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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:  05/12/2003
 
Trade Name:  Allegra
 
Generic Name or Proper Name (*):  fexofenadine
 
Indications Studied:  Allergic rhinitis
 
Label Changes Summary:  * Three clinical safety studies in 845 children with allergic rhinitis are described in the label
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Aventis
 
Pediatric Exclusivity Granted Date:  01/27/2003
 
NNPS:  FALSE
 
Therapeutic Category:  Antihistamine
 
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