Oral Dosage Form New Animal Drugs; Spinosad and Milbemycin Oxime
other · Food and Drug Administration · Rule · Published 2011-03-08 · Effective 2011-03-08 · 76 FR 12563
Document
Document number
2011-5144
Federal Register citation
76 FR 12563
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2011-03-08
Effective date
2011-03-08
HHS docket
Docket No. FDA-2011-N-0003
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 chewable tablets containing spinosad and milbemycin oxime in dogs for the treatment and prevention of flea infestations and for the prevention and control of various internal parasites.