federal_register: 2011-30472

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-30472 Determination That TAXOTERE (Docetaxel) Injection, 40 Milligrams/Milliliter Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA) has determined that TAXOTERE (docetaxel) Injection, 40 milligrams/milliliter (mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for docetaxel injection, 40 mg/mL, if all other legal and regulatory requirements are met. 2011-11-28 2011 11 https://www.federalregister.gov/documents/2011/11/28/2011-30472/determination-that-taxotere-docetaxel-injection-40-milligramsmilliliter-was-not-withdrawn-from-sale https://www.govinfo.gov/content/pkg/FR-2011-11-28/pdf/2011-30472.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) has determined that TAXOTERE (docetaxel) Injection, 40 milligrams/milliliter (mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated...

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