| Document Date: 2009-03-31 17:02:42
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Company Lennox / Ames / / Event FDA Phase / Product Issues / Product Recall / / Facility Laboratory Tests / / IndustryTerm machinery / alkaline solutions / black pharmaceutical ink / food / soft food / / MedicalCondition glaucoma / myopia / kidney stone / least six partial onset seizures / hypospadias / bladder tumor / lymphoma / seizures / Kidney Stones / tonic and absence-like seizures / clonic seizures / primary generalized tonic-clonic seizures / tonic and clonic seizures / drop attacks / pediatric partial onset seizures / smooth muscle tumor / fatigue / renal disease / hypersensitivity / tonic-clonic seizures / partial onset seizures / ataxia / secondarily generalized seizures / convulsions / personality disorder / Carcinogenesis / hyperemia / Mydriasis / seizure / angle closure glaucoma / speech disorders / epilepsy / bladder tumors / amelia / dizziness / maximal electroshock seizure / depression / diplopia / paresthesia / disorders / least three primary generalized tonic-clonic seizures / / MedicalTreatment Oral Contraceptives / adjunctive therapy / Hemodialysis / drug therapy / dialysis / / Organization NC NC / DOSAGE AND ADMINISTRATION / / Position physician / General / Major / / Product probenecid / Topiramate / Primidone / Carbamazepine / polyethylene glycol / TOPAMAX / acetazolamide / Sprinkle Capsules / Phenytoin / estradiol / Digoxin / Valproic acid / norethindrone and ethinyl estradiol / flumazenil / AEDs Antiepileptic / Y1 / S-002 / the clearance / Y2 / Y3 / subjects / S-010 / / ProvinceOrState North Carolina / / Technology Pharmacokinetics / DNA synthesis / Pharmacodynamics / dialysis / /
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NDA[removed]S-002 NDA[removed]S-010 Approved Labeling Text dated[removed]Page 1 DESCRIPTION Topiramate is a sulfamate-substituted monosaccharide that is intended for use as an antiepileptic drug. TOPAMAX (topiramate)