Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Mometasone Furoate, Clotrimazole Otic Suspension
other · Food and Drug Administration · Rule · Published 2003-03-31 · Effective 2003-03-31 · 68 FR 15370
Document
Document number
03-7534
Federal Register citation
68 FR 15370
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-03-31
Effective date
2003-03-31
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 Schering-Plough Animal Health Corp. The supplemental NADA provides for the addition of once-daily administration to the dosage regimens for gentamicin/mometasone/ clotrimazole otic suspension used to treat otitis externa in dogs and for revision of the indications to reflect a current format.