FDA — authorised 31 October 1949
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
🇺🇸 Aralen in United States
FDA authorised Aralen on 31 October 1949
Marketing authorisations
FDA — authorised 21 January 2011
- Application: ANDA091621
- Marketing authorisation holder: NATCO PHARMA LTD
- Status: approved
FDA — authorised 28 April 2020
- Application: ANDA040516
- Marketing authorisation holder: IMPAX LABS
- Indication: Labeling
- Status: approved
FDA — authorised 17 March 2022
- Application: ANDA080880
- Marketing authorisation holder: IMPAX LABS
- Indication: Labeling
- Status: approved
FDA — authorised 10 March 2023
- Application: ANDA214756
- Marketing authorisation holder: SUVEN PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 24 July 2023
- Application: ANDA090612
- Marketing authorisation holder: NATCO PHARMA LTD
- Indication: Labeling
- Status: approved
Aralen 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 Aralen approved in United States?
Yes. FDA authorised it on 31 October 1949; FDA authorised it on 21 January 2011; FDA authorised it on 28 April 2020.
Who is the marketing authorisation holder for Aralen in United States?
SANOFI AVENTIS US holds the US marketing authorisation.