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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
Sponsor:  Teva
Therapeutic Category:  Contraceptive