Oral Dosage Form New Animal Drugs; Clomipramine Tablets
other · Food and Drug Administration · Rule · Published 2007-01-04 · Effective 2007-01-04 · 72 FR 261
Document
Document number
E6-22509
Federal Register citation
72 FR 261
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2007-01-04
Effective date
2007-01-04
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 adds a 5-milligram tablet size of clomipramine hydrochloride, used in dogs for treatment of separation anxiety.