🇺🇸 DOXORUBICIN in United States

FDA authorised DOXORUBICIN on 23 December 1987

Marketing authorisations

FDA — authorised 23 December 1987

  • Application: NDA050629
  • Marketing authorisation holder: PFIZER
  • Status: supplemented

FDA — authorised 17 March 1989

  • Application: ANDA062975
  • Marketing authorisation holder: HIKMA
  • Status: supplemented

FDA — authorised 11 August 2017

  • Application: ANDA209825
  • Marketing authorisation holder: GLAND
  • Status: supplemented

FDA — authorised 27 June 2025

  • Application: ANDA219199
  • Marketing authorisation holder: ALEMBIC
  • Status: approved

FDA — authorised 3 February 2026

  • Application: ANDA219881
  • Marketing authorisation holder: QILU PHARM HAINAN
  • Status: approved

FDA

  • Status: approved

DOXORUBICIN 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 DOXORUBICIN approved in United States?

Yes. FDA authorised it on 23 December 1987; FDA authorised it on 17 March 1989; FDA authorised it on 11 August 2017.

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

PFIZER holds the US marketing authorisation.