FDA — authorised 7 July 2005
- Application: NDA021794
- Marketing authorisation holder: ALMIRALL
- Local brand name: ACZONE
- Indication: GEL — TOPICAL
- Status: approved
🇺🇸 Dapsone 7.5 % gel in United States
FDA authorised Dapsone 7.5 % gel on 7 July 2005
Marketing authorisations
FDA — authorised 24 February 2016
- Application: NDA207154
- Marketing authorisation holder: ALMIRALL
- Local brand name: ACZONE
- Indication: GEL — TOPICAL
- Status: approved
Other Dermatology approved in United States
Frequently asked questions
Is Dapsone 7.5 % gel approved in United States?
Yes. FDA authorised it on 7 July 2005; FDA authorised it on 24 February 2016.
Who is the marketing authorisation holder for Dapsone 7.5 % gel in United States?
ALMIRALL holds the US marketing authorisation.