🇺🇸 Purixan in United States

FDA authorised Purixan on 11 September 1953

Marketing authorisations

FDA — authorised 11 September 1953

  • Marketing authorisation holder: STASON PHARMS
  • Status: approved

FDA — authorised 13 February 2004

  • Application: ANDA040528
  • Marketing authorisation holder: HIKMA
  • Local brand name: MERCAPTOPURINE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 1 July 2005

  • Application: ANDA040594
  • Marketing authorisation holder: MYLAN
  • Local brand name: MERCAPTOPURINE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 28 April 2014

  • Application: NDA205919
  • Marketing authorisation holder: NOVA LABS LTD
  • Local brand name: PURIXAN
  • Indication: SUSPENSION — ORAL
  • Status: approved

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FDA — authorised 26 February 2025

  • Application: ANDA216418
  • Marketing authorisation holder: HIKMA
  • Local brand name: MERCAPTOPURINE
  • Indication: SUSPENSION — ORAL
  • Status: approved

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Purixan in other countries

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

Other Oncology approved in United States

Frequently asked questions

Is Purixan approved in United States?

Yes. FDA authorised it on 11 September 1953; FDA authorised it on 13 February 2004; FDA authorised it on 1 July 2005.

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

STASON PHARMS holds the US marketing authorisation.