New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications
other · Food and Drug Administration · Rule · Published 2014-12-15 · Effective 2014-12-15 · 79 FR 74018
Document
Document number
2014-29249
Federal Register citation
79 FR 74018
CFR reference
21 CFR 510
Type
Rule
Action
Final rule, technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2014-12-15
Effective date
2014-12-15
HHS docket
Docket No. FDA-2014-N-0002
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of six NADAs and four ANADAs, the voluntary withdrawal of approval of an ANADA, and a correcting amendment.