Oral Dosage Form New Animal Drugs; Enrofloxacin Tablets
other · Food and Drug Administration · Rule · Published 1999-09-03 · Effective 1999-09-03 · 64 FR 48295
Document
Document number
99-22998
Federal Register citation
64 FR 48295
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1999-09-03
Effective date
1999-09-03
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 an additional tablet size for enrofloxacin tablets used in dogs and cats for the management of diseases associated with bacteria susceptible to enrofloxacin and for the removal of a tablet size no longer marketed.