FDA — authorised 29 December 1993
- Application: NDA020273
- Marketing authorisation holder: LEO PHARMA AS
- Local brand name: DOVONEX
- Indication: OINTMENT — TOPICAL
- Status: approved
🇺🇸 Dovonex in United States
FDA authorised Dovonex on 29 December 1993
Marketing authorisations
FDA — authorised 22 July 1996
- Application: NDA020554
- Marketing authorisation holder: LEO PHARMA AS
- Local brand name: DOVONEX
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 6 May 2008
- Application: ANDA078305
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: CALCIPOTRIENE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 20 November 2009
- Application: ANDA077029
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CALCIPOTRIENE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 30 May 2012
- Application: ANDA200935
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CALCIPOTRIENE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 12 December 2014
- Application: ANDA200174
- Marketing authorisation holder: PADAGIS ISRAEL
- Indication: Not Applicable
- Status: approved
FDA — authorised 9 June 2015
- Application: ANDA205772
- Marketing authorisation holder: GLENMARK SPECLT
- Status: approved
FDA — authorised 8 March 2016
- Application: NDA207589
- Marketing authorisation holder: LEO PHARMA AS
- Indication: Labeling
- Status: approved
FDA — authorised 26 December 2017
- Application: ANDA207163
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CALCIPOTRIENE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 24 May 2019
- Application: ANDA090633
- Marketing authorisation holder: GLENMARK PHARMS
- Indication: Labeling
- Status: approved
Dovonex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Dovonex approved in United States?
Yes. FDA authorised it on 29 December 1993; FDA authorised it on 22 July 1996; FDA authorised it on 6 May 2008.
Who is the marketing authorisation holder for Dovonex in United States?
LEO PHARMA AS holds the US marketing authorisation.