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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:  07/08/2019
 
Trade Name:  Katerzia oral suspension
 
Generic Name or Proper Name (*):  amlodipine benzoate
 
Indications Studied:  Hypertension in children 6 years and older
 
Label Changes Summary:  *New oral suspension 1 mg/mL approved in pediatric patients 6 years and older. *New dosage form.
 
PREA(P):  P
 
Sponsor:  Silvergate Pharmaceuticals, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antihypertensive
 
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