federal_register: 2010-30570

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2010-30570 Determination That GLEEVEC (Imatinib Mesylate) Capsules, 50 Milligrams and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA) has determined that GLEEVEC (imatinib mesylate) Capsules, 50 milligrams (mg) and 100 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 imatinib mesylate capsules, 50 mg and 100 mg, if all other legal and regulatory requirements are met. 2010-12-07 2010 12 https://www.federalregister.gov/documents/2010/12/07/2010-30570/determination-that-gleevec-imatinib-mesylate-capsules-50-milligrams-and-100-milligrams-were-not https://www.govinfo.gov/content/pkg/FR-2010-12-07/pdf/2010-30570.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) has determined that GLEEVEC (imatinib mesylate) Capsules, 50 milligrams (mg) and 100 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve...

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