FDA — authorised 26 February 1993
- Status: approved
🇺🇸 Leustatin in United States
FDA authorised Leustatin on 26 February 1993
Marketing authorisations
FDA — authorised 7 February 2007
- Application: ANDA075405
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 29 September 2015
- Application: ANDA076571
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
FDA — authorised 25 November 2019
- Application: ANDA210856
- Marketing authorisation holder: HISUN PHARM HANGZHOU
- Status: approved
FDA — authorised 6 December 2023
- Application: NDA022561
- Marketing authorisation holder: EMD SERONO INC
- Indication: Labeling
- Status: approved
FDA — authorised 24 November 2025
- Application: ANDA218425
- Marketing authorisation holder: APOTEX
- Status: approved
Leustatin 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 Leustatin approved in United States?
Yes. FDA authorised it on 26 February 1993; FDA authorised it on 7 February 2007; FDA authorised it on 29 September 2015.
Who is the marketing authorisation holder for Leustatin in United States?
Marketing authorisation holder not available in our data.