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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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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 indicatedNew dose and dosing regimen
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Warner Chilcott
 
NNPS:  TRUE'
 
Therapeutic Category:  Contraceptive
 
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