FDA — authorised 19 November 2018
- Application: ANDA208724
- Marketing authorisation holder: ENCUBE
- Local brand name: AZELAIC ACID
- Indication: GEL — TOPICAL
- Status: approved
🇺🇸 Azelaic Acid 15% topical gel in United States
FDA authorised Azelaic Acid 15% topical gel on 19 November 2018
Marketing authorisations
FDA — authorised 19 November 2018
- Application: ANDA208011
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: AZELAIC ACID
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 23 August 2019
- Application: ANDA210549
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: AZELAIC ACID
- Indication: GEL — TOPICAL
- Status: approved
FDA
- Application: ANDA212581
- Marketing authorisation holder: TARO PHARM INDS LTD
- Local brand name: AZELAIC ACID
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
Frequently asked questions
Is Azelaic Acid 15% topical gel approved in United States?
Yes. FDA authorised it on 19 November 2018; FDA authorised it on 19 November 2018; FDA authorised it on 23 August 2019.
Who is the marketing authorisation holder for Azelaic Acid 15% topical gel in United States?
ENCUBE holds the US marketing authorisation.