FDA — authorised 24 December 2002
- Application: NDA021470
- Marketing authorisation holder: LEO PHARMA AS
- Local brand name: FINACEA
- Indication: GEL — TOPICAL
- Status: approved
🇺🇸 azelaic acid 15% gel in United States
FDA authorised azelaic acid 15% gel on 24 December 2002
Marketing authorisations
FDA — authorised 29 July 2015
- Application: NDA207071
- Marketing authorisation holder: LEO PHARMA AS
- Local brand name: FINACEA
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
Other Dermatology approved in United States
Frequently asked questions
Is azelaic acid 15% gel approved in United States?
Yes. FDA authorised it on 24 December 2002; FDA authorised it on 29 July 2015.
Who is the marketing authorisation holder for azelaic acid 15% gel in United States?
LEO PHARMA AS holds the US marketing authorisation.