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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
Sponsor:  Merck
Pediatric Exclusivity Granted Date:  12/10/2001
Therapeutic Category:  Antiasthmatic