Implantation or Injectable Dosage Form New Animal Drugs; Tylosin
other · Food and Drug Administration · Rule · Published 2009-03-19 · Effective 2009-03-19 · 74 FR 11643
Document
Document number
E9-6009
Federal Register citation
74 FR 11643
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-03-19
Effective date
2009-03-19
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 Elanco Animal Health. The supplemental NADA provides for changing scientific nomenclature for a bovine pathogen on labeling for tylosin injectable solution.