Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol
other · Food and Drug Administration · Rule · Published 2009-12-16 · Effective 2009-12-16 · 74 FR 66573
Document
Document number
E9-29875
Federal Register citation
74 FR 66573
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-12-16
Effective date
2009-12-16
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 Intervet, Inc. The supplemental NADA adds Mycoplasma bovis to the bovine respiratory disease pathogens for which florfenicol injectable solution is approved as a treatment.