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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:  10/22/1999
 
Trade Name:  Zantac
 
Generic Name or Proper Name (*):  ranitidine
 
Indications Studied:  Gastroesophageal Reflux
 
Label Changes Summary:  * Small studies in newborns 0 to 1 month receiving ECMO did not demonstrate efficacy but provided information on dose and PK
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Glaxo
 
Pediatric Exclusivity Granted Date:  01/19/1999
 
NNPS:  FALSE
 
Therapeutic Category:  Antiulcerative
 
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