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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:  01/11/2016
 
Trade Name:  E-Z-HD
 
Generic Name or Proper Name (*):  barium sulfate
 
Indications Studied:  For use in double contrast radiographic examinations of the esophagus, stomach and duodenum to visualize the gastrointestinal tract in patients 12 years and older
 
Label Changes Summary:  *Approved for use in adults and pediatric patients 12 years and older *Safety and efficacy have not been approved in pediatric patients less than 12 years of age * Information on dosing, adverse reactions *New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bracco Diagnostics
 
NNPS:  FALSE
 
Therapeutic Category:  Medical imaging
 
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