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:
10/22/1999
Trade Name:
Zantac
Generic Name or Proper Name (*):
ranitidine
Indications Studied:
Gastroesophageal Reflux
Label Changes Summary:
Small studies in newborns 0 to 1 month receiving ECMO did not demonstrate efficacy but provided information on dose and PK
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Glaxo
Pediatric Exclusivity Granted Date:
01/19/1999
NNPS:
FALSE'
Therapeutic Category:
Antiulcerative
-
-