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Last Updated: July 7, 2020

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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 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-two suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 022157
Applicant:Sanofi Aventis Us
Ingredient:levocetirizine dihydrochloride
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 0024-5804 0024-5804-05 1 BOTTLE in 1 CARTON (0024-5804-05) > 148 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 022157
Tradename Dosage Ingredient NDA Submissiondate
XYZAL SOLUTION;ORAL levocetirizine dihydrochloride 022157 2009-01-14

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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