NDA 207589, held by Leo Pharma As. Betamethasone Dipropionate; Calcipotriene.
As of Nov 13, 2026, NDA 207589 (Enstilar), held by Leo Pharma As, was first approved by FDA on Oct 16, 2015, with 7 approved supplements and 0 published complete response letters.
| Oct 16, 2020 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jul 30, 2019 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Oct 16, 2015 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Enstilar0.064%;0.005% · aerosol, foam;topical | Betamethasone Dipropionate; Calcipotriene | RxReference drug |
| Aug 6, 2021 | Supplement 11Labeling · Standard review | Approved | |
| Oct 16, 2020 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jul 30, 2019 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Jul 30, 2019 | Supplement 6Labeling · Standard review | Approved | |
| Jul 30, 2019 | Supplement 7Labeling · Standard review | Approved | |
| Jun 20, 2016 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 8, 2016 | Supplement 1Labeling · Standard review | Approved | |
| Oct 16, 2015 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
