Oral Dosage Form New Animal Drugs; Clomipramine Hydrochloride Tablets
other · Food and Drug Administration · Rule · Published 1999-01-12 · Effective 1999-01-12 · 64 FR 1761
Document
Document number
99-639
Federal Register citation
64 FR 1761
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1999-01-12
Effective date
1999-01-12
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The NADA provides for oral veterinary prescription use of clomipramine hydrochloride tablets to be used as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.