Application Nr Approved Date Route Status External Links
ANDA202717 2012-09-21 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Montelukast Sodium Tablets Are A Leukotriene Receptor Antagonist Indicated For: Prophylaxis And Chronic Treatment Of Asthma In Patients 15 Years Of Age And Older ( 1.1). Acute Prevention Of Exercise-Induced Bronchoconstriction (eib) In Patients 15 Years Of Age And Older ( 1.2). Relief Of Symptoms Of Allergic Rhinitis (ar): Seasonal Allergic Rhinitis (sar) In Patients 15 Years Of Age And Older, And Perennial Allergic Rhinitis (par) In Patients 15 Years Of Age And Older ( 1.3). 1.1 Asthma Montelukast Sodium Tablet Is Indicated For The Prophylaxis And Chronic Treatment Of Asthma In Adults And Pediatric Patients 15 Years Of Age And Older. 1.2 Exercise-Induced Bronchoconstriction (eib) Montelukast Sodium Tablet Is Indicated For Prevention Of Exercise-Induced Bronchoconstriction (eib) In Patients 15 Years Of Age And Older. 1.3 Allergic Rhinitis Montelukast Sodium Tablet Is Indicated For The Relief Of Symptoms Of Seasonal Allergic Rhinitis In Patients 15 Years Of Age And Older And Perennial Allergic Rhinitis In Patients 15 Years Of Age And Older.

All Formulated Excipients (1 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved

Active Ingredients ( 1 Total)

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

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