New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
other · Food and Drug Administration · Rule · Published 2014-04-15 · Effective 2014-04-15 · 79 FR 21126
Document
Document number
2014-08445
Federal Register citation
79 FR 21126
CFR reference
21 CFR 522
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2014-04-15
Effective date
2014-04-15
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 March 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 for an ANADA.