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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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