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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
 
PREA(P):  P
 
Sponsor:  Duramed
 
NNPS:  FALSE
 
Therapeutic Category:  Contaceptive
 
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