Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin
other · Food and Drug Administration · Rule · Published 2007-09-26 · Effective 2007-09-26 · 72 FR 54539
Document
Document number
E7-18983
Federal Register citation
72 FR 54539
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2007-09-26
Effective date
2007-09-26
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 the addition of a pathogen to the indication for use of tulathromycin, by injection, for the control of respiratory disease in high-risk cattle.