FDA — authorised 18 June 2014
- Application: ANDA203869
- Marketing authorisation holder: HENGRUI PHARMA
- Status: approved
🇺🇸 Eloxatin in United States
FDA authorised Eloxatin on 18 June 2014
Marketing authorisations
FDA — authorised 10 September 2015
- Application: ANDA091358
- Marketing authorisation holder: MYLAN LABS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 11 May 2016
- Application: ANDA204616
- Marketing authorisation holder: QILU PHARM HAINAN
- Status: approved
FDA — authorised 11 December 2023
- Application: ANDA207325
- Marketing authorisation holder: GLAND
- Indication: Labeling
- Status: approved
FDA — authorised 15 January 2026
- Application: ANDA219765
- Marketing authorisation holder: SHANDONG
- Status: approved
Eloxatin 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 Eloxatin approved in United States?
Yes. FDA authorised it on 18 June 2014; FDA authorised it on 10 September 2015; FDA authorised it on 11 May 2016.
Who is the marketing authorisation holder for Eloxatin in United States?
HENGRUI PHARMA holds the US marketing authorisation.