Implantation or Injectable Dosage Form New Animal Drugs; Atipamezole
other · Food and Drug Administration · Rule · Published 1996-09-17 · Effective 1996-09-17 · 61 FR 48829
Document
Document number
96-23758
Federal Register citation
61 FR 48829
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1996-09-17
Effective date
1996-09-17
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 Pfizer, Inc. The NADA provides for intramuscular use of atipamezole hydrochloride sterile injectable solution in dogs as a medetomidine reversing agent.