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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:  01/30/2002
 
Trade Name:  Xopenex Inhalation Solution
 
Generic Name or Proper Name (*):  levalbuterol
 
Indications Studied:  Treatment and prevention of bronchspasm
 
Label Changes Summary:  Approved down to 6 years of age; recommended dose is 0.31mg TID for patients 6-11 years of age
 
Product Labeling:  Labeling  Opens a new window
 
Pediatric Rule (R):  R
 
Sponsor:  Sepracor
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiasthmatic
 
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