federal_register: 2010-28358

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2010-28358 Determination That Amphetamine Sulfate, 5 and 10 Milligram Tablets, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA) has determined that Amphetamine sulfate, 5 and 10 milligram (mg) tablets, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Amphetamine sulfate, 5 mg and 10 mg tablets, if all other legal and regulatory requirements are met. 2010-11-10 2010 11 https://www.federalregister.gov/documents/2010/11/10/2010-28358/determination-that-amphetamine-sulfate-5-and-10-milligram-tablets-was-not-withdrawn-from-sale-for https://www.govinfo.gov/content/pkg/FR-2010-11-10/pdf/2010-28358.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) has determined that Amphetamine sulfate, 5 and 10 milligram (mg) tablets, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug...  

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