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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:  07/12/2002
 
Trade Name:  Prilosec
 
Generic Name or Proper Name (*):  omeprazole
 
Indications Studied:  Gastroesophageal reflux and erosive esophagitis
 
Label Changes Summary:  * Safety and effectiveness established in pediatric patients 2-16 years of age * Information on dose, PK parameters, exposure/response and AE profile
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  AstraZeneca
 
NNPS:  FALSE
 
Therapeutic Category:  Antiulcerative
 
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