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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
 
BPCA(B):  B
 
Sponsor:  Bristol-Myers Squibb
 
Pediatric Exclusivity Granted Date:  01/27/2003
 
NNPS:  FALSE
 
Therapeutic Category:  Antihypertensive
 
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