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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:  12/17/2008
 
Trade Name:  Epiduo
 
Generic Name or Proper Name (*):  adapalene and benzoyl peroxide
 
Indications Studied:  Topical treatment of acne vulgaris in patients 12 years of age and older
 
Label Changes Summary:  Safety and effectiveness established in patients 12 years of age and older Safety and effectiveness in pediatric patients under the age of 12 have not been established New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Galderma
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiacne, topical
 
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