Oral Dosage Form New Animal Drugs; Amoxicillin Trihydrate and Clavulanate Potassium
other · Food and Drug Administration · Rule · Published 1998-03-18 · 63 FR 13121
Document
Document number
98-6907
Federal Register citation
63 FR 13121
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-03-18
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADA's) filed by Pfizer, Inc. The supplemental NADA's provide for oral use amoxicillin trihydrate and clavulanate potassium tablets and suspension for treatment of dogs for periodontal infections due to susceptible strains of aerobic and anaerobic bacteria.