federal_register: 2013-26856

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2013-26856 Determination That Adderall (Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate) Tablet and 13 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. 2013-11-12 2013 11 https://www.federalregister.gov/documents/2013/11/12/2013-26856/determination-that-adderall-amphetamine-aspartate-amphetamine-sulfate-dextroamphetamine-saccharate https://www.govinfo.gov/content/pkg/FR-2013-11-12/pdf/2013-26856.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval...

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