Oral Dosage Form New Animal Drugs; Orbifloxacin Suspension
other · Food and Drug Administration · Rule · Published 2010-05-12 · Effective 2010-05-12 · 75 FR 26646
Document
Document number
2010-11245
Federal Register citation
75 FR 26646
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2010-05-12
Effective date
2010-05-12
HHS docket
Docket No. FDA-2010-N-0002
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of an oral suspension containing orbifloxacin for the treatment of various bacterial infections in dogs and cats.