Taclonex

Treats plaque psoriasis of the scalp and body. NDA 22185, held by Leo Pharma As. Betamethasone Dipropionate; Calcipotriene, Betamethasone Dipropionate; Calcipotriene Hydrate.

As of Nov 14, 2026, NDA 22185 (Taclonex), held by Leo Pharma As, was first approved by FDA on May 9, 2008, with 15 approved supplements and 0 published complete response letters.

First approved: May 9, 2008
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Taclonex Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 12 years and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Jul 25, 2019	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Label
Aug 29, 2014	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Oct 17, 2012	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 9, 2008	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter

Products

2 strengths and forms


Taclonex0.064%;0.005% · suspension;topical	Betamethasone Dipropionate; Calcipotriene	RxReference drug
Taclonex0.064%;0.005% · suspension;topical	Betamethasone Dipropionate; Calcipotriene Hydrate	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Jul 25, 2019	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Label
Jun 19, 2017	Supplement 25Manufacturing	Approved	Label
Jun 21, 2016	Supplement 24Manufacturing	Approved	Label
Mar 18, 2016	Supplement 23Manufacturing · Standard review	Approved	None posted
Feb 5, 2016	Supplement 22Manufacturing · Standard review	Approved	None posted
Oct 29, 2015	Supplement 19Manufacturing · Standard review	Approved	Label
Aug 29, 2014	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jul 28, 2014	Supplement 20Labeling · Standard review	Approved	Label Letter
Feb 26, 2014	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 7, 2013	Supplement 16Labeling · Standard review	Approved	Letter Label
Nov 7, 2013	Supplement 15Manufacturing · Standard review	Approved	Label Letter
Jun 28, 2013	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 30, 2012	Supplement 12Labeling	Approved	Letter Label
Oct 17, 2012	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 20, 2009	Supplement 3Manufacturing	Approved	Letter
May 9, 2008	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter

Identifiers

Application: NDA 22185
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