Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
-
-