• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
-
 
Pediatric Labeling Date:  10/21/2010
 
Trade Name:  Lo Loestrin Fe
 
Generic Name or Proper Name (*):  norethindrone acetate/ ethinyl estradiol
 
Indications Studied:  Prevention of pregnancy
 
Label Changes Summary:  * Safety and efficacy have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents <18 years and for users e18 years * Use before menarche is not indicated* New dose and dosing regimen
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Warner Chilcott
 
NNPS:  TRUE
 
Therapeutic Category:  Contraceptive
 
-
-