FDA — authorised 25 April 2019
- Application: NDA209354
- Marketing authorisation holder: BAUSCH
- Local brand name: DUOBRII
- Indication: LOTION — TOPICAL
- Status: approved
🇺🇸 Duobrii® in United States
FDA authorised Duobrii® on 25 April 2019
Marketing authorisations
FDA — authorised 2 May 2025
- Application: ANDA217190
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: HALOBETASOL PROPIONATE AND TAZAROTENE
- Indication: LOTION — TOPICAL
- Status: approved
Other Dermatology approved in United States
Frequently asked questions
Is Duobrii® approved in United States?
Yes. FDA authorised it on 25 April 2019; FDA authorised it on 2 May 2025.
Who is the marketing authorisation holder for Duobrii® in United States?
BAUSCH holds the US marketing authorisation.