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New Animal Drugs; Change of Sponsor; Fomepizole

other · Food and Drug Administration · Rule · Published 2009-06-05 · Effective 2009-06-05 · 74 FR 26951

Document

Document number
E9-13126
Federal Register citation
74 FR 26951
CFR reference
21 CFR 510
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-06-05
Effective date
2009-06-05
HHS docket
Docket No. FDA-2009-N-0665

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 Jazz Pharmaceuticals, Inc., to Paladin Labs (USA), Inc.

Source

Authoritative
Federal Register document
Machine
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