New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N-Butyl Chloride; Competitive Exclusion Culture; Dichlorophene and Toluene; Flurogestone Acetate; Isoflurane; Pyrantel; Tylosin; Tylosin and Sulfamethazine
other · Food and Drug Administration · Rule · Published 2013-03-07 · Effective 2013-03-18 · 78 FR 14667
Document
Document number
2013-04999
Federal Register citation
78 FR 14667
CFR reference
21 CFR 510
Type
Rule
Action
Final rule, technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2013-03-07
Effective date
2013-03-18
HHS docket
Docket No. FDA-2012-N-1167
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of 19 new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA). The applications are being withdrawn for lack of compliance with the reporting requirements in an FDA regulation.