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Details for New Drug Application (NDA): 021963

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NDA 021963 describes ALLEGRA, which is a drug marketed by Sanofi Aventis Us and is included in five NDAs. It is available from one supplier. There are nine patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ALLEGRA profile page.

The generic ingredient in ALLEGRA is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Sixteen suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.

Summary for NDA: 021963

Tradename:
ALLEGRA
Applicant:
Sanofi Aventis Us
Ingredient:
fexofenadine hydrochloride
Patents:1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021963

Suppliers and Packaging for NDA: 021963

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALLEGRA
fexofenadine hydrochloride
SUSPENSION;ORAL 021963 NDA sanofi-aventis U.S. LLC 0088-1097 0088-1097-10 30 mL in 1 BOTTLE (0088-1097-10)
ALLEGRA
fexofenadine hydrochloride
SUSPENSION;ORAL 021963 NDA sanofi-aventis U.S. LLC 0088-1097 0088-1097-20 300 mL in 1 BOTTLE (0088-1097-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength30MG/5ML
Approval Date:Oct 16, 2006TE:ABRLD:Yes
Patent:6,037,353Patent Expiration:Mar 14, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN CHILDREN 2 TO 11 YEARS AND FOR THE RELIEF OF SYMPTOMS ASSOCIATED WITH UNCOMPLICATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA IN CHILDREN 6 MONTHS TO 11 YEARS

Expired Orange Book Patents for NDA: 021963

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
ALLEGRA
fexofenadine hydrochloride
SUSPENSION;ORAL021963-001Oct 16, 20065,578,610► subscribe
Sanofi Aventis Us
ALLEGRA
fexofenadine hydrochloride
SUSPENSION;ORAL021963-001Oct 16, 20067,138,524*PED► subscribe
Sanofi Aventis Us
ALLEGRA
fexofenadine hydrochloride
SUSPENSION;ORAL021963-001Oct 16, 20066,399,632► subscribe
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