FDA — authorised 14 January 2013
- Application: ANDA201615
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
🇺🇸 Enstilar in United States
FDA authorised Enstilar on 14 January 2013 · 1,003 US adverse-event reports
Marketing authorisations
FDA — authorised 12 December 2014
- Application: ANDA200174
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
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 11 May 2020
- Application: ANDA210765
- Marketing authorisation holder: COSETTE
- Local brand name: CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
- Indication: SUSPENSION — TOPICAL
- Status: approved
FDA — authorised 2 September 2020
- Application: ANDA213269
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
- Indication: SUSPENSION — TOPICAL
- Status: approved
FDA — authorised 21 March 2023
- Application: ANDA214688
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 1,003
Most-reported reactions
- Psoriasis — 291 reports (29.01%)
- Drug Ineffective — 122 reports (12.16%)
- Diarrhoea — 108 reports (10.77%)
- Headache — 85 reports (8.47%)
- Pruritus — 81 reports (8.08%)
- Pain — 75 reports (7.48%)
- Arthralgia — 61 reports (6.08%)
- Psoriatic Arthropathy — 61 reports (6.08%)
- Rash — 60 reports (5.98%)
- Nausea — 59 reports (5.88%)
Enstilar in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Enstilar approved in United States?
Yes. FDA authorised it on 14 January 2013; FDA authorised it on 12 December 2014; FDA authorised it on 16 October 2015.
Who is the marketing authorisation holder for Enstilar in United States?
CHARTWELL RX holds the US marketing authorisation.