other · Food and Drug Administration · Rule · Published 2008-08-06 · Effective 2008-08-06 · 73 FR 45610
Document
Document number
E8-18093
Federal Register citation
73 FR 45610
CFR reference
21 CFR 520
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2008-08-06
Effective date
2008-08-06
HHS docket
Docket No. FDA-2008-N-0039
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 Phibro Animal Health. The supplemental NADA provides for label revisions associated with a previous change of sponsorship and other minor changes for amprolium concentrate solution to make medicated drinking water for chickens and turkeys for the treatment of coccidiosis. The product approval is being codified for the first time.