Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Suspension
other · Food and Drug Administration · Rule · Published 1997-07-15 · Effective 1997-07-15 · 62 FR 37711
Document
Document number
97-18459
Federal Register citation
62 FR 37711
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1997-07-15
Effective date
1997-07-15
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 Lambert-Kay, Division of Carter-Wallace, Inc. The supplemental ANADA provides for oral use 4.54 milligrams per milliliter (mg/mL) pyrantel pamoate suspension in addition to the 2.27 mg/mL product for removal of large roundworms and hookworms in puppies and dogs and to prevent reinfections of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping.