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Generated: November 16, 2018

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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 six 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 nine 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

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION;ORALStrength30MG/5ML
Approval Date:Jan 24, 2011TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 16, 2032Product 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:➤ Sign UpPatent Expiration:Aug 16, 2032Product 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 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride SUSPENSION;ORAL 201373-001 Jan 24, 2011 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride SUSPENSION;ORAL 201373-001 Jan 24, 2011 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us CHILDREN'S ALLEGRA HIVES fexofenadine hydrochloride SUSPENSION;ORAL 201373-002 Jan 24, 2011 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us CHILDREN'S ALLEGRA HIVES fexofenadine hydrochloride SUSPENSION;ORAL 201373-002 Jan 24, 2011 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride SUSPENSION;ORAL 201373-001 Jan 24, 2011 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Daiichi Sankyo
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