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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
Sponsor:  Aventis
Pediatric Exclusivity Granted Date:  01/27/2003
Therapeutic Category:  Antihistamine