Oral Dosage Form New Animal Drugs; Orbifloxacin Tablets
other · Food and Drug Administration · Rule · Published 1997-11-19 · Effective 1997-11-19 · 62 FR 61626
Document
Document number
97-30411
Federal Register citation
62 FR 61626
CFR reference
21 CFR 510
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1997-11-19
Effective date
1997-11-19
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 Schering-Plough Animal Health. The supplemental NADA provides for veterinary prescription use of orbifloxacin tablets for management of diseases in cats associated with bacteria susceptible to orbifloxacin.