federal_register: 2016-29674

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2016-29674 Determination That SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (Sodium Chloride), Injectable, 234 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA or Agency) has determined that SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 sodium chloride, injectable, 234 mg/mL, if all other legal and regulatory requirements are met. 2016-12-12 2016 12 https://www.federalregister.gov/documents/2016/12/12/2016-29674/determination-that-sodium-chloride-234-in-plastic-container-sodium-chloride-injectable-234 https://www.govinfo.gov/content/pkg/FR-2016-12-12/pdf/2016-29674.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) has determined that SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This...

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