FDA — authorised 21 August 2012
- Application: ANDA091558
- Marketing authorisation holder: APOTEX INC
- Local brand name: MYCOPHENOLATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 EC-MPS in United States
FDA authorised EC-MPS on 21 August 2012
Marketing authorisations
FDA — authorised 8 January 2014
- Application: ANDA091248
- Marketing authorisation holder: RK PHARMA
- Local brand name: MYCOPHENOLATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 23 August 2017
- Application: ANDA202555
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: MYCOPHENOLATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 10 February 2021
- Application: ANDA214376
- Marketing authorisation holder: YICHANG HUMANWELL
- Local brand name: MYCOPHENOLATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 23 September 2021
- Application: ANDA208315
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: MYCOPHENOLATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 29 November 2023
- Application: ANDA217031
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: MYCOPHENOLATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
EC-MPS in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is EC-MPS approved in United States?
Yes. FDA authorised it on 21 August 2012; FDA authorised it on 8 January 2014; FDA authorised it on 23 August 2017.
Who is the marketing authorisation holder for EC-MPS in United States?
APOTEX INC holds the US marketing authorisation.