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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022064

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NDA 022064 describes XYZAL, which is a drug marketed by Sanofi Aventis Us and is included in four NDAs. It is available from one supplier. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the XYZAL profile page.

The generic ingredient in XYZAL is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 022064
Tradename:XYZAL
Applicant:Sanofi Aventis Us
Ingredient:levocetirizine dihydrochloride
Patents:0
Pharmacology for NDA: 022064
Suppliers and Packaging for NDA: 022064
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064 NDA Sanofi-Aventis U.S. LLC 0024-5803 0024-5803-90 90 TABLET, FILM COATED in 1 BOTTLE (0024-5803-90)
Paragraph IV (Patent) Challenges for 022064
Tradename Dosage Ingredient NDA Submissiondate
XYZAL TABLET;ORAL levocetirizine dihydrochloride 022064 2007-12-17

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 25, 2007TE:ABRLD:Yes

Expired US Patents for NDA 022064

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007   Start Trial   Start Trial
Sanofi Aventis Us XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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