Application Nr Approved Date Route Status External Links
ANDA078605 2012-08-03 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Montelukast Sodium Is A Leukotriene Receptor Antagonist Indicated For: Prophylaxis And Chronic Treatment Of Asthma In Patients 2 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 2 Years Of Age And Older, And Perennial Allergic Rhinitis (par) In Patients 2 Years Of Age And Older (1.3). 1.1 Asthma Montelukast Sodium Is Indicated For The Prophylaxis And Chronic Treatment Of Asthma In Adults And Pediatric Patients 2 Years Of Age And Older. 1.2 Exercise-Induced Bronchoconstriction Montelukast Sodium Is Indicated For Prevention Of Exercise-Induced Bronchoconstriction (eib) In Patients 15 Years Of Age And Older. Pediatric Use Information For Patients Ages 6 To 14 Years Of Age For Acute Prevention Of Exercise-Induced Bronchoconstriction (eib) Is Approved For Merck Sharp & Dohme Corp’s Montelukast Tablet Products. However, Due To Merck Sharp & Dohme Corp’s Marketing Exclusivity Rights, This Drug Product Is Not Labeled With That Pediatric Information. 1.3 Allergic Rhinitis Montelukast Sodium Is Indicated For The Relief Of Symptoms Of Seasonal Allergic Rhinitis In Patients 2 Years Of Age And Older And Perennial Allergic Rhinitis In Patients 2 Years Of Age And Older.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Ferric Oxide Red FERRIC OXIDE RED Molecular
3. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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