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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
Therapeutic Category:  CNS Stimulant