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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  12/31/2002
 
Trade Name:  Singulair Oral Granules, Tablets, and Chewable Tablets
 
Generic Name or Proper Name (*):  montelukast
 
Indications Studied:  Seasonal allergic rhinitis in children 2 years of age and older
 
Label Changes Summary:  *Effectiveness extrapolated from studies in patients 15 years of age and older and supported with one pediatric safety trial in patients 2-14 years of age *New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Merck
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic; antiallergy
 
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