Oral Dosage Form New Animal Drugs; Orbifloxacin Tablet
other · Food and Drug Administration · Rule · Published 1997-05-29 · Effective 1997-05-29 · 62 FR 29012
Document
Document number
97-14107
Federal Register citation
62 FR 29012
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1997-05-29
Effective date
1997-05-29
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 Schering-Plough Animal Health. The NADA provides for use of orbifloxacin for dogs for management of diseases associated with bacteria susceptible to orbifloxacin.