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Generated: November 13, 2018

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 two suppliers. 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. Thirty-seven 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)
XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064 NDA UCB, Inc. 50474-920 50474-920-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-920-90)

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 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi-aventis Us XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
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Accenture
McKinsey
Express Scripts
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Moodys
Baxter
Deloitte

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