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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:  03/17/2010
 
Trade Name:  Differin Lotion
 
Generic Name or Proper Name (*):  adapalene
 
Indications Studied:  Acne
 
Label Changes Summary:  * Safety and effectiveness established in 2 clinical studies in patients 12 years and older * Safety and effectiveness in pediatric patients less than 12 years have not been established * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Galderma
 
NNPS:  FALSE
 
Therapeutic Category:  Antiacne, topical
 
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