other · Food and Drug Administration · Rule · Published 2009-02-13 · Effective 2009-02-13 · 74 FR 7180
Document
Document number
E9-3131
Federal Register citation
74 FR 7180
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-02-13
Effective date
2009-02-13
HHS docket
Docket No. FDA-2009-N-0665
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for removal of a 250-pound weight restriction and the addition of a reproductive caution statement to labeling of tiamulin concentrate solution used in drinking water for the treatment of certain bacterial respiratory and enteric diseases in swine.