FDA — authorised 27 February 2004
- Marketing authorisation holder: NOVARTIS
- Status: approved
🇺🇸 Mycophenolate in United States
FDA authorised Mycophenolate on 27 February 2004
Marketing authorisations
FDA — authorised 25 September 2012
- Application: NDA050791
- Marketing authorisation holder: NOVARTIS
- Indication: Labeling
- Status: approved
FDA — authorised 15 January 2021
- Application: ANDA211173
- Marketing authorisation holder: CONCORD BIOTECH LTD
- Indication: REMS
- Status: approved
FDA — authorised 10 January 2023
- Application: ANDA214630
- Marketing authorisation holder: BIOCON PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 29 May 2024
- Application: ANDA216637
- Marketing authorisation holder: FOSUN WANBANG
- Status: approved
FDA — authorised 14 January 2026
- Application: ANDA218603
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Indication: Labeling
- Status: approved
Mycophenolate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Mycophenolate approved in United States?
Yes. FDA authorised it on 27 February 2004; FDA authorised it on 25 September 2012; FDA authorised it on 15 January 2021.
Who is the marketing authorisation holder for Mycophenolate in United States?
NOVARTIS holds the US marketing authorisation.