FDA — authorised 3 May 1995
- Application: NDA050722
- Marketing authorisation holder: ROCHE PALO
- Status: supplemented
🇺🇸 CellCept in United States
FDA authorised CellCept on 3 May 1995
Marketing authorisations
FDA — authorised 19 June 1997
- Application: NDA050723
- Marketing authorisation holder: ROCHE PALO
- Status: supplemented
FDA — authorised 12 August 1998
- Application: NDA050758
- Marketing authorisation holder: ROCHE PALO
- Status: supplemented
FDA — authorised 1 October 1998
- Application: NDA050759
- Marketing authorisation holder: ROCHE PALO
- Status: supplemented
FDA — authorised 22 April 2009
- Application: ANDA090499
- Marketing authorisation holder: APOTEX
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 May 2009
- Application: ANDA090253
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 May 2009
- Application: ANDA065520
- Marketing authorisation holder: MYLAN
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 May 2009
- Application: ANDA065521
- Marketing authorisation holder: MYLAN
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 December 2009
- Application: ANDA090111
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 June 2010
- Application: ANDA090456
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 July 2010
- Application: ANDA090606
- Marketing authorisation holder: AMNEAL
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 September 2010
- Application: ANDA090464
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 November 2011
- Application: ANDA091249
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 June 2013
- Application: ANDA200197
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 December 2014
- Application: ANDA090762
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 November 2017
- Application: ANDA204077
- Marketing authorisation holder: ZHEJIANG HISUN PHARM
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 November 2017
- Application: ANDA204076
- Marketing authorisation holder: ZHEJIANG HISUN PHARM
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 February 2019
- Application: ANDA210370
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 31 July 2020
- Application: ANDA212087
- Marketing authorisation holder: CONCORD BIOTECH LTD
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 November 2021
- Application: ANDA214871
- Marketing authorisation holder: AMNEAL
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 11 September 2023
- Application: ANDA213955
- Marketing authorisation holder: RISING
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 January 2024
- Application: ANDA217828
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 May 2024
- Application: NDA216482
- Marketing authorisation holder: AZURITY
- Local brand name: MYHIBBIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 26 September 2024
- Application: ANDA218227
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 7 November 2024
- Application: ANDA214079
- Marketing authorisation holder: WUXI
- Local brand name: MYCOPHENOLATE MOFETIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
CellCept 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 CellCept approved in United States?
Yes. FDA authorised it on 3 May 1995; FDA authorised it on 19 June 1997; FDA authorised it on 12 August 1998.
Who is the marketing authorisation holder for CellCept in United States?
ROCHE PALO holds the US marketing authorisation.