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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Merck
NNPS:
FALSE'
Therapeutic Category:
Antiasthmatic; antiallergy
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