FDA — authorised 26 January 2016
- Application: ANDA203560
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: DEFERASIROX
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
🇺🇸 osveral in United States
FDA authorised osveral on 26 January 2016
Marketing authorisations
FDA — authorised 18 May 2017
- Application: NDA207968
- Marketing authorisation holder: NOVARTIS
- Local brand name: JADENU SPRINKLE
- Indication: GRANULE — ORAL
- Status: approved
FDA — authorised 20 November 2019
- Application: ANDA210060
- Marketing authorisation holder: ALEMBIC
- Local brand name: DEFERASIROX
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 20 November 2019
- Application: ANDA211383
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: DEFERASIROX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 November 2019
- Application: ANDA209782
- Marketing authorisation holder: SUN PHARM
- Local brand name: DEFERASIROX
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 20 November 2019
- Application: ANDA211824
- Marketing authorisation holder: ALEMBIC
- Local brand name: DEFERASIROX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 December 2019
- Application: ANDA208697
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: DEFERASIROX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 December 2019
- Application: ANDA210727
- Marketing authorisation holder: STEVENS J
- Local brand name: DEFERASIROX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 January 2020
- Application: ANDA209433
- Marketing authorisation holder: GLENMARK SPECLT
- Local brand name: DEFERASIROX
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 14 May 2021
- Application: ANDA214341
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: DEFERASIROX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 September 2022
- Application: ANDA207124
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: DEFERASIROX
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 16 October 2023
- Application: ANDA214474
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DEFERASIROX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 March 2024
- Application: ANDA211395
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: DEFERASIROX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 May 2024
- Application: ANDA213146
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: DEFERASIROX
- Indication: GRANULE — ORAL
- Status: approved
FDA — authorised 5 November 2024
- Application: ANDA209426
- Marketing authorisation holder: TORRENT
- Local brand name: DEFERASIROX
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 11 April 2025
- Application: ANDA211660
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: DEFERASIROX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 September 2025
- Application: ANDA215137
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: DEFERASIROX
- Indication: GRANULE — ORAL
- Status: approved
Other Other approved in United States
Frequently asked questions
Is osveral approved in United States?
Yes. FDA authorised it on 26 January 2016; FDA authorised it on 18 May 2017; FDA authorised it on 20 November 2019.
Who is the marketing authorisation holder for osveral in United States?
ACTAVIS ELIZABETH holds the US marketing authorisation.