FDA — authorised 7 August 1974
- Status: approved
🇺🇸 Doxorubicin Hydrochloride in United States
FDA authorised Doxorubicin Hydrochloride on 7 August 1974
Marketing authorisations
FDA — authorised 1 December 1998
- Application: ANDA064097
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 3 November 2014
- Application: ANDA200170
- Marketing authorisation holder: MYLAN LABS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 11 August 2017
- Application: ANDA209825
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 3 January 2025
- Application: ANDA212299
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Indication: Labeling
- Status: approved
The FDA approved Doxorubicin Hydrochloride, a chemotherapy medication, for marketing in the United States. The approval was granted to ZYDUS LIFESCIENCES on 3 January 2025, following a standard review pathway. The medication is used for various types of cancer, as indicated in its labelling.
FDA — authorised 3 February 2026
- Application: ANDA219881
- Marketing authorisation holder: QILU PHARM HAINAN
- Status: approved
Doxorubicin Hydrochloride 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 Doxorubicin Hydrochloride approved in United States?
Yes. FDA authorised it on 7 August 1974; FDA authorised it on 1 December 1998; FDA authorised it on 3 November 2014.
Who is the marketing authorisation holder for Doxorubicin Hydrochloride in United States?
Pfizer is the originator. The local marketing authorisation holder may differ — check the official source linked above.