🇺🇸 QUINIDINE in United States

FDA authorised QUINIDINE on 26 September 1983

Marketing authorisations

FDA — authorised 26 September 1983

  • Application: ANDA088072
  • Marketing authorisation holder: EPIC PHARMA LLC
  • Status: supplemented

FDA — authorised 11 February 1987

  • Application: ANDA089338
  • Marketing authorisation holder: SUN PHARM INDUSTRIES
  • Status: supplemented

FDA — authorised 17 September 2021

  • Application: ANDA212589
  • Marketing authorisation holder: HIBROW HLTHCARE
  • Status: supplemented

FDA — authorised 28 August 2024

  • Application: ANDA218426
  • Marketing authorisation holder: HETERO LABS LTD III
  • Status: approved

FDA

  • Status: approved

QUINIDINE 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 QUINIDINE approved in United States?

Yes. FDA authorised it on 26 September 1983; FDA authorised it on 11 February 1987; FDA authorised it on 17 September 2021.

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

EPIC PHARMA LLC holds the US marketing authorisation.