FDA — authorised 10 September 1998
- Application: NDA020905
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: supplemented
🇺🇸 ARAVA in United States
FDA authorised ARAVA on 10 September 1998
Marketing authorisations
FDA — authorised 13 September 2005
- Application: ANDA077087
- Marketing authorisation holder: FOSUN WANBANG
- Local brand name: LEFLUNOMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 September 2005
- Application: ANDA077090
- Marketing authorisation holder: APOTEX
- Local brand name: LEFLUNOMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 September 2005
- Application: ANDA077083
- Marketing authorisation holder: BARR
- Local brand name: LEFLUNOMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 September 2005
- Application: ANDA077084
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: LEFLUNOMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 September 2005
- Application: ANDA077085
- Marketing authorisation holder: SANDOZ
- Local brand name: LEFLUNOMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 September 2005
- Application: ANDA077086
- Marketing authorisation holder: HERITAGE
- Local brand name: LEFLUNOMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2019
- Application: ANDA212453
- Marketing authorisation holder: ABHAI LLC
- Local brand name: LEFLUNOMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 February 2020
- Application: ANDA211863
- Marketing authorisation holder: LUPIN
- Local brand name: LEFLUNOMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 March 2021
- Application: ANDA213652
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: LEFLUNOMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 2021
- Application: ANDA213497
- Marketing authorisation holder: AET PHARMA
- Local brand name: LEFLUNOMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
ARAVA in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is ARAVA approved in United States?
Yes. FDA authorised it on 10 September 1998; FDA authorised it on 13 September 2005; FDA authorised it on 13 September 2005.
Who is the marketing authorisation holder for ARAVA in United States?
SANOFI AVENTIS US holds the US marketing authorisation.