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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:  07/10/2009
Trade Name:  Plan B One Step
Generic Name or Proper Name (*):  levonorgestrel
Indications Studied:  Emergency contraception - OTC in women 17 years and older; RX for women younger than age 17 years
Label Changes Summary:  * New single dose 1.5 mg tablet * New dosage regimen
Product Labeling:  Labeling  Opens a new window
Sponsor:  Duramed
Therapeutic Category:  Contaceptive