2026-03495: Determination That Klonopin (Clonazepam) Tablets, 0.125 Milligrams and 0.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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The Food and Drug Administration (FDA or Agency) has determined that KLONOPIN (clonazepam) tablets, 0.125 milligrams (mg) and 0.25 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for clonazepam tablets, 0.125 mg and 0.25 mg, if all other legal and regulatory requirements are met.
The agency’s own summary, as published.
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