other · Food and Drug Administration · Rule · Published 2006-05-16 · Effective 2006-05-16 · 71 FR 28265
Document
Document number
06-4534
Federal Register citation
71 FR 28265
CFR reference
21 CFR 510
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2006-05-16
Effective date
2006-05-16
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for fomepizole solution for injection from Orphan Medical, Inc., to Jazz Pharmaceuticals, Inc. The regulations are also being amended to reflect approval of a supplemental NADA to remove a vial of saline diluent from this product.