Oral Dosage Form New Animal Drugs; Selegiline Hydrochloride Tablets
other · Food and Drug Administration · Rule · Published 1999-01-13 · Effective 1999-01-13 · 64 FR 2121
Document
Document number
99-739
Federal Register citation
64 FR 2121
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1999-01-13
Effective date
1999-01-13
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 Pfizer, Inc. The supplemental NADA provides for oral veterinary prescription use of selegiline hydrochloride tablets for dogs for the control of clinical signs associated with cognitive dysfunction syndrome.