Clarinex

NDA 21300, held by Organon LLC. Desloratadine.

As of Nov 14, 2026, NDA 21300 (Clarinex), held by Organon LLC, was first approved by FDA on Sep 1, 2004, with 8 approved supplements and 0 published complete response letters.

First approved: Sep 1, 2004
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Sep 1, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clarinex0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;oral	Desloratadine	DiscontinuedReference drug

All 9 submissions, including labeling and manufacturing supplements


Mar 15, 2019	Supplement 19Labeling · Standard review	Approved	Letter Label
Mar 1, 2019	Supplement 17Labeling · Standard review	Approved	Letter Label
Apr 23, 2014	Supplement 14Labeling · Standard review	Approved	Label Letter
Dec 22, 2010	Supplement 11Labeling · Standard review	Approved	Letter
Dec 14, 2006	Supplement 1Labeling · Standard review	Approved	Letter
Dec 14, 2006	Supplement 3Labeling · Standard review	Approved	Letter
Dec 14, 2006	Supplement 4Labeling · Standard review	Approved	None posted
Dec 14, 2006	Supplement 5Labeling · Standard review	Approved	Letter
Sep 1, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21300
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