Oral Dosage Form New Animal Drugs; Difloxacin Tablets
other · Food and Drug Administration · Rule · Published 1998-02-18 · Effective 1998-02-18 · 63 FR 8122
Document
Document number
98-3984
Federal Register citation
63 FR 8122
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-02-18
Effective date
1998-02-18
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 Fort Dodge Animal Health. The NADA provides for oral use of difloxacin tablets for management of diseases in dogs associated with bacteria susceptible to difloxacin.