FDA — authorised 3 July 1979
- Application: ANDA086841
- Marketing authorisation holder: EVEREST LIFE SCI
- Local brand name: DAPSONE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Aczone 5% gel in United States
FDA authorised Aczone 5% gel on 3 July 1979
Marketing authorisations
FDA — authorised 3 July 1979
- Application: ANDA086842
- Marketing authorisation holder: EVEREST LIFE SCI
- Local brand name: DAPSONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 2016
- Application: ANDA204074
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: DAPSONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 December 2016
- Application: ANDA206505
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: DAPSONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 2017
- Application: ANDA204380
- Marketing authorisation holder: ACTAVIS LLC
- Local brand name: DAPSONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 2017
- Application: ANDA209506
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 1 March 2019
- Application: ANDA209430
- Marketing authorisation holder: TARO
- Local brand name: DAPSONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 May 2019
- Application: ANDA207165
- Marketing authorisation holder: RISING
- Local brand name: DAPSONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 June 2019
- Application: ANDA210191
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 10 February 2022
- Application: ANDA214722
- Marketing authorisation holder: TORRENT
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 31 March 2022
- Application: ANDA210178
- Marketing authorisation holder: COSETTE
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 31 May 2023
- Application: ANDA212701
- Marketing authorisation holder: AMNEAL
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 6 June 2023
- Application: ANDA213907
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 13 October 2023
- Application: ANDA212383
- Marketing authorisation holder: ENCUBE
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 19 October 2023
- Application: ANDA209890
- Marketing authorisation holder: AMNEAL
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 27 October 2023
- Application: ANDA215718
- Marketing authorisation holder: ALEMBIC
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 8 May 2024
- Application: ANDA214019
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 26 August 2024
- Application: ANDA213636
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 4 April 2025
- Application: ANDA218457
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 26 February 2026
- Application: ANDA220103
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: DAPSONE
- Indication: TABLET — ORAL
- Status: approved
Other Dermatology approved in United States
Frequently asked questions
Is Aczone 5% gel approved in United States?
Yes. FDA authorised it on 3 July 1979; FDA authorised it on 3 July 1979; FDA authorised it on 10 May 2016.
Who is the marketing authorisation holder for Aczone 5% gel in United States?
EVEREST LIFE SCI holds the US marketing authorisation.