FDA — authorised 23 December 1987
- Application: NDA050629
- Marketing authorisation holder: PFIZER
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Doxorubicin Hydrochloride in United States
FDA authorised Doxorubicin Hydrochloride on 23 December 1987
Marketing authorisations
FDA — authorised 17 March 1989
- Application: ANDA062975
- Marketing authorisation holder: HIKMA
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 May 1990
- Application: ANDA063097
- Marketing authorisation holder: PHARMACHEMIE BV
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 July 1995
- Application: ANDA064140
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 December 1998
- Application: ANDA064097
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 28 October 2011
- Application: ANDA200170
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 February 2012
- Application: ANDA200901
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 February 2012
- Application: ANDA091418
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 July 2012
- Application: ANDA200146
- Marketing authorisation holder: HLTHCARE
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 November 2012
- Application: ANDA065515
- Marketing authorisation holder: ALMAJECT
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 March 2013
- Application: ANDA091495
- Marketing authorisation holder: SAGENT PHARMS
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 June 2014
- Application: ANDA203622
- Marketing authorisation holder: ACTAVIS INC
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 August 2017
- Application: ANDA209825
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 13 May 2019
- Application: ANDA206062
- Marketing authorisation holder: HISUN PHARM HANGZHOU
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- 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, under the application number ANDA212299. The medication is used for various indications as per the approved labeling.
FDA — authorised 3 February 2026
- Application: ANDA219881
- Marketing authorisation holder: QILU PHARM HAINAN
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE, LIPOSOMAL — INJECTION
- Status: approved
The FDA approved Doxorubicin Hydrochloride Injection, manufactured by QILU PHARM HAINAN, on 3 February 2026. This approval was granted under the standard expedited pathway. Doxorubicin Hydrochloride Injection is indicated for use in patients with various types of cancer. The approval was based on an application number of ANDA219881.
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 23 December 1987; FDA authorised it on 17 March 1989; FDA authorised it on 21 May 1990.
Who is the marketing authorisation holder for Doxorubicin Hydrochloride in United States?
PFIZER holds the US marketing authorisation.