who is the marketing authorisation holder for Aggressive Blood Pressure control in United States?

NOVARTIS holds the US marketing authorisation.