FDA — authorised 18 April 1991
- Application: NDA020038
- Marketing authorisation holder: GENZYME CORP
- Local brand name: FLUDARA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Fludara in United States
FDA authorised Fludara on 18 April 1991
Marketing authorisations
FDA — authorised 18 April 1991
- Status: approved
FDA — authorised 28 April 2004
- Application: ANDA076661
- Marketing authorisation holder: SAGENT PHARMS INC
- Status: approved
FDA — authorised 21 September 2007
- Application: NDA022137
- Marketing authorisation holder: CAPLIN ONE LABS
- Local brand name: FLUDARABINE PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 October 2007
- Application: ANDA078393
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 15 October 2007
- Application: ANDA078544
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: FLUDARABINE PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 February 2009
- Application: ANDA078610
- Marketing authorisation holder: ACTAVIS TOTOWA
- Local brand name: FLUDARABINE PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 February 2017
- Application: ANDA203738
- Marketing authorisation holder: ACTAVIS LLC
- Local brand name: FLUDARABINE PHOSPHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 March 2023
- Application: ANDA090724
- Marketing authorisation holder: AREVA PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
Fludara 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 Fludara approved in United States?
Yes. FDA authorised it on 18 April 1991; FDA authorised it on 18 April 1991; FDA authorised it on 28 April 2004.
Who is the marketing authorisation holder for Fludara in United States?
GENZYME CORP holds the US marketing authorisation.