Clarinex

Relieves nasal and non-nasal symptoms. NDA 21165, held by Organon. Desloratadine.

As of Nov 14, 2026, NDA 21165 (Clarinex), held by Organon, was first approved by FDA on Dec 21, 2001, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 21, 2001
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CLARINEX is a histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older. Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months of age and older. Chronic Idiopathic Urticaria: symptomatic relief of pruritus, reduction in the number of hives, and size of hives in patients 6 months of age and older. 1.1 Seasonal Allergic Rhinitis CLARINEX is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Dec 21, 2001	Original applicationNew molecular entity · Standard review	Approved	Label Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clarinex5MG · tablet;oral	Desloratadine	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Mar 15, 2019	Supplement 22Labeling · Standard review	Approved	Label Letter
Mar 1, 2019	Supplement 20Labeling · Standard review	Approved	Letter Label
Jun 16, 2016	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 16, 2016	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 23, 2014	Supplement 17Labeling · Standard review	Approved	Label Letter
Jul 23, 2013	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 22, 2010	Supplement 14Labeling · Standard review	Approved	Label Letter
Dec 14, 2006	Supplement 9Labeling · Standard review	Approved	Letter
Dec 14, 2006	Supplement 8Labeling · Standard review	Approved	Letter
Dec 14, 2006	Supplement 7Labeling · Standard review	Approved	Letter
Jan 29, 2004	Supplement 6Labeling · Standard review	Approved	Letter
Feb 8, 2002	Supplement 1Labeling · Standard review	Approved	Label Review Letter
Dec 21, 2001	Original applicationNew molecular entity · Standard review	Approved	Label Letter Review

Identifiers

Application: NDA 21165
Drugs@FDA: Overview at FDA
Company: Organon

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