Oral Dosage Form New Animal Drugs; Clindamycin Capsules and Tablets
other · Food and Drug Administration · Rule · Published 2004-06-09 · Effective 2004-06-09 · 69 FR 32272
Document
Document number
04-12961
Federal Register citation
69 FR 32272
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-06-09
Effective date
2004-06-09
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental abbreviated new animal drug applications (ANADAs) filed by Phoenix Scientific, Inc. One supplemental ANADA provides for an expanded dose range and revised indications wording for the oral use of clindamycin hydrochloride capsules in dogs for the treatment of certain bacterial diseases. The other supplemental ANADA provides for use of a 300-milligram capsule size.