federal_register: 2015-08024

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2015-08024 Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Fomepizole Rule The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) for a fomepizole injectable solution used as an antidote for ethylene glycol poisoning in dogs. This action is being taken at the sponsor's request because this product is no longer manufactured or marketed. 2015-04-08 2015 4 https://www.federalregister.gov/documents/2015/04/08/2015-08024/implantation-or-injectable-dosage-form-new-animal-drugs-withdrawal-of-approval-of-new-animal-drug https://www.govinfo.gov/content/pkg/FR-2015-04-08/pdf/2015-08024.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) for a fomepizole injectable solution used as an antidote for ethylene glycol poisoning in dogs. This action is being taken at the sponsor's request...  

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