Oral Dosage Form New Animal Drugs; Clindamycin Liquid
other · Food and Drug Administration · Rule · Published 2006-07-13 · Effective 2006-07-13 · 71 FR 39543
Document
Document number
E6-10971
Federal Register citation
71 FR 39543
CFR reference
21 CFR 520
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2006-07-13
Effective date
2006-07-13
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 liquid in dogs and cats for the treatment of certain bacterial diseases.