Treats plaque psoriasis. NDA 21852, held by Leo Pharma As. Betamethasone Dipropionate; Calcipotriene.
As of Nov 14, 2026, NDA 21852 (Taclonex), held by Leo Pharma As, was first approved by FDA on Jan 9, 2006, with 10 approved supplements and 0 published complete response letters.
Calcipotriene and Betamethasone Dipropionate Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.
| Dec 23, 2014 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Jan 9, 2006 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Taclonex0.064%;0.005% · ointment;topical | Betamethasone Dipropionate; Calcipotriene | RxReference drug |
| Dec 21, 2018 | Supplement 20Labeling · Standard review | Approved | |
| Dec 23, 2014 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Jul 28, 2014 | Supplement 16Labeling · Standard review | Approved | |
| Jun 12, 2014 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Mar 13, 2014 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Apr 25, 2013 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Nov 30, 2012 | Supplement 12Labeling | Approved | |
| Mar 30, 2010 | Supplement 6Labeling · Standard review | Approved | |
| Sep 26, 2007 | Supplement 2Labeling · Standard review | Approved | |
| Sep 15, 2006 | Supplement 1Manufacturing | Approved | None posted |
| Jan 9, 2006 | Original applicationNew combination · 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
