FDA — authorised 17 February 2021
- Application: ANDA211819
- Marketing authorisation holder: UNICHEM
- Local brand name: APREMILAST
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 CC10004 in United States
FDA authorised CC10004 on 17 February 2021
Marketing authorisations
FDA — authorised 30 June 2021
- Application: ANDA211782
- Marketing authorisation holder: AMNEAL
- Local brand name: APREMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 September 2021
- Application: ANDA211761
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: APREMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 2023
- Application: ANDA211774
- Marketing authorisation holder: SHILPA
- Local brand name: APREMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 July 2023
- Application: ANDA211756
- Marketing authorisation holder: DR REDDYS
- Local brand name: APREMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 2023
- Application: ANDA211716
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: APREMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 2023
- Application: ANDA211674
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: APREMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 February 2024
- Application: ANDA211734
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: APREMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 November 2024
- Application: ANDA211788
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: APREMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 August 2025
- Application: NDA210745
- Marketing authorisation holder: AMGEN INC
- Local brand name: OTEZLA XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Frequently asked questions
Is CC10004 approved in United States?
Yes. FDA authorised it on 17 February 2021; FDA authorised it on 30 June 2021; FDA authorised it on 21 September 2021.
Who is the marketing authorisation holder for CC10004 in United States?
UNICHEM holds the US marketing authorisation.