Oral Dosage Form New Animal Drugs; Nicarbazin; Oclacitinib; Zilpaterol
other · Food and Drug Administration · Rule · Published 2013-07-15 · Effective 2013-07-15 · 78 FR 42006
Document
Document number
2013-16258
Federal Register citation
78 FR 42006
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2013-07-15
Effective date
2013-07-15
HHS docket
Docket No. FDA-2013-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 May 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.