FDA — authorised 13 February 2009
- Application: NDA021856
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: ULORIC
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Uloric in United States
FDA authorised Uloric on 13 February 2009
Marketing authorisations
FDA — authorised 13 February 2009
- Marketing authorisation holder: TAKEDA PHARMS USA
- Status: approved
FDA — authorised 1 July 2019
- Application: ANDA205421
- Marketing authorisation holder: ALEMBIC
- Status: approved
FDA — authorised 1 July 2019
- Application: ANDA205385
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: FEBUXOSTAT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2019
- Application: ANDA205414
- Marketing authorisation holder: HIKMA
- Local brand name: FEBUXOSTAT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 December 2019
- Application: ANDA210461
- Marketing authorisation holder: MSN
- Local brand name: FEBUXOSTAT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 December 2019
- Application: ANDA210292
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: FEBUXOSTAT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2020
- Application: ANDA205374
- Marketing authorisation holder: DR REDDYS
- Local brand name: FEBUXOSTAT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 December 2021
- Application: ANDA212924
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: FEBUXOSTAT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 March 2022
- Application: ANDA206266
- Marketing authorisation holder: PRINSTON INC
- Local brand name: FEBUXOSTAT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 September 2023
- Application: ANDA207293
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: FEBUXOSTAT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 October 2023
- Application: ANDA210741
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: FEBUXOSTAT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 December 2023
- Application: ANDA211837
- Marketing authorisation holder: TORRENT
- Local brand name: FEBUXOSTAT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 January 2024
- Application: ANDA205406
- Marketing authorisation holder: LUPIN
- Local brand name: FEBUXOSTAT
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA211339
- Marketing authorisation holder: BEIJING SL PHARMA CO LTD
- Local brand name: FEBUXOSTAT
- Indication: TABLET — ORAL
- Status: approved
Uloric 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 Uloric approved in United States?
Yes. FDA authorised it on 13 February 2009; FDA authorised it on 13 February 2009; FDA authorised it on 1 July 2019.
Who is the marketing authorisation holder for Uloric in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.