Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Mometasone Furoate, Clotrimazole Otic Suspension; Technical Amendment
other · Food and Drug Administration · Rule · Published 2005-06-23 · Effective 2005-06-23 · 70 FR 36338
Document
Document number
05-12402
Federal Register citation
70 FR 36338
CFR reference
21 CFR 524
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2005-06-23
Effective date
2005-06-23
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 a new container size, a 7.5-gram dropper bottle, from which gentamicin sulfate, mometasone furoate, clotrimazole otic suspension may be administered for the treatment of otitis externa in dogs. The regulations are also being amended to correct the description of a previously approved container size. This action is being taken to improve the accuracy of the regulations.