Oral Dosage Form New Animal Drugs; Milbemycin Oxime Tablet
other · Food and Drug Administration · Rule · Published 1998-05-29 · 63 FR 29351
Document
Document number
98-14182
Federal Register citation
63 FR 29351
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-05-29
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 Novartis Animal Health US, Inc. The supplemental NADA provides for expanding the indications to include separate dosage and labeling for use of milbemycin oxime in cats.