Oral Dosage Form New Animal Drugs; Praziquantel Tablets
other · Food and Drug Administration · Rule · Published 2003-10-03 · Effective 2003-10-03 · 68 FR 57351
Document
Document number
03-25090
Federal Register citation
68 FR 57351
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-10-03
Effective date
2003-10-03
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The ANADA provides for the oral use of praziquantel tablets for the removal and control of certain cestode parasites in dogs.