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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:  12/14/2009
 
Trade Name:  Daytrana
 
Generic Name or Proper Name (*):  methylphenidate
 
Indications Studied:  Postmarketing safety study
 
Label Changes Summary:  * Information added to Warnings and Adverse Reactions on skin reactions observed in a postmarketing dermal study in pediatric patients
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Shire
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulant
 
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