FDA — authorised 16 October 2015
- Application: NDA207589
- Marketing authorisation holder: LEO PHARMA AS
- Local brand name: ENSTILAR
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA authorised Calcipotriene and betamethasone dipropionate ointment on 16 October 2015
Yes. FDA authorised it on 16 October 2015.
LEO PHARMA AS holds the US marketing authorisation.