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Last Updated: July 5, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201373


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NDA 201373 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 201373
Tradename:CHILDREN'S ALLEGRA HIVES
Applicant:Sanofi Aventis Us
Ingredient:fexofenadine hydrochloride
Patents:1
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 201373
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride SUSPENSION;ORAL 201373 NDA Chattem, Inc. 41167-4244 41167-4244-1 1 BOTTLE in 1 CARTON (41167-4244-1) > 240 mL in 1 BOTTLE
CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride SUSPENSION;ORAL 201373 NDA Chattem, Inc. 41167-4244 41167-4244-4 1 BOTTLE in 1 CARTON (41167-4244-4) > 120 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 201373
Tradename Dosage Ingredient NDA Submissiondate
CHILDREN'S ALLEGRA HIVES SUSPENSION;ORAL fexofenadine hydrochloride 201373 2010-01-25
CHILDREN'S ALLEGRA ALLERGY SUSPENSION;ORAL fexofenadine hydrochloride 201373 2010-01-25

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION;ORALStrength30MG/5ML
Approval Date:Jan 24, 2011TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 2, 2030Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SUSPENSION;ORALStrength30MG/5ML
Approval Date:Jan 24, 2011TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 2, 2030Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 201373

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us CHILDREN'S ALLEGRA HIVES fexofenadine hydrochloride SUSPENSION;ORAL 201373-002 Jan 24, 2011   Start Trial   Start Trial
Sanofi Aventis Us CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride SUSPENSION;ORAL 201373-001 Jan 24, 2011   Start Trial   Start Trial
Sanofi Aventis Us CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride SUSPENSION;ORAL 201373-001 Jan 24, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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