Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Suspension
other · Food and Drug Administration · Rule · Published 2003-09-23 · Effective 2003-09-23 · 68 FR 55199
Document
Document number
03-24162
Federal Register citation
68 FR 55199
CFR reference
21 CFR 520
Type
Rule
Action
Final rule, technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-09-23
Effective date
2003-09-23
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 over-the-counter marketing status for pyrantel pamoate suspension, when labeled for oral administration to horses and ponies for the removal and control of certain internal parasites.