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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:  03/26/2015
 
Trade Name:  Oraltag
 
Generic Name or Proper Name (*):  iohexol
 
Indications Studied:  Computed tomography of the abdomen and pelvis
 
Label Changes Summary:  *Safety and effectiveness of oral iohexol have been established in pediatric patients *Information on dosing and preparation and administration instructions *New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Interpharma Praha, a.s.
 
Therapeutic Category:  Medical Imaging
 
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