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 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:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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	⤷ Sign Up	⤷ Sign Up
Chattem Sanofi	XYZAL	levocetirizine dihydrochloride	TABLET;ORAL	022064-001	May 25, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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