Determination That TOPAMAX (Topiramate) Sprinkle Capsules, 50 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that TOPAMAX (topiramate) sprinkle capsules, 50 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for topiramate, sprinkle capsules, 50 mg, if all other legal and regulatory requirements are met.
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