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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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