Oral Dosage Form New Animal Drugs; Marbofloxacin Tablets
other · Food and Drug Administration · Rule · Published 2001-09-05 · Effective 2001-09-05 · 66 FR 46369
Document
Document number
01-22165
Federal Register citation
66 FR 46369
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2001-09-05
Effective date
2001-09-05
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 the use of marbofloxacin tablets in cats for the treatment of infections associated with bacteria susceptible to marbofloxacin.