New Animal Drug Approvals; Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol; Sevoflurane; Triamcinolone Acetonide
fda-drug · Food and Drug Administration · Rule · Published 2013-03-25 · Effective 2013-03-25 · 78 FR 17866
Document
Document number
2013-06748
Federal Register citation
78 FR 17866
CFR reference
21 CFR 510
Type
Rule
Action
Final rule.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2013-03-25
Effective date
2013-03-25
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 January 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship for an NADA and ANADA, and a change of a sponsor's drug labeler code.