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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:  08/28/2001
 
Trade Name:  Topamax Tablets and Sprinkle Capsules
 
Generic Name or Proper Name (*):  topiramate
 
Indications Studied:  Seizures associated with Lennox-Gastaut syndrome
 
Label Changes Summary:  * Approved for treatment down to 2 years of age
 
Product Labeling:  Labeling  Opens a new window
 
Pediatric Rule (R):  R
 
Sponsor:  R.W. Johnson
 
NNPS:  FALSE
 
Therapeutic Category:  Anticonvulsant
 
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