Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin
other · Food and Drug Administration · Rule · Published 2008-02-01 · Effective 2008-02-01 · 73 FR 6017
Document
Document number
E8-1906
Federal Register citation
73 FR 6017
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2008-02-01
Effective date
2008-02-01
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 veterinarian prescription use of tulathromycin injectable solution for the treatment of infectious bovine keratoconjunctivitis and the addition of a pathogen to the indication for use for treatment of swine respiratory disease.