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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Teva
 
NNPS:  TRUE
 
Therapeutic Category:  Contraceptive
 
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