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Last Updated: December 11, 2025

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. 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. Fifty-two 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

Pharmacology for NDA: 022064

Mechanism of Action	Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 022064

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XYZAL	levocetirizine dihydrochloride	TABLET;ORAL	022064	NDA	Chattem, Inc.	41167-5803	41167-5803-9	90 TABLET, FILM COATED in 1 BOTTLE (41167-5803-9)
XYZAL	levocetirizine dihydrochloride	TABLET;ORAL	022064	NDA	Chattem, Inc.	41167-5804	41167-5804-5	1 BOTTLE in 1 CARTON (41167-5804-5) / 148 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 25, 2007	TE:		RLD:	Yes

Expired US Patents for NDA 022064

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	XYZAL	levocetirizine dihydrochloride	TABLET;ORAL	022064-001	May 25, 2007	4,525,358	⤷ Get Started Free
Chattem Sanofi	XYZAL	levocetirizine dihydrochloride	TABLET;ORAL	022064-001	May 25, 2007	5,698,558*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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