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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:  04/28/2016
 
Trade Name:  ProAir RespiClick
 
Generic Name or Proper Name (*):  albuterol sulfate
 
Indications Studied:  Asthma in pediatric patients between the ages 4 to 11 years
 
Label Changes Summary:  * Expanded the indication down to pediatric patients 4-11 years; previously approved in 12 years and older. * Safety and effectiveness in pediatric patients below the age of 4 years have not been established. * Information on dosing, adverse reactions, and clinical trials. * Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Teva
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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