other · Food and Drug Administration · Rule · Published 2002-08-27 · Effective 2002-08-27 · 67 FR 54954
Document
Document number
02-21733
Federal Register citation
67 FR 54954
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2002-08-27
Effective date
2002-08-27
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Pharmacia and Upjohn Co. for clindamycin hydrochloride oral dosage forms. The supplement to the NADA for an oral liquid provides for an expanded dose range for the use of clindamycin hydrochloride in both dogs and cats for the treatment of certain bacterial infections. The supplement to the NADA for oral capsules provides for an expanded dose range in dogs and for use of a 300-milligram (mg) strength capsule.