federal_register: E7-22973

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E7-22973 Determination That ELOXATIN (Oxaliplatin for Injection), 50 and 100 Milligrams Per Vial, Sterile Lyophilized Powder for Injection, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA) has determined that ELOXATIN (oxaliplatin for injection), 50 and 100 milligrams (mg) per vial, sterile lyophilized powder for injection, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for oxaliplatin sterile lyophilized powder for injection, 50 and 100 mg/ vial. 2007-11-26 2007 11 https://www.federalregister.gov/documents/2007/11/26/E7-22973/determination-that-eloxatin-oxaliplatin-for-injection-50-and-100-milligrams-per-vial-sterile https://www.govinfo.gov/content/pkg/FR-2007-11-26/pdf/E7-22973.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) has determined that ELOXATIN (oxaliplatin for injection), 50 and 100 milligrams (mg) per vial, sterile lyophilized powder for injection, was not withdrawn from sale for reasons of safety or effectiveness. This...

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