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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:  07/26/2002
 
Trade Name:  Singulair
 
Generic Name or Proper Name (*):  montelukast
 
Indications Studied:  Prophylaxis and chronic treatment of asthma
 
Label Changes Summary:  Safety and effectiveness established in patients 12 months to 5 years of age Information on dose, PK parameters and AE profile in patients 12-23 months and 2-5 years New 4mg chewable tablet and 4mg oral granule formulations developed. The chewable tablets contain aspartame whereas the oral granule formulation does not
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Merck
 
Pediatric Exclusivity Granted Date:  12/10/2001
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiasthmatic
 
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