FDA — authorised 23 December 1987
- Application: NDA050629
- Marketing authorisation holder: PFIZER
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 ATI-0918 in United States
FDA authorised ATI-0918 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 17 March 1989
- Application: ANDA062921
- 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 February 1995
- Application: ANDA063336
- 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 26 October 1995
- Application: ANDA063277
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 November 1995
- Application: NDA050718
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: DOXIL (LIPOSOMAL)
- Indication: INJECTABLE, LIPOSOMAL — INJECTION
- 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
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- 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 February 2026
- Application: ANDA219881
- Marketing authorisation holder: QILU PHARM HAINAN
- Local brand name: DOXORUBICIN HYDROCHLORIDE
- Indication: INJECTABLE, LIPOSOMAL — INJECTION
- Status: approved
Frequently asked questions
Is ATI-0918 approved in United States?
Yes. FDA authorised it on 23 December 1987; FDA authorised it on 17 March 1989; FDA authorised it on 17 March 1989.
Who is the marketing authorisation holder for ATI-0918 in United States?
PFIZER holds the US marketing authorisation.