Claritin, Claritin Hives Relief

NDA 19658, held by Bayer Healthcare LLC. Loratadine.

As of Nov 13, 2026, NDA 19658 (Claritin, Claritin Hives Relief), held by Bayer Healthcare LLC, was first approved by FDA on Apr 12, 1993, with 34 approved supplements and 0 published complete response letters.

First approved: Apr 12, 1993
Review: Standard
Supplements approved: 34
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 35 submissions below

Date	Submission	Status	Documents
Nov 19, 2003	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Letter
Nov 27, 2002	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Review Letter
Sep 20, 1995	Supplement 3Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 12, 1993	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Claritin10MG · tablet;oral	Loratadine	OTCReference drug
Claritin Hives Relief10MG · tablet;oral	Loratadine	OTCReference drug

All 35 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 25, 2026	Supplement 64Labeling · Standard review	Approved	Letter Label
Apr 17, 2025	Supplement 62Labeling · Standard review	Approved	Label Letter
Feb 6, 2019	Supplement 56Labeling · Standard review	Approved	Label Letter
Dec 21, 2018	Supplement 55Labeling · Standard review	Approved	Letter Label
Oct 3, 2018	Supplement 54Labeling · Standard review	Approved	Label Letter
Jul 5, 2018	Supplement 53Labeling · Standard review	Approved	Label
May 30, 2018	Supplement 52Labeling · Standard review	Approved	Letter Label
May 30, 2018	Supplement 51Labeling · Standard review	Approved	Letter Label
Jan 12, 2018	Supplement 50Manufacturing	Approved	None posted
Apr 26, 2017	Supplement 48Labeling · Standard review	Approved	Letter Label
Dec 14, 2016	Supplement 46Labeling · Standard review	Approved	Label Letter
Aug 9, 2016	Supplement 45Labeling · Standard review	Approved	Label Letter
Dec 18, 2015	Supplement 44Labeling · Standard review	Approved	Letter Label
Sep 14, 2015	Supplement 43Manufacturing · Standard review	Approved	None posted
Jun 5, 2013	Supplement 40Manufacturing · Standard review	Approved	None posted
Nov 16, 2012	Supplement 39Manufacturing · Standard review	Approved	None posted
Dec 20, 2007	Supplement 26Labeling · Standard review	Approved	Label Letter
Nov 19, 2003	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Letter
Jun 25, 2003	Supplement 21Labeling · Standard review	Approved	Letter
Dec 10, 2002	Supplement 19Manufacturing · Standard review	Approved	None posted
Nov 27, 2002	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Review Letter
Jul 23, 1999	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 27, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 29, 1998	Supplement 14Manufacturing · Standard review	Approved	Review
May 8, 1998	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 27, 1998	Supplement 9Labeling · Standard review	Approved	None posted
Jan 23, 1998	Supplement 10Manufacturing · Standard review	Approved	Review
Jul 14, 1997	Supplement 8Labeling · Standard review	Approved	None posted
Sep 12, 1996	Supplement 1Labeling · Standard review	Approved	None posted
Oct 12, 1995	Supplement 5Labeling · Standard review	Approved	Review
Sep 20, 1995	Supplement 3Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 1, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 9, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 17, 1993	Supplement 2Labeling · Standard review	Approved	None posted
Apr 12, 1993	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19658
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