New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction
other · Food and Drug Administration · Rule · Published 2025-09-19 · Effective 2025-09-19 · 90 FR 45134
Document
Document number
2025-18217
Federal Register citation
90 FR 45134
CFR reference
21 CFR 558
Type
Rule
Action
Final rule; correction.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2025-09-19
Effective date
2025-09-19
HHS docket
Docket No. FDA-2025-N-0002
Abstract
The Food and Drug Administration (FDA or we) is correcting a final rule entitled "New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address" that appeared in the Federal Register of August 22, 2025. That final rule updated regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during April, May, and June of 2025. The final rule published with an inadvertent error. This document corrects that error.