🇺🇸 Corgard in United States

FDA authorised Corgard on 10 December 1979

Marketing authorisations

FDA — authorised 10 December 1979

  • Application: NDA018063
  • Marketing authorisation holder: USWM
  • Local brand name: CORGARD
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 10 December 1979

  • Marketing authorisation holder: KING PHARMS
  • Status: approved

FDA — authorised 31 October 1993

  • Application: ANDA074172
  • Marketing authorisation holder: RISING
  • Local brand name: NADOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 31 August 1994

  • Application: ANDA074368
  • Marketing authorisation holder: TEVA PHARMS
  • Local brand name: NADOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 9 November 1995

  • Application: ANDA074501
  • Marketing authorisation holder: SANDOZ
  • Local brand name: NADOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 24 January 1996

  • Application: ANDA074255
  • Marketing authorisation holder: HERITAGE PHARMA
  • Local brand name: NADOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 30 August 1996

  • Application: ANDA074229
  • Marketing authorisation holder: HERITAGE PHARMA
  • Local brand name: NADOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 5 October 2017

  • Application: ANDA209309
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: NADOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 1 June 2018

  • Application: ANDA210786
  • Marketing authorisation holder: NOVAST LABS
  • Local brand name: NADOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 13 September 2019

  • Application: ANDA212856
  • Marketing authorisation holder: RK PHARMA
  • Local brand name: NADOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 2 June 2023

  • Application: ANDA211763
  • Marketing authorisation holder: ALEMBIC
  • Local brand name: NADOLOL
  • Indication: TABLET — ORAL
  • Status: approved

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Corgard in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Metabolic approved in United States

Frequently asked questions

Is Corgard approved in United States?

Yes. FDA authorised it on 10 December 1979; FDA authorised it on 10 December 1979; FDA authorised it on 31 October 1993.

Who is the marketing authorisation holder for Corgard in United States?

USWM holds the US marketing authorisation.