Clarinex-D 12 Hour

Relieves nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal…. NDA 21313, held by Organon LLC. Desloratadine; Pseudoephedrine Sulfate.

As of Nov 15, 2026, NDA 21313 (Clarinex-D 12 Hour), held by Organon LLC, was first approved by FDA on Feb 1, 2006, with 7 approved supplements and 0 published complete response letters.

First approved: Feb 1, 2006
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CLARINEX-D 12 HOUR is a combination product containing a histamine-1 (H1) receptor antagonist and an alpha adrenergic agonist indicated for: Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. 1.1 Seasonal Allergic Rhinitis CLARINEX-D 12 HOUR Extended Release Tablets is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Feb 1, 2006	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clarinex-D 12 Hour2.5MG;120MG · tablet, extended release;oral	Desloratadine; Pseudoephedrine Sulfate	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Mar 15, 2019	Supplement 12Labeling · Standard review	Approved	Letter Label
Apr 19, 2018	Supplement 10Labeling · Standard review	Approved	Letter Label
Feb 6, 2018	Supplement 9Labeling · Standard review	Approved	Letter Label
Oct 16, 2015	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 7, 2014	Supplement 5Labeling · Standard review	Approved	Letter Label
Dec 30, 2009	Supplement 2Labeling · Standard review	Approved	Label Letter
Jul 19, 2007	Supplement 1Labeling · Standard review	Approved	Letter Label
Feb 1, 2006	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21313
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