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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 Ucb Inc and Sanofi-aventis Us and is included in four NDAs. It is available from five suppliers. 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 NDA: 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
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
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)

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
Ucb Inc
levocetirizine dihydrochloride
SOLUTION;ORAL022157-001Jan 28, 20085,698,558*PED► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.