← REGULATORY CHANGES
FEDERAL REGISTER · RULEMay 9, 2025IN FORCE

New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSIN FORCE
EFFECTIVEMay 9, 2025
COMMENTS CLOSE—
APPLIES TO · SPEQ TAGDrugVeterinary
Document type
Rule
Agency
Health and Human Services Department
Published
May 9, 2025
Effective
May 9, 2025
Document number
2025-08137
CFR references
21 CFR 510, 21 CFR 516, 21 CFR 520, 21 CFR 522, 21 CFR 524
Docket
FDA-2025-N-0002
ABSTRACT

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during January, February, and March 2025. The animal drug regulations are also being amended to improve their accuracy and readability.

Abstract as published in the Federal Register.

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