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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:  09/17/1999
 
Trade Name:  Accolate Tablets
 
Generic Name or Proper Name (*):  zafirlukast
 
Indications Studied:  Prophylaxis and chronic treatment of asthma
 
Label Changes Summary:  * Approved down to 7 years of age; efficacy extrapolated from demonstrated efficacy in patients 15 years and older
 
Product Labeling:  Labeling  Opens a new window
 
Pediatric Rule (R):  R
 
Sponsor:  AstraZeneca
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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