Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin
other · Food and Drug Administration · Rule · Published 2006-09-29 · Effective 2006-09-29 · 71 FR 57416
Document
Document number
E6-15965
Federal Register citation
71 FR 57416
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2006-09-29
Effective date
2006-09-29
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 in cattle, by injection, for the treatment of respiratory disease.