Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin
other · Food and Drug Administration · Rule · Published 2007-03-09 · Effective 2007-03-09 · 72 FR 10596
Document
Document number
E7-4206
Federal Register citation
72 FR 10596
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2007-03-09
Effective date
2007-03-09
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 Bayer HealthCare LLC. The supplemental NADA provides for changing scientific nomenclature for a bovine respiratory pathogen on labeling for enrofloxacin injectable solution.