Oral Dosage Form New Animal Drugs; Levamisole Powder for Oral Solution
other · Food and Drug Administration · Rule · Published 2004-03-02 · Effective 2004-03-02 · 69 FR 9753
Document
Document number
04-4518
Federal Register citation
69 FR 9753
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-03-02
Effective date
2004-03-02
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The supplemental NADA revises the description of various internal parasites in labeling for levamisole powder, used to make a drench solution for oral administration to cattle and sheep.