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Oral Dosage Form New Animal Drugs; Amprolium

other · Food and Drug Administration · Rule · Published 2009-03-11 · Effective 2009-03-11 · 74 FR 10483

Document

Document number
E9-5131
Federal Register citation
74 FR 10483
CFR reference
21 CFR 520
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-03-11
Effective date
2009-03-11
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 an abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides for the use of generic amprolium concentrate solution to make medicated drinking water for chickens and turkeys for the treatment of coccidiosis.

Source

Authoritative
Federal Register document
Machine
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