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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:
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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