federal_register: 2024-27090
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024-27090 | Determination That IC-GREEN (Indocyanine Green), 25 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | The Food and Drug Administration (FDA or Agency) has determined that IC-GREEN (indocyanine green), 25 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness.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 IC-GREEN (indocyanine green), 25 mg/vial, if all other legal and regulatory requirements are met. | 2024-11-20 | 2024 | 11 | https://www.federalregister.gov/documents/2024/11/20/2024-27090/determination-that-ic-green-indocyanine-green-25-milligramsvial-was-not-withdrawn-from-sale-for | https://www.govinfo.gov/content/pkg/FR-2024-11-20/pdf/2024-27090.pdf | Health and Human Services Department; Food and Drug Administration |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Drug Administration (FDA or Agency) has determined that IC-GREEN (indocyanine green), 25 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new... |