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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:  01/08/2004
 
Trade Name:  Norvasc
 
Generic Name or Proper Name (*):  amlodipine
 
Indications Studied:  Hypertension
 
Label Changes Summary:  * Information on dose, PK in pediatric patients 6-17 years of age * Adverse event profile in pediatric patients was similar to that seen in adults
 
BPCA(B):  B
 
Sponsor:  Pfizer
 
Pediatric Exclusivity Granted Date:  11/27/2001
 
NNPS:  FALSE
 
Therapeutic Category:  Antihypertensive
 
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