Application Nr Approved Date Route Status External Links
ANDA203328 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Montelukast Sodium Tablets, Chewable Tablets, And Oral Granules Are A Leukotriene Receptor Antagonist Indicated For: • Prophylaxis And Chronic Treatment Of Asthma In Patients 12 Months Of Age And Older ( 1.1 ). • Acute Prevention Of Exercise-Induced Bronchoconstriction (eib) In Patients 6 Years Of Age And Older ( 1.2 ). • Relief Of Symptoms Of Allergic Rhinitis (ar): Seasonal Allergic Rhinitis (sar) In Patients 2 Years Of Age And Older, And Perennial Allergic Rhinitis (par) In Patients 6 Months Of Age And Older ( 1.3 ). 1.1 Asthma Montelukast Sodium Tablets, Chewable Tablets And Oral Granules Are Indicated For The Prophylaxis And Chronic Treatment Of Asthma In Adults And Pediatric Patients 12 Months Of Age And Older. 1.2 Exercise-Induced Bronchoconstriction (eib) Montelukast Sodium Tablets And Chewable Tablets Are Indicated For Prevention Of Exercise-Induced Bronchoconstriction (eib) In Patients 6 Years Of Age And Older. 1.3 Allergic Rhinitis Montelukast Sodium Tablets, Chewable Tablets And Oral Granules Are Indicated For The Relief Of Symptoms Of Seasonal Allergic Rhinitis In Patients 2 Years Of Age And Older And Perennial Allergic Rhinitis In Patients 6 Months Of Age And Older.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Montelukast Sodium MONTELUKAST SODIUM ZINC3831151

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