FDA — authorised 28 April 2004
- Application: ANDA076661
- Marketing authorisation holder: SAGENT PHARMS INC
- Status: approved
🇺🇸 Fludarabine Phosphate in United States
FDA authorised Fludarabine Phosphate on 28 April 2004
Marketing authorisations
FDA — authorised 15 October 2007
- Application: ANDA078393
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 11 February 2009
- Application: ANDA078610
- Marketing authorisation holder: ACTAVIS TOTOWA
- Status: approved
FDA — authorised 29 March 2023
- Application: ANDA090724
- Marketing authorisation holder: AREVA PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
Fludarabine Phosphate 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 Fludarabine Phosphate approved in United States?
Yes. FDA authorised it on 28 April 2004; FDA authorised it on 15 October 2007; FDA authorised it on 11 February 2009.
Who is the marketing authorisation holder for Fludarabine Phosphate in United States?
SAGENT PHARMS INC holds the US marketing authorisation.