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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:  08/01/2000
 
Trade Name:  Concerta Extended Release Tablets
 
Generic Name or Proper Name (*):  methylphenidate
 
Indications Studied:  ADHD
 
Label Changes Summary:  Efficacy established down to 6 years of age
 
Product Labeling:  Labeling  Opens a new window
 
Pediatric Rule (R):  R
 
Sponsor:  Alza
 
NNPS:  FALSE'
 
Therapeutic Category:  CNS Stimulant
 
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