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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
Sponsor:  AstraZeneca
Therapeutic Category:  Antiulcerative