federal_register: 2018-26975

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2018-26975 Determination That IC-GREEN (Indocyanine Green for Injection), 10 Milligrams/Vial, 40 Milligrams/Vial, and 50 Milligrams/Vial Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA or Agency) has determined that IC-GREEN (indocyanine green for injection), 10 milligrams (mg)/vial, 40 mg/vial, and 50 mg/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for indocyanine green for injection, 10 mg/vial, 40 mg/vial, and 50 mg/vial if all other legal and regulatory requirements are met. 2018-12-13 2018 12 https://www.federalregister.gov/documents/2018/12/13/2018-26975/determination-that-ic-green-indocyanine-green-for-injection-10-milligramsvial-40-milligramsvial-and https://www.govinfo.gov/content/pkg/FR-2018-12-13/pdf/2018-26975.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) has determined that IC-GREEN (indocyanine green for injection), 10 milligrams (mg)/vial, 40 mg/vial, and 50 mg/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination...

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