FDA — authorised 7 August 2009
- Application: ANDA078812
- Marketing authorisation holder: SANDOZ
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 mFOLFOX6 regimen in United States
FDA authorised mFOLFOX6 regimen on 7 August 2009
Marketing authorisations
FDA — authorised 7 August 2009
- Application: ANDA078818
- Marketing authorisation holder: SUN PHARM
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 7 August 2009
- Application: NDA022160
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 7 August 2009
- Application: ANDA078813
- Marketing authorisation holder: HOSPIRA WORLDWIDE
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 7 August 2009
- Application: ANDA078810
- Marketing authorisation holder: FRESENIUS KABI ONCOL
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 30 September 2009
- Application: ANDA078815
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 2 June 2010
- Application: ANDA078819
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 10 June 2010
- Application: ANDA078811
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 24 January 2011
- Application: ANDA078817
- Marketing authorisation holder: SANDOZ
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 28 April 2011
- Application: ANDA090849
- Marketing authorisation holder: SANDOZ
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 8 August 2012
- Application: ANDA200979
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 8 August 2012
- Application: ANDA078803
- Marketing authorisation holder: ACTAVIS TOTOWA
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 8 April 2014
- Application: ANDA202922
- Marketing authorisation holder: SUN PHARM
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 7 June 2016
- Application: ANDA204368
- Marketing authorisation holder: QILU PHARM HAINAN
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 21 March 2017
- Application: ANDA207474
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 12 May 2017
- Application: ANDA204378
- Marketing authorisation holder: AM REGENT
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 6 September 2017
- Application: ANDA205529
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 16 October 2018
- Application: ANDA207562
- Marketing authorisation holder: NOVAST LABS
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA078816
- Marketing authorisation holder: MUSTAFA NEVSAT IIAC SANAYII A.S.
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA078943
- Marketing authorisation holder: PLIVA LACHEMA
- Local brand name: OXALIPLATIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
mFOLFOX6 regimen 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 mFOLFOX6 regimen approved in United States?
Yes. FDA authorised it on 7 August 2009; FDA authorised it on 7 August 2009; FDA authorised it on 7 August 2009.
Who is the marketing authorisation holder for mFOLFOX6 regimen in United States?
SANDOZ holds the US marketing authorisation.