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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
Bristol-Myers Squibb
Pediatric Exclusivity Granted Date:
01/27/2003
NNPS:
FALSE'
Therapeutic Category:
Antihypertensive
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