FDA — authorised 25 April 1962
- Application: NDA012209
- Marketing authorisation holder: SPECTRUM PHARMS
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 FLUOROURACIL in United States
FDA authorised FLUOROURACIL on 25 April 1962 · 45,700 US adverse-event reports
Marketing authorisations
FDA — authorised 29 July 1970
- Application: NDA016831
- Marketing authorisation holder: EXTROVIS
- Status: supplemented
FDA — authorised 30 September 1998
- Application: ANDA040279
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 September 1998
- Application: ANDA040278
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 March 1999
- Application: ANDA040291
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 January 2000
- Application: ANDA040333
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 February 2000
- Application: ANDA040334
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 July 2001
- Application: NDA020985
- Marketing authorisation holder: EXTROVIS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 5 November 2003
- Application: ANDA076526
- Marketing authorisation holder: TARO
- Local brand name: FLUOROURACIL
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 26 April 2007
- Application: ANDA040743
- Marketing authorisation holder: ACCORD HLTHCARE
- Status: approved
FDA — authorised 26 April 2007
- Application: ANDA040798
- Marketing authorisation holder: ACCORD HLTHCARE
- Status: supplemented
FDA — authorised 11 April 2008
- Application: ANDA077524
- Marketing authorisation holder: DR REDDYS LABS SA
- Status: approved
FDA — authorised 17 July 2012
- Application: ANDA202669
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Status: approved
FDA — authorised 17 July 2012
- Application: ANDA202668
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Indication: Labeling
- Status: approved
FDA — authorised 27 October 2017
- Application: ANDA210123
- Marketing authorisation holder: GLAND
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 December 2017
- Application: ANDA210124
- Marketing authorisation holder: GLAND
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 October 2021
- Application: ANDA214845
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: FLUOROURACIL
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 3 March 2023
- Application: ANDA217295
- Marketing authorisation holder: ALEMBIC
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 September 2024
- Application: ANDA216494
- Marketing authorisation holder: KINDOS
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 February 2025
- Application: ANDA215699
- Marketing authorisation holder: KINDOS
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 February 2025
- Application: ANDA216942
- Marketing authorisation holder: ENCUBE
- Local brand name: FLUOROURACIL
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 20 February 2026
- Application: NDA220201
- Marketing authorisation holder: AVYXA HOLDINGS
- Local brand name: FAVLYXA
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
The FDA granted marketing authorisation to AVYXA HOLDINGS for FLUOROURACIL (FAVLYXA) on 20 February 2026. This approval is for the intravenous solution of FLUOROURACIL. The application number for this approval is NDA220201.
FDA
- Application: ANDA088929
- Marketing authorisation holder: ABIC
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089368
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: FLUOROURACIL
- Indication: Injectable — Injection
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 45,700
Most-reported reactions
- Diarrhoea — 7,890 reports (17.26%)
- Neutropenia — 5,920 reports (12.95%)
- Nausea — 5,758 reports (12.6%)
- Vomiting — 4,636 reports (10.14%)
- Off Label Use — 3,943 reports (8.63%)
- Disease Progression — 3,586 reports (7.85%)
- Neuropathy Peripheral — 3,574 reports (7.82%)
- Fatigue — 3,510 reports (7.68%)
- Pyrexia — 3,474 reports (7.6%)
- Thrombocytopenia — 3,409 reports (7.46%)
FLUOROURACIL in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is FLUOROURACIL approved in United States?
Yes. FDA authorised it on 25 April 1962; FDA authorised it on 29 July 1970; FDA authorised it on 30 September 1998.
Who is the marketing authorisation holder for FLUOROURACIL in United States?
SPECTRUM PHARMS holds the US marketing authorisation.