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Tradename: Singulair

Summary for Tradename: Singulair

Suppliers: see list11
patent expirations by year for

Pharmacology for Tradename: Singulair

Clinical Trials for: Singulair

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)
Status: Completed Condition: Asthma

The Effect of Montelukast in Patients With Chronic Cough and Bronchial Hyperreactivity
Status: Completed Condition: Cough; Bronchial Hyperreactivity

Genotype Stratified Pharmacokinetic Study of Montelukast
Status: Recruiting Condition: Asthma

A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)
Status: Withdrawn Condition: Asthma, Bronchial

Study of the Safety and Pharmacokinetics of MK-0476 in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520)
Status: Completed Condition: Perennial Allergic Rhinitis

The Effect of Montelukast Treatment in Wheezy Infants
Status: Completed Condition: Lung Disease, Obstructive; Signs and Symptoms, Respiratory

Effects of Leukotriene Modulator Montelukast on Cough Variant Asthma
Status: Recruiting Condition: Asthma

Safety and the Pharmacokinetic Study of Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium)to Treat Asthma
Status: Recruiting Condition: Asthma and Allergic Rhinitis

Roflumilast Plus Montelukast in Adults With Severe Asthma
Status: Completed Condition: Asthma

Bioequivalence Study of Montelukast 10 mg Tablets
Status: Completed Condition: Asthma

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
montelukast sodium
GRANULE;ORAL021409Jul 26, 2002RXYes<disabled><disabled>
montelukast sodium
GRANULE;ORAL021409Jul 26, 2002RXYes8,007,830<disabled>Y<disabled>
montelukast sodium
TABLET, CHEWABLE;ORAL020830Feb 20, 1998RXYes<disabled><disabled>
montelukast sodium
TABLET, CHEWABLE;ORAL020830Mar 3, 2000RXNo<disabled><disabled>
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Paragraph IV activity for: SINGULAIR

Drugname Dosage Strength RLD Submissiondate
montelukastTablets10 mgSingulair2/20/2007
montelukast sodiumChewable Tablets4 mg and 5 mgSingulair12/26/2006

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