Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Mometasone Furoate, Clotrimazole Otic Suspension
other · Food and Drug Administration · Rule · Published 2001-01-04 · Effective 2001-01-04 · 66 FR 712
Document
Document number
01-140
Federal Register citation
66 FR 712
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2001-01-04
Effective date
2001-01-04
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 Schering-Plough Animal Health Corp. The NADA provides for veterinary prescription use of gentamicin/mometasone/clotrimazole otic suspension to treat otitis externa in dogs.