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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
Therapeutic Category:  Antiasthmatic