Claritin, Claritin Hives Relief

NDA 20641, held by Bayer Healthcare LLC. Loratadine.

As of Nov 13, 2026, NDA 20641 (Claritin, Claritin Hives Relief), held by Bayer Healthcare LLC, was first approved by FDA on Oct 10, 1996, with 28 approved supplements and 0 published complete response letters.

First approved: Oct 10, 1996
Review: Standard
Supplements approved: 28
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 sneezing itchy, watery eyes 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 29 submissions below

Date	Submission	Status	Documents
Nov 19, 2003	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter
Nov 27, 2002	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Review Letter
Dec 4, 2000	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Oct 10, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Claritin1MG/ML · syrup;oral	Loratadine	OTCReference drug
Claritin Hives Relief1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · syrup;oral	Loratadine	DiscontinuedReference drug

All 29 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 22, 2024	Supplement 48Manufacturing	Approved	Label Letter
Feb 28, 2019	Supplement 46Labeling · Standard review	Approved	Letter Label
May 14, 2018	Supplement 45Labeling · Standard review	Approved	Label Letter
Aug 9, 2016	Supplement 42Labeling · Standard review	Approved	Label Letter
Feb 12, 2016	Supplement 41Manufacturing · Standard review	Approved	None posted
Dec 30, 2015	Supplement 40Labeling · Standard review	Approved	Label Letter
Dec 10, 2015	Supplement 39Manufacturing · Standard review	Approved	None posted
Nov 12, 2015	Supplement 38Labeling · Standard review	Approved	Label Letter
Oct 21, 2015	Supplement 37Manufacturing	Approved	Label Letter
Apr 16, 2015	Supplement 36Manufacturing · Standard review	Approved	Letter Label
May 15, 2014	Supplement 35Manufacturing · Standard review	Approved	None posted
Apr 16, 2013	Supplement 33Manufacturing · Standard review	Approved	None posted
Feb 28, 2013	Supplement 32Manufacturing · Standard review	Approved	Label Letter
Nov 20, 2012	Supplement 30Manufacturing · Standard review	Approved	None posted
Jul 25, 2008	Supplement 25Labeling · Standard review	Approved	Letter
Jul 25, 2008	Supplement 24Manufacturing	Approved	Letter
Jun 14, 2005	Supplement 18Manufacturing · Standard review	Approved	Letter
Oct 27, 2004	Supplement 17Manufacturing · Standard review	Approved	Letter
Jul 15, 2004	Supplement 16Manufacturing · Standard review	Approved	Letter
Nov 19, 2003	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter
Dec 9, 2002	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 27, 2002	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Review Letter
Jul 23, 2002	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 4, 2000	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Jan 7, 1999	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 29, 1998	Supplement 3Manufacturing · Standard review	Approved	Review
Mar 30, 1998	Supplement 2Labeling · Standard review	Approved	None posted
Jan 23, 1998	Supplement 1Manufacturing · Standard review	Approved	Review
Oct 10, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20641
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