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.
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Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Fomepizole
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 glyc...
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80 FR 18777
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“Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Fomepizole,” thefederalregister.org (April 8, 2015), https://thefederalregister.org/documents/2015-08024/implantation-or-injectable-dosage-form-new-animal-drugs-withdrawal-of-approval-of-new-animal-drug-application-fomepizole.