Children'S Allegra Allergy, Children'S Allegra Hives

NDA 21909, held by Chattem Sanofi. Fexofenadine Hydrochloride.

As of Nov 14, 2026, NDA 21909 (Children'S Allegra Allergy, Children'S Allegra Hives), held by Chattem Sanofi, was first approved by FDA on Jul 26, 2007, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 26, 2007
Review: Standard
Supplements approved: 10
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, water 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 11 submissions below


Jan 24, 2011	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 26, 2007	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

2 strengths and forms


Children'S Allegra Allergy30MG · tablet, orally disintegrating;oral	Fexofenadine Hydrochloride	DiscontinuedReference drug
Children'S Allegra Hives30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, orally disintegrating;oral	Fexofenadine Hydrochloride	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Jun 4, 2026	Supplement 19Labeling · Standard review	Approved	Letter Label
Dec 3, 2020	Supplement 15Labeling · Standard review	Approved	Label Letter
Aug 5, 2016	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 1, 2016	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 10, 2016	Supplement 10Labeling · Standard review	Approved	Label Letter
Jan 31, 2014	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 9, 2013	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 28, 2013	Supplement 7Labeling · Standard review	Approved	Label Letter
Aug 23, 2012	Supplement 6Labeling · Standard review	Approved	Letter
Jan 24, 2011	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 26, 2007	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21909
Drugs@FDA: Overview at FDA
Company: Chattem Sanofi

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