Implantation or Injectable Dosage Form New Animal Drugs; Danofloxacin
other · Food and Drug Administration · Rule · Published 2012-01-27 · Effective 2012-01-27 · 77 FR 4226
Document
Document number
2012-1743
Federal Register citation
77 FR 4226
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2012-01-27
Effective date
2012-01-27
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 Pfizer, Inc. The supplemental NADA provides for an additional dosage regimen for use of danofloxacin mesylate injectable solution for the treatment of bovine respiratory disease in beef cattle.