Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin
other · Food and Drug Administration · Rule · Published 2011-04-22 · Effective 2011-04-22 · 76 FR 22610
Document
Document number
2011-9765
Federal Register citation
76 FR 22610
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2011-04-22
Effective date
2011-04-22
HHS docket
Docket No. FDA-2011-N-0003
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 the addition of a pathogen to the indications for use of enrofloxacin solution in cattle, as a single injection, for the treatment of respiratory disease.