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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:  04/15/2003
 
Trade Name:  Methylin Chewable Tablets
 
Generic Name or Proper Name (*):  methylphenidate
 
Indications Studied:  Treatment of Attention-Deficit Hyperactivity Disorder in children 6 years of age and older treatment of narcolepsy in children 6 years of age and older
 
Label Changes Summary:  * Bioequivalence studies in adults * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Mallinckrodt
 
NNPS:  FALSE
 
Therapeutic Category:  CNS Stimulant
 
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