Dovonex

Treats plaque psoriasis. NDA 20273, held by Leo Pharma As. Calcipotriene.

As of Nov 13, 2026, NDA 20273 (Dovonex), held by Leo Pharma As, was first approved by FDA on Dec 29, 1993, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 29, 1993
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Calcipotriene Ointment, 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Jul 7, 1999	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Review
Mar 20, 1997	Supplement 3Efficacy (new indication or use) · Standard review	Approved	None posted
Aug 15, 1996	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 29, 1993	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dovonex0.005% · ointment;topical	Calcipotriene	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Oct 3, 2025	Supplement 15Labeling · Standard review	Approved	Letter Label
Mar 11, 2015	Supplement 13Labeling · Standard review	Approved	Label Letter
Jul 3, 2014	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 26, 2007	Supplement 9Labeling · Standard review	Approved	Letter Label
Apr 28, 2005	Supplement 8Labeling · Standard review	Approved	Review Letter Label
Mar 23, 2001	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 11, 2000	Supplement 6Labeling · Standard review	Approved	None posted
Jul 7, 1999	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Review
Mar 11, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 20, 1997	Supplement 3Efficacy (new indication or use) · Standard review	Approved	None posted
Aug 15, 1996	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Jul 13, 1995	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 29, 1993	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 20273
Drugs@FDA: Overview at FDA
Company: LEO Pharma

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