FDA — authorised 25 April 1962
- Marketing authorisation holder: SPECTRUM PHARMS
- Status: approved
🇺🇸 Carac in United States
FDA authorised Carac on 25 April 1962
Marketing authorisations
FDA — authorised 25 April 1962
- Application: NDA012209
- Marketing authorisation holder: SPECTRUM PHARMS
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 October 1982
- Application: ANDA087792
- Marketing authorisation holder: SPECTRUM PHARMS
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 January 1983
- Application: ANDA087791
- Marketing authorisation holder: MARCHAR
- 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 30 September 1998
- Application: ANDA040279
- 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 15 November 2000
- Application: ANDA040379
- Marketing authorisation holder: FRESENIUS KABI 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
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 April 2008
- Application: ANDA077524
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: FLUOROURACIL
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 5 March 2010
- Application: ANDA090368
- Marketing authorisation holder: TARO
- Local brand name: FLUOROURACIL
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 2 May 2011
- Application: ANDA091299
- Marketing authorisation holder: SANDOZ
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 July 2012
- Application: ANDA202668
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA granted marketing authorisation to EUGIA PHARMA SPECLTS for Carac on 21 March 2024. This authorisation was approved under the standard expedited pathway. The approved indication for Carac is for its labelling.
FDA — authorised 17 July 2012
- Application: ANDA202669
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 February 2016
- Application: ANDA203609
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 May 2017
- Application: ANDA203608
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- 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 12 December 2019
- Application: ANDA209219
- Marketing authorisation holder: NOVAST LABS
- 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 2 November 2023
- Application: ANDA215612
- Marketing authorisation holder: ENCUBE
- Local brand name: FLUOROURACIL
- Indication: SOLUTION — TOPICAL
- 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
FDA
- Application: ANDA089368
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: FLUOROURACIL
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA088929
- Marketing authorisation holder: ABIC
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088767
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089428
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089434
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088766
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: FLUOROURACIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089455
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: FLUOROURACIL
- Indication: Injectable — Injection
- Status: approved
Carac 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 Carac approved in United States?
Yes. FDA authorised it on 25 April 1962; FDA authorised it on 25 April 1962; FDA authorised it on 13 October 1982.
Who is the marketing authorisation holder for Carac in United States?
SPECTRUM PHARMS holds the US marketing authorisation.