FDA — authorised 18 December 1970
- Status: approved
🇺🇸 Fudr in United States
FDA authorised Fudr on 18 December 1970
Marketing authorisations
FDA — authorised 18 December 1970
- Application: NDA016929
- Marketing authorisation holder: HOSPIRA
- Local brand name: FUDR
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 April 2000
- Application: ANDA075387
- Marketing authorisation holder: HIKMA
- Local brand name: FLOXURIDINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 February 2001
- Application: ANDA075837
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: FLOXURIDINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 November 2017
- Application: ANDA203008
- Marketing authorisation holder: AM REGENT
- Local brand name: FLOXURIDINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071055
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: FLOXURIDINE
- Indication: Injectable — Injection
- Status: approved
Fudr 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 Fudr approved in United States?
Yes. FDA authorised it on 18 December 1970; FDA authorised it on 18 December 1970; FDA authorised it on 6 April 2000.
Who is the marketing authorisation holder for Fudr in United States?
Marketing authorisation holder not available in our data.