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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:  05/27/2003
Trade Name:  Monopril
Generic Name or Proper Name (*):  fosinopril
Indications Studied:  Hypertension
Label Changes Summary:  * New data from a double-blind study in 252 patients 6-16 years of age * New recommended dose in children weighing more than 50kg * New Information on PK parameters * An appropriate dosage strength is not available for children weighing less than 50kg
Product Labeling:  Labeling  Opens a new window
Sponsor:  Bristol-Myers Squibb
Pediatric Exclusivity Granted Date:  01/27/2003
Therapeutic Category:  Antihypertensive