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Last Updated: August 9, 2020

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Details for New Drug Application (NDA): 021909

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NDA 021909 describes CHILDREN'S ALLEGRA HIVES, which is a drug marketed by Sanofi Aventis Us and is included in three NDAs. It is available from three suppliers. There are two patents protecting this drug. Additional details are available on the CHILDREN'S ALLEGRA HIVES profile page.

The generic ingredient in CHILDREN'S ALLEGRA HIVES is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and two suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 021909
Tradename:CHILDREN'S ALLEGRA HIVES
Applicant:Sanofi Aventis Us
Ingredient:fexofenadine hydrochloride
Patents:1
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021909
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021909 NDA Chattem, Inc. 41167-4232 41167-4232-1 2 BLISTER PACK in 1 CARTON (41167-4232-1) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021909 NDA Chattem, Inc. 41167-4232 41167-4232-6 4 BLISTER PACK in 1 CARTON (41167-4232-6) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength30MG
Approval Date:Jan 24, 2011TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Nov 26, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength30MG
Approval Date:Jan 24, 2011TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Nov 26, 2021Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021909

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us CHILDREN'S ALLEGRA HIVES fexofenadine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021909-003 Jan 24, 2011   Start Trial   Start Trial
Sanofi Aventis Us CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021909-002 Jan 24, 2011   Start Trial   Start Trial
Sanofi Aventis Us CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021909-002 Jan 24, 2011   Start Trial   Start Trial
Sanofi Aventis Us CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021909-002 Jan 24, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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