New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
fda-drug · Food and Drug Administration · Rule · Published 2015-03-13 · Effective 2015-03-13 · 80 FR 13226
Document
Document number
2015-05644
Federal Register citation
80 FR 13226
CFR reference
21 CFR 510
Type
Rule
Action
Final rule; technical amendments.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2015-03-13
Effective date
2015-03-13
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 November and December 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 eight NADAs and nine ANADAs, and to make correcting amendments for a drug labeler code.