Children'S Claritin, Claritin

NDA 21891, held by Bayer Healthcare LLC. Loratadine.

As of Nov 14, 2026, NDA 21891 (Children'S Claritin, Claritin), held by Bayer Healthcare LLC, was first approved by FDA on Aug 23, 2006, with 26 approved supplements and 0 published complete response letters.

First approved: Aug 23, 2006
Review: Standard
Supplements approved: 26
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: ●runny nose ●itchy, watery eyes ●sneezing ●itching of the nose or throat

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below


Mar 3, 2010	Supplement 8New dosage form · Standard review	Approved	Letter
Aug 23, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Children'S Claritin5MG · tablet, chewable;oral	Loratadine	OTCReference drug
Claritin10MG · tablet, chewable;oral	Loratadine	OTCReference drug

All 27 submissions, including labeling and manufacturing supplements


May 20, 2026	Supplement 47Labeling · Standard review	Approved	Letter Label
May 14, 2025	Supplement 45Labeling · Standard review	Approved	Letter Label
Apr 17, 2025	Supplement 46Manufacturing	Approved	Label Letter
Jul 11, 2024	Supplement 44Manufacturing	Approved	Label Letter
Dec 27, 2022	Supplement 43Labeling · Standard review	Approved	Label Letter
Apr 2, 2021	Supplement 38Labeling · Standard review	Approved	Label Letter
Jan 7, 2021	Supplement 36Labeling · Standard review	Approved	Label Letter
Aug 7, 2020	Supplement 34Labeling · Standard review	Approved	Label Letter
Nov 7, 2019	Supplement 32Manufacturing	Approved	Label Letter
Oct 3, 2019	Supplement 33Labeling · Standard review	Approved	Label Letter
Jun 17, 2019	Supplement 31Labeling · Standard review	Approved	Label Letter
Jan 3, 2019	Supplement 28Labeling · Standard review	Approved	Label Letter
Nov 21, 2018	Supplement 29Manufacturing	Approved	Label Letter
Jul 20, 2018	Supplement 27Labeling · Standard review	Approved	Label Letter
Feb 15, 2018	Supplement 26Labeling · Standard review	Approved	Label Letter
May 22, 2017	Supplement 23Labeling · Standard review	Approved	Letter Label
Apr 5, 2016	Supplement 21Labeling · Standard review	Approved	Label Letter
Dec 23, 2015	Supplement 20Labeling · Standard review	Approved	Label Letter
Sep 24, 2015	Supplement 19Manufacturing	Approved	None posted
Jul 25, 2014	Supplement 18Labeling · Standard review	Approved	Label Letter
Sep 10, 2013	Supplement 17Manufacturing · Standard review	Approved	None posted
Mar 26, 2013	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 4, 2013	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 3, 2010	Supplement 8New dosage form · Standard review	Approved	Letter
Oct 21, 2008	Supplement 4Labeling · Standard review	Approved	Letter
Oct 8, 2008	Supplement 5Manufacturing · Standard review	Approved	Label Letter
Aug 23, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21891
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