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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Teva
NNPS:
FALSE
Therapeutic Category:
Antiasthmatic
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