FDA — authorised 4 May 2009
- Application: ANDA065521
- Marketing authorisation holder: MYLAN
- Status: approved
🇺🇸 Mycophenolate in United States
FDA authorised Mycophenolate on 4 May 2009
Marketing authorisations
FDA — authorised 4 May 2009
- Application: ANDA065520
- Marketing authorisation holder: MYLAN
- Status: supplemented
FDA — authorised 9 August 2012
- Application: ANDA091249
- Marketing authorisation holder: ALKEM LABS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 27 September 2013
- Application: ANDA065413
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 14 November 2014
- Application: ANDA203005
- Marketing authorisation holder: ALKEM LABS LTD
- Status: supplemented
FDA — authorised 13 November 2015
- Application: ANDA065416
- Marketing authorisation holder: ACCORD HLTHCARE
- Indication: REMS
- Status: approved
FDA — authorised 8 January 2019
- Application: ANDA210181
- Marketing authorisation holder: CONCORD BIOTECH LTD
- Indication: Labeling
- Status: approved
FDA — authorised 29 August 2023
- Application: ANDA212634
- Marketing authorisation holder: STRIDES PHARMA INTL
- Status: approved
FDA — authorised 14 January 2026
- Application: ANDA217937
- Marketing authorisation holder: AUROBINDO PHARMA
- 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 Nephrology approved in United States
Frequently asked questions
Is Mycophenolate approved in United States?
Yes. FDA authorised it on 4 May 2009; FDA authorised it on 4 May 2009; FDA authorised it on 9 August 2012.
Who is the marketing authorisation holder for Mycophenolate in United States?
MYLAN holds the US marketing authorisation.