🇺🇸 cardio selective betablocker in United States

FDA authorised cardio selective betablocker on 8 June 1984

Marketing authorisations

FDA — authorised 8 June 1984

  • Application: NDA018760
  • Marketing authorisation holder: TWI PHARMS
  • Local brand name: TENORETIC 50
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 15 July 1988

  • Application: ANDA072304
  • Marketing authorisation holder: AIPING PHARM INC
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 31 May 1990

  • Application: ANDA072302
  • Marketing authorisation holder: AIPING PHARM INC
  • Local brand name: ATENOLOL AND CHLORTHALIDONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 17 September 1991

  • Application: ANDA073026
  • Marketing authorisation holder: PHARMOBEDIENT
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 19 December 1991

  • Application: ANDA073543
  • Marketing authorisation holder: NOVITIUM PHARMA
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 19 December 1991

  • Application: ANDA073542
  • Marketing authorisation holder: NOVITIUM PHARMA
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 27 December 1991

  • Application: ANDA073352
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 27 December 1991

  • Application: ANDA073353
  • Marketing authorisation holder: WATSON LABS TEVA
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 24 January 1992

  • Application: ANDA073457
  • Marketing authorisation holder: MYLAN
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 28 April 1992

  • Application: ANDA074099
  • Marketing authorisation holder: NOVITIUM PHARMA
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 2 July 1992

  • Application: ANDA073665
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: ATENOLOL AND CHLORTHALIDONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 30 October 1992

  • Application: ANDA073676
  • Marketing authorisation holder: SCS
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 30 March 1993

  • Application: ANDA073476
  • Marketing authorisation holder: SUN PHARM INDUSTRIES
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 30 March 1993

  • Application: ANDA073475
  • Marketing authorisation holder: SUN PHARM INDUSTRIES
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 29 April 1993

  • Application: ANDA073582
  • Marketing authorisation holder: SUN PHARM INDUSTRIES
  • Local brand name: ATENOLOL AND CHLORTHALIDONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 28 May 1993

  • Application: ANDA073316
  • Marketing authorisation holder: TEVA
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 28 May 1993

  • Application: ANDA073315
  • Marketing authorisation holder: TEVA
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 31 October 1993

  • Application: ANDA074203
  • Marketing authorisation holder: AUROBINDO PHARMA USA
  • Local brand name: ATENOLOL AND CHLORTHALIDONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 28 February 1994

  • Application: ANDA074265
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 18 January 1995

  • Application: ANDA074056
  • Marketing authorisation holder: TEVA
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 17 July 1997

  • Application: ANDA074101
  • Marketing authorisation holder: PLIVA
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 30 July 1997

  • Application: ANDA074499
  • Marketing authorisation holder: SUN PHARM INDUSTRIES
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 24 September 1997

  • Application: ANDA074107
  • Marketing authorisation holder: PLIVA
  • Local brand name: ATENOLOL AND CHLORTHALIDONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 14 May 1998

  • Application: ANDA074404
  • Marketing authorisation holder: NOSTRUM LABS
  • Local brand name: ATENOLOL AND CHLORTHALIDONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 30 July 2004

  • Application: ANDA076907
  • Marketing authorisation holder: ABLE
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 28 January 2005

  • Application: ANDA076900
  • Marketing authorisation holder: ZYDUS PHARMS USA
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 31 July 2006

  • Application: ANDA076969
  • Marketing authorisation holder: SANDOZ
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 13 September 2006

  • Application: ANDA077443
  • Marketing authorisation holder: UNIQUE
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 18 May 2007

  • Application: ANDA076640
  • Marketing authorisation holder: NESHER PHARMS
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 31 October 2007

  • Application: ANDA078512
  • Marketing authorisation holder: AUROBINDO PHARMA
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 20 March 2008

  • Application: ANDA077779
  • Marketing authorisation holder: NESHER PHARMS
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 14 May 2008

