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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:  07/23/1999
Trade Name:  Topamax Tablets
Generic Name or Proper Name (*):  topiramate
Indications Studied:  Adjunctive treatment of partial onset seizures and generalized tonic clonic seizures
Label Changes Summary:  * Approved down to 2 years of age
Product Labeling:  Labeling  Opens a new window
Pediatric Rule (R):  R
Sponsor:  Ortho-McNeil
Therapeutic Category:  Anticonvulsant