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Profile for Tradename: XYZAL

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

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

Summary for Tradename: XYZAL

Suppliers / Packagers: see list12

Pharmacology for Tradename: XYZAL

Clinical Trials for: XYZAL

Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg of Dr. Reddy's Under Fed Conditions
Status: Completed Condition: Healthy

Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema
Status: Completed Condition: Dermatitis; Eczema

Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg of Dr. Reddy's Under Fasting Conditions
Status: Completed Condition: Fasting

Omnaris Versus Levocetirizine Phase 4 Study
Status: Completed Condition: Allergic Rhinitis

Levocetirizine Plus Bed-Time Hydroxyzine in the Management of Corticodependent Chronic Urticaria Versus Levocetirizine Alone in High Doses
Status: Completed Condition: Chronic Urticaria

Study to Evaluate the Pharmacokinetics and Safety of Singulair and Xyzal in Free Combination and Fixed-dose Combination
Status: Completed Condition: Rhinitis

Management of Pruritus With Xyzal in Atopic Dermatitis
Status: Completed Condition: Atopic Dermatitis; Pruritus

The Effect of Levocetirizine on Inflammatory Mediators in Dermatographism
Status: Terminated Condition: Rhinitis; Urticaria

Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months
Status: Completed Condition: Allergic Rhinitis; Chronic Urticaria

Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin
Status: Completed Condition: Allergic Rhinitis; Chronic Urticaria

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

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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