Oral Dosage Form New Animal Drugs; Clindamycin Capsules and Tablets
other · Food and Drug Administration · Rule · Published 2006-07-12 · Effective 2006-07-12 · 71 FR 39203
Document
Document number
E6-10877
Federal Register citation
71 FR 39203
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2006-07-12
Effective date
2006-07-12
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Virbac AH, Inc. The supplemental ANADA provides for an expanded dose range and revised wording of indications for the oral use of clindamycin hydrochloride tablets in dogs for the treatment of certain bacterial diseases.