Claritin-D 24 Hour

NDA 20470, held by Bayer Healthcare LLC. Loratadine; Pseudoephedrine Sulfate.

As of Nov 14, 2026, NDA 20470 (Claritin-D 24 Hour), held by Bayer Healthcare LLC, was first approved by FDA on Aug 23, 1996, with 23 approved supplements and 0 published complete response letters.

First approved: Aug 23, 1996
Review: Standard
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing itchy, watery eyes runny nose itching of the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below


Jul 30, 2004	Supplement 22Efficacy (new indication or use)	Approved	Label Letter
Nov 27, 2002	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Review Letter
Aug 23, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Claritin-D 24 Hour10MG;240MG · tablet, extended release;oral	Loratadine; Pseudoephedrine Sulfate	OTCReference drug

All 24 submissions, including labeling and manufacturing supplements


Nov 9, 2023	Supplement 52Labeling · Standard review	Approved	Label Letter
Jul 31, 2018	Supplement 47Labeling · Standard review	Approved	Letter Label
Nov 25, 2015	Supplement 44Labeling · Standard review	Approved	Label Letter
Jan 3, 2014	Supplement 43Manufacturing · Standard review	Approved	None posted
Apr 26, 2013	Supplement 41Manufacturing · Standard review	Approved	None posted
Feb 13, 2013	Supplement 40Manufacturing · Standard review	Approved	None posted
Jan 25, 2010	Supplement 34Labeling	Approved	Letter
Jul 30, 2004	Supplement 22Efficacy (new indication or use)	Approved	Label Letter
Jul 15, 2004	Supplement 23Labeling · Standard review	Approved	Letter
Jun 25, 2003	Supplement 19Labeling · Standard review	Approved	Letter
Dec 9, 2002	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 27, 2002	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Review Letter
Jan 30, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 13, 2000	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 13, 2000	Supplement 10Manufacturing · Standard review	Approved	Review
Feb 14, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 1, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 4, 1998	Supplement 5Manufacturing · Standard review	Approved	Review
Oct 29, 1998	Supplement 7Manufacturing · Standard review	Approved	Review
May 4, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 23, 1998	Supplement 3Manufacturing · Standard review	Approved	Review
Oct 6, 1997	Supplement 2Labeling · Standard review	Approved	None posted
Mar 26, 1997	Supplement 1Labeling · Standard review	Approved	None posted
Aug 23, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20470
Drugs@FDA: Overview at FDA
Company: Bayer Healthcare

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