Oral Dosage Form New Animal Drugs; Clindamycin Liquid
other · Food and Drug Administration · Rule · Published 2004-06-07 · Effective 2004-06-07 · 69 FR 31733
Document
Document number
04-12718
Federal Register citation
69 FR 31733
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-06-07
Effective date
2004-06-07
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 Phoenix Scientific, Inc. The supplemental ANADA provides for an expanded dose range and revised indications for the use of clindamycin hydrochloride oral liquid in both dogs and cats for the treatment of certain bacterial diseases.