Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin
other · Food and Drug Administration · Rule · Published 2009-10-16 · Effective 2009-10-16 · 74 FR 53164
Document
Document number
E9-24882
Federal Register citation
74 FR 53164
CFR reference
21 CFR 522
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-10-16
Effective date
2009-10-16
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 Pfizer, Inc. The supplemental NADA provides for veterinary prescription use of tulathromycin injectable solution for the control of swine respiratory disease (SRD) in groups of pigs where SRD has been diagnosed.