← HHS Federal Register rules

Oral Dosage Form New Animal Drugs; Fluoxetine

other · Food and Drug Administration · Rule · Published 2007-02-12 · Effective 2007-02-12 · 72 FR 6463

Document

Document number
E7-2172
Federal Register citation
72 FR 6463
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2007-02-12
Effective date
2007-02-12

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 Elanco Animal Health. The NADA provides for veterinary prescription use of fluoxetine hydrochloride chewable tablets for the treatment of canine separation anxiety.

Source

Authoritative
Federal Register document
Machine
JSON-LD · Markdown