Oral Dosage Form New Animal Drugs; Enrofloxacin Tablets
other · Food and Drug Administration · Rule · Published 1997-07-21 · 62 FR 38906
Document
Document number
97-19125
Federal Register citation
62 FR 38906
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1997-07-21
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 Bayer Corp., Agriculture Division, Animal Health. The supplemental NADA provides for revised conditions for use (dose, indications, and limitations) of enrofloxacin tablets in dogs and cats for the management of diseases associated with bacteria susceptible to enrofloxacin.