FDA — authorised 21 February 2001
- Application: ANDA075568
- Marketing authorisation holder: RISING
- Indication: Labeling
- Status: approved
🇺🇸 Imuran in United States
FDA authorised Imuran on 21 February 2001
Marketing authorisations
FDA — authorised 18 July 2001
- Application: ANDA075252
- Marketing authorisation holder: AAIPHARMA LLC
- Indication: Labeling
- Status: approved
FDA — authorised 9 July 2008
- Application: NDA016324
- Marketing authorisation holder: LEGACY PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 20 June 2011
- Application: ANDA077621
- Marketing authorisation holder: ZYDUS PHARMS USA
- Indication: Labeling
- Status: approved
FDA — authorised 13 June 2025
- Application: ANDA208687
- Marketing authorisation holder: ALKEM LABS LTD
- Indication: Labeling
- Status: approved
ALKEM LABS LTD received marketing authorisation for Imuran from the FDA on 2025-06-13. The application number for this approval is ANDA208687. The approved indication for Imuran is labelled, but the specific details of the labelling are not provided.
Imuran 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 Imuran approved in United States?
Yes. FDA authorised it on 21 February 2001; FDA authorised it on 18 July 2001; FDA authorised it on 9 July 2008.
Who is the marketing authorisation holder for Imuran in United States?
RISING holds the US marketing authorisation.