🇺🇸 E-Z-Hd in United States

FDA authorised E-Z-Hd on 11 January 2016

Marketing authorisations

FDA — authorised 11 January 2016

  • Application: NDA208036
  • Marketing authorisation holder: BRACCO
  • Local brand name: E-Z-PAQUE
  • Indication: FOR SUSPENSION — ORAL
  • Status: approved

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FDA — authorised 14 October 2016

  • Application: NDA208844
  • Marketing authorisation holder: BRACCO
  • Local brand name: VARIBAR PUDDING
  • Indication: PASTE — ORAL
  • Status: approved

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FDA — authorised 23 January 2018

  • Application: NDA208143
  • Marketing authorisation holder: BRACCO
  • Indication: Efficacy
  • Status: approved

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FDA — authorised 1 August 2025

  • Application: NDA219840
  • Marketing authorisation holder: BRACCO
  • Indication: Type 7 - Drug Already Marketed without Approved NDA
  • Status: approved

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E-Z-Hd in other countries

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

Other Gastroenterology approved in United States

Frequently asked questions

Is E-Z-Hd approved in United States?

Yes. FDA authorised it on 11 January 2016; FDA authorised it on 14 October 2016; FDA authorised it on 23 January 2018.

Who is the marketing authorisation holder for E-Z-Hd in United States?

BRACCO holds the US marketing authorisation.