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Details for Generic Name: levocetirizine dihydrochloride

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Levocetirizine dihydrochloride is the generic ingredient in two branded drugs marketed by Apotex Inc, L Perrigo Co, Taro Pharm Inds, Ucb Inc, Dr Reddys Labs Ltd, Glenmark Generics, Hetero Labs Ltd Iii, Micro Labs Ltd India, Sandoz, Sciegen Pharms Inc, Sun Pharma Global, Synthon Pharms, and Teva Pharms, and is included in fourteen NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for levocetirizine dihydrochloride. Six suppliers are listed for this compound.

Summary for Generic Name: levocetirizine dihydrochloride

Tradenames:2
Patents:1
Applicants:13
NDAs:14
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

The Effect of Desloratadine and Levocetirizine on Nasal Obstruction (Study P03609)
Status: Completed Condition: Allergic Rhinitis

A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
Status: Completed Condition: Seasonal Allergic Rhinitis

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

Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fed Condition
Status: Completed Condition: Fed

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

Levocetirizine + Capecitabine + Bevacizumab for Patients With Refractory Colorectal Cancer
Status: Recruiting Condition: Colorectal Neoplasms

Open Study to Evaluate the Safety of Levocetirizine in Young Children (2 - 6 Years) Suffering From Allergic Rhinitis
Status: Completed Condition: Allergic Rhinitis

Prevention of Asthma With Levocetirizine (36 Month Treatment) in Young Children Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and House Dust Mite and Having Completed the Previous EPAAC Trial (NCT00152464)
Status: Terminated Condition: Asthma

Facial Thermography Study of Levocetirizine Versus Cetirizine
Status: Completed Condition: Anti-allergic Agents

A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
Status: Completed Condition: Seasonal Allergic Rhinitis

Safety Study of Levocetirizine and Fexofenadine
Status: Completed Condition: Allergic Rhinitis

Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fasting Condition
Status: Completed Condition: Fasting State

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

Drug Use Investigation for XYZAL (Levocetirizine)
Status: Completed Condition: Rhinitis, Allergic, Perennial and Seasonal

3-D Visualization of the Anti-Obstructive Effect of Levocetirizine
Status: Completed Condition: Allergic Rhinitis

Levocetirizine Effect on Nasal Nitric Oxide and Nasal Eosinophils in Subjects With Perennial Allergic Rhinitis
Status: Completed Condition: Perennial Allergic Rhinitis

Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing SAR Symptoms in Ragweed Sensitive Subjects
Status: Completed Condition: Rhinitis, Allergic, Seasonal

Compare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen
Status: Completed Condition: Rhinitis, Allergic, Seasonal

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

Evaluation of Safety of Levocetirizine in Routine Clinical Practice-non- Interventional Study
Status: Completed Condition: Rhinitis Allergic, Persistent

Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites
Status: Completed Condition: Rhinitis; Allergic; Perennial

Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis
Status: Completed Condition: Rhinitis, Allergic, Seasonal

Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen
Status: Completed Condition: Rhinitis, Allergic, Seasonal

Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis
Status: Completed Condition: Rhinitis; Allergic; Perennial

Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR
Status: Completed Condition: Rhinitis, Allergic, Seasonal

Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria
Status: Completed Condition: Urticaria

To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis
Status: Completed Condition: Rhinitis; Allergic; Seasonal

Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects
Status: Completed Condition: Rhinitis, Allergic, Seasonal

Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children
Status: Completed Condition: Cough

Wheal and Flare Reaction During 24 Hours in Allergic Volunteers.
Status: Completed Condition: Allergy

To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis
Status: Completed Condition: Allergic Rhinitis

The Efficacy and Safety of Desloratadine With Levocetirizine in Treatment of Chronic Idiopathic Urticaria
Status: Recruiting Condition: Chronic Idiopathic Urticaria; Urticaria

Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Allergic Rhinitis
Status: Completed Condition: Perennial Allergic Rhinitis

CUTE (Chronic Urticaria Treatment Evaluation)
Status: Completed Condition: Chronic Idiopathic Urticaria

POPULAR (Preference Of Patient Using Levocetirizine in Allergic Rhinitis)
Status: Completed Condition: Seasonal Allergic Rhinitis

LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis)
Status: Completed Condition: Rhinitis, Allergic, Perennial

Effects of Levocetirizine and Hydroxyzine on Cognitive and Psychomotor Functioning During Simulated Diving
Status: Completed Condition: Healthy Volunteers

Prevention of Asthma With Levocetirizine 18 Month Treatment in Infants (12 - 24 Months) Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and/or House Dust Mite (HDM)
Status: Completed Condition: Dermatitis, Atopic

Levocetirizine 5 mg: Reduction of Symptoms, Airway Resistance and Sleep Impairment in Persistent Allergic Rhinitis
Status: Completed Condition: Allergic Rhinitis

Is Levocetirizine Less Sedating Than Cetirizine?
Status: Completed Condition: Allergic Rhinitis

Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination Therapy
Status: Enrolling by invitation Condition: Perennial Allergic Rhinitis

ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)
Status: Completed Condition: Rhinitis, Allergic, Perennial

Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis
Status: Completed Condition: Vasomotor Rhinitis

Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria
Status: Completed Condition: Urticaria

Characterization of the Role of Histamine in Children With Asthma
Status: Recruiting Condition: Asthma; Allergic Asthma; Non-allergic Asthma

The Duration of the Suppressive Effects of Desloratadine on Allergen Prick Tests After Discontinuation (P04441)
Status: Completed Condition: Hypersensitivity

A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
Status: Completed Condition: Chronic Idiopathic Urticaria

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd Iii
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL091264Jun 29, 2012RXNo<disabled><disabled>
Dr Reddys Labs Ltd
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL090392Feb 24, 2011RXNo<disabled><disabled>
Sun Pharma Global
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL090362Jan 31, 2013RXNo<disabled><disabled>
Synthon Pharms
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL090229Nov 26, 2010RXNo<disabled><disabled>
Glenmark Generics
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride
TABLET;ORAL090385Feb 24, 2011RXNo<disabled><disabled>
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