  • Application: ANDA077176
  • Marketing authorisation holder: NESHER PHARMS
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 3 August 2009

  • Application: ANDA076862
  • Marketing authorisation holder: ACTAVIS LABS FL INC
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 25 September 2009

  • Application: ANDA078254
  • Marketing authorisation holder: NORTHSTAR HLTHCARE
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 22 July 2010

  • Application: ANDA090615
  • Marketing authorisation holder: WOCKHARDT BIO AG
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 15 December 2011

  • Application: ANDA202033
  • Marketing authorisation holder: MYLAN PHARMS INC
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 1 August 2012

  • Application: ANDA090617
  • Marketing authorisation holder: DR REDDYS LABS LTD
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 15 August 2012

  • Application: ANDA078889
  • Marketing authorisation holder: REDDYS
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 25 November 2016

  • Application: ANDA204161
  • Marketing authorisation holder: ACTAVIS ELIZABETH
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 26 January 2018

  • Application: NDA210428
  • Marketing authorisation holder: SPIL
  • Local brand name: KAPSPARGO SPRINKLE
  • Indication: CAPSULE, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 6 February 2018

  • Application: ANDA204106
  • Marketing authorisation holder: NOVAST LABS
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 26 October 2018

  • Application: ANDA207465
  • Marketing authorisation holder: CIPLA
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 19 December 2018

  • Application: ANDA207206
  • Marketing authorisation holder: VISUM PHARM
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 8 March 2019

  • Application: ANDA210028
  • Marketing authorisation holder: ZYDUS PHARMS
  • Local brand name: ATENOLOL AND CHLORTHALIDONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 21 November 2019

  • Application: ANDA213136
  • Marketing authorisation holder: UNICHEM
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 30 March 2020

  • Application: ANDA203699
  • Marketing authorisation holder: PHARMADAX
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 31 March 2020

  • Application: ANDA203028
  • Marketing authorisation holder: PHARMADAX
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 6 November 2020

  • Application: ANDA205541
  • Marketing authorisation holder: HETERO LABS LTD III
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 25 November 2020

  • Application: ANDA213302
  • Marketing authorisation holder: UNICHEM
  • Local brand name: ATENOLOL AND CHLORTHALIDONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 25 November 2020

  • Application: ANDA211143
  • Marketing authorisation holder: ALKEM LABS LTD
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 25 October 2021

  • Application: ANDA215560
  • Marketing authorisation holder: NOVITIUM PHARMA
  • Local brand name: ATENOLOL AND CHLORTHALIDONE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 26 September 2022

  • Application: ANDA214004
  • Marketing authorisation holder: SUNSHINE
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 18 October 2022

  • Application: ANDA215637
  • Marketing authorisation holder: ACCORD HLTHCARE
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 12 June 2023

  • Application: ANDA216916
  • Marketing authorisation holder: GRANULES
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 7 August 2023

  • Application: ANDA216509
  • Marketing authorisation holder: GRANULES
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 15 August 2023

  • Application: ANDA209272
  • Marketing authorisation holder: LUPIN
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 26 July 2024

  • Application: ANDA214110
  • Marketing authorisation holder: ZHEJIANG JUTAI PHARM
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 25 June 2025

  • Application: ANDA206980
  • Marketing authorisation holder: IPCA LABS LTD
  • Local brand name: METOPROLOL SUCCINATE
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA

  • Application: ANDA073317
  • Marketing authorisation holder: APOTHECON
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA073318
  • Marketing authorisation holder: APOTHECON
  • Local brand name: ATENOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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Frequently asked questions

Is cardio selective betablocker approved in United States?

Yes. FDA authorised it on 8 June 1984; FDA authorised it on 15 July 1988; FDA authorised it on 31 May 1990.

Who is the marketing authorisation holder for cardio selective betablocker in United States?

TWI PHARMS holds the US marketing authorisation.