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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Chinese Patent Office
Fish and Richardson

Generated: December 15, 2017

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 five 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 suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.

Summary for 022157

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 0024-5801-20 148 mL in 1 BOTTLE, GLASS (0024-5801-20)
XYZAL levocetirizine dihydrochloride SOLUTION;ORAL 022157 NDA Sanofi-Aventis U.S. LLC 0024-5801 0024-5801-15 6 BOTTLE, GLASS in 1 CARTON (0024-5801-15) > 15 mL in 1 BOTTLE, GLASS

Summary for product number 001

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

Expired Orange Book Patents for NDA: 022157

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi-aventis UsXYZALlevocetirizine dihydrochlorideSOLUTION;ORAL022157-001Jan 28, 2008► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
US Army
Harvard Business School

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