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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 022064


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NDA 022064 describes XYZAL, which is a drug marketed by Chattem Sanofi and is included in four NDAs. 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. Fifty-one suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 022064
Tradename:XYZAL
Applicant:Chattem Sanofi
Ingredient:levocetirizine dihydrochloride
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 25, 2007TE:RLD:Yes

Expired US Patents for NDA 022064

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chattem Sanofi XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007 ⤷  Subscribe ⤷  Subscribe
Chattem Sanofi XYZAL levocetirizine dihydrochloride TABLET;ORAL 022064-001 May 25, 2007 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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