Ophthalmic and Topical Dosage Form New Animal Drugs; Eprinomectin
other · Food and Drug Administration · Rule · Published 1998-11-05 · Effective 1998-11-05 · 63 FR 59715
Document
Document number
98-29614
Federal Register citation
63 FR 59715
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-11-05
Effective date
1998-11-05
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 Merial Ltd. The supplemental NADA provides for topical use of eprinomectin on cattle for treatment and control of two additional gastrointestinal roundworms and to establish of an acceptable daily intake (ADI) and tolerance for eprinomecrin residues in cattle muscle.