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XYZAL Drug Profile

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Xyzal is a drug marketed by Ucb Inc and is included in two NDAs. It is available from five suppliers.

The generic ingredient in XYZAL is levocetirizine dihydrochloride. There are twelve drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.

Summary for Tradename: XYZAL

Patents:0
Applicants:1
NDAs:2
Suppliers / Packagers: see list5

Pharmacology for Tradename: XYZAL

Clinical Trials for: XYZAL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ucb Inc
XYZAL
levocetirizine dihydrochloride
SOLUTION;ORAL022157-001Jan 28, 2008RXYes<disabled><disabled>
Ucb Inc
XYZAL
levocetirizine dihydrochloride
TABLET;ORAL022064-001May 25, 2007RXYes<disabled><disabled>
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Expired Patents for Tradename: XYZAL

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc
XYZAL
levocetirizine dihydrochloride
SOLUTION;ORAL022157-001Jan 28, 20085,698,558*PED<disabled>
Ucb Inc
XYZAL
levocetirizine dihydrochloride
TABLET;ORAL022064-001May 25, 20075,698,558*PED<disabled>
Ucb Inc
XYZAL
levocetirizine dihydrochloride
TABLET;ORAL022064-001May 25, 20074,525,358<disabled>
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Paragraph IV activity for: XYZAL

Drugname Dosage Strength RLD Submissiondate
levocetirizine dihydrochlorideOral Solution0.5 mg/mLXyzal1/14/2009
levocetirizine dihydrochlorideTablets5 mgXyzal12/17/2007
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