federal_register: 2026-03495

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2026-03495 Determination That Klonopin (Clonazepam) Tablets, 0.125 Milligrams and 0.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA or Agency) has determined that KLONOPIN (clonazepam) tablets, 0.125 milligrams (mg) and 0.25 mg, were not withdrawn from sale for reasons of safety or effectiveness.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. 2026-02-23 2026 2 https://www.federalregister.gov/documents/2026/02/23/2026-03495/determination-that-klonopin-clonazepam-tablets-0125-milligrams-and-025-milligrams-were-not-withdrawn https://www.govinfo.gov/content/pkg/FR-2026-02-23/pdf/2026-03495.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and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(FDA or Agency) has determined that KLONOPIN (clonazepam) tablets, 0.125 milligrams (mg) and 0.25 mg, were not withdrawn from sale for reasons of safety or effectiveness.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...

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