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:
03/28/2013
Trade Name:
Quartette
Generic Name or Proper Name (*):
levonorgestrel/ethinyl estradiol and ethinyl estradiol
Indications Studied:
Prevention of pregnancy
Label Changes Summary:
Safety and efficacy have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents less than 18 years and for users 18 years and older. Use before menarche is not indicated
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Teva
NNPS:
TRUE'
Therapeutic Category:
Contraceptive
-
-