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Details for Generic Name: levocetirizine dihydrochloride

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Summary for Generic Name: levocetirizine dihydrochloride

Drug Master File Entries: see list12
Suppliers: see list6
Therapeutic Class:Respiratory Tract Agents

Pharmacology for Ingredient: levocetirizine dihydrochloride

Clinical Trials for: levocetirizine dihydrochloride

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

Safety Study of Levocetirizine Oral Solution for Japanese Pediatrics
Status: Completed Condition: Rhinitis

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

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

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

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

Pharmacokinetic Study of Levocetirizine Oral Solution
Status: Completed Condition: Rhinitis, Allergic, Perennial and Seasonal

Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients
Status: Completed Condition: Perennial 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

A Drug Interaction Study of Montelukast and Levocetirizine
Status: Completed Condition: Healthy

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Micro Labs Ltd India
levocetirizine dihydrochloride
TABLET;ORAL202046Sep 17, 2013RXNo<disabled><disabled>
Taro Pharm Inds
levocetirizine dihydrochloride
SOLUTION;ORAL202673Jul 26, 2013RXNo<disabled><disabled>
Teva Pharms
levocetirizine dihydrochloride
TABLET;ORAL090199Aug 22, 2011RXNo<disabled><disabled>
Apotex Inc
levocetirizine dihydrochloride
SOLUTION;ORAL202915Aug 21, 2014RXNo<disabled><disabled>
Synthon Pharms
levocetirizine dihydrochloride
TABLET;ORAL090229Nov 26, 2010RXNo<disabled><disabled>
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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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