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Chinese Patent Office
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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022157

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NDA 022157 describes XYZAL, which is a drug marketed by Sanofi-aventis Us and is included in four NDAs. It is available from four suppliers. There is one patent protecting this drug and two 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-six suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 022157
Tradename:XYZAL
Applicant:Sanofi-aventis Us
Ingredient:levocetirizine dihydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Pharmacology for NDA: 022157
Suppliers and Packaging for NDA: 022157
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XYZAL levocetirizine dihydrochloride SOLUTION;ORAL 022157 NDA Sanofi-Aventis U.S. LLC 0024-5801 E 0024-5801-15
XYZAL levocetirizine dihydrochloride SOLUTION;ORAL 022157 NDA Sanofi-Aventis U.S. LLC 0024-5801 E 0024-5801-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength2.5MG/5ML
Approval Date:Jan 28, 2008TE:AARLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
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