FDA — authorised 3 July 1979
- Marketing authorisation holder: JACOBUS
- Status: approved
🇺🇸 Aczone in United States
FDA authorised Aczone on 3 July 1979
Marketing authorisations
FDA — authorised 24 August 2009
- Application: ANDA086842
- Marketing authorisation holder: EVEREST LIFE SCI
- Indication: Labeling
- Status: approved
FDA — authorised 16 October 2017
- Application: ANDA209506
- Marketing authorisation holder: SUN PHARMA CANADA
- Status: approved
FDA — authorised 31 March 2022
- Application: ANDA210178
- Marketing authorisation holder: COSETTE
- Status: approved
FDA — authorised 4 April 2025
- Application: ANDA218457
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 23 April 2025
- Application: ANDA206505
- Marketing authorisation holder: NOVITIUM PHARMA
- Indication: Labeling
- Status: approved
The FDA approved Aczone for its indicated use as stated in the labeling. This approval was granted to NOVITIUM PHARMA on 2025-04-23, following a standard expedited pathway. The application number for this approval is ANDA206505.
Aczone 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 Aczone approved in United States?
Yes. FDA authorised it on 3 July 1979; FDA authorised it on 24 August 2009; FDA authorised it on 16 October 2017.
Who is the marketing authorisation holder for Aczone in United States?
JACOBUS holds the US marketing authorisation.