other · Food and Drug Administration · Rule · Published 2009-06-26 · Effective 2009-06-26 · 74 FR 30463
Document
Document number
E9-15152
Federal Register citation
74 FR 30463
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-06-26
Effective date
2009-06-26
HHS docket
Docket No. FDA-2009-N-0665
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the supplemental approval of a new animal drug application (NADA) filed by Dechra, Ltd. The supplemental NADA provides for the addition of a 10-milligram capsule size of trilostane, used in dogs for treatment of hyperadrenocorticism.