Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Suspension
other · Food and Drug Administration · Rule · Published 1998-08-28 · Effective 1998-08-28 · 63 FR 45944
Document
Document number
98-23107
Federal Register citation
63 FR 45944
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-08-28
Effective date
1998-08-28
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 use of pyrantel pamoate suspension for removal of large roundworms and hookworms and to prevent reinfections of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping.