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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:  05/25/2004
 
Trade Name:  Axid
 
Generic Name or Proper Name (*):  nizatidine
 
Indications Studied:  Esophagitis, and heartburn due to GERD
 
Label Changes Summary:  * Indicated in pediatric patients 12 years and older * Information on dose, PK parameters, and AE profile
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Reliant Pharms
 
NNPS:  FALSE
 
Therapeutic Category:  Antiulcerative
 
